Study: NCT04626427

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Mid Cubital Post Surgical Vein Stenosis - Day 152, Day 203 and Day 256 - Not Related to Device or Procedure; Definitely Related to AV Access Circuit.
Frequency: 1 affected / 14 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Ulnar Vein Stenosis - Day 245 - Not Related to Device or Procedure; Definitely Related to AV Access Circuit.
Frequency: 1 affected / 14 at risk

Adverse event: Arteriovenous fistula site pseudoaneurysm
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Anastomosis Ulnar Site: Pseudoaneurysm - Day 373 - Possibly Related to Device and Procedure; Definitely Related to AV Access Circuit.
Frequency: 1 affected / 14 at risk

Adverse event: Arteriovenous fistula thrombosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Anastomosis Ulnar Site: Thrombosis - Day 373 - Possibly Related to Device and Procedure; Definitely Related to AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Stenosis Basilic Vein - Day 185 - Not Related to Device or Procedure; Definitely Related to AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Carcinoma - Day 216 - Not Related to Device, Procedure or AV Access Circuit.
Frequency: 1 affected / 14 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Stenosis In Left Radial Vein - Day 218 - Not Related to Device or Procedure; Definitely Related to the AV Access Circuit.
Frequency: 1 affected / 14 at risk

Adverse event: Azotaemia
Serious: yes
Organ System: Renal and urinary disorders
Notes: Worsening Renal Function - Aggravated Pre-Existing Uremia - Day 8 - Not Related to Device; Possibly Related to Procedure; Not Related to AV Access Circuit.
Frequency: 1 affected / 14 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Stenosis Between Vena Perforans and Vena Cephalica, Right Arm - Day 120 - Not Related to Device or Procedure; Definitely Related to AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: Arteriovenous fistula site complication
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Stenosis Left Arm Perforator Vein - Day 136 - Not Related to Device or Procedure; Definitely Related to AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: Staphylococcal sepsis
Serious: yes
Organ System: Infections and infestations
Notes: Infection With Staphylococcus Aureus - Sepsis - Day 145 - Not Related to Device, Procedure, or AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: Brachiocephalic vein stenosis
Serious: yes
Organ System: Vascular disorders
Notes: Stenosis Vena Brachiocephalica Left - Day 163 - Not Related to Device or Procedure; Definitely Related to AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: Puncture site haematoma
Serious: no
Organ System: General disorders
Notes: Mild Hematoma - Day 1 - Not Related to Device; Definitely Related to Procedure and AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Notes: Covid-19 - Day 298 - Not Related to Device, Procedure, or AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: Limb fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Fracture Dig. V, Left Hand - Day 164 - Not Related to Device, Procedure, or AV Access Circuit
Frequency: 1 affected / 14 at risk

Adverse event: Catheter site haemorrhage
Serious: no
Organ System: General disorders
Notes: Seeping Hemorrhage Palindroma Catheter Right - Day 163 - Not Related to Device, Procedure, or AV Access Circuit
Frequency: 1 affected / 14 at risk