MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC 8MM/29MM VIABAHN ENDOVASCULAR STENT; SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVEN DIALYSIS ACCESS CIRCUIT STENOSIS TREATMEN

Catalog Number LOG890255

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/22/2022

Event Type  Injury  

Event Description

Stent broke off of wire before deployment necessitating retrieval by mds.Fda safety report id #(b)(4).

• Brand Name: 8MM/29MM VIABAHN ENDOVASCULAR STENT
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, ARTERIOVEN DIALYSIS ACCESS CIRCUIT STENOSIS TREATMEN
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC
• MDR Report Key: 15674528
• MDR Text Key: 302513372
• Report Number: MW5112874
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: LOG890255
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic