MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. 7MM X 5CM COVERED VBX GORE STENT; ILIAC COVERED STENT, ARTERIAL

Patient Problem Foreign Body Embolism (4439)

Event Date 10/13/2022

Event Type  Injury  

Event Description

A stent that was placed in my subclavian artery broke and caused a blood clot, limiting blood flow to my arm.

• Brand Name: 7MM X 5CM COVERED VBX GORE STENT
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.
• MDR Report Key: 17652557
• MDR Text Key: 322507971
• Report Number: MW5145072
• Device Sequence Number: 1
• Product Code: PRL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White