MAUDE Adverse Event Report: VERYAN MEDICAL LTD / VERYAN MEDICAL BIOMIMICS VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY

Lot Number 0000131305

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Part of the stent broke off in the body during attempt at retrieval.Fda safety report id # (b)(4).

• Brand Name: BIOMIMICS VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): VERYAN MEDICAL LTD / VERYAN MEDICAL; parkmore, galway ; EI
• MDR Report Key: 14788655
• MDR Text Key: 294804316
• Report Number: MW5110473
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 0000131305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Male