MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES, INC. VIABAHN GORE CARDIAC STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number VIABAHN 8MM X 100MM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2020

Event Type  Injury  

Event Description

Issue with cardiac stent during (b)(6) 2020 surgery.Due to covid 19, peer review of incident was delayed.It was discussed during peer review that there is a known complication related to the viabahn gore cardiac stents which were used during this patient's procedure.It was discussed that the known complication occurs in 2.1% of cases.Therefore our hospital decided to report to fda, and this is why the reporting is late.From operative report: viabahn 8mm x 100mm stent was selected and advanced over wire.There was stent malfunction while advancing into the left 8 french sheath and the stent self deployed in the left external iliac artery.A balloon was placed and an angioplasty was performed within the stent.The short 8-french sheath was exchanged for a long 8-french sheath.A second viabahn 8mm x 100mm balloon was advanced over wire into the right external iliac artery.It was deployed under fluoroscopy with no difficulty.While pulling the stent deployment device into the sheath, it became dislodged of the device it was attached to.Fda safety report id # (b)(4).

• Brand Name: VIABAHN GORE CARDIAC STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES, INC.
• MDR Report Key: 10307630
• MDR Text Key: 200194105
• Report Number: MW5095653
• 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: 07/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VIABAHN 8MM X 100MM
• Device Catalogue Number: NOT KNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR