MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS; NIP/STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number VBH091002

Device Problem Occlusion Within Device (1423)

Patient Problems Thrombosis (2100); Vascular System (Circulation), Impaired (2572)

Event Date 01/16/2014

Event Type  Injury  

Event Description

On (b)(6) 2013, two gore viabahn endoprosthesis devices were implanted for the treatment of a popliteal artery aneurysm.On (b)(6) 2018, the pt returned to the hospital with a cold leg.Imaging revealed thrombosis was present in the viabahn devices.The pt was admitted to the hospital and received thrombolytic therapy throughout the night.The next morning, the devices appeared patent and the pt was scheduled for discharge from the hospital.

Manufacturer Narrative

Method: review of the manufacturing paperwork has been conducted.Results: the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Note: this reported event involved two device implants device # 1 lot # 11815010 - mfr report #2017233-2014-00063.Device # 2 lot #11810534 - mfr report #2017233-2014-00064.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS
• Type of Device: NIP/STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer Contact: roger smith ; 1500 north fourth st.; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3650174
• MDR Text Key: 21447217
• Report Number: 2017233-2014-00064
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Catalogue Number: VBH091002
• Device Lot Number: 11810534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2014
• Initial Date FDA Received: 02/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR