MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Catalog Number	VBH090502A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Thromboembolism (2654)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Results: a review of the manufacturing records for the device verified the lot met all pre-release specifications.
Event or Problem Description
The following information was reported to gore: on (b)(6) 2018 a patient was undergoing a trans femoral transcatheter aortic valve replacement.Following placement of the aortic valve device, a perforation of the right common femoral artery was recognized.A gore® viabahn® endoprosthesis was advanced over a wholey wire through a 9fr.Pinnacle sheath.When deployment was attempted, the device only partially expanded.The distal most aspect of the device (3-4mm) did not expand.The deployment line was pulled hard to try to get the device to completely expand.The deployment line eventually broke.It was not possible to remove the catheter and the partially deployed device.The procedure was converted to open repair for stent removal while the catheter was still in place.The stent and catheter were removed surgically and the artery was also repaired surgically.Later in the night the patient had a peripheral embolization requiring thrombectomy of the right popliteal anterior tibial/posterior tibial arteries and a four-compartment fasciotomy of the right calf.The patient was sent to the intensive care unit.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Common Device Name: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8011360
• Report Number: 2017233-2018-00651
• Device Sequence Number: 1262903
• Product Code: PFV
• UDI-Device Identifier: 00733132623174
• UDI-Public: 00733132623174
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2019
• Device Catalogue Number: VBH090502A
• Device Lot Number: 16097154
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention
• Patient Age: 73 YR