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

Catalog Number PAH111002E

Device Problem Separation Failure (2547)

Patient Problem Thrombosis (2100)

Event Date 05/22/2020

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications and no manufacturing anomalies could be identified with the products returned.

Event Description

It was reported to gore that the patient suffered from atrial fibrillation and former cvl which was treated with an endovascular aneurysm repair (evar) in 2018.It was stated that ct has shown graft thrombosis in the right iliac stent graft and emboli in the femoral bifurcation of the right leg.The patient was treated with open thrombectomy in the common femoral artery and afs.It was reported that according to the plan a 11mm x 10cm gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn device) from evar flow split and distally covering the thrombus.When expanding the viabahn device to the full length the thread did not come loose.With a 10mm balloon placed proximal it was managed to bring the thread out with some force.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1500 n. 4th street; 9285263030
• MDR Report Key: 10189218
• MDR Text Key: 196293578
• Report Number: 2017233-2020-00449
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2022
• Device Catalogue Number: PAH111002E
• Device Lot Number: 20225482
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2019
• 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): Other
• Patient Age: 72 YR