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

Catalog Number JHJR050502J

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/13/2019

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2019, the patient underwent treatment for a significantly calcified occlusion lesion in the left superficial femoral artery using two gore® viabahn® endoprosthesis with heparin bioactive surface (viabahn) from the superficial femoral artery (sfa) to below knee (bk) bypass procedure.A 6mm x 5cm viabahn was placed first followed by a 5mm x 5cm viabahn.Upon removal of the 5mm x 5cm viabahn delivery catheter, strong resistance was encountered.However, the delivery catheter was removed from the patient.Then a smart stent was placed within the two viabahns.After the treatment of the occlusion lesion in the left sfa, the sfa-bk bypass procedure was performed.During the bypass procedure, it was observed that a separated tip/portion of the delivery catheter remained in the left sfa.The length of the separated tip was about 5cm.The tip was immediately retracted from the patient.The bypass procedure was completed without further issue.The patient tolerated the procedure.It was reported that pre-ballooning was not performed.Reportedly, the tip of the delivery catheter may have been caught on the sheath tip or caught within the significantly calcified occlusion lesion and may have become separated during removal of the delivery catheter.It was stated that the second device was identified as the device with the delivery catheter tip separation.

Manufacturer Narrative

Results code 1: 213: a review of the manufacturing records for the device verified the lot met pre-release specifications.Results code 2: 213: the engineering evaluation stated the following: the distal shaft, upon which the endoprosthesis was mounted, and the distal tip was returned.Approximately 5 cm of the distal shaft was returned with a kink approximately 2 cm from the transition end of the distal shaft.The stainless steel braid in the distal shaft on the transition end appeared to be frayed and broken.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #20746523.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Additional manufacturer narrative: a1.- patient identifier.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9537153
• MDR Text Key: 195951433
• Report Number: 2017233-2020-00001
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/12/2022
• Device Catalogue Number: JHJR050502J
• Device Lot Number: 20746523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1