MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAJR060502E

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/05/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, a further investigation on the device cannot be performed.The customer was requested to make images available so that an imaging evaluation can be done.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that the same patient who underwent endovascular treatment for a peripheral arterial occlusive disease (paod; stage ii) on (b)(6) 2020 with a gore® viabahn® endoprosthesis with propaten bioactive surface (viabahn-device) in the superficial femoral artery (sfa) and whose viabahn-device got occluded 2 weeks later (case 02871) returned to the hospital on (b)(6) 2021.It was stated that a re-intervention was performed using a rotarex-device to treat the occlusion.In addition, another viabahn-device was placed in the proximal part of the sfa.It was reported that on (b)(6) 2021 the patient returned to the hospital and it was found that the total stented tract was occluded.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr-reviews: phr- review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Phr review heparin coatings: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Phr-review sterilization: a review of these records indicate the lot met all pre-release specifications.Imaging evaluation summary: one time point available for evaluation: intra-operative angiogram images dated (b)(6) 2020.8:47:00 there appears to be areas of stenosis or partial occlusions in the left sfa (superficial femoral artery).9:11:38 image appears to show a possible pta (percutaneous transluminal angioplasty) balloon in the left sfa.9:17:10 images appear to show the left sfa, post pta, to be patent.9:18:01 image appears to show the pta balloon again.9:26:02 image appears to show an underployed stent in the left sfa.9:49:25 image appears to show a deployed stent in the left sfa.9:51:02 there appears to be flow through the implanted stent.The left sfa appears to be patent.9:51:54, 9:52:50, and 9:54:38 images appear to show patency of vessels distal to the implanted stent into the left ankle and foot.Product investigation report conclusion: the specific cause of this complaint could not be determined.Gore did not receive the explanted device, and information regarding the device form was not available.A product history review was conducted for the vsx device in this complaint, and the review of the manufacturing records, including the device manufacturing, heparin coating, and sterilization processes, indicated the lot met pre-release manufacturing specifications.The imaging provided to gore indicates the vessel / stent graft were patent after the index procedure, but no images were provided representing the (b)(6) 2021 dates in the complaint.The investigation confirms the subsequent occlusion but is unable to assign cause.There are potential failure modes identified for which cause is possible, but no conclusion can be drawn because evaluation of the device was not possible.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11398856
• MDR Text Key: 234249009
• Report Number: 2017233-2021-01720
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Catalogue Number: PAJR060502E
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR