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

Catalog Number PAH091502E

Device Problems Separation Failure (2547); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  Injury  

Event Description

It was reported to gore that the patient underwent endovascular treatment for a popliteal artery aneurysm with a gore® viabahn® endoprosthesis with propaten bioactive surface.It was stated that the proximal part of the device did not fully deploy.The deployment was stuck and after several attempts of pulling the deployment line it broke.It was reported that the last 5 mm of the endoprosthesis did not deploy and was stuck on the catheter.About 6 hours later the patients popliteal artery was blocked and a surgical reintervention had to be done.It was stated that the deployment line and catheter fragments as well as the top part of the prosthesis were removed.The patient tolerated the procedure.

Manufacturer Narrative

Evaluation codes investigation findings 213 refers to the product history review: a review of the manufacturing records indicated the lot met pre-release manufacturing specifications.An engineering investigation of an accessory and of a part of the prosthesis as well as an imaging evaluation have to be performed.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

Imaging evaluation the images received cannot be used to perform a full imaging evaluation.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the available images provided for review.Gore cannot guarantee the images provided are accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.Summary: three jpeg radiographic images received for evaluation.No names, dates, or demographics included on the images.First jpeg image appears to show: the hub end of the implanted device is not fully deployed and appears to remain on the deployment catheter.Radiopaque marker at the hub end appears to be in place and no deployment line can be visualized.The 2nd and 3rd jpeg images appears to show: the hub end of the implanted device is still not fully deployed.The deployment catheter is pulled back, by location of the radiopaque marker.There appears to be a broken deployment line present.Engineering evaluation evaluation of the returned device items is consistent with the reported complaint but is unable to confirm the partial deployment.A broken deployment line, cut delivery catheter, and cut endoprosthesis were observed.Returned device the delivery catheter, distal tip and partial distal shaft (separated), deployment line, and hub were returned.Part of the endoprosthesis was returned deployment knob was not attached to the hub as-returned deployment line deployment line is fully outside the delivery catheter the deployment line is broken 207.8cm of deployment line is attached to the hub zipper: 11mm of the zipper constrains a section of the endoprosthesis distal shaft cut 14.5cm from the transition 1.6cm of distal shaft is attached to distal tip dual lumen has a minor kink 92cm from the hub endoprosthesis.The endoprosthesis appears cut 1.1 cm length of endoprosthesis was returned constrained by the zipper.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12868234
• MDR Text Key: 281197116
• Report Number: 2017233-2021-02568
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: NL
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Catalogue Number: PAH091502E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2019
• 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): Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male