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

Catalog Number JHJR052502J

Device Problem Activation Failure (3270)

Patient Problem Occlusion (1984)

Event Date 06/10/2019

Event Type  malfunction  

Manufacturer Narrative

Review of the manufacturing records indicated the device met pre-release specifications.The investigation is ongoing.

Event Description

The following was reported to gore: on (b)(6) 2019, this patient underwent endovascular treatment using gore® viabahn® endoprosthesis (viabahn) for chronic total occlusion of the superficial femoral artery.When the viabahn was deployed half way, the deployment line stuck and broke.As the viabahn was unable to deploy, the hub was cut to remove the shortened sheath.Next, a 6fr guiding sheath was inserted, the unopened half of viabahn was put into the sheath, and the viabahn and the sheath were removed from the patient.Another viabahn was implanted without issue.The patient tolerated the procedure and no adverse event was reported.

Manufacturer Narrative

Corrected date: h6: results code 2.H6: conclusions code 1.Additional manufacturer narrative: examination of the returned device revealed the following: the endoprothesis, deployment knob, deployment line, the hub end of the delivery catheter, as well as an introducer sheath were returned; the introducer sheath was not evaluated as it is not a gore product; the deployment line appeared to be broken with on single fiber on the end; the deployment was approximately 178cm with an 11cm single fiber on the end; the delivery catheter appeared to be cut and the hub and shrink sleeve were returned; the piece measured 3.5cm from the end of the hub; there appeared to be delamination throughout the body of the endoprosthesis; approximately 3cm of the endoprothesis was protruding from the distal end of the introducer sheath; approximately 4cm of the deployment line was looped back into the distal end of the introducer sheath.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.All information has been placed on file for use in tracking and trending.

Manufacturer Narrative

Corrected data: d10: returned to manufacturer on: (mm/dd/yyyy)the date the device was returned to gore.Additional manufacturer narrative: g5: combination product.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8749650
• MDR Text Key: 150279904
• Report Number: 2017233-2019-00486
• 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
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2021
• Device Catalogue Number: JHJR052502J
• Device Lot Number: 20105143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1