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

Catalog Number JHJR062502J

Device Problem Activation Failure (3270)

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

Event Date 12/05/2019

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2019, this patient underwent an endovascular repair for chronic total occlusion (cto) with excessive calcification from the left external iliac artery to the left popliteal artery using a gore® viabahn® endoprostheses with heparin bioactive surface and a gore® viabahn® vbx balloon expandable endoprosthesis.Pre-ballooning to the whole length of the lesion was performed using nse (4mm x 40mm) and shiden (6mm x 150mm) balloon catheters, and an eluvia stent was implanted in the popliteal artery.The first gore® viabahn® endoprosthesis with heparin bioactive surface was implanted in the distal area of the superficial femoral artery with no issue.The deployment of the second gore® viabahn® endoprosthesis with heparin bioactive surface was started, however, the deployment line was stuck in something when around 2 cm of the endprosthesis expanded.The delivery catheter was removed with sheath from the patient.Another gore® viabahn® endoprosthesis with heparin bioactive surface was implanted in the proximal area of the artery with no issue.Additionally, an attempt was made to deliver a gore® viabahn® vbx balloon expandable endoprosthesis through a 7fr ansel sheath to the external iliac artery.However, the delivery catheter would not go into the sheath.The catheter was removed from the patient.A gore® viabahn® endoprosthesis with heparin bioactive surface was implanted in the artery instead of the gore® viabahn® vbx balloon expandable endoprosthesis.The procedure was completed, and the patient tolerated the procedure.The procedure was reportedly performed in accordance with the instructions for use for the devices utilized.

Manufacturer Narrative

H.6.Results code 1: 213: a review of the manufacturing records for the device verified the lot met all pre-release specifications.H.6.Results code 2: 213: the engineering evaluation stated the following: the entire device was returned with an introducer sheath.However, the introducer sheath was not evaluated as it was not a gore product.There was approximately 57.3cm of deployment line between the hub and deployment knob.Approximately 1.6cm of the endoprosthesis was coming from the end of the introducer sheath and was expanded.This portion of the endoprosthesis appeared to be damaged and contained delamination and outwardly flared struts.The remainder of the endoprosthesis was within the introducer sheath.The remainder of the device was unremarkable.Based on the device examination performed, no manufacturing anomalies were identified to which the event could be definitively attributed.Engineering evaluation conclusion is inconclusive as it relates to the event description.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9521801
• MDR Text Key: 197840151
• Report Number: 2017233-2019-01277
• 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
• Report Date: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2022
• Device Catalogue Number: JHJR062502J
• Device Lot Number: 21020508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR