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

Catalog Number PAJR051002B

Device Problem Complete Blockage (1094)

Patient Problems Hematoma (1884); Perforation of Vessels (2135)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified the lot met all pre-release specifications.An engineering evaluation is currently in progress.

Event Description

As reported, on an unknown date, approximately 6 months ago, (b)(6) 2019, a patient underwent treatment of a superficial femoral (sfa) and popliteal artery (pa) lesion with a supera 5.5mm x 15cm stent and two eluvia stents, 6mm x 80mm and 5mm x 60mm.On an unknown date a diagnosis of semi-acute occlusion of the sfa and pa was made.On an unknown date, approximately 3 weeks ago, (b)(6) 2019 the patient presented with sudden increase in pain in the leg.On (b)(6), the patient was hospitalized.A thrombus measuring approximately 35cm was found occluding the vessel above the stents and within.On (b)(6) 2019 a reintervention was performed.An up and over the iliac bifurcation approach was used to prevent disturbance of the thrombus.The lesion was pre-dilated to 3mm.A 5mm x 25cm gore® viabahn® endoprosthesis with propaten bioactive surface was deployed distally within the stent without incident.A 5 mm x 10 cm gore® viabahn® endoprosthesis with propaten bioactive surface was then advanced and deployment was initiated, however halfway through deployment, the deployment line snapped, leaving the device half deployed.An attempt was made to pull the device back into the 6fr long sheath, however it became necessary to create a cut-down in the groin to retrieve it while still partially in the sheath.Following the procedure a hematoma was in the groin was noted, but the patient was recovering well.

Manufacturer Narrative

A.1 and a.2.Updated.The patient age is unknown.H.6.Results code 2: 213: the engineering evaluation stated the following: the endoprosthesis, delivery catheter, and part of the deployment line were returned.An introducer sheath was returned, this was not evaluated as it is not a gore device.There was approximately 4.5 cm of the straight cut end of the endoprosthesis with approximately 5 cm of broken deployment line coming out of the introducer sheath.There was body delamination throughout the body of the endoprosthesis.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.

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9077776
• MDR Text Key: 162903810
• Report Number: 2017233-2019-00867
• 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: 10/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/15/2022
• Device Catalogue Number: PAJR051002B
• Device Lot Number: 20619441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention