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

Catalog Number JHJR051502J

Device Problem Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 06/27/2018

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.Examination of the returned device is in process.

Event Description

On (b)(6) 2018, the patient presented for an endovascular repair of an occlusion of the right superficial femoral artery using gore® viabahn® endoprosthesis with heparin bioactive surface.It was reported that during deployment the endoprosthesis partially expanded then ceased.The partially expanded endoprosthesis was manipulated to a place in the right groin where a cut down was performed and the entire device removed.

Manufacturer Narrative

Additional manufacturer narrative: examination of the returned device revealed the following: the device arrived in 3 separate pieces: the delivery catheter with part of the distal shaft (upon which the endoprosthesis was mounted), the deployment line connected to a deployment knob, and a partially expanded endoprosthesis mounted on a portion of the distal shaft; approximately 152 cm of deployment line was connected to the deployment knob; the distal shaft was broken/cut at 7 cm from the transition; approximately 1.7 cm of distal shaft was exposed on which the constrained endoprosthesis was mounted on; at 9.5 cm past the deployment line connected to constrained endoprosthesis, there were 2 fibers extending another 27.5 cm; there was approximately 7.5 cm of expanded endoprosthesis; the constrained endoprosthesis appeared to be bunched into expanded endoprosthesis; deployment could be continued with traction on the deployment line at endoprosthesis.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7715192
• MDR Text Key: 114869689
• Report Number: 2017233-2018-00423
• 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: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2020
• Device Catalogue Number: JHJR051502J
• Device Lot Number: 16454003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR