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

Catalog Number PAH061001

Device Problems Detachment Of Device Component (1104); Material Separation (1562)

Patient Problem No Information (3190)

Event Date 04/21/2017

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).Further investigation is being conducted and the information will be included in the final report.

Event Description

The patient was presented with an aneurysm in the popliteal artery which was treated with a gore® viabahn® endoprosthesis.It was stated that the endoprosthesis could be inserted and advanced to the target lesion without any complications.Even though medical device deployment could be initiated without any difficulties and a successful device deployment was reported.It was reported to gore that when the device catheter was removed from the patient, it was recognized that the olive got detached from the shaft.An angiography confirmed the olive detachment and indicated that the olive was floating in the popliteal segment 3.The patient was converted to open surgery where the olive could be removed without any difficulties.It was stated that the patient is doing well following he procedure.

Manufacturer Narrative

Our engineers have evaluated the returned device.Their investigation showed following: there was no endoprosthesis, deployment knob, deployment line, nor distal tip returned.The distal shaft, upon which the endoprosthesis was mounted, is approximately 10.7 with no distal tip at the end of the distal shaft.The distal end of the distal shaft showed no melting or disruption of the pebax coating.The length of the device from the tip of the distal shaft to the hub is approximately 71.5 cm.Based on the device examination performed, manufacturing anomalies were identified that potentially could have contributed to the event.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6607204
• MDR Text Key: 76492821
• Report Number: 2017233-2017-00283
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2018
• Device Catalogue Number: PAH061001
• Device Lot Number: 13588822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2015
• 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