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

Catalog Number VBJR082502A

Device Problems Break (1069); Premature Activation (1484); Sticking (1597); Failure to Advance (2524)

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

Event Date 08/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The following observations were made by engineering: the distal shaft was broken at the catheter tubing transition.Approximately 22cm of the deployment line was intact between the catheter tubing and the introducer sheath valve.The endoprosthesis expansion was not confirmed as it was located inside the introducer sheath, rendering it inaccessible.Based on the device examination performed, no manufacturing anomalies were identified.

Event Description

The patient presented with in-stent restenosis and thrombosis in the left leg (common iliac, external iliac, common femoral and superficial femoral artery).Access was gained from the left brachial artery.A 7fr 90cm cook shuttle sheath was being used to advance the gore viabahn endoprosthesis over a platinum plus.018 guide wire.The gore viabahn endoprosthesis was just starting to be advanced into the sheath when it became stuck.As the constrained gore viabahn endoprosthesis was being pulled out of the sheath, the device broke inside the sheath.The deployment line got caught and was inadvertently pulled, causing the gore viabahn endoprosthesis to deploy inside the sheath.The sheath and device were removed together.A new sheath was inserted and a non-gore device was used to complete the procedure.The patient did not experience any adverse consequences.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5947293
• MDR Text Key: 54995868
• Report Number: 2017233-2016-00748
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2019
• Device Catalogue Number: VBJR082502A
• Device Lot Number: 15059125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• 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
• Treatment: 7FR 90CM COOK SHEATH, PLATINUM PLUS .018 WIRE
• Patient Age: 70 YR
• Patient Weight: 72