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

Catalog Number VBJR062502A

Device Problems Break (1069); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Review of device manufacturing record history confirmed device met pre-release specifications.The endoprosthesis remains implanted.The delivery catheter was received in two pieces, with the distal shaft separated from the proximal catheter at the transition.A snare (non-gore) was attached approximately 6cm from the distal tip.Based on the device examination performed, no manufacturing anomalies were identified.Ifu statement, directions for use state, inspection prior to use, prior to using the gore® viabahn® endoprosthesis, all materials and equipment to be used for the procedure should be carefully examined for bends, kinks, or other damage.Do not use any defective equipment.Do not use the gore® viabahn® endoprosthesis if the sterile package is compromised or the gore® viabahn® endoprosthesis is damaged.

Event Description

Patient presented with an in-stent restenosis in the superficial femoral artery.It was reported that during preparation for a procedure, a kinked delivery catheter was straightened out, then delivered into the patient's vessel.A 7fr pinnacle destination sheath was used to advance the gore viabahn endoprosthesis over a.014 grand slam guidewire.The gore viabahn endoprosthesis reached the target lesion and deployed about 15cm when the deployment line became stuck.The gore viabahn endoprosthesis was eventually deployed with some manipulation.When the delivery catheter was withdrawn, it was found the catheter was broken at the transition.A snare was used to retrieve the distal shaft and tip of the catheter.The procedure continued with additional devices being deployed to cover the target lesion.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 86001
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5384427
• MDR Text Key: 36962357
• Report Number: 2017233-2016-00075
• 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: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2018
• Device Catalogue Number: VBJR062502A
• Device Lot Number: 14341818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2016
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2015
• 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 Age: 55 YR