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

Catalog Number	PHA070802A
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing records are currently being reviewed.The specimen was returned and is currently being evaluated.
Event or Problem Description
The following was reported to gore: patient presented for treatment of a stenosis in the popliteal artery.A gore® tigris® vascular stent was advanced through a 6fr cordis sheath over a.014 spider guidewire.The physician reported there was tremendous resistance as the tigris stent was advanced through the sheath.The tigris stent was able to reach the intended treatment site and deployment was initiated.About three-fourth of the stent expanded when deployment wheel could no longer be rotated.Most of the stent was pulled back into the 6fr cordis sheath and removed in tandem.Wire access was maintained, which allowed for everflex stents to be deployed.As reported, patient did not experience any adverse consequences.
Additional Manufacturer Narrative
H6 - code 213: review of device manufacturing record history confirmed device met pre-release specifications.The engineering evaluation state the returned device was kinked at multiple locations along the catheter, including near the strain relief.The lock slider was in the unlocked position.An introducer sheath was positioned covering the distal end of the device, consistent with the reported event description.Due to the location of the introducer sheath, ability to determine if the outer sheath was locked near or over the proximal edge of the constrained portion of the stent was not possible.The distal-most row of the stent was visible from the distal end of the introducer sheath, and the visible portion appeared partially expanded.The constraint sleeve of the device was not visible due to the position of the introducer sheath.The outer sheath was kinked and buckled approximately 5mm distal of the strain relief.Upon disassembly of the handle, the outer sheath was also buckled within the strain relief component.The inner shaft was kinked at the location of the pulley within the handle and at the location of the strain relief (consistent with the location of the observed outer sheath buckle within the strain relief component).Upon disassembly of the introducer sheath and catheter, the constraint sleeve was found to be fully translated into the outer sheath, and no longer covering the stent.Based on the device examination performed, no manufacturing anomalies were identified.

• Brand Name: GORE TIGRIS® VASCULAR STENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8201753
• Report Number: 2017233-2018-00800
• Device Sequence Number: 16533381
• Product Code: NIP
• UDI-Device Identifier: 00733132636372
• UDI-Public: 00733132636372
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P160004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/23/2019
• Device Catalogue Number: PHA070802A
• Device Lot Number: 15348734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SPIDER .014 FILTER WIRE, 6FR CORDIS SHEATH; SPIDER .014 FILTER WIRE, 6FR CORDIS SHEATH
• Patient Age: 65 YR
• Patient Weight: 93