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

Catalog Number PHB050402

Device Problem Insufficient Information (3190)

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

Event Date 08/18/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, two gore® tigris® vascular stent¿s were implanted within the left popliteal artery.It was reported to gore that on (b)(6) 2018, the gore medical devices were explanted during a left transfemoral amputation because of the bad evolution of the left lower limb.

Manufacturer Narrative

Results code 213: a review of the manufacturing records indicated the lots met pre-release specifications.The gore® tigris® vascular stent was returned to geprovas, independent laboratory, for investigation.The scope and results of the investigation were summarized and a report was submitted to w.L.Gore & associates.An explant investigator (ei) at w.L.Gore & associates reviewed the report.The following is a summary of the ei observations: tissue present: yes device is fully encapsulated in white to yellow biologic tissue.The lumen is obstructed with dark red/brown biologic material.Device patency could not be determined with the information provided.The specimen containing the devices retained a ¿j¿ shape.Request for additional analysis: yes reason: level 2 analysis was requested from geprovas but could not be provided.The device was sent to cvpath institute for mct and histological analysis as part of a study.As information revealed that another gore® tigris® vascular stent was involved in the medical device incident, the second gore device will be also reported to the fda under the mfr report #2017233-2018-00692.

Manufacturer Narrative

The gore® tigris® vascular stent was returned to geprovas, independent laboratory, for investigation.Additional analysis revealed new findings.The scope and results of the investigation were summarized and a report was submitted to w.L.Gore & associates.An explant investigator (ei) at w.L.Gore & associates reviewed the report.Tissue present: yes devices are fully encapsulated in white to yellow biologic tissue.The lumens are obstructed with dark red/brown biologic material.Device patency could not be determined with the information provided.The specimen containing the devices retained a ¿j¿ shape.Review of the level 2 analysis, showed the devices were deployed in a dissected artery; arterial tissue pathology was consistent with atherosclerotic disease.In addition, due to the short implant duration, healing could not be assessed.Request for additional analysis: no reason: level 2 analysis was requested from geprovas and a complimentary report was provided summarizing the cvpath results.Based on the ei's review of the level 1 and 2 geprovas reports, no additional analysis is requested.As information revealed that another gore® tigris® vascular stent was involved in the medical device incident, the second gore device will be also reported to the fda under the mfr report #2017233-2018-00692.Initially this incident was reported under mfr report #2017233-2018-00693.

Manufacturer Narrative

Correction of conclusion code.

• Brand Name: GORE® TIGRIS® VASCULAR STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8070330
• MDR Text Key: 127121857
• Report Number: 2017233-2018-00693
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P160004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2020
• Device Catalogue Number: PHB050402
• Device Lot Number: 18154082
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR