MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number HT066070

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Peripheral Vascular Disease (2002); Tissue Damage (2104)

Event Date 02/12/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).

Event Description

On (b)(6) 2018, a gore® propaten® vascular graft was implanted from the common femoral artery to the tibial anterior artery in order to treat an acute right limb ischemia.On (b)(6) 2018, following the revascularization failure of the medical device the patient underwent an above knee amputation of the right leg.

Manufacturer Narrative

The following section was updated within this report: d4.Patient; device; method and conclusion codes were added.The gore® propaten® vascular graft 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 scattered dark red/brown tissue was present on the albumen of both fragments.The lumens of both fragments contained a small amount of dark red/brown material.Device patency of the device fragments could not be determined from the information provided.Segment 1: both poles were transected.Extremity b was ovular in shape and beveled.Segment 2: both poles were transected.Extremity b had a continuous blue running suture around the transected edge that is beveled, which suggested an anastomotic site.Rings were absent from the fragment, starting just past halfway and going toward extremity b.No additional disruptions were observed on the device fragments.From gross images all material disruptions (i.E., material transections), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors), likely used during the explant procedure.Request for additional analysis: no.Reason: material disruptions are consistent with those caused by surgical instrumentation during a surgical procedure.Based on the ei's review of the geprovas report, no additional analysis is requested.

• Brand Name: GORE® PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7509860
• MDR Text Key: 108085125
• Report Number: 2017233-2018-00277
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2020
• Device Catalogue Number: HT066070
• Device Lot Number: 5219836PP002
• Was Device Available for Evaluation?: No
• 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; Disability
• Patient Age: 81 YR