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

Catalog Number	SB1601D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	03/18/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
The gore-tex® vascular graft was implanted on (b)(6) 2019, in order to treat an abdominal aorta aneurysm.Later in the same day, the prosthesis was explanted due to a thrombosis of the patient's left leg.The surgeon specifies that the period between the thrombosis and the explantation is 12 hours.
Additional Manufacturer Narrative
The gore-tex® 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.The abluminal surface of the device fragment was devoid of tissue; red/brown mottling was present.The lumen was occluded with dark brown/red thrombotic material.Light tan/yellow tissue with dark red/brown mottling was returned attached to the device fragment; consistent with a segment of native artery.The device fragment was connected to a fragment of native artery via an anastomotic site with blue running suture at extremity a.The suture throws appeared to be widely and unevenly spaced, where visible.The device was transected at extremity b and ovular in shape.A metallic stent was reported to be encapsulated between the explanted artery and graft fragment but is not observable with the information provided.From gross images all material disruptions (i.E., material transections/cuts and suturing), appear to be consistent with cutting by sharp surgical instruments (i.E., scalpel or scissors) and creation of an anastomotic site, likely occurring during a surgical procedure.Request for additional analysis: no.Reason: material disruptions are consistent with those caused by surgical instrumentation during the explant process.Based on the ei's review of the geprovas report, no additional analysis is requested.H6: results code 1: 213 - all lots have met all manufacturing requirements.

• Brand Name: GORE-TEX VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8656631
• Report Number: 2017233-2019-00382
• Device Sequence Number: 14024998
• Product Code: DSY
• UDI-Device Identifier: 00733132611829
• UDI-Public: 00733132611829
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K802095
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/11/2023
• Device Catalogue Number: SB1601D
• Device Lot Number: 17881466
• Was Device Available for Evaluation?: No
• 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: 05/30/2019
• Supplement Report FDA Received Date: 10/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR