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

Model Number	H060040A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2020 the patient was implanted with a gore® propaten® vascular graft for av access in the left common iliac artery.On an unknown date, delamination of the graft was reportedly identified.On (b)(6), the gore® propaten® vascular graft was surgically removed from the patient in multiple pieces.
Additional Manufacturer Narrative
Additional manufacturer narrative: c1.Name (#1) (b)(6); manufacturer/compounder: w.L.Gore & associates, inc.Lot #6252642pp006.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.
Additional Manufacturer Narrative
H6.Method code 2 h6.Results code 2.Device fragments of a gore® propaten® vascular graft were returned to w.L.Gore & associates for investigation.Submitted unfixed were five gore® propaten® vascular graft fragments.The device fragments had been transected prior to arrival at w.L.Gore & associates.Histopathologic analysis was not performed, due to the lack of fixation prior to arrival.The device fragments were subjected to an enzymatic digestion process to remove biologic debris.No material integrity concerns were identified.The material disruptions identified (transections, radial disruption, evenly spaced serration marks, flattened/torn material, radial film disruptions, cannulation marks, electrocautery burns, transmural punctures) are consistent with surgical instrumentation manipulation (e.G., scalpel/scissors, forceps/clamps, grasping/pulling, cannulation needles, electrocautery instrument, and anastomotic sutures), which were likely used during a surgical procedure.Disruptions identified were not associated with handling or manufacturing process at w.L.Gore & associates.In our experience, the number of cannulations present, on three of the graft fragments, is greater than the expected number of cannulations for a 14-day implant.It is possible that the fragments returned were from more than one implant timeframe.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10176855
• Report Number: 2017233-2020-00446
• Device Sequence Number: 11433221
• Product Code: DSY
• UDI-Device Identifier: 00733132605811
• UDI-Public: 00733132605811
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

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: 02/05/2023
• Device Model Number: H060040A
• Device Catalogue Number: H060040A
• Device Lot Number: 6252642PP006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/31/2020; 02/16/2021
• 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: Hospitalization; Required Intervention