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

Model Number H060040A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Code Available (3191)

Event Date 05/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event 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.

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.

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
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10176855
• MDR Text Key: 195902909
• Report Number: 2017233-2020-00446
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132605811
• UDI-Public: 00733132605811
• Combination Product (y/n): N
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention