MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN VASCULAR GRAFT (STRETCH REMOVABLE RING); PROSTHESIS, VASCULAR GRAFT

Catalog Number	HAX02A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Seroma (2069)
Date of Event	07/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of device manufacturing record history confirmed device met pre-release specifications.The device remains implanted.Therefore, direct product analysis was not possible.
Event or Problem Description
The following was reported to gore: on (b)(6) 2019, a gore® propaten® vascular graft (standard-walled, axillobifemoral, removable ringed) was implanted using a gore tunneler.Around (b)(6) 2019 (reported as 6-8 weeks ago), patient received treatment due to seroma.Clear fluid was drained.Another intervention was performed after (b)(6) (date unspecified) and clear fluid was drained again.As reported, fluid was tested each time.Cultures were negative for infection and there was no blood in the aspirated fluid.On (b)(6) 2019, patient presented with seroma and clear fluid was drained again.During this intervention, the vascular graft was relined almost entirely with several gore® viabahn® endoprostheses.Before implantation, cat scan measurements were taken to ensure correct sizing.It was reported only a 4 cm segment was left unlined.A drainage tube was left in place.Patient was reported to be recovering well following the procedure.

• Brand Name: GORE PROPATEN VASCULAR GRAFT (STRETCH REMOVABLE RING)
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9221646
• Report Number: 2017233-2019-01076
• Device Sequence Number: 14153441
• Product Code: DSY
• UDI-Device Identifier: 00733132617692
• UDI-Public: 00733132617692
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K062161
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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: 04/15/2022
• Device Catalogue Number: HAX02A
• Device Lot Number: 5924775PP001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2019
• 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: 52 YR
• Patient Weight: 81