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

Catalog Number	S0602
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	07/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.All information has been placed on file for use in tracking and trending.
Event or Problem Description
The following was reported to gore: the graft was implanted in the av patient on (b)(6) 2019.During the procedure the doctor observed clear fluid around the graft.The procedure was completed with no further incidents.The doctor called gore on (b)(6) 2019 reporting that he realigned the graft.
Additional Manufacturer Narrative
Corrected data: d6: if implanted, give date.
Additional Manufacturer Narrative
Additional manufacturer narrative: a1.Patient identifier.

• Brand Name: GORE-TEX STRETCH VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8819498
• Report Number: 2017233-2019-00550
• Device Sequence Number: 14230337
• Product Code: DSY
• UDI-Device Identifier: 00733132611270
• UDI-Public: 00733132611270
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K903931
• 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,Followup,Followup
• Report Date (Section B): 08/23/2019

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: 09/24/2023
• Device Catalogue Number: S0602
• Device Lot Number: 18628594
• 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; Not provided
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 08/23/2019; 08/23/2019
• 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