MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Model Number	S0508
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Seroma (2069); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was stated that the device is available for investigation, but was not yet returned.Patient details (age and weight) were requested but not provided.Evaluation codes investigation findings 213 refers to the phr.A review of the manufacturing records indicated the lots met all pre-release specifications.
Event or Problem Description
It was reported that the patient underwent surgical treatment for a fistula in the arm with a gore-tex® stretch vascular graft non-ringed.It was stated that on (b)(6) 2021 the physician implanted a gore-tex® stretch vascular graft to reduce the blood flow of a fistula.Some days later the patient presented with a lymphocele.It was reported that a re-intervention took place on (b)(6) 2021 to drain the lymphocele.Hereby the physician realized that the wall of the graft was permeable all along.It was stated that the physician decided to replace the graft which was performed on (b)(6) 2021.The patient tolerated the procedure.
Additional Manufacturer Narrative
Explant investigation: a fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore-tex stretch vascular graft fragment.The device fragment had been transected, prior to arrival at w.L.Gore and associates.The abluminal surface was generally devoid of tissue, except for scattered, plagues of tan/brown tissue.The lumen was generally devoid of tissue, with small fragments of white/tan to red/brown gelatinous tissue scattered on the luminal surface.The lumen was widely patent.Histopathological examination of one transverse section was performed.The gross and microscopic observations of proteinaceous fluid within the eptfe graft interstices and acellular protein coagulum on the abluminal surface was consistent with the clinical assessment of graft seroma.There was no evidence of inflammation or collagenous organization within the graft or abluminal coagulum.The fragment was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the fragment was examined for material disruptions with the aid of a stereomicroscope.The material disruptions identified were consistent with interaction with surgical instrumentation, likely used during a surgical procedure.Disruptions identified were not associated with handling or manufacturing process at w.L.Gore & associates.The disruptions are consistent with a surgical procedure.No disruptions that would contribute to seroma were identified on the returned fragment.The cause of the seroma could not be determined with the information provided.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Common Device Name: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12702589
• Report Number: 2017233-2021-02490
• Device Sequence Number: 11152588
• Product Code: DSY
• UDI-Device Identifier: 00733132611256
• UDI-Public: 00733132611256
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K903931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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: 11/29/2025
• Device Model Number: S0508
• Device Catalogue Number: S0508
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 04/01/2022
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male