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

Model Number	RRT07070080L
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	05/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis-report from third party was received, and will be further investigated.
Event or Problem Description
It was reported to gore that patient underwent endovascular treatment for a critical limb ischemia with a gore-tex® vascular graft - thin-walled removable ringed.It was stated that the prosthesis was implanted on (b)(6) 2019 as a below-the-knee femoro-popliteal bypass.It was reported that the clinical history takes notes of several revascularizations¿ surgeries in the context of ischemia.It was stated that on (b)(6) 2019, after about 1 month, two segments of the prosthesis were explanted due to infection to staphylococcus méti-s.
Additional Manufacturer Narrative
H6 evaluation codes investigation findings 213 refers to the product history review.A review of the manufacturing records indicated the lot met all pre-release specifications.Explant investigation (ei): the following is a summary of the ei observations: tissue present: yes.Segment 1 (19-112): the segment consisted of a gore-tex vascular graft (thin wall removable ring) fragment.The abluminal surface was generally devoid of tissue, except for multi-focal plaques of red/brown tissue.Both extremities were transected.Extremity a was transected in a non-uniform manner, as evident by cross-sectional view.The luminal view presented with dark brown/red and tan tissue occluding the lumen.Extremity b was ovular in shape and the luminal view presented in an unobstructed manner.The luminal patency could not be determined with the images/information provided.Segment 2 (19-113): the segment consisted of a gore-tex vascular graft fragment (type not provided) transected at an angle and connected to a dacron graft (presumptive) via blue running sutures (presumptive prolene®).The blue orientation line was consistent with that of a gore non-stretch vascular graft.The dacron graft was also connected to pink/red/brown native tissue via blue running sutures.The abluminal surface was generally devoid of tissue, except for minimal scattered plaques of red/brown tissue.Dark brown staining was observable on the abluminal surface.A partial, transverse transection, which was closed via blue, monofilament running suture, was present at approximately mid-graft.Multiple areas with evenly spaced serration marks, consistent with grasping/pulling with forceps/clamps, were present around the partial transection on the abluminal surface.Extremity a was transected and ovular in shape and the luminal view presented with brown/red and tan tissue occluding the lumen.The luminal patency could not be determined with the images/information provided.Material disruptions (i.E., transections, forceps marks, running suture) are consistent with those caused by surgical instrumentation (i.E., scalpel/scissors, forceps/clamps, suturing needle) likely used during a surgical procedure.The returned segments could not be correlated to a specific surgical or clinical event, from the information provided.Request for additional analysis: no.Reason: based on the ei¿s review of the third party report and reason for removal (infection), no additional analysis is requested.
Additional Manufacturer Narrative
A review of the sterilization records indicated the lot met all pre-release specifications.

• Brand Name: GORE-TEX® 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: 11027049
• Report Number: 2017233-2020-01538
• Device Sequence Number: 10960326
• Product Code: DSY
• UDI-Device Identifier: 00733132611034
• UDI-Public: 00733132611034
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K880167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/27/2021

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: 06/10/2023
• Device Model Number: RRT07070080L
• Device Catalogue Number: RRT07070080L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2020
• Supplement Date Received by Manufacturer: 10/28/2021; 12/07/2021
• Initial Report FDA Received Date: 12/17/2020
• Supplement Report FDA Received Date: 11/26/2021; 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2018
• 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 Age: 69 YR
• Patient Sex: Male