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

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 07/01/2020

Event Type  Injury  

Manufacturer Narrative

Analysis-report from third party was received and will be further investigated.The exact type and name as well as the serial-/lot no.Of the gore prosthesis and the exact implantation date were requested from the third party, but not provided yet.

Event Description

It was reported to gore that patient underwent endovascular treatment for a left limb ischemia without trophic disorders with a gore-tex® vascular graft.It was stated that the prosthesis was implanted in 2010 as a left axillo- deep-femoral bypass.It was reported that on (b)(6) 2020, after about 10 years, the prosthesis was explanted due to infection.The germ is not specified by the surgeon.

Manufacturer Narrative

The exact type and name as well as the serial-/lot no.Of the gore prosthesis and the exact implantation date were requested from the third party, but not provided.Therefore a product history review could not be performed, as the device serial number remains unknown.Explant scientist observations: the returned specimen was reportedly unfixed upon arrival; at which time it was placed in a formalin solution (concentration not provided).Segment 1 was reported as measuring 100 mm in length and presented in a wave pattern with both ends transected.The ablumen of the graft fragment was circumferentially covered in light tan tissue with multifocal yellow tissue deposits (presumed adipose tissue).One pole was misshapen in a flattened configuration with a corresponding impression of multiple evenly spaced serration marks (e.G., hemostat, clamp marks), in the abluminal tissue.The visible luminal surfaces appeared to have a thin layer of light tan tissue present.Patency was confirmed via a water test, performed by the third party.Segment 2, measurement was not provided, however the graft fragment appeared to be approximately 25-30 mm in length using the ruler depicted with the specimen.Both poles were transected, and the fragment was severely disrupted (e.G., cut, pulled, grasped, twisted).There were multiple areas of evenly spaced serration marks (e.G., hemostat, clamp marks) visible on the abluminal surface of the graft and on the abluminal tissue.The lumen appeared to be intermittently covered in light tan tissue.One pole was misshapen in a flattened configuration similar to segment 1.The luminal tissue was also similar to segment 1 but appeared to have increased accumulation.Material disruptions (e.G., cutting, clamping and manipulation) appeared consistent with those caused by surgical instrumentation (e.G., scissors, scalpel, hemostat, clamp) likely used during the explant procedure.Request for additional analysis: no.Reason: based on the explant scientist¿s review of the third party report, no additional analysis is requested.The reported reason for removal was infection, type and source were not provided, additionally there was no direct association towards gore¿s device and the reason for removal from the physician.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: 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: 12047800
• MDR Text Key: 257694306
• Report Number: 2017233-2021-02109
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Sex: Male