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

Catalog Number HT076080

Device Problem Contamination (1120)

Patient Problem Unspecified Infection (1930)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Analysis-report from third party was received and will be further investigated.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent endovascular treatment for a right-left crossed femoro-femoral bypass with a gore® propaten® vascular graft - thin-walled removable ringed.It was stated that the prosthesis was implanted on (b)(6) 2020 in order to treat an acute ischemia of the left lower limb following the treatment of a type a aortic dissection by open surgery.It was reported that on (b)(6) 2020, after about 2 months, the distal part of the prosthesis was explanted due to a rupture of the distal anastomosis (case (b)(4)).It was stated that 6 days later, the rest of the prosthesis was explanted due to the infection.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr-review: a review of the manufacturing records indicated the released portion of the lot met all pre-release specifications.Analysis-report from third party was received and will be further investigated.

Manufacturer Narrative

Explant investigation: the device was returned to geprovas for investigation.Submitted in formalin was one gore® propaten® vascular graft fragment.The scope and results of the investigation were summarized, and a report was submitted to w.L.Gore & associates.An explant scientist at w.L.Gore & associates reviewed the report and performed in person on-site evaluation of the specimen.Explant scientist observations: the graft fragment was reported to measure 120 mm in length with both ends transected.The ablumen was encased in light tan/tan tissue with multifocal deposits yellow (presumed adipose) tissue.Blue alignment marks were faintly visible on inspection.The lumen of extremity a was occupied with gelatinous brown tissue.Extremity b was ligated with multifilament blue-green suture in a continuous running pattern.The graft fragment was not patent.Reason: based on the explant scientist¿s review of the geprovas report, no additional analysis is requested.The reported reason for removal was infection with no accusation of infection being device related from the physician.The origin of infection cannot be determined with the information provided nor via the analyses available.

Manufacturer Narrative

Product history review: a review of the sterilization records indicated the lot met all pre-release specifications.

Manufacturer Narrative

Added to section c1: suspect products: name: cbas® heparin surface.Manufacturer/compounder: w.L.Gore & associates, inc.Lot number: 6670923pp002.

• Brand Name: GORE® PROPATEN® 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: 11313502
• MDR Text Key: 231369965
• Report Number: 2017233-2021-01663
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2024
• Device Catalogue Number: HT076080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2020
• 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: 71 YR
• Patient Sex: Male