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 Bacterial Infection (1735)

Event Date 09/30/2020

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 the follow-up was marked by an abscess of the left femoral surgical access, treated with lavage and drainage.The biologic probes revealed an infection to pseudomonas aeruginosa and to klebsiella.

Manufacturer Narrative

H6 evaluation codes investigation findings 213 refers to the phr- and sterilization review.Phr-review: a review of the manufacturing records indicated the released portion of the lot met all pre-release specifications.Sterilization-review: a review of the sterilization records indicated the lot met all pre-release specifications.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Manufacturer Narrative

Explant investigation: the device was returned to geprovas for investigation.Submitted in formalin were 5 specimens of gore® propaten® vascular graft fragments and tissue (segments 1-5).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 encompassing both level 1 and level 2.Based on the explant scientist¿s review of the reports, in conjunction with on-site analysis, no additional information is requested.There were no indications of material failure such as suture pull through or suture hole elongation and radial film remained present along the returned fragments.Further details were requested, like if the abscess is linked to the prosthesis and or caused by it (graft infection?) which answer was not provided and if the graft is visible in the abscess which was answered with no.With the information provided to gore, the cause of the reported issue cannot be established.

Manufacturer Narrative

H1 type of reportable event must be "other" instead of "serious injury".This report was submitted in the abundance of caution, because as a general principle, gore is committed to the predisposition to report rather than not to report in case of doubt on the reportability of a complaint.Further information regarding this event was requested by gore, but no further information has been reported.Neither clinical images enabling direct assessment of product performance nor the product evaluation revealed a problem with the gore device.The scope of this case is related to the abscess at the access site, which is outside of the scope for the explant evaluation.There was no complaint of infection associated with this portion of the graft as it was explanted due to reported distal anastomosis rupture.The explant evaluation is limited to the time the device was explanted and the reason for removal.The reported event description states that the infection occurred at the surgical access site, not at the graft, and therefore does not reasonably suggest that the reported wound infection is related to the gore device.Therefore this event is considered not reportable.For that reasons this report is being retracted.

• 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: 11313152
• MDR Text Key: 231317817
• Report Number: 2017233-2021-01661
• 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
• Report Date: 11/14/2022

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: 11/11/2022
• 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