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

Catalog Number ECH060040

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); Insufficient Information (4580)

Event Date 02/16/2021

Event Type  Death  

Manufacturer Narrative

Please notice that no information was received yet for patient information, implant date and date of death.This information will be requested and included in the final report.As the device is not available (remains implanted), a further investigation cannot be performed.(b)(4).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 with a gore® acuseal vascular graft.It was stated that there was a perigraft reaction after implantation.Reportedly the patient died in the course of this reaction.

Manufacturer Narrative

After no reply to several emails and phone calls to the involved physician, field sales had the opportunity to talk to the chief physician of the vascular department in this hospital and was able to get some information about the case from her.The event-, implant- and explant-dates as well as the date of death, patient details and - history were provided.It was stated that no device is available for further investigation and that no autopsy was performed.With the information provided to gore and the fact that no device is available for further investigation, the cause of the reported event could not be established.B3: date of event was corrected.B5: event description was updated.B7: patient history updated.D6a and d6b updated.

Event Description

Updated event description: it was reported to gore that patient underwent surgical treatment for a femoro-femoral arteriovenous shunt graft with a gore® acuseal vascular graft.The patient was discharged from the hospital and two weeks later he returned because of wound healing disorder.It was stated that to solve the issue, two revision surgery were performed.A vacuum assisted closure therapy, a patch plastic and the donation of antibiotics were applied.One week later the vascular graft had to be explanted because of an infection.Reportedly the patient died in the course of this reaction.

Manufacturer Narrative

Revised b5.Added additional information to h6 to reflect results of a sterilization investigation performed by w.L.Gore & associates based on the device serial/lot number.The results of this investigation indicated: a review of the sterilization records indicated the lot met all pre-release sterilization specifications.

Event Description

The following was reported to gore: on (b)(6) 2021, a patient with a history of renal disease underwent surgical procedure due to restricted function demers-catheter.A gore® acuseal vascular graft (vascular graft) was implanted in a femoro-femoral bypass as an arteriovenous shunt.On (b)(6) 2021, the patient was discharged from the hospital.On (b)(6) 2021, the patient presented with a wound healing disorder.On (b)(6) 2021, a revision-op was done.Treatment included vac-therapy, antibiotics, and patch-plastic.On (b)(6) 2021, patient had a follow-up.Results were not made available.On (b)(6) 2021, the vascular graft was explanted due to a graft infection.On (b)(6) 2021, the patient expired 'in the course of this reaction'.As reported, an autopsy was not performed and the physician stated he did not know the cause of the event.Patient's history include: immunodeficiency (lack of igg, iga), infantile brain damage.

• Brand Name: GORE® ACUSEAL 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: 11627561
• MDR Text Key: 244192347
• Report Number: 2017233-2021-01850
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/17/2023
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• 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): Death
• Patient Age: 48 YR
• Patient Sex: Female