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

Catalog Number ECH060040W

Device Problem Peeled/Delaminated (1454)

Patient Problem Vascular Dissection (3160)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The identity of the device was provided; however, the device history record did not identify any potential root causes attributable to the manufacture of the device.The case description could not be confirmed, as no images of the device were provided for evaluation.The reported failure mode(s) reflect(s) the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

The following was reported to gore: on (b)(6) 2021, a patient was implanted with a gore® acuseal vascular graft during arteriovenous graft (avg) procedure (from brachial artery to basilic vein) in eastern dialysis center of the first affiliated (b)(6).On (b)(6) the patient was examined with b-ultrasound due to thrombosis.It was found that there were 2cm dissections at vascular graft located about 5cm away from the venous anastomosis.Anastomosis and vein were free of stenosis.The physician replaced the dissection vascular graft with gore® viabahn® endoprosthesis with heparin bioactive surface.There was 20cm vascular graft was removed, and 15cm remained.The patient tolerated the procedure.The vascular graft was good now.The patient was not performed in the same dialysis center.

• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13382528
• MDR Text Key: 284684189
• Report Number: 2017233-2022-02696
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/02/2023
• Device Catalogue Number: ECH060040W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2022
• Date Device Manufactured: 06/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 70 KG