MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Device Problem Peeled/Delaminated (1454)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/19/2022

Event Type  Injury  

Manufacturer Narrative

Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.Instructions for use for gore® acuseal vascular graft technical information vascular access procedures state: patients should be carefully monitored when using gore® acuseal vascular grafts for vascular access.Puncture sites must be adequately separated when repeated needle punctures of the graft are necessary.Multiple punctures in the same area may lead to disruption of the graft material or formation of a perigraft hematoma or pseudoaneurysm.Possible complications with the use of any vascular prosthesis: complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and/or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.Patient information was requested, but was not available: patient identifier, age, gender, weight, date of birth and medications date of event: it is unknown the exact event date, so date gore was notified was used as event date.Implant date: implant date was also estimated as date was requested, but not provided.

Event Description

The following was reported to gore: on an unknown date, a gore® acuseal vascular graft was implanted for a dialysis shunt in a patient's arm.About 12 months later (date unknown) post-implant, delamination was suspected between media and adventitia of the gore® acuseal vascular graft at the puncture sites.The patient was asymptomatic, so the physician chose to monitor the patient.An echo exam, a color doppler exam, and an angiography were performed.After review of these exams, the physician stated it seemed there was delamination.However, no revision was done as the delamination was not observed in the graft lumen structure.About two years (date unknown) after the gore® acuseal vascular graft was implanted, an occlusion it was observed at the suspected delamination area.A pta ballooning was performed in the delaminated area of the vascular graft.The physician suggested that it is possible the occlusion occurred due to the narrowed graft lumen because of the suspected delamination and/or the delamination obstructed the graft lumen.The gore® acuseal vascular graft remains implanted.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14623188
• MDR Text Key: 293483246
• Report Number: 2017233-2022-02997
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention