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

Device Problem Peeled/Delaminated (1454)

Patient Problem Stenosis (2263)

Event Date 05/01/2020

Event Type  Injury  

Manufacturer Narrative

Case # 1 is being reported under mfr report # 2017233-2020-00373.

Event Description

The following information was reported to gore: in an article titled "arteriovenous graft delamination and dissection as a cause of graft dysfunction" it states a patient had elevated avg pressure within her gore® acuseal vascular graft 193 days after placement.Graft venography demonstrated 2 unusual filling defects within the venous limb of the graft.Angioplasty was performed using a 7-mm high-pressure balloon, but without improvement in appearance.Longitudinal and transverse ultrasonography demonstrated posterior displacement of the anterior (superficial) graft wall, resulting in >80% narrowing of the graft.The venous limb was stented with an 8mm x 10cm gore® viabahn® endoprosthesis.Literature citation: dai r, broadwell sr, lessne ml, kim cy.Arteriovenous graft delamination and dissection as a cause of graft dysfunction.Journal of vascular & interventional radiology 2020;31(5):852-854.E1.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: heidi inskeep ; 1500 n. 4th street; 9285263030
• MDR Report Key: 10072639
• MDR Text Key: 193934845
• Report Number: 2017233-2020-00372
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 30 YR