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

Device Problem Occlusion Within Device (1423)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); Swelling (2091); Thrombosis (2100); Numbness (2415); Vascular System (Circulation), Impaired (2572)

Event Date 02/27/2014

Event Type  Injury  

Event Description

A physician reported a case in which following the gore® acuseal vascular graft implant, the patient developed arterial steal.On (b)(6) 2014, a gore® acuseal vascular graft was implanted as a left brachio-brachial forearm loop arteriovenous graft.Four days post implant the patient reported numbness but tolerating it well.On (b)(6) 2014, the patient experienced forearm swelling with low flows in the graft.A fistulogram and balloon angioplasty of the venous anastomosis with a 6mm balloon was performed.The patient had good result and had dialysis successfully thereafter.The patient returned on (b)(6) 2014 with hand pain and neurologic deficit.Axillary artery stenosis was treated on (b)(6) 2014, with a gore® viabahn® endoprosthesis but symptoms did not improve.The graft thrombosed a few days later but due to the worsening arterial steal and risk of hand loss, a decision was made not to salvage it.The patient¿s hand motor dysfunction exists to date, though gradually improving with physical therapy.The physician further reports, "this is an anticipated complication of all accesses, particularly in diabetic patients and these observations may just represent random non-significant events, falling within the accepted complication rates.".

Manufacturer Narrative

No testing methods performed.No results available since no evaluation performed.

• 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: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4775558
• MDR Text Key: 5799890
• Report Number: 2017233-2015-00292
• 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
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2015
• 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 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): Required Intervention
• Patient Age: 45 YR