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

Catalog Number ECH060040J

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Unspecified Infection (1930); Necrosis (1971); Pneumonia (2011)

Event Date 03/04/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was not returned; consequently, a direct product analysis was not possible.

Event Description

On (b)(6) 2016, a patient was implanted with a goreacuseal vascular graft for arteriovenous access.The graft was anastomosed from the right brachial artery to the right basilic vein in an over-the-elbow loop graft.The patient tolerated the procedure.On (b)(6) 2016, the patient presented with a graft infection caused by skin necrosis around the implanted goreacuseal vascular graft in the right forearm.It was stated that the graft was externally visible in the area of skin necrosis.On (b)(6) 2016, the existing goreacuseal vascular graft was explanted to treat the skin necrosis.On (b)(6) 2016, a new arteriovenous shunt was prepared in the left arm using another surgical graft.On (b)(6) 2016, the patient expired due to aspiration pneumonia.It was stated that the patient has thin subcutaneous tissue and the goreacuseal vascular graft was implanted just above the fascia.Pressure was put to the subcutaneous tissue by the implantation of the goreacuseal vascular graft, and blood flow to the distal portion of the right forearm was not adequate, which may have caused incomplete wound healing.

• 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5727906
• MDR Text Key: 47493692
• Report Number: 2017233-2016-00584
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2018
• Device Catalogue Number: ECH060040J
• Device Lot Number: 4821868PP047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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: 83 YR