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

Catalog Number ECH060040A

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Staphylococcus Aureus (2058)

Event Date 01/23/2014

Event Type  Injury  

Event Description

Forearm loop implant was in the patient's left brachial artery to cephalic vein.Reason for treatment end stage renal disease.

Manufacturer Narrative

Review of device manufacturing record history confirmed device met pre-release specifications.

Event Description

On (b)(6) 2013, the patient was implanted with a gore acuseal vascular graft.On (b)(6) 2014, the gore acuseal vascular graft was explanted due to an infection.It was also reported that the patient had mrsa.The graft had not been cannulated.

Manufacturer Narrative

Review of device sterilization record history confirmed device met pre-release specifications.

• 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: genevieve begay ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3644547
• MDR Text Key: 4340602
• Report Number: 2017233-2014-00089
• 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,Followup,Followup
• Report Date: 04/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2016
• Device Catalogue Number: ECH060040A
• Device Lot Number: 4088342PP019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/25/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/06/2014; 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2013
• 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: 44 YR
• Patient Weight: 84