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

Catalog Number ECH060040A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tingling (2171); Numbness (2415)

Event Date 02/18/2014

Event Type  Injury  

Event Description

On an unknown date, a gore acuseal vascular graft was implanted in a patient.While patient was still in hospital after primary procedure, the surgeon banded the gore acuseal vascular graft to prevent arterial steal development.Treatment was performed due to some tingling and numbness.The patient has diabetes and multiple complications, including carpal tunnel syndrome.

Manufacturer Narrative

Device lot number was not made available and device remains in patient.

Manufacturer Narrative

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

Event Description

On (b)(6) 2014, a gore acuseal vascular graft was implanted in patient's left arm, from brachial artery to axillary vein.The graft remains implanted.Patient's complaint about pain continued after surgery.Banding procedure was done on (b)(6) 2014, to reduce swelling and pain.

Manufacturer Narrative

(b)(4).Device manufacturing record history currently in progress.

• 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: 3678030
• MDR Text Key: 16775663
• Report Number: 2017233-2014-00128
• 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: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2016
• Device Catalogue Number: ECH060040A
• Device Lot Number: 4195454PP006
• 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: 09/10/2013
• 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: 79 YR