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

Catalog Number ECH060040J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Numbness (2415); Pseudoaneurysm (2605); Alteration In Body Temperature (2682)

Event Date 12/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2016, a patient presented with an infection and a pseudo-aneurysm formation of an existing av graft (unknown manufacturer).The previously implanted av graft was explanted, and a gore® acuseal vascular graft was implanted in the patient's upper left arm in an arteriovenous access application.On or about (b)(6) 2016, the patient presented with coldness and numbness in the left fingers and was diagnosed with arterial steal syndrome.On (b)(6) 2016, the patient underwent proximal arterial inflow (pai) procedure using another graft (unknown manufacturer) to treat arterial steal syndrome.The symptom was resolved.

• 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 ; 9285263030
• MDR Report Key: 6641358
• MDR Text Key: 77578702
• Report Number: 2017233-2017-00298
• 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: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/09/2019
• Device Catalogue Number: ECH060040J
• Device Lot Number: 5156047PP020
• 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: 03/09/2016
• 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: 80 YR