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

Catalog Number ECH470045A

Device Problem Material Discolored (1170)

Patient Problems Autoimmune Disorder (1732); Inflammation (1932); Swelling (2091)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The explanted graft is expected to be returned.

Event Description

It was reported to gore that on (b)(6) 2017, a gore® acuseal vascular graft was implanted in a patient's arm in an arteriovenous access application.On (b)(6) 2017, the patient presented with bullous pemphigoid on the arm.The physician stated the blisters first occurred over the vascular graft shortly (unspecified date) after the implant procedure.In a conservative approach, the physician elected to explant the gore® acuseal vascular graft.It was stated the vascular graft had elicited an immune response with no incorporation in the tunnel and caseating granulomatous severe inflammation at the anastomoses.As reported, the vascular graft also had a strange color.Cultures were sent to the user facility laboratory to rule out infection.

Manufacturer Narrative

Udi number: (b)(4).Device lot number was provided.Review of device manufacturing record history confirmed device met pre-release specifications.

Manufacturer Narrative

Patient's age and dob were received.

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 ; 9285263030
• MDR Report Key: 6666929
• MDR Text Key: 78389557
• Report Number: 2017233-2017-00322
• 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,Followup
• Report Date: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/08/2018
• Device Catalogue Number: ECH470045A
• Device Lot Number: 5010853PP004
• 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: 11/09/2015
• 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: 60 YR