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

Catalog Number ECH060040J

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Erosion (1750); Unspecified Infection (1930)

Event Date 09/09/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).No lot number information was supplied; therefore, no review of the manufacturing paperwork could be performed.The device was not returned.Therefore, direct product analysis was not possible.

Event Description

It was reported to gore that in 2016 (date unknown), a patient was implanted with a gore® acuseal vascular graft in the forearm for arteriovenous access.The graft was anastomosed as a loop graft.On (b)(6) 2017, patient presented with tissue and graft infection, as well as graft exposure.The acuseal vascular graft was explanted and a gore® propaten® vascular graft was implanted at the same location in the arm.The patient tolerated the procedure.It was also reported the patient has thin subcutaneous tissue.

Manufacturer Narrative

Additional medical history was entered.The explant date was entered.

Manufacturer Narrative

Medical history was modified.Explant date was corrected.The explant date listed in follow-up #1 is incorrect.

• 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: 6912762
• MDR Text Key: 88104592
• Report Number: 2017233-2017-00520
• 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,Followup,Followup
• Report Date: 11/09/2017

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 Catalogue Number: ECH060040J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/09/2017; 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 70 YR