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

Catalog Number ECH060040J

Device Problem Hole In Material (1293)

Patient Problems Hematoma (1884); Swelling (2091)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was not returned; consequently, a direct product analysis was not possible.

Event Description

On (b)(6) 2016, a gore acuseal vascular graft was implanted in an arteriovenous access application.The implant was successful.On (b)(6) 2016, the graft was cannulated for dialysis access.Homeostasis was confirmed after holding pressure for 15 minutes.It was reported to gore that the patient presented with a swollen arm immediately.A hematoma was observed near the cannulation site.On the same day, the graft was explanted and a central catheter was placed.It was reported that the patient did not have sufficient subcutaneous tissues and the puncture was accidentally made on the side of the graft which made the homeostasis difficult.

• 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5737154
• MDR Text Key: 47791201
• Report Number: 2017233-2016-00591
• 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: 06/01/2016

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: 02/24/2019
• Device Catalogue Number: ECH060040J
• Device Lot Number: 5144757PP014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2016
• 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: 70 YR