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

Catalog Number ECH060040

Device Problem Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 11/19/2015

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing records verified that this lot met all pre-release specifications.(b)(4).The review of the sterilization records verified that this lot met all pre-release specifications.The device was discarded, so no engineering investigation could be performed.

Event Description

On (b)(6) 2015, a gore acuseal vascular graft was successfully implanted with the intention to be used for the patient's dialysis.Unfortunately, the patient was not referred back to the physician despite an open wound over the graft (at releasing incision) for something like 6 weeks.On (b)(6) 2015, by the time the patient presented, there was approximately 2cm of exposed graft but no clinical signs of infection of the anastomoses.Therefore, given the patient's extensive co-morbidities and on discussion with the renal team, it was decided to manage the exposed graft conservatively with a negative pressure wound therapy (pico) and continue dialysis in the well-incorporated distal 10cm of graft.This was well controlled until a decision was made in the community (not by the surgeon) to stop applying the pico.Subsequently, control was lost at the local site and the physician made the decision to remove the gore acuseal vascular graft on (b)(6) 2015, and returned the patient to a tunneled neckline.

• 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: barbara ulrich ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5317474
• MDR Text Key: 34076976
• Report Number: 2017233-2015-00908
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/18/2015

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: 03/25/2018
• Device Catalogue Number: ECH060040
• Device Lot Number: 4797639PP021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2015
• 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