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

Catalog Number 0650HYB0910A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 03/16/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records verified that the lot met all pre-release specifications.The device remains implanted, therefore a direct product analysis could not be performed.The instructions for use address the potential for the following events among others: "complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: redundancy; infection; ultrafiltration or perigraft seroma; thrombosis; mechanical disruption or tearing of the suture line, graft, and / or host vessel; excessive suture hole bleeding; formation of pseudoaneurysms due to excessive, localized, or large needle punctures; or perigraft hematomas.

Event Description

It was reported to gore that on (b)(6) 2016 a patient underwent the placement of a gore® hybrid vascular graft for av hemodialysis access.The graft was placed in the left arm in a loop configuration.On (b)(6) 2016, thrombosis was identified in the arterial and venous anastomoses.The patient underwent a thrombectomy on (b)(6) 2016 and on (b)(6) 2016, the graft was found to be patent upon duplex ultrasound.

• Brand Name: GORE® HYBRID VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL CENTRAL B/P; 1500 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gretchen farrall ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5691220
• MDR Text Key: 46284097
• Report Number: 2017233-2016-00543
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093934
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2016
• Device Catalogue Number: 0650HYB0910A
• Device Lot Number: 11530242A
• 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: 06/04/2013
• 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: 54 YR
• Patient Weight: 93