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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969)

Event Date 07/01/2014

Event Type  Injury  

Manufacturer Narrative

Physician stated the event was not related to the graft itself, but was related to the patient's condition.

Event Description

On (b)(6) 2014, a patient was implanted with a gore acuseal vascular graft in the right brachial axillary for arteriovenous access.The graft was cannulated on (b)(6) 2014.It was reported to gore that on (b)(6) 2014, the graft lost primary patency.In (b)(6) 2014, two central venous catheters were implanted.Further it was stated that the patient had frail skin which exposed the graft.The graft was explanted since it was not usable, developed pseudo aneurysm and patient bled from arterial end of graft after explanation , further re-exploration was required.The patient died on (b)(6) 2014 on a myocardial infarction.This is part of a data collection study from dr.(b)(6) using the gore acuseal vascular graft for arteriovenous access.

• 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: 5238378
• MDR Text Key: 31675666
• Report Number: 2017233-2015-00820
• 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,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 82 YR
• Patient Weight: 54