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

Catalog Number S47048

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Date 11/18/2007

Event Type  Injury  

Manufacturer Narrative

Shemesh d, goldin i, hijazi j.A prospective randomized study of heparin-bonded graft (propaten) versus standard graft in prosthetic arteriovenous access.J vasc surg 2015;62:115-22.(see attachment below) lot: 05091769.(b)(4).Medications: asa.A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remained implanted; consequently, a direct product analysis was not possible.

Event Description

In the medical literature, an article, "a prospective randomized study of heparin-bonded graft (propaten) versus standard graft in prosthetic arteriovenous access." was reviewed.Patients with end-stage renal failure requiring a prosthetic access were randomized to receive either a standard expanded polytetrafluroethylene (eptfe) graft or a heparin-bonded eptfe graft.Patients were enrolled from june 2007 until november 2011 and were followed up until july 2013, when the study concluded.The performance of gore propaten vascular grafts in resisting thrombosis, decreasing early failure and possibly prolonging patency was assessed.On (b)(6) 2007, a patient was implanted with a gore-tex stretch vascular graft for arteriovenous access from the brachial artery to the basilic vein.It was reported to gore that on (b)(6) 2007, the patient presented with a thrombosed graft.A declot procedure was performed.

• Brand Name: GORE-TEX® STRETCH 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: 5085707
• MDR Text Key: 26114283
• Report Number: 2017233-2015-00616
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Report Date: 09/07/2015

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: 05/29/2012
• Device Catalogue Number: S47048
• Device Lot Number: 05091769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2007
• 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: 69 YR