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

Catalog Number ECH060040

Device Problem Contamination (1120)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Thrombosis (2100); Stenosis (2263)

Event Date 03/29/2012

Event Type  Injury  

Event Description

On (b)(6) 2012, a patient in a study was implanted with a gore® acuseal® vascular graft from the left superficial femoral artery to the femoral vein.On (b)(6) 2012, the graft was first cannulated.On (b)(6) 2012, the patient presented with venous stenosis, thrombosis and an infected hematoma.A declot procedure and angioplasty was performed.On (b)(6) 2012, the patient presented with venous anastomotic stenosis and a surgical revision was performed.On (b)(6) 2012, the infected graft was explanted.On (b)(6) 2012, the patient received a transplanted kidney.

Manufacturer Narrative

This event is from the following literature article: aitken el, jackson aj, kingsmore db.Early cannulation prosthetic graft (acuseal¿) for arteriovenous access: a useful option to provide a personal vascular access solution.Journal of vascular access.In press.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.No further information is available.Without additional information it is impossible to further investigate this event.

Manufacturer Narrative

A review of the sterilization records for the device verified that the lot met all pre-release specifications.

• 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 86004 ; 9285263030
• MDR Report Key: 3854068
• MDR Text Key: 15818506
• Report Number: 2017233-2014-00296
• 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: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/26/2014

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: 09/28/2014
• Device Catalogue Number: ECH060040
• Device Lot Number: 3646113PP006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/06/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/26/2014; 06/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2011
• 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: 41 YR