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

Catalog Number ECH060040A

Device Problem Occlusion Within Device (1423)

Patient Problem Thrombus (2101)

Event Date 10/13/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a patient was implanted with a gore® acuseal vascular graft for arteriovenous access.The dialysis center reported to gore that on (b)(6) 2014, the graft clotted when cannulated with a 15g needle in the medial aspect of the right lower arm on the venous return side of the gore® acuseal vascular graft.On (b)(6) 2014, the graft clotted when cannulated with a 15g needle in the lateral aspect of the right lower arm on the arterial outflow side of the gore® acuseal vascular graft.The graft is currently open and able to be dialized.

Manufacturer Narrative

Results: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Conclusions: the device remained implanted; consequently, a direct product analysis was not possible.Without additional information it is impossible to further investigate this event.

Event Description

The graft is still implanted but the clots have been removed and it is difficult to dialyze the patient through the graft.

• 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: 4243353
• MDR Text Key: 5046594
• Report Number: 2017233-2014-00587
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2017
• Device Catalogue Number: ECH060040A
• Device Lot Number: 4492471PP009
• 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: 06/18/2014
• 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: 85 YR