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

Catalog Number ECH060040J

Device Problem Complete Blockage (1094)

Patient Problem Seroma (2069)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing records could not be performed as no lot number information was provided.The investigation is ongoing.(b)(4).

Event Description

The following was reported to gore: a gore® acuseal vascular graft was implanted in an arteriovenous access application for the patient with renal dysfunction.At a later date, the doctor reported possible seroma/thrombus was observed in the graft near the patient¿s elbow.The doctor reported that part of the graft was removed and another vascular graft was implanted fto complete the vascular reconstruction.

Manufacturer Narrative

Examination of the returned specimen revealed the following: no silicone was present in the device lumen, and no evidence of bacteria was noted.The returned device was subjected to an enzymatic digestion process.Manipulation of the graft material associated with repeated cannulation is evident.Examination of the abluminal surface demonstrates that the cannulation sites are occupied by silicone.Post digestion image of the device fragment revealed several marks consistent with double pass through the graft during cannulation.All information has been placed on file for use in tracking and trending.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7173829
• MDR Text Key: 96695965
• Report Number: 2017233-2018-00009
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ECH060040J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention