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

Device Problems Complete Blockage (1094); Peeled/Delaminated (1454); Material Puncture/Hole (1504)

Patient Problem Occlusion (1984)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

Review of the manufacturing records could not be performed as no lot number information was provided.Examination of the returned specimen revealed the following: material disruptions were consistent with needle puncture during cannulation of the graft while implanted and handling of the device with surgical instrumentation (e.G., scalpel, forceps) during the explant procedure.The extent of luminal disruptions were not consistent with the disruptions observed on the abluminal surface.The additional luminal damage appeared to be a result of the shallow angle of cannulation however, contribution from use of a thrombectomy device cannot be ruled out; details on the thrombectomy procedure were not provided.All information has been placed on file for use in tracking and trending.

Event Description

On (b)(6) 2017, the patient was implanted with a gore® acuseal vascular graft for hemodialysis shunt.The patient tolerated the procedure.On (b)(6) 2018, follow-up revealed graft occlusion at outflow of the vein and delamination at puncture spot.On (b)(6) 2018, a thrombectomy was performed.A section of graft was removed and another gore® propaten® vascular graft was implanted.The patient tolerated the procedure.

Manufacturer Narrative

Corrected data: date of event additional manufacturer narrative: gore became aware of the reportability of this event on (b)(6)2018.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8449855
• MDR Text Key: 139803387
• Report Number: 2017233-2019-00171
• 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: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• 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
• Patient Age: 81 YR