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

Catalog Number ECH460045J

Device Problem Peeled/Delaminated (1454)

Patient Problem Renal Failure (2041)

Event Date 02/27/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

The following was reported to gore: on (b)(6) 2019, the patient presented for shunt construction in the arm because of renal failure.A gore® acuseal vascular graft was implanted.Approximately 2-3 week post implant, the first puncture was performed.On (b)(6) 2020, ultrasound scan revealed irregularities within the graft (details are unknown).On (b)(6) 2020, pta ballooning was performed.On (b)(6) 2020, ultrasound scan revealed a flap-like part in the venous side of the acuseal vascular graft.The physician suspected delamination of the graft.On the arterial side of the acuseal vascular graft, traces of wall puncture were observed.The physician suspected thrombus.A part of the device was removed by the physician.

Manufacturer Narrative

Corrected date: h6.Results code 1 additional manufacturer narrative: review of the manufacturing records verified that the lot met release requirements.The investigation is ongoing.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #6365351pp007.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Manufacturer Narrative

Corrected data: h6.- method code 2; h6.- results code 2; h6.- conclusions code 1; additional manufacturer narrative: examination of the returned device revealed the following: all material findings (i.E., radial film disruptions, cannulation holes, forceps marks) appear to be consistent with intervention during a surgical procedure (i.E., tunneling, cannulation, and grasping/pulling).There was no ¿flaplike structure¿ observed in the lumen during post-digestion analysis.The graft layers were intact and material delamination was not observed on any device fragment.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9879034
• MDR Text Key: 189484377
• Report Number: 2017233-2020-00213
• 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,Followup,Followup
• Report Date: 08/06/2020

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: 05/10/2022
• Device Catalogue Number: ECH460045J
• Device Lot Number: 6365351PP007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 03/31/2020; 07/31/2020; 08/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other