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

Catalog Number ECH050050J

Device Problem Mechanical Problem (1384)

Patient Problem Occlusion (1984)

Event Date 02/21/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

On an unknown date, this patient underwent treatment in the right forearm for chronic renal failure using a gore® acuseal vascular graft as a shunt.On an (b)(6) 2020, it was reported the acuseal was occluded.A thrombectomy procedure was performed to treat the occlusion.The physician suspected delamination of the acuseal.The cause of occlusion and delamination is unknown.In addition, the physician reportedly did not suspect that the cause of occlusion is the delamination.The patient tolerated.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #6292945pp007.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

Additional manufacturer narrative: d7.If explanted, give date.G4.Date received by manufacturer (mm/dd/yyyy).H6.Method code 2.H6.Results code 2.The specimen was returned to w.L.Gore & associates for investigation.Submitted in formalin was one specimen reportedly removed from a gore® acuseal vascular graft.The specimen appeared to consist of varied thickness tissue with no presence of biomaterial evident.The specimen was tubular in shape, possessed a patent lumen and presented light tan to light yellow and was opaque.The abluminal surface was smooth with a single linear disruption visible on the abluminal surface which appeared consistent with a cannulation site.Along one pole of the specimen, the tissue appeared to slightly protrude inward into the lumen.Histopathological examination of a cross section of the specimen was performed.Based on the gross and microscopic appearance of the tubular-shaped tissue, it is determined to be acute thrombus originating from the luminal surface, presumably of a gore® acuseal vascular graft.The lumen that the tissue formed was patent.Red blood cells did not predominate in the tissue specimen and the inflammatory cells that were present were sparsely interspersed throughout and consequently were determined to have been entrapped during thrombus formation.There was no gross or microscopic evidence of graft material in the submitted specimen.Finally, there was no microscopic evidence of infection.The remainder of the specimen was submitted for enzymatic digestion to rule out the presence of any nonbiologic materials.During the enzyme digestion process the specimen was completely consumed further supporting it was comprised of biologic material only with no graft material present within the retuned specimen.

Manufacturer Narrative

Corrected data: h6 - conclusions code 1.

• Brand Name: GORE ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9837689
• MDR Text Key: 196399463
• Report Number: 2017233-2020-00187
• 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: 03/04/2021

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: 03/10/2022
• Device Catalogue Number: ECH050050J
• Device Lot Number: 6292945PP007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/31/2020; 02/18/2021; 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 89 YR