MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® ACUSEAL VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Catalog Number ECH060040

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

As the device remains implanted, a further investigation on the device cannot be performed.It was requested if the thrombus is available to be sent back for further investigation.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

Event Description

It was reported to gore that patient underwent surgical treatment on (b)(6) 2021 for a centralization of a loop shunt with gore-tex® interponat with end-to-side anastomosis at the axillary artery and end-to-end anastomosis at the cephalic vein on the proximal upper arm with a gore® acuseal vascular graft.It was stated that on (b)(6) 2021 there was an acute loop shunt occlusion at the axillary artery and cephalic vein (upper arm) left because of an extensive stenosis of the cephalic vein.To solve the issue a thrombectomy of the loop-shunt and an extension of the venous limb on the brachial vein at the proximal upper arm left was performed.It was reported that the patient has tolerated the procedure.

Manufacturer Narrative

Product history review: a review of the manufacturing records indicated the lots met all pre-release specifications.Explant investigation of the returned thrombus a tissue fragment was returned to w.L.Gore & associates for investigation.Submitted in formalin was a tissue fragment that had been reportedly removed via thrombectomy from an implanted gore acuseal vascular graft.The fragment was tan to dark brown, linear soft tissue, in a tubular/luminal cast of tissue.The fragment measured approximately 90 mm (length) x 3-6 mm (diameter).The specimen was submitted for histopathologic sampling.Tissue preservation was poor with marked loss of stain/cellular differentiation.Fibrin deposition with varying reorganization and infiltration by minute inflammation within the lumen of the gore acuseal vascular graft was typical and an expected normal healing response to a chronically implanted device.It is uncertain if cannulation interaction may have induced infiltration of the external fibrous connective tissue to the unorganized luminal thrombus, which after time becomes organized into fibrous connective tissue (i.E., neointima).

Manufacturer Narrative

Product history review: a review of the sterilization records indicated the lots met all pre-release specifications.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12346898
• MDR Text Key: 267410938
• Report Number: 2017233-2021-02292
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: GM
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2023
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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: 66 YR
• Patient Sex: Male