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

Catalog Number ECH060040

Device Problems Complete Blockage (1094); Peeled/Delaminated (1454)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/08/2021

Event Type  Injury  

Event Description

On (b)(6) 2020, a gore® acuseal vascular graft was implanted in the left forearm as a loop shunt for arteriovenous access for hemodialysis.On (b)(6) 2021, the graft occluded.A thrombectomy was performed to resolve the occlusion.On (b)(6) 2021, the graft occluded again.The physicians performed a thrombectomy to resolve the occlusion.During the procedure they suspected delamination of the graft.On (b)(6) 2021, duplex ultrasound was performed, and the radiologist confirmed delamination of the graft.Reportedly the graft was further used as a dialysis access.Reportedly there was a peculiar circumstance, where the shunt suddenly closed "unannounced" during dialysis.It was reported that the physicians therefore decided to implant a new gore® acuseal vascular graft on (b)(6) 2021, as a loop graft bypassing the occluded graft implanted previously.During the intervention they removed a small part of the previously implanted graft.The remaining graft remains implanted.They inspected the explanted graft and found delamination of the graft.

Manufacturer Narrative

(b)(4).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

H6-codes b14 and c19: a review of the manufacturing records indicated the lots met all pre-release specifications.

Event Description

The patient presented with hypertension, copd, diabetes, peripheral vein disease and renal disease.On (b)(6) 2020, a gore® acuseal vascular graft was implanted in the left forearm as a loop shunt for arteriovenous access for hemodialysis.On (b)(6) 2021, the graft occluded.The physicians performed a thrombectomy to resolve the occlusion.During the procedure they suspected delamination of the graft.On (b)(6) 2021, duplex ultrasound was performed, and the radiologist confirmed delamination of the graft.Reportedly the graft was further used as a dialysis access.Reportedly there was a peculiar circumstance, where the shunt suddenly closed "unannounced" during dialysis.It was reported that the physician therefore decided to implant a new gore® acuseal vascular graft on (b)(6) 2021, as a loop graft bypassing the occluded graft implanted previously.During the intervention they removed a small part of the previously implanted graft.The rest of the graft remains implanted.It was reported to gore, that they inspected the explanted graft and found delamination of the graft.

Manufacturer Narrative

Cause investigation and conclusion: a review of the manufacturing records indicated the lots met all pre-release specifications.The device remains implanted in the patient.Therefore a device evaluation could not be performed.During an additional surgery (reported with gore ref number (b)(4), it 2063970 / 2021171) a small section of the graft has been explanted.Reportedly the explanted section of the graft was discarded at the facility.Therefore an explant evaluation could not be performed.Dicom images have been requested but, as reported to gore, the requested images are not available.Therefore, an imaging evaluation could not be performed.A sketch of the hemodynamics, pictures of the explanted part of the graft, and two screenshot of duplex ultrasound images were provided to gore for evaluation.An engineering evaluation was performed based on these pictures.The evaluation summary states the following: the identity of the reported device is consistent with the device described in the case.The case description could not be confirmed, as no sufficient images of the device were provided for evaluation.The reported failure mode reflects the case description but could not be confirmed.The evaluation found no anomalies attributable to the manufacture of the device.The sketch of the hemodynamics is not complete enough to aid the investigation.The information written down on that sketch list a mix of velocities and volumetric flow rates at what appears to be different locations along the graft that cannot be confirmed and doesn¿t add value the evaluation.Based on the event description and the subsequent investigation we are unable to determine the cause of this incident and assign a root cause.In the instructions for use the following possible complications are stated: v.Possible complications with the use of any vascular prosthesis a.Complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis; mechanical disruption of the graft.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14850054
• MDR Text Key: 294903277
• Report Number: 2017233-2022-03060
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: NL
• 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: 01/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2023
• Device Catalogue Number: ECH060040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2020
• 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): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Female