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

Catalog Number ECH470045A

Device Problem Device Damaged by Another Device (2915)

Patient Problems Occlusion (1984); Blood Loss (2597)

Event Date 09/26/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to gore that on (b)(6) 2016, a gore® acuseal vascular graft was implanted in a patient's upper left arm in a loop fashion.The acuseal graft had been implanted for arteriovenous access and was cannulated numerous times post implant.As reported, multiple interventions were performed due to recurrent thromboses.On (b)(6) 2017, the patient presented with thrombosis and open thrombectomy, angioplasty and stenting were performed at the distal end of the graft.On (b)(6) 2017, the patient's arm was bleeding.It was reported that during the intervention, the middle layer of the graft was observed to be loose inside the lumen.The acuseal graft was explanted and a perm catheter was placed.The patient was reported to be doing well post-procedure.

Manufacturer Narrative

The explant evaluation states, submitted unfixed was one gore® acuseal vascular graft fragment (vgf-1).The fragment had been transected at both poles and longitudinally transected prior to arrival at w.L.Gore and associates.The albumen contained scattered plaques of fibroadipose tissue.The lumen was largely devoid of tissue with a single firm nodule of soft tissue.There were two areas of linear material separation in the lumen.Multiple transmural perforations were grossly visible.Histopathological examination of three fragment cross-sectional specimens from vgf-1 was performed.The submitted fragment of gore® acuseal vascular graft was patent and had two grossly evident partially transmural linear disruptions in the luminal surface associated with transmural perforations (cannulations, presumptive).The remainder of the specimen was grossly unremarkable.Microscopically, there were multiple transmural perforations filled with mature collagenous connective tissue.Connective tissue extended through the perforations and was present as flat plaques of tissue between the basetube and elastomeric layer as well as on the luminal surface of the graft where it was admixed with thrombus.There was marked disruption of the elastomeric layer which may be partially secondary to histologic processing (as is typical for silicone biomaterial) but also existed in-vivo as evidenced by the intramural connective tissue.There was no evidence of infection.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices were examined for material disruptions with the aid of a stereomicroscope.Vgf-1c was platinum sputter coated and examined with a scanning electron microscope.Disruptions identified were not associated with handling or manufacturing process at wl gore and associates.The transected ends and edges are consistent with a sharp instrument used during a surgical procedure.The numerous penetrating perforations are consistent with cannulation of the graft for dialysis access.Material layer separation is observed in heavily cannulated regions.In two locations, longitudinal division of the silicone layer and separation of the luminal film is present.Both areas are located directly beneath the plane of longitudinal transection.The cause of those disruptions cannot be determined.

• Brand Name: GORE® ACUSEAL VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: genevieve begay ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6977970
• MDR Text Key: 90284549
• Report Number: 2017233-2017-00555
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2018

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: 05/13/2019
• Device Catalogue Number: ECH470045A
• Device Lot Number: 5200523PP003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2016
• 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: 71 YR
• Patient Weight: 95