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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Unspecified Infection (1930); No Code Available (3191)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

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

The following was reported to gore: this clinical trial case concerns an (b)(6)-year old white male subject (b)(6).On (b)(6) 2017, a study conduit was placed in the left upper arm.On (b)(6) 2020, 1127 days after implant, the subject experienced stenosis of vascular access.He attended his month 36 study visit that day.A duplex ultrasound (us) of the study conduit revealed stenosis on the arterial side of the graft.Pseudoaneurysm was seen on the arterial side of the graft measuring 0.50 cm x 0.41 cm.Stenosis was seen on the venous side of the graft.Subclavian and axillary vein outflows were patent without evidence of stenosis or thrombus.On (b)(6) 2020, the subject was hospitalized for the event stenosis of vascular access, and infection of the vascular access in the axillary vein.He had presented for fistulogram with angioplasty that day, and an ulceration was found overlying the graft, with pus present.Fistulogram was performed, confirming high-grade stenosis at of the distal graft at the site of the overlying ulceration.Approximately 50 % stenosis of the venous anastomosis was seen; the remaining axillary vein, left subclavian vein, left innominate vein, and superior vena cava were otherwise widely patent.Angioplasty of the venous anastomosis was performed using a 6 x 40 mm balloon.Post-angioplasty fistulogram demonstrated no significant residual stenosis.Operative revision of the study conduit was planned for the following day.On (b)(6) 2020, following unsuccessful overnight attempts to cannulate the study conduit for dialysis, the subject experienced thrombosis of vascular access.Therefore, he underwent surgical revision of the study conduit with excision of the ulcerated study conduit and interposition of a 6 mm bovine graft, thrombectomy at the distal graft and mid graft, and angioplasty of the proximal study conduit.The study conduit was dissected proximally and distally; no thrill was present within.A longitudinal incision was made overlying the distal portion in the medial arm proximal to the venous anastomosis.The study conduit was dissected free circumferentially; 1000 units of heparin were administered, and the distal portion was opened and revealed a fresh thrombus.A 5 french embolectomy catheter was used to thrombectomize the venous limb.There was good backbleeding.The graft was then irrigated using heparinized saline.The mid graft was then opened which revealed another fresh thrombus; 2000 units of heparin were administered.Thrombectomy was performed with a 4 french catheter which resulted in good pulsatile inflow.The arterial limb was then irrigated using heparinized saline and the graft was clamped.The mid graft and distal end were then dissected back and then transected.A 6 mm bovine graft was then anastomosed to the study conduit, which resulted in a palpable thrill throughout the length of the graft.The proximal graft was then cannulated; fistulogram revealed a focal area of stenosis which was dilated with a 6 mm cook balloon.There were two wound beds which were irrigated and then closed in layers.An incision was made around the areas of ulceration and purulent drainage was visualized and cultured.Next, the study conduit was dissected free in its entirety and sent for cultures.There was a good thrill overlying the graft and a palpable radial pulse.All three events were considered resolved after the procedure.On (b)(6) 2020, exploration, washout and closure of the surgical wound were performed.The wound bed was irrigated; there was no purulent drainage; the wound was closed and wrapped.There was a strong thrill over the graft and triphasic and ulnar signals following the procedure.On (b)(6) 2020, the subject was discharged from the hospital.

Manufacturer Narrative

As the graft was previously cannulated for av access the infection will be considered non-reportable and this medwatch report will be retracted.

• Brand Name: GORE PROPATEN 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
• MDR Report Key: 10805237
• MDR Text Key: 215338973
• Report Number: 2017233-2020-01425
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Patient Sequence Number: 1