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

Device Problem Complete Blockage (1094)

Patient Problem No Code Available (3191)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

No actual event date was provided.Therefore, date of event is an estimate based on 4 weeks post implant (per the doctor).Review of the manufacturing records could not be performed as no lot number information was provided.The device(s) was not returned.Consequently, direct product analysis was not possible.Additional information about this event could not be obtained.As a result, no conclusion can be drawn.All information has been placed on file for use in tracking and trending.

Event Description

The following published article was reviewed: 'preservation of heparin-bonded prosthetic graft for hemodialysis in the setting of early heparin-induced thrombocytopenia'; scott r.Levin, alik farber, and jeffrey j.Siracuse, boston, ma.Published by 2020 elsevier inc.; https://doi.Org/10.1016/j.Avsg.2019.12.017.The aim of this case study was to evaluate outcomes of the preservation of heparin-bonded prosthetic grafts for hemodialysis in the setting of early heparin-induced thrombocytopenia.There was one patient, a (b)(6) year old female treated with a tapered 4-7mm gore® propaten® vascular graft.She was given 5,000 units of subcutaneous heparin preoperatively and received no heparin during the procedure.She was discharged without perioperative complications.At follow-up two weeks postoperatively, the patient¿s wounds were well-healed, and her graft was patent with a palpable thrill.Subsequently, at one month postoperatively, she presented with volume overload and was found to have an occluded av graft.To expedite hemodialysis initiation, she was admitted and underwent endovascular intervention with balloon maceration, angioplasty of the venous outflow, and over-the-wire balloon embolectomy of the arterial inflow.She was administered 5,000 units of intravenous heparin during the case and 5,000 units of subcutaneous heparin three times daily that was started one day prior and continued post-procedurally.The patient's platelet count pre-procedurally was 303,000 per microliter (ml).On post-procedure day (ppd) 1, her platelets decreased to 14,000/ml.There were no other significant laboratory abnormalities.Given the possibility of hit, all heparin products were held, and argatroban started.A serotonin release assay resulted positive, confirming the diagnosis.Hemodialysis through the av graft was initiated on ppd 2.Platelet levels gradually recovered to within normal limits by ppd 6 at which point she was transitioned to warfarin for a planned 1-month course.At 21 months after index av graft placement, she had a patent av graft that was still being used for heparin-free dialysis, and she was not requiring anticoagulation.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #unk.Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10254380
• MDR Text Key: 201442022
• Report Number: 2017233-2020-00464
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• 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: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARGATROBAN
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR