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

Model Number HT067090A

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Thrombus (2101); No Code Available (3191)

Event Date 04/16/2020

Event Type  Injury  

Manufacturer Narrative

A direct product analysis is ongoing.

Event Description

It was reported to gore: a bypass was performed with a 6 mm gore® propaten® vascular graft in the morning, and clotted in the afternoon.The physician went in for revision of the graft at the tibial artery, the doctor mentioned the artery was small but did not indicate the size of the artery diameter.He placed a stent (unknown device) at the tibial artery.Doctor mentioned that only a small portion of the propaten® vascular graft was exposed to the blood stream at the femoral artery due to the additional stent placement.The patient received 6000 iu at the beginning of the procedure, then 2000iu about 45 minutes later during the procedure (it was not clear if he meant initial procedure or de-clot/stent procedure), doctor starting seeing clot after 8000 iu of systemic heparin had been given.He saw clot in the field and thrombus in the graft again, thrombus in the graft was noted as white clot, which could be doctor knew to be indicative of hit.He began the cessation of systemic heparin and placed patient on agatroban®.Has a hematologist on the case; sent out a hit panel, but does not have results yet.Patient platelets were initially 189,000, three days later were measured at 130,000.Doctor didn't believe the small amount of the propaten graft interacting with the blood could trigger hit, but also was concerned that this patient to his knowledge had never received heparin prior to this procedure and had an immediate reaction.Timeline from the doctor suggests he implanted the device in the morning and clot/revision procedure in the afternoon of the same day.Doctor mentioned if he decided he needed to re-operate, he would completely re-do the bypass with a new graft.The doctor decided to explant the gore® propaten® vascular graft and us a different gore device that was not a propaten® device along with agatroban® on (b)(6) 2020.It was stated that the hemotologist still can not explain what happened during the initial surgeries.The explanted graft is being held in the hospital's pathology department, and will be returned to gore once the histology kit has been received.

Manufacturer Narrative

Additional manufacturing narrative: c1.Name (#1) - cbas® heparin surface; manufacturer/compounder: w.L.Gore & associates, inc.Lot #5418525pp007.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

Additional manufacturer narrative: examination of the returned device revealed the following: tissue present along the luminal surface of the submitted gore® propaten® vascular graft segment was consistent with acute thrombus.Aside from red blood cells either interspersed throughout and/or sedimented as part of the post-explantation process, the tissue contained few entrapped leukocytes.The amount of tissue, present along the luminal surface, ranged from small to moderate and the lumen of the vascular graft segment was patent.Tissue present along the abluminal surface and within the vascular graft wall was proteinaceous and paucicellular.There was no microscopic evidence of an infection.

Manufacturer Narrative

Additional manufacturer narrative: review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• Brand Name: GORE PROPATEN VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 10059578
• MDR Text Key: 194674362
• Report Number: 2017233-2020-00359
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132606665
• UDI-Public: 00733132606665
• 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,Followup,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2020
• Device Model Number: HT067090A
• Device Catalogue Number: HT067090A
• Device Lot Number: 5418525PP007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2020
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other