MAUDE Adverse Event Report: CRYOLIFE, INC. HERO GRAFT; VASCULAR GRAFT

Model Number HERO 1001

Device Problems Complete Blockage (1094); Insufficient Information (3190)

Patient Problems Thrombosis (2100); Obstruction/Occlusion (2422)

Event Date 05/08/2015

Event Type  Injury  

Event Description

According to the notification form, "hero graft removal due to blockage.Full details not yet available awaiting surgeon feedback.".

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Manufacturer Narrative

According to the notification form, "hero graft removal due to blockage.Full details not yet available awaiting surgeon feedback." although this report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.According to the operation report supplied by the surgeon, on (b)(6) 2015 the procedure was "removal of perm cath.[catheter] drainage of the pseudoaneurysm." pathology was listed as "occluded hero graft in a patient with esrd [end-stage renal disease].He also has a pacemaker." the procedure notes stated the following: "identify the connection of the atrial stented catheter and the ptfe graft in the deltoid groove.Attempt at thromboembolectomy with a no 3 fogarty without any success.Explore the distal anastomosis which was performed to the existing av [arteriovenous] fistula and the venous component.This indicated a sever stenosis due to most probably new intimal hyperplasia.Considering the situation the proximal part of the vein was not regarded as optimal for an av fistula and the graft was severed.The graft was left in situ.The pseudoaneurysm was drained and 19 french drain inserted.The atrial stent is removed as well as the connector.All wounds rinsed with saline.Haemostasis acquired as good as possible in a patient with a bleeding tendency.A 19 french drain inserted in the arm in the pseudoaneurysm site.A compression bandage is applied at the end of the procedure.Radial palpable." the surgeon commented on the operation report "after removal of the hero graft, the most significant finding was that of stenosis and subsequent occlusion of the graft vein anastomosis of the existing av fistula.The diameter of the vein at the anastomotic site might not have been adequate to support flow in order to prevent thrombosis." further additional information was received from the surgeon.The date of implant was (b)(6) 2015.Lot numbers included h14ak002 (accessory component kit; not investigated as it would not contribute to the reported event), h14vc019, and h14av008.The occlusion was first discovered on (b)(6) 2015 and the explant occurred on (b)(6) 2015.The venous outflow plus anastomosis onto previous avf [arteriovenous fistula] was explanted.The patient's medical history included "esrd due to diabetes and hypertensive nephropathies.Rrt [renal replacement therapy] dependent since 2010.Previous access: pd [peritoneal dialysis] failed? peritonitis/right brachiocephalic avf - pulsatile pseudoaneurysm, no outflow / left brachiocephalic avf primary failure.Complicated by pacemaker." the patient's access history included "(b)(6) 2014 failing (r) brachiocephalic avf." the patient did not suffer from a hypercoagulable disease, the hero graft was not being cannulated at the time of the occlusion, and cannulation was never attempted, thus the primary failure.The patient's current status was listed as "wounds did heal.Dialysis via a femoral catheter." manufacturing records for lots h14vc019 and h14av008 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met cryolife release specifications.A review was performed of the available information.The patient had a hero graft implanted in (b)(6) of 2015, which was anastomosed to an existing avf.In early (b)(6) 2015 graft occlusion was first identified and in (b)(6) 2015 the voc and a portion of the acc which was anastomosed to the previous avf was explanted; a majority of the agc was left in situ.Prior to explant a thrombectomy was attempted but was unsuccessful.Partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).The following information was not reported: implant operative notes and medical history.Patient history was significant for diabetes, hypertensive nephropathologies, peritonitis, a pacemaker, "bleeding tendency," and a pulsatile pseudoaneurysm (associated with previous right brachiocephalic avf).There was no documented history of a hypercoagulable disease.Severe stenosis was due to "most probably new intimal hyperplasia" and was discovered around the distal anastomosis of the avf and the graft.The surgeon noted that the diameter of the vein at the anastomotic site "might not have been adequate to support flow in order to prevent thrombosis." the hero graft ifu states that a brachial or target artery inner diameter that is less than 3mm is considered a contraindication for hero graft implantation.It is unclear what the diameter of the vein was and if it met the aforementioned eligibility requirements.Without additional information on the implant procedure, the relationship between the hero graft and the occlusion cannot be established.At the time of explant the patient required drainage of a pseudoaneurysm.The patient had a failing right brachiocephalic avf in (b)(6) 2014 which was associated with a pulsatile pseudoaneurysm.Therefore, the source of the pseudoaneurysm is unknown, but the location was reported to be in the avf.The surgeon attributed the occlusion to intimal hyperplasia at the anastomotic site and noted a concern regarding vein diameter.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk.The ifu lists the following potential complications with the use of the hero graft: partial stenosis or full occlusion of prosthesis or vasculature.The ifu states "the following patient considerations should be evaluated prior to initiating the implant procedure: the target artery must have an [interior diameter] id of at least 3mm to provide adequate arterial inflow to support the graft.".

Event Description

According to the notification form, "hero graft removal due to blockage.Full details not yet available awaiting surgeon feedback." although this report is submitted for product code hero 1001, both product codes hero 1001 and hero 1002 were investigated.

• Brand Name: HERO GRAFT
• Type of Device: VASCULAR GRAFT
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 4931575
• MDR Text Key: 6435637
• Report Number: 1063481-2015-00125
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: HERO 1001
• Device Lot Number: H14VC019, H14AV008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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