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

Model Number HERO 1001

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Sudden Cardiac Death (2510)

Event Date 06/17/2015

Event Type  Death  

Event Description

According to the report, the graft was implanted on (b)(6) 2015 without incident.Right side implant with flixene graft anastomoses to portion of hero arterial graft.Arterial anastomoses to brachial artery which measured 4-6mm under us.Surgeon was very happy with outcome of surgery.About 18 hours after implant, the graft was cannulated and the patient was receiving dialysis (about 2 hours in), when the patient had a cardiac arrest and died.The family denied post-mortem to determine cause of death.Received confirmation from surgeon, chief nephrologist and vascular access clinician that patient was very sick and had a previous dnr order.

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, the graft was implanted on (b)(6) 2015 without incident.Right side implant with flixene graft anastomoses to portion of hero arterial graft.Arterial anastomoses to brachial artery which measured 4-6mm under us.Surgeon was very happy with outcome of surgery.About 18 hours after implant, the graft was cannulated and the patient was receiving dialysis (about 2 hours in), when the patient had a cardiac arrest and died.The family denied post-mortem to determine cause of death.Received confirmation from surgeon, chief nephrologist and vascular access clinician that patient was very sick and had a previous dnr order.Manufacturing records were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The hero graft instructions for use (ifu) lists death as a potential intraoperative and post-operative complication.In this case of a patient with a hero graft anastomosed to a flixene graft, the patient died the day after surgery while receiving dialysis with the altered hero graft; the unofficial diagnosis was "cardiac arrest death." there is no official cause of death, as the family denied "post-mortem" examination.The provided patient history indicates that the patient was "very sick and had a previous dnr order." recent publications have reported on the modification of the hero graft with flixene and the associated ability to cannulate earlier than the typical two weeks.Patients reported in this study were first successfully cannulated as early as 1 day post hero graft implantation with the flixene graft.Four deaths were reported in the publication, but the patients died of causes unrelated to the hero graft.At this time, the role of the hero graft in this post-op death cannot be determined as the hero graft operative notes, patient history and cause of death were not available.The surgeon was pleased with the initial outcome of surgery and did not allege that the hero graft contributed to the death.The patient reported here had a procedure modification to include flixene graft attached to the arterial graft component (agc).The ifu provides adequate instructions to implant the device in the intended configuration.Clinical outcomes with the hero graft in conjunction with a flixene graft have not been evaluated by cryolife.The flixene graft is an approved medical device to be used for av access, so one would anticipate similar clinical outcomes, including anticipated adverse events as those reported above.

Event Description

According to the report, the graft was implanted on (b)(6) 2015 without incident.Right side implant with flixene graft anastomoses to portion of hero arterial graft.Arterial anastomoses to brachial artery which measured 4-6mm under us.Surgeon was very happy with outcome of surgery.About 18 hours after implant, the graft was cannulated and the patient was receiving dialysis (about 2 hours in), when the patient had a cardiac arrest and died.The family denied post-mortem to determine cause of death.Received confirmation from surgeon, chief nephrologist and vascular access clinician that patient was very sick and had a previous dnr order.

• 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: 4875238
• MDR Text Key: 6061106
• Report Number: 1063481-2015-00103
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K124029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,User Facility,consumer,foreign,use
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/22/2015

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: Physician
• Device Model Number: HERO 1001
• Device Lot Number: H14VC022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/22/2015
• Initial Date FDA Received: 06/29/2015
• 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): Death