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

Model Number HERO 1001 AND HERO 1002

Device Problem Complete Blockage (1094)

Patient Problems Ischemia (1942); Thrombosis (2100); Sudden Cardiac Death (2510)

Event Date 11/01/2014

Event Type  Death  

Manufacturer Narrative

Note: this mdr is being re-sent as initial.This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to the report, "after multiple shunt revision left patient received hero (b)(6)2014 with arterial anastomosis on the shuntvene lower arm 11/2014 closure of shuntvene vene and hero (b)(6) 2014 thrombectomy hero, revise arterial anastomosis on brachialis, shunt ligature - 5 days post operative mensenteriale ischemia - 5 days later patient death after successless reanimation on intensive care ward - cardiac reasion.".

Manufacturer Narrative

According to the report, "after multiple shunt revision left patient received hero (b)(6) 2014 with arterial anastomosis on the shuntvene lower arm, (b)(6) 2014 closure of shuntvene vene and hero, (b)(6) 2014 thrombektomie hero, revise arterial anastomosis on brachialis, shuntligatur, 5 days postoperative mesenteriale ischemia, 5 days later patient death after successless reanimation on intensive care ward, cardia reason." multiple contact attempts were made to obtain date of implant and lot number, the date of the occlusion, the date of the thrombectomy, meaning of terminology used, patient impact, and any other patient information available including whether or not the mesenteric ischemia and death were related to the hero graft.The following additional information was received: the lot numbers associated with this complaint are h14av014 and h14vc030."[male] patient r.68j [(b)(6)] hero graft implantation (b)(6) 2014; (b)(6) 2014 occlusion of the inflow shunt vein and occlusion of the hero.Shunt drainage through side branch (200ml/min), (b)(6) 2014 thrombectomy of the hero graft, anastomosis of the ptfe-prosthesis to the brachialis bifurcation, shunt ligated after peripheral dialysis through hero-graft; (b)(6) 2014 5 days post-operative mesenteric ischemia-> surgery; patient dies 5 days later in the intensive care from cardiac cause after unsuccessful reanimation." the manufacturing records for lots h14av014 and h14vc030 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.The patient was implanted with a hero graft in (b)(6) 2014.In (b)(6) 2014 (specific date unknown) the patient had an occlusion involving both the venous outflow component (voc) and the arterial graft component (agc).The patient was treated with "shunt drainage through side branch (200ml/min)." in (b)(6) 2014 (specific date unknown) the patient had another occlusion event which required thrombectomy, a graft revision that included "anastomosis of the ptfe-prosthesis to the brachialis bifurcation," and "shunt ligated after peripheral dialysis through hero graft." partial stenosis or full occlusion of prosthesis or vasculature is listed as a potential complication in the hero graft instructions for use (ifu).Hypercoagulability states or inadequately maintained anticoagulation therapy could contribute to an increased risk of thrombosis.Precautions regarding inadequate anticoagulation are provided in the ifu.The following information is not available for consideration in any reported event: patient medical history, implant/intervention notes, and dialysis information.The specific relationship between the thrombosis/occlusion events and the hero graft was not documented and cannot be determined with the information provided.Five days after the aforementioned surgical procedure in (b)(6) 2014 the patient developed post-operative mesenteric ischemia.Five days following initial admission into intensive care the patient died from "cardiac cause after unsuccessful reanimation." the cause of the patient's mesenteric ischemia was not documented.According to the documented cause of death ("cardiac"), the hero graft was not implicated in the patient's death.However, death is a potential intraoperative and post-operative complication listed in the hero graft ifu.The specific relationship between the patient's death and the hero graft cannot be assessed with the information provided.The ifu lists the following potential complications with the use of the hero graft: partial stenosis or full occlusion of prosthesis or vasculature, vascular graft revision/replacement, and death.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." the ifu also states "verify the systolic blood pressure is at least 100mmhg.As with conventional grafts hero graft may occlude in patients with systemic low blood pressure or sever hypotension following fluid removal post dialysis", and "as with conventional grafts, hero graft may occlude in patients with insufficient anticoagulation or non-compliance with anticoagulation medication." this event does not identify additional hazards or modify the probability and severity of existing hazards.

Event Description

According to the report, "after multiple shunt revision left patient received hero (b)(6) 2014 with arterial anastomosis on the shuntvene lower arm (b)(6) 2014 closure of shuntvene vene and hero (b)(6) 2014 thrombectomy hero, revise arterial anastomosis on brachialis, shunt ligature - 5 days post operative mesenteriale ischemia - 5 days later patient death after successless reanimation on intensive care ward - cardiac reason.".

• 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: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 5399756
• MDR Text Key: 83893504
• Report Number: 1063481-2015-00353
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2016

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 Expiration Date: 05/19/2016
• Device Model Number: HERO 1001 AND HERO 1002
• Device Lot Number: H14AV014; H14VC030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 01/29/2016
• Supplement Dates Manufacturer Received: 10/29/2015
• Supplement Dates FDA Received: 01/29/2016
• 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; Other
• Patient Age: 68 YR