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

Model Number HERO 1001

Device Problems Device Operates Differently Than Expected (2913); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Death (1802); Dyspnea (1816); Reaction (2414)

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to the report, "hero registry patient was implanted with a hero graft on (b)(6) 2014.The patient was hospitalized on (b)(6) 2014 for unspecified mechanical complications [clarified to be steal syndrome] involving the graft and on (b)(6) 2014 for shortness of breath secondary to pulmonary embolus." the steal syndrome was treated via placement occlusion induced balloon catheter.Additional information indicated that the patient died on (b)(6) 2014; the cause of death was ruled pulmonary embolism.The complaint investigation will focus on the hero 1001 component but the hero 1002 will be investigated out of an abundance of caution.

Manufacturer Narrative

According to the report, "hero patient was implanted with a hero graft on (b)(6) 2014.The patient was hospitalized on (b)(6) 2014 for unspecified mechanical complications [clarified to be steal syndrome] involving the graft and on (b)(6) 2014 for shortness of breath secondary to pulmonary embolus." the steal syndrome was treated via placement occlusion induced balloon catheter.Additional information indicated that the patient died on (b)(6) 2014; the cause of death was ruled pulmonary embolism.The complaint investigation will focus on the hero 1001 component but the hero 1002 will be investigated out of an abundance of caution.Additional clarifying information was received from the representative on (b)(6) 2015.She stated that recent follow-up visit records were received and the complaint now includes death, steal syndrome, pulmonary embolism (pe), and occlusion.The study coordinator also conveyed to the representative that, "yes, pe is cause of death.A new pe developed and was discovered during her last patient clinic visit," and "cause of death via phone today as pe.The obit did not state cause or location of death." according to the progress notes provided, the hero graft was implanted on (b)(6) 2014.The patient developed right hand weakness secondary to steal syndrome.On (b)(6) 2014 the hero was balloon occluded at the bedside to relieve steal syndrome and patient dialyzed through a right femoral permcath.Patient was discharged on (b)(6) 2014 with some improvement to hand function and a follow-up appointment was scheduled on (b)(6) 2014.On (b)(6) 2014 the patient was a direct admission from the clinic for a new pulmonary embolus diagnosed on ventilation/perfusion (v/q) scan.Patient was anticoagulated with warfarin and a heparin bridge and became therapeutic on (b)(6) 2014 and was discharged.An open thrombectomy of the hero graft with coarctation was scheduled for (b)(6) 2014 but the patient passed away on (b)(6) 2014 with cause of death being ruled a pe.The manufacturing records for lots h14vc004 and h14av005 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 had a hero graft implanted in (b)(6) 2014.The patient developed steal syndrome immediately post op.The hero graft instructions for use (ifu) lists vascular insufficiency due to steal syndrome as a potential complication that ranges from 2.6% to 3.8% with hero, and 3.8% in arteriovenous grafts (avg).Steal syndrome is not unique to the hero graft and is a well-known complication of arteriovenous (av) access conduits; fistula, prosthetic, biologic and xenograft inclusive.This patient was initially treated with bair hugger, hot packs and nitropaste.However, on (b)(6) 2014 the patient was hospitalized with right hand weakness and was treated with a balloon occlusion of the hero graft.Symptoms steadily improved following the occlusion procedure.The patient has a history of a failed avg and swelling secondary to left subclavian vein occlusion.The patient was hospitalized on (b)(6) 2014 for a new pe.The hero graft ifu lists embolism as a potential intraoperative and post-operative complication.The patient has a history of a massive pe in (b)(6) 2013 and a history of non-compliance on warfarin.However, hematology did not believe there was another anticoagulation option, so the patient was restarted on warfarin while in the hospital.The patient didn't become therapeutic on warfarin until (b)(6) 2014.On (b)(6) 2014 the patient died; the cause of death was ruled to be pe.The hero graft ifu lists death as a potential intraoperative and post-operative complication.In this case, the death resulted from the pe, which was a result of a hypercoagulable condition which predated hero graft implantation.During the (b)(6) 2014 hospitalization the patient reported significant pain at the hero graft site and due to the pe.The hero graft ifu lists pain as a potential vascular graft and catheter complication.The vascular surgeon was not concerned upon inspection of the site and was "pleased with her wound healing." blood cultures were taken on (b)(6) 2015 and remained negative for infection.The patient has a complex history of extensive co-morbidities, specifically chronic back pain.However, from the information provided, the surgical site pain is consistent with standard post-operative pain.Although the root cause of the pe that was ruled the cause of death for this patient is unknown, the patient's history of a massive pe in 2013 and non-compliance/resistance to anticoagulation therapy increased the risk of reoccurrence.Steal syndrome and site pain are known complications of the hero graft.

Event Description

According to the report, "hero patient was implanted with a hero graft on (b)(6) 2014.The patient was hospitalized on (b)(6) 2014 for unspecified mechanical complications [clarified to be steal syndrome] involving the graft and on (b)(6) 2014 for shortness of breath secondary to pulmonary embolus." the steal syndrome was treated via placement occlusion induced balloon catheter.Additional information indicated that the patient died on (b)(6) 2014; the cause of death was ruled pulmonary embolism.The complaint investigation will focus on the hero 1001 component but the hero 1002 will be investigated out of an abundance of caution.

• 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: 5038244
• MDR Text Key: 24363585
• Report Number: 1063481-2015-00213
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study,use
• Reporter Occupation: Other
• Report Date: 08/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2015
• 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: H14VC004, H14AV005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• 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: 34 YR