MAUDE Adverse Event Report: CRYOLIFE, INC. CRYOVALVE AORTIC ROOT AND CONDUIT; HUMAN HEART ALLOGRAFT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Tachycardia (2095); Respiratory Failure (2484)

Event Date 03/13/2003

Event Type  Death  

Event Description

Study patient (b)(6) ((b)(6) study) underwent aortic valve replacement on (b)(6) 2003 with concomitant coronary artery bypass grafting (cabg) and transmyocardial revascularization (tmr).The patient experienced wide complex sinus tachycardia and died on (b)(6) 2003.Cause of death ruled respiratory and cardiac arrest.This investigation is in reference to the aortic valve allograft.

Manufacturer Narrative

According to the case report forms (crfs), operative notes and the report the patient underwent aortic valve replacement on (b)(6) 2003 (av00 - aortic valve and conduit, (b)(6)) with concomitant cabg, tmr, and atrioventricular pacemaker placement.The patient experienced wide complex sinus tachycardia and died on (b)(6) 2003.Cause of death ruled respiratory and cardiac arrest.As noted in the patient medical history captured in the crfs and the operative notes (provided on 04/28/2015), the indications for the procedure on (b)(6) 2003 was coronary artery disease with aortic insufficiency, status post ascending aortic dissection ((b)(6) 2002).Preoperative transthoracic echocardiogram (tee) on (b)(6) 2003 revealed and ejection fraction (ef) of 51% and mild insufficiency (+1).The cardiac cath and doppler from (b)(6) 2003 indicated the following: aortic root 3.6 cm, left ventricle normal size, left atrium enlarged with mild hypokinesia of inferior wall, small pericardial effusion, aortic leaflets slightly thickened with tri-leaflet configuration, atrial valve with normal flow and velocity with mild-moderate atrial regurgitation, mitral annular calcification, trace mitral regurgitation, normal pulmonary artery pressure, and severe multi-vessel coronary artery disease (cad).The cardiac related complications on (b)(6) 2003 were diagnosed as agonal respirations, wide complex tachycardia, cardiac arrest, and respiratory arrest.The cause of death was ruled cardiac and respiratory arrest.This allograft was not returned to cryolife so no direct observations can be made.According to the processing record, this allograft did not contain any attributes that would have rejected the allograft per the specifications at that time.A review of the certificate of assurance for serial identification number 7163921 was performed and no rejectable attributes were documented.The patient underwent homograft implant at age (b)(6).The patient had an extensive pre-operative medical history including alcohol use (8 drinks/week), chronic lung disease, moderate chronic obstructive pulmonary disease (copd), cigarette smoking (current or quit within past year), hypertension, home oxygen use at night, previous myocardial infarction, coronary artery disease, increased liver function tests, shortness of breath, multiple episodes of pneumonia, arthritis, chronic back pain, fibromyalgia and depression.Cardiac history was significant for mitral valve calcification and insufficiency.Previous cardiac surgical history included cabg ((b)(6) 2002), ascending aortic dissection repair ((b)(6) 2002), previous stent implant ((b)(6) 2002), and angioplasty.At the time of avr, the patient was nyha class iv and was admitted with pulmonary edema requiring diuresis and bi-level positive airway pressure (bipap).Indication for avr was primary aortic disease - annulo aortic ectasia.The patient underwent sternotomy, aortic valve replacement via aortic root replacement, cabg, and tmr.Rates of 30-day mortality following aortic valve replacement with an aortic homograft have been reported in the literature and range from 1.1%-9.5% (dossche 1999, doty 1998, fukushima 2013, kaya 2005, kilian 2004, o'brien 2001, talwar 2005).Dossche et al.Reported 12 early deaths (9.1%) in a series of 132 patients who underwent aortic root replacement (arr) with an aortic allograft (dossche 1999).In addition, it was noted that rates of early mortality were higher for patients who underwent concomitant procedures at time of arr versus those who underwent arr alone (12.5% vs.8.3%, respectively; dossche 1999).Stamou et al.Also reported increased mortality in patients undergoing arr who had also undergone concomitant valve or cabg or valve surgery versus arr alone (21% vs.4.2%, respectively; stamou 2015).Fukushima et al.Identified a number of risk factors for early mortality in a series of 840 patients undergoing avr with an aortic homograft (fukushima 2013).These included older age (> 65 years at time of implant), hypertension, smoking history, and new york heart association functional class iii or iv (fukushima 2013).The patient in this complaint had 3 out of 4 of the risk factors identified by fukushima et al.Including hypertension, smoking history, and nyha class iv.Early mortality occurred in 21 patients (2.5%); of these, 11 showed evidence of post-operative ventricular problems, with 9 having global dysfunction and 2 having tachyarrhythmia (fukushima 2013).Similarly, the patient in this complaint also displayed post-operative tachycardia.O'brien et al.Cited a 3% rate of 30-day mortality in a series of 1,022 patients who underwent avr with aortic homografts (o'brien 2001).O'brien et al.Also discussed cause of death and relation to the homograft, stating that causes of early deaths were multifactorial and appeared unrelated specifically to homograft valve dysfunction or to the use of a homograft itself.However, subtle factors such as surgical inexperience, technical or myocardial protection difficulties during an operation can always be present; they are also difficult to pinpoint as being due to the specific use of a homograft (o'brien 2001).Early, sudden mortality after aortic valve replacement, with or without concomitant procedures, is not unexpected.The literature has reported overall rates of thirty-day mortality for avr with an aortic homograft ranging from 1.1%-9.1%, and up to 21% for avr and concomitant procedures.In addition, risk factors such as smoking, hypertension, and nyha class iii-iv have also been identified as potential risk factors for 30-day mortality after avr.An intraoperative echocardiogram showed normal allograft function.The patient also underwent cabg and tmr.The patient's history is remarkable for severe coronary artery disease, myocardial infarction, and myocardial dysfunction noted on a coronary cath performed on 03/06/2003.The cause of the sudden cardiac death was likely a lethal arrhythmia.The patient's preexisting heart disease was a significant risk factor.Given the normal function of the allograft, it is unlikely that it contributed to the reported event.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

Event Description

Study patient (b)(6) underwent aortic valve replacement on (b)(6) 2003 with concomitant coronary artery bypass grafting (cabg) and transmyocardial revascularization (tmr).The patient experienced wide complex sinus tachycardia and died on (b)(6) 2003.Cause of death ruled respiratory and cardiac arrest.This investigation is in reference to the aortic valve allograft.

Manufacturer Narrative

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

• Brand Name: CRYOVALVE AORTIC ROOT AND CONDUIT
• Type of Device: HUMAN HEART ALLOGRAFT
• 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: 4725019
• MDR Text Key: 5865016
• Report Number: 1063481-2015-00051
• Device Sequence Number: 1
• Product Code: MIE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Other Device ID Number: DONOR NUMBER 55778
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 61 YR
• Patient Weight: 57