MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problems Occlusion Within Device (1423); Structural Problem (2506)

Patient Problems Death (1802); Pulmonary Insufficiency (2022); Pulmonary Valve Stenosis (2024); Obstruction/Occlusion (2422); No Code Available (3191)

Event Date 07/19/2010

Event Type  Death  

Event Description

Medtronic received information from a retrospective study in the annals of thoracic surgery; (b)(6) 2011; 91:188¿94, that summarized the 20-year experience of the rastelli procedure to treat transposition of the great arteries (tga) and pulmonary stenosis (ps) in pediatric patients.Between 1988 and 2008, 40 patients underwent ro (median age 4 years; range 9 months to 17 years; 24 male, 16 female).The right ventricular outflow tract (rvot) was obstructed in 32 and atretic in 8 patients.The right ventricular (rv) to pulmonary artery (pa) was reconstructed with a homograft (n=25), contegra bovine jugular vein conduit (n=8), polyethylene terephthalate fiber nonvalved graft conduit (n=5) or freestyle porcine valved root (n=2).The mean size of the rv-pa conduit was 17.3 plus or minus 2.33 mm (range 13 to 22 mm).Within a mean follow-up of 8.6 years, there was: 1) one early reoperation for bleeding.No adverse patient effects were reported.2) permanent pacemakers were implanted post-operatively in 5 patients for permanent atrio-ventricular (av) block (n=2) complete av block (n=2), and sick sinus syndrome (n=1).No further adverse patient effects were reported.3) there were 3 late deaths and one cardiac transplantation.The first death occurred in a patient with coronary artery anomaly (rv branches arising from the left coronary artery) who died suddenly 1 year postoperatively.This patient had documented sinus rhythm and no obstruction.The second death presented with multiple stenoses of the peripheral and central pulmonary arteries and klippel-feil syndrome, with multiple skeletal and rib anomalies.The patient died of low cardiac output 3 months after the ro.The third death was in a patient with a myelomeningocele who expired at another hospital 6 months after ro secondary to pneumonia and sepsis.A fourth patient underwent two reinterventions for pacemaker exchange due to complete atrioventricular block.Before cardiac transplantation (12 years after ro), he presented with severely impaired right and left ventricular function with end-stage heart failure and ejection fraction of 15%.4) sixteen patients had reoperation for rv-pa conduit stenosis (mean 7.8 plus or minus 3.8 years) without mortality.Two patients required reoperation for left ventricular outflow tract (lvot) obstruction due to scar formation within the baffle pathway from the ventricular septal defect (vsd) to the aortic valve.The average time to conduit failure was 7.8 plus or minus 3.8 years (range 2 to 16 years).The mean age at reoperation was 12 plus or minus 6 years (range 4 to 27 years).The peak systolic gradient across the rvot before conduit replacement was 59 plus or minus 8 mm hg (range 30 to 80 mmhg).The most common indication for conduit replacement was stenosis, which was present in 14 of the 16 replacement procedures.A less frequent primary indication for conduit replacement was conduit valve insufficiency, noted in 2 patients.All conduits that required replacement had varying degrees of insufficiency (mild=6, moderate=8, severe=2).Thirteen patients underwent replacement with a second biologic valve, while 3 had the conduit revised with the insertion of a polytetrafluroethylene monocusp valve.Of the 18 patients who did not require reoperation, freedom from lvot obstruction or aortic insufficiency was 89% and 95%, respectively.One patient had a 22 mmhg lvot obstruction gradient, and another had mild aortic insufficiency.Two patients presented with moderate stenosis of the conduit (41 and 47 mmhg); no treatment was prescribed and no adverse patient effects were reported.At last follow-up, sinus rhythm with complete right bundle branch block (rbbb) was present in 31 patients.It is unknown if a medtronic product was related to the reported deaths, reoperations or pacemaker implantations.The date of death(s) is an approximate date based on day of the completion of the study.The age and weight of the patient(s) is the mean.

Manufacturer Narrative

Multiple attempts to obtain additional information regarding the products in the article were unsuccessful.Without the return of the product(s), no definitive conclusion can be made regarding the clinical observation(s).(b)(4).Citation: title:"rastelli operation for transposition of the great arteries with ventricular septal defect and pulmonary stenosis" authors: john w.Brown, md, mark ruzmetov, md, phd, daniel huynh, bs, mark d.Rodefeld, md, mark w.Turrentine, md, and andrew c.Fiore, md section of cardiothoracic surgery, indiana university school of medicine, indianapolis, indiana; and st.Louis university school of medicine, st.Louis, missouri the annals of thoracic surgery; 2011;91:188¿94.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4200998
• MDR Text Key: 17991176
• Report Number: 2025587-2014-00790
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• 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; Required Intervention
• Patient Age: 00004 YR
• Patient Weight: 23