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

Model Number 995

Device Problem Structural Problem (2506)

Patient Problems Aortic Regurgitation (1716); Stroke/CVA (1770); Death (1802); Endocarditis (1834); Transient Ischemic Attack (2109); Complete Heart Block (2627)

Event Date 06/25/2014

Event Type  Death  

Manufacturer Narrative

Based on the content of the article, there was no information as to which devices were associated with the adverse events.A device history records review could not be performed, as the device serial numbers were not provided.Based on the limited information received, a root cause cannot be determined.

Event Description

Medtronic received information from a journal article that reviewed short-, medium- and long-term outcomes in studies of patients with aortic valve and/or aortic root replacement alternatives, including implant of a model of aortic root bioprosthesis from this device family.The article¿s primary analysis was conducted via a search and review of electronic databases and current literature, with secondary analysis conducted from case series that included more than 100 patients in their populations.Within the article¿s narrative and graphic summaries, 199 patients were identified from randomized studies with implant of a device from this model family.The patients were predominately male with an average age of 70.In 15 selected case series, over 6000 patients in total were managed with implant of a model of this device.A slight majority were male, with an average patient age of 70.The findings from the randomized studies found 7 patients experienced hospital mortality.18 patients experienced heart block, two experienced a cerebral vascular accident (cva) and three experienced endocarditis.A summary of the findings from the selected case studies of 6463 patients reported that there were 476 cases of operative mortality, 301 neurological events (defined as a cva or transient ischemic attack), and 80 cases of endocarditis.Cited articles that included unspecified structural valve dysfunction findings cited incidence rates of 0.2% - 0.6%, and moderate to severe aortic regurgitation (ar) incidence rates of 0% - 0.9%.The date of death reported here is an arbitrarily chosen date (the first of the year of the first article cited in the bibliography) to enable report submission, as there was not specific information provided in the article or subsequently available regarding the operative mortalities.

Manufacturer Narrative

Additional information was requested from the article¿s corresponding author, who noted in his reply that the article was based on a database review across several medical centers, and that the requested individualized device/patient information was beyond the scope of the primary research.A review of medtronic¿s complaint database showed that the articles cited by name and patient outcomes in this meta-analysis had not previously been reported to medtronic.Without identifying device information, medtronic¿s complaint database could not be searched to determine if individual complaints previously had been received and reported for any of the patients included in this article¿s findings.(b)(4).The freestyle aortic bioprosthesis: a systematic review authors: andrew g.Sherrah, mbbs; j.James b.Edelman, mbbs, phd; shane r.Thomas, phd; peter w.Brady, fracs; michael k.Wilson, fracs; richmond w.Jeremy, phd, fracp; paul g.Bannon, phd, fracs; michael p.Vallely, phd, fracs heart, lung and circulation (2014), 1¿8 1443-9506/04/ http://dx.Doi.Org/10.1016/j.Hlc.2014.04.262 published august 13, 2014 published online june 25, 2014.

Manufacturer Narrative

Corrected information: no eval explain code.

• 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: 4171132
• MDR Text Key: 12482779
• Report Number: 2025587-2014-00762
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/28/2014
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization; Required Intervention
• Patient Age: 00070 YR