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

Model Number 995

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problems Death (1802); Embolism (1829); Endocarditis (1834); Hemorrhage/Bleeding (1888); No Information (3190)

Event Date 02/26/2014

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 medical journal article examining long-term outcomes for 500 patients from a single center over a 13-year period that there were 109 valve-related deaths.In addition, there were twenty-six perioperative deaths that occurred during the initial hospitalization or within 30 days after device implant surgery.The long-term outcome analysis indicated that the 109 valve-related deaths included: 11 deaths caused by structural and nonstructural device dysfunction, 8 fatal embolic events, 14 fatal hemorrhagic events, 4 fatal endocarditis events, 19 sudden death, and 53 unexplained deaths.The patient study population included 488 patients for whom follow-up was achieved for post-implant time periods ranging from one to 155 months, with a median of 105 months.The average demographics of the larger cohort of 500 patients were 75 years of age and 52% male.

Manufacturer Narrative

Additional information has been requested from the article's author contact.Without device-identifying information, medtronic¿s database could not be searched to determine if any of these events were previously reported.The reported date of death is the last date of the reported follow-up period conducted by the article's investigator.A separate report has been filed for reported structural valve deterioration and procedure-related serious injuries.(b)(4).¿long-term results of freestyle stentless bioprosthesis in the aortic position: a single-center prospective cohort of 500 patients¿ authors: nicolas amabile, md, phd, olivier m.Bical, md, alexandre azmoun, md, ramzi ramadan, md, remi nottin, md, and philippe h.Deleuze, md the journal of thoracic and cardiovascular surgery http://dx.Doi.Org/10.1016/j.Jtcvs.2014.02.063.

Manufacturer Narrative

Subsequently, the article¿s author contact reported that the statistical analysis was performed after the patient data had been anonymized, and that it would not be possible to retrospectively align the patient outcomes and device issues discussed in the article with individual devices or patients.

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: 4114270
• MDR Text Key: 12549100
• Report Number: 2025587-2014-00687
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2014
• 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
• Patient Age: 00075 YR