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

Model Number FR995

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

Patient Problems Abscess (1690); Death (1802); Endocarditis (1834)

Event Date 10/24/2016

Event Type  Death  

Manufacturer Narrative

The device return has been requested, but it has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.Additionally, the pathology report and autopsy report for this patient has been requested but not yet received.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this patient expired due to cardiac arrest following the implant of this bioprosthetic valve, and prior to complete closure of the patient's chest.This valve was implanted during a replacement procedure for a non-medtronic mechanical aortic heart valve, that had been implanted one month and three weeks prior.The patient had been placed on antibiotics due to an ongoing infection following the implant of this non-medtronic mechanical valve.Subsequently, the patient presented to the emergency room with symptoms indicative of endocarditis; a blood test returned positive results for staphylococcus epidermidis resulting in sepsis, most likely due to pneumonia.A replacement was undertaken with a medtronic bioprosthetic device.Upon opening the patient, it was observed that in addition to endocarditis, the patient had extensive aortic root abscess and left ventricular outflow tract (lvot) abscess.Following implant of this medtronic device, but prior the chest cavity being completely closed, the patient entered ventricular fibrillation and expired following wean off cardiopulmonary bypass.Per the autopsy results: "the cause of death in this case was cardiac arrest following surgical replacement aortic valve, debridement of aortic root abscess, and closure of intracardiac fistula due to staphylococcus epidermidis vegetative endocarditis.Other significant contributory factors included athe rosclerotic cardiovascular disease, valvular heart disease, and end stage renal disease.".

Manufacturer Narrative

Conclusion: the autopsy results stated "the cause of death in this case was cardiac arrest following surgical replacement aortic valve, debridement of aortic root abscess, and closure of intracardiac fistula due to staphylococcus epidermidis vegetative endocarditis.Other significant contributory factors included atherosclerotic cardiovascular disease, valvular heart disease, and end stage renal disease." based on the received information, the endocarditis is a preexisting condition.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Based on the received information, there was no allegation against the device to cause or contribute to the death.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6137140
• MDR Text Key: 61186234
• Report Number: 2025587-2016-01885
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169002159
• UDI-Public: 00643169002159
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2018
• Device Model Number: FR995
• Device Catalogue Number: FR995-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/18/2013
• 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: 51 YR
• Patient Weight: 115