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

Model Number FR995

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Calcium Deposits/Calcification (1758); Cardiomyopathy (1764); Stroke/CVA (1770); Congestive Heart Failure (1783); Death (1802); Endocarditis (1834); Thrombus (2101); No Code Available (3191)

Event Date 05/23/2015

Event Type  Death  

Event Description

Medtronic received information that eleven years, six months post implant of this aortic bioprosthetic valve, this patient experienced a stroke.The patient's physician stated it was not clear whether the stroke was directly attributed to this valve.An echocardiogram showed a mass connected to the valve on the left ventricle.The echocardiographer reported differential diagnoses of mass include vegetation of endocarditis, and less likely thrombus, calcification, myxoma, fibroblastoma or tumor.A blood culture showed no growth after five days.It was also reported that the valve was insufficiently sealing.The patient subsequently expired.The cause of death was provided as septic emboli, endocarditis, cerebrovascular accident (cva), cirrhosis, congestive heart failure (chf) and cardiomyopathy.The physician reported that the valve caused or contributed to the death.

Manufacturer Narrative

The device expiration and manufacturing dates have been added.

Manufacturer Narrative

Date of event is an approximate date.The device has not been returned.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Conclusion: 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.A variety of factors can influence the onset of stroke, and a conclusive cause could not be determined from the limited information available.In addition a relationship between the device and the death also could not be established.The sterilization process used by medtronic has an anti-microbial kill on the microorganisms, and has demonstrated the ability to inactivate the biological indicator which is representative bioburden for the microbial flora found in our manufacturing controlled environment.Also, this event the occurrence of endocarditis was greater than 12 months post implant.Based on the descriptive comments outlined from the journal literature, complaints which occurred greater than 12 months post implant were largely considered to be community acquired (refer to note 1 below).Therefore, it was unlikely that the endocarditis originally came from the device and/or manufacturing valve process.The organism was not provided and blood cultures showed no growth after five days.Without the return of the valve, a root cause of the regurgitation was unable to be determined.(b)(4).

Manufacturer Narrative

No eval explain code.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.

• Brand Name: FREESTYLE
• 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: 4853491
• MDR Text Key: 5946487
• Report Number: 2025587-2015-00661
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2008
• Device Model Number: FR995
• Device Catalogue Number: FR99529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/24/2003
• 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: 00063 YR