MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; TIMER, CLOT, AUTOMATED

Model Number 30525

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Congestive Heart Failure (1783); Death (1802); Endocarditis (1834); Rupture (2208); Low Cardiac Output (2501); Sudden Cardiac Death (2510)

Event Date 02/12/2015

Event Type  Death  

Event Description

Medtronic received information that a retrospective study of 207 patients (predominantly female; mean age of 74 years) was performed to evaluate the mid to long-term durability and hemodynamics of a small-size bioprosthetic stented porcine aortic valve as compared to larger sizes.A 19-mm, 21-mm, 23-mm, 25-mm, and 27-mm prosthesis was implanted in 103, 53, 35, 13, and 3 patients, respectively.The study assessed patients between the years 2000 to 2012, with a mean follow-up of 3.5 years.The 30-day mortality rate was 1.9%, which included deaths due to left ventricle rupture (n=2), low output syndrome (n=2), and mediastinitis (n=1).There were 22 late deaths, 5 of which were from cardiac conditions: heart failure (n=2), sudden death (n=2), endocarditis (n=1), and cerebral bleeding (n=1).Other adverse patient effects included chronic heart failure (n=5), implant of a permanent pacemaker (n=5) and cerebral infarction/bleeding (n=4).Valve-related comorbidities occurred in 3 patients: structural valve deterioration (svd) noted as leaflet degradation requiring reoperation at 7.2 years (n=1), and endocarditis (n=2).No additional adverse patient effects were reported.

Event Description

Additional information revealed the physician stated the observed adverse events were not caused or contributed to by the devices.Also, the specific model/serial information was not disclosed.

Manufacturer Narrative

The date of death was not reported; an estimated date of jan 1, 2000 was chosen as the earliest possible date of death within the study time frame.The devices were not returned to medtronic.(b)(4).Title: hemodynamic performance and durability of mosaic bioprostheses for aortic valve replacement, up to 13 years authors: yorihiko matsumoto, md; tomoyuki fujita, md, phd; hiroki hata, md, phd; yusuke shimahara, md; shunsuke sato, md; junjiro kobayashi, md, phd doi: 10.1253/circj.Cj-14-0990.

Manufacturer Narrative

Conclusion: without return of the product, no definitive conclusions can be drawn regarding the clinical observation(s).Without product serial number(s) no device history records could be pulled for review.

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: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• Type of Device: TIMER, CLOT, AUTOMATED
• 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: 4633453
• MDR Text Key: 5594339
• Report Number: 2025587-2015-00363
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990064
• 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,Followup
• Report Date: 04/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 30525
• Device Catalogue Number: 30525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/24/2015
• Initial Date FDA Received: 03/25/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; 04/24/2015
• Supplement Dates FDA Received: 03/31/2015; 05/05/2015; 09/18/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 00074 YR