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

Model Number 305C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Pulmonary Insufficiency (2022); Valvular Stenosis (2697)

Event Date 02/19/2015

Event Type  Injury  

Event Description

Medtronic received information from the patient's physician that three years post implant of this bioprosthetic valve, a 22mm transcatheter bioprosthetic valve was implanted valve-in-valve due to valvular stenosis and resultant severe pulmonary insufficiency.No further adverse patient effects were reported.

Manufacturer Narrative

The device remains implanted, therefore no product analysis can be performed.Without return of the product, no definitive conclusions could 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.Medtronic received information that the mosaic valve was implanted in the pulmonary position.Per the mosaic instructions for use (ifu) the ¿mosaic bioprostheses are indicated for the replacement of pathologic or prosthetic aortic and mitral valves.¿ without the return of the valve for analysis, a root cause for the reported clinical observation cannot be determined.Medtronic will continue to monitor field performance for similar events should they occur.

Manufacturer Narrative

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

• Brand Name: MOSAIC AORTIC BIOPROSTHETIC HEART VALVE
• 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: 4610657
• MDR Text Key: 5765181
• Report Number: 2025587-2015-00330
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• 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
• Report Date: 03/25/2015

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: 305C
• Device Catalogue Number: 305C223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 03/17/2015
• Supplement Dates Manufacturer Received: Not provided; 03/25/2015
• Supplement Dates FDA Received: 04/07/2015; 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): Required Intervention
• Patient Age: 00015 YR