MAUDE Adverse Event Report: HEART VALVES SANTA ANA MOSAIC; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 305C25

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Regurgitation (2259)

Event Date 12/05/2013

Event Type  Injury  

Event Description

Medtronic received information that following implant of this bioprosthetic valve, the valve was explanted due to prosthetic regurgitation.

Manufacturer Narrative

Product analysis: no product was returned, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Attempts to obtain additional information have been unsuccessful.Should the device be returned or additional information be received, a supplemental report will be filed.(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.Without the return of the valve, a root cause of the event was unable to 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
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 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: 4491268
• MDR Text Key: 5567209
• Report Number: 2025587-2015-00157
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2012
• Device Model Number: 305C25
• Device Catalogue Number: 305C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2015
• 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