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

Model Number 305U223

Device Problems Gradient Increase (1270); Occlusion Within Device (1423); Incomplete Coaptation (2507)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/16/2014

Event Type  Injury  

Event Description

Medtronic received information that this bioprosthetic aortic heart valve was exhibiting severe stenosis and high gradients approximately nine months after implant and that two of the valve's leaflets were not opening.The device remained implanted.There was no report of adverse patient effects.Subsequently, additional information was received that the valve was explanted 18 months after its implant and replaced with a non-medtronic mechanical valve.It was not immediately known if the valve would be returned for analysis.There were no reported adverse effects beyond the reoperation.It was reported that additional information would be provided.

Manufacturer Narrative

The device history record was previoulsy 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.

Manufacturer Narrative

A supplemental report will be filed when the investigation is completed.(b)(4).

Manufacturer Narrative

To date, the valve has not been returned for analysis.Without device return, a root cause cannot be determined.A supplemental report will be filed if the device is returned or if additional information is received.

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: 4166329
• MDR Text Key: 4867843
• Report Number: 2025587-2014-00756
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: UY
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/01/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2017
• Device Model Number: 305U223
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2014
• Initial Date FDA Received: 10/13/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/01/2014
• Supplement Dates FDA Received: 10/13/2014; 12/09/2014; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2012
• 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: 00065 YR