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

Model Number 310F29

Device Problems Gradient Increase (1270); Device Operates Differently Than Expected (2913)

Patient Problems High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965); Low Cardiac Output (2501)

Event Date 07/30/2014

Event Type  Injury  

Event Description

Medtronic received information that a bioprosthetic mitral heart valve was explanted after its initial implant due to mild central regurgitation, severe mitral stenosis and pulmonary hypertension, and unsatisfactory hemodynamics.The valve was replaced by another bioprosthesis of the same design; the device serial number was not available, and it was not immediately known if the replacement device was the same model and/or size.No adverse patient effects were reported.

Manufacturer Narrative

Additional information has been requested.It was reported that the explanted valve will be returned for analysis.A supplemental report will be filed when the investigation is completed or if additional information is received.(b)(4).

Manufacturer Narrative

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 for analysis, a root cause cannot be determined.

Manufacturer Narrative

Received corrected information on the explanted valve: medtronic received information that 114 months post-implant of this bioprosthetic valve, the valve was explanted due to mild regurgitation, severe mitral stenosis, severe pulmonary hypertension, a mean gradient of 15, and an ejection fraction of 53%.Identification of the explanted valve was difficult due to heavy calcification.The valve was replaced by a medtronic bioprosthesis, resolving the reported conditions.It was reported that the explanted valve will be not be returned for analysis.

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): 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: 4030943
• MDR Text Key: 4878965
• Report Number: 2025587-2014-00596
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P980043
• 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: 08/26/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: 310F29
• Device Catalogue Number: 310F29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 08/22/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 08/26/2014
• Supplement Dates FDA Received: 08/26/2014; 09/16/2014; 09/15/2017
• 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: 00080 YR