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

Model Number 310C

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Structural Problem (2506)

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

Event Date 03/12/2015

Event Type  Injury  

Event Description

Medtronic received information that 25 months post-implant of this bioprosthetic valve, paravalvular leak (pvl), ejection fraction of 45%, gradient reading of 5.5 mmhg, and structural valve dysfunction was noted.Subsequently, the valve was explanted and replaced with non-medtronic device.No adverse patient effects were reported.

Manufacturer Narrative

The product has not been returned for analysis, however, the return is anticipated.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

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.

Manufacturer Narrative

Additional information was received that the patient had endocarditis with the cusps being destroyed and noted to be a lifesaving procedure.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, all leaflets were stiff due to host tissue on the inflow and outflow, except along a section of the free margin and lunula of the left and right cusps.All leaflets were intact.All commissures were intact, however, host tissue encapsulated all commissures, which made it difficult to determine the condition.Glistening off-white pannus lined the sewing ring on the inflow, extending to the tissue and base stitching, over the inflow margin of attachment, into all inferior coaptive areas and onto the inflow, reducing the inflow orifice area.Pannus covered the outflow rail adjacent to all cusps, extending to all stent posts, encapsulating all stent posts and commissural areas, filling and stiffening all cusps, resulting with restricted leaflet movement.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: the implant of this device in the tricuspid position is off-label use.The impairment of leaflet mobility may have led to stenosis / high gradient.Based on the received information and the returned product analysis, the root cause of the paravalvular leak (pvl) cannot be determined.However, stenosis / high gradient are most likely caused by the pannus.Pannus overgrowth has been an inherent risk of surgical valve replacement.(b)(4).

Manufacturer Narrative

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

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC HEART VALVE
• 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: 4623427
• MDR Text Key: 5656007
• Report Number: 2025587-2015-00345
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: HR
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2014
• Device Model Number: 310C
• Device Catalogue Number: 310C27
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2009
• 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): Other; Required Intervention
• Patient Age: 00034 YR