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

Model Number 310CJ

Device Problem Material Perforation (2205)

Patient Problem Mitral Regurgitation (1964)

Event Date 06/25/2015

Event Type  Injury  

Event Description

Medtronic received information that 2 years and 4 months post implant of this mitral bioprosthetic valve, it was explanted and replaced with another manufacturer's device due to a tear at the root of the leaflet and regurgitation of unknown severity.No other adverse patient effects were reported.

Manufacturer Narrative

Patient age, sex, and weight was requested but unavailable.The device has been returned for analysis.A supplemental report will be filed upon completion of the device analysis and investigation.(b)(4).

Manufacturer Narrative

Product analysis: 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.Upon receipt at medtronic's quality laboratory, visual inspection of the device found the stent posts slightly deflected.All leaflets were slightly stiff but flexible.A perforation observed in the left cusp along the margin of attachment adjacent to the non-coronary left commissure was determined to be associated with contact with the tissue and base stitching.The base stitching was visible from the outflow aspect.All commissures were intact.Remnants of pannus remained attached to the sewing ring on the inflow, extending slightly onto the tissue and base stitching adjacent to the non-coronary left inferior coaptive area.Pannus remained attached to the sewing ring on the outflow, with a thin layer extending along all outflow rails and stent posts.Radiography showed trace mineralization in all leaflets, commissures and along the sewing ring.Conclusion: based on the received information and the returned product analysis, the reported regurgitation is most likely due to the cuspal tear/perforation.The tears in the left cusp of this explanted valve were determined be due to repeated contact of the leaflet with the base suture line.The analysis showed distortion of the annular ring which can restrict the leaflets from fully opening and/or cause misalignment of leaflets during valve closure.Based on historical observations, the distortion of the annular ring can result in more contact of the leaflet with the cloth due to the altered position of the outflow rail and stent posts.The analysis also showed trace of calcification and pannus overgrowth.These can be additional contributing factors to the cuspal tear.

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): 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: 4939502
• MDR Text Key: 6037127
• Report Number: 2025587-2015-00775
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 09/09/2015

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 Expiration Date: 10/13/2016
• Device Model Number: 310CJ
• Device Catalogue Number: 310CJ25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2015
• Initial Date FDA Received: 07/24/2015
• Supplement Dates Manufacturer Received: 09/09/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2012
• 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: 00069 YR