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

Model Number 310

Device Problem Material Perforation (2205)

Patient Problems Corneal Pannus (1447); Mitral Regurgitation (1964)

Event Date 12/01/2014

Event Type  Injury  

Event Description

Medtronic received information that 35 months post implant of this bioprosthetic valve, the patient was found to be in poor condition with central regurgitation of the valve.Subsequently, the valve was explanted with a noted tear and pannus formation at the circumferences of stent and cuff.No further adverse patient effects were reported.

Manufacturer Narrative

The device has been returned for analysis, analysis is in process.Once the analysis is complete, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, the device was received in a clear 0.2% glutaraldehyde solution in an explant kit.All leaflets were slightly stiff but flexible.A large tear in the left cusp along the inflow margin of attachment was determined to be associated with restricted leaflet movement due to adhered host tissue.Tiny tears along the inflow margin of attachment adjacent to all cusps was determined to be associated with the removal of host tissue.All commissures were intact.Traces of pannus remained attached to the inflow.Glistening off-white pannus remained attached to the right non-coronary and non-coronary left stent posts, along the outflow rail adjacent to the right and non-coronary cusps, extending slightly onto the sewing ring adjacent to the right cusp.An unknown amount of pannus was removed on the inflow and outflow during explant.Small yellow clusters of protein deposits or fibrin were observed in the belly of the right cusp.Radiography showed no evidence of mineralization in the valve and/or host tissue.

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.Collagen degeneration was observed, but no inflammation was found in the left cusp at the tear.The conclusive root cause of the tear cannot be determined.In addition, the regurgitation was reported as central regurgitation, which is not consistent with the location of the hole tear.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 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: 4371774
• MDR Text Key: 5239328
• Report Number: 2025587-2014-01039
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/02/2015

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: 310
• Device Catalogue Number: 310CJ25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 03/02/2015
• Supplement Dates FDA Received: 02/12/2015; 03/09/2015; 09/15/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 00086 YR