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

Model Number 305U2J23

Device Problem Structural Problem (2506)

Patient Problems Corneal Pannus (1447); Unspecified Infection (1930)

Event Date 12/25/2013

Event Type  Injury  

Event Description

Medtronic received information that approximately 36 months post-implant of this bioprosthetic aortic valve, moderate aortic regurgitation (ar) was observed.Intervention was required 59 months post-implant and the valve was explanted.Upon removal of the valve, pannus, vegitation and a tear was observed.The location of the tear was near the left of the native cusp.Due to observing the vegitation, an infection was suspected however was not confirmed by the health care facility.Only portions of the valve will be returned to medtronic as it was sent to the histopahology department at the hospital.No adverse patient effects were reported.

Manufacturer Narrative

Analysis results: the product has been returned, however analysis is ongoing.A supplemental report will be filed upon completion of analysis.(b)(4).

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the valve was slightly distorted in an oval shape, and one leaflet and the non-coronary cusp appeared to have been excised.The existing left and right cusps were slightly stiff but flexible except where host tissue extended on the inflow and outflow.Small tears and abrasions along the lunula and free margin of the left cusp appeared to be due to contact with the two long suture tails embedded in host tissue over the outflow rail.(the tears may have increased in size during explant with the removal of host tissue on the inflow and/or excision of the non-coronary cusp.) a large cut or tear in the left cusp along the non-coronary left commissure appeared to have occurred during explant.The left right commissure was intact.The condition of the right non-coronary and non-coronary left commissures could not be determined due to the excision of the non-coronary cusp at explant.A large remnant of pannus remained attached to the tissue and base stitching along the non-coronary cusp, to the inflow margin of attachment of the left cusp, extending into the non-coronary left and left right inferior coaptive areas, and one to f our millimeters onto the existing leaflets showing a reduced inflow orifice area.Pannus remained attached to the non-coronary left stent post to the outflow rail adjacent to the left cusp.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Remnants of tan thrombotic-appearing host tissue lined the outflow of the right cusp.Radiography showed no evidence of mineralization in the valve and/or host tissue.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.Histopathology evaluation conducted on the valve found evidence of bioprosthetic valvular endocarditis, with gram positive coccoid bacteria colonization on the right cusp.Based on the analysis of the returned valve, the reported event was caused by endocarditis.Although the species of the bacteria could not be determined, gram positive coccoid bacteria such as streptococcus and staphylococcus are killed by medtronic¿s sterilization process.In addition, endocarditis cases that occur more than 12 months after the procedure are called late prosthetic-valve endocarditis and are largely community-acquired.Therefore it is unlikely that the cause of the endocarditis was related to the valve.A review of the sterilization lot record of this valve showed that there have been no additional complaints for devices sterilized under this lot.

• Brand Name: MOSAIC ULTRA PORCINE 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: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3586808
• MDR Text Key: 15817311
• Report Number: 2025587-2014-00009
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/09/2013
• Device Model Number: 305U2J23
• Device Catalogue Number: 305U2J23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2008
• 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: 00070 YR