MAUDE Adverse Event Report: HEART VALVES SANTA ANA 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 11/15/2016

Event Type  Injury  

Manufacturer Narrative

This device was made for distribution outside the united states.As such, there is not a pre-market approval, or 510(k) approval number associated with the device.The device serial number was not provided.Without the device serial number, the device manufacturing date and expiration date may not be obtained; also, the unique device identifier may not be obtained.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that approximately four years post implant of this bioprosthetic mitral valve, the patient had recurrent mitral valve regurgitation.The valve had been implanted in a position where the stent post directed towards the left ventricular outflow tract.Perforations were identified on the valve cusp, and a larger perforation was made while explanting the device.The device was replaced with a non-medtronic product.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the returned product specimen was visually examined.All leaflets were slightly stiff but flexible except where host tissue extended on the inflow and/or outflow of the left and right cusps.The right cusp appeared intact.Two large tears were observed along the inflow margin of attachment in both the non-coronary and left cusps.The origin of the tears is unknown but due to the location, they may have been associated with wear along the base stitching as observed on historical events.The tear in the non-coronary cusp appeared to have increased in size during explant.Damage on the sewing to the tissue and bases stitching adjacent to the tear appeared to be associated with a sharp object such as forceps.(removal of host tissue on the inflow may have contributed to the increase in size of the tear.) tissue thinning was observed in the non-coronary cusp adjacent to the non-coronary left inferior coaptive area.All commissures appeared intact.Note: although host tissue parti ally covers the right non-coronary commissure, the commissure appears intact.Glistening off white pannus lines the sewing ring on the inflow adjacent to all cusps, extending to the tissue and base stitching, along the inflow margin of attachment, into all inferior coaptive areas, and 1 to 3.5 mm onto all cusps showing possible restricted leaflet movement.Pannus on the outflow lines the sewing ring on the outflow, to the outflow rail adjacent to all cusps, extending to all stent posts, partially encapsulating the right non-coronary stent post and commissure, slightly restricting leaflet movement.Pannus on the outflow rail adjacent to the left cusp appeared to have extended to the outflow margin of attachment.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography showed no evidence of mineralization in the valve and/or host tissue.Conclusion: a review of the device history record (dhr) was also performed for this valve; there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.Based on the analysis and received information, the reported regurgitation is found to be caused by the pannus overgrowth.Pannus overgrowth is associated with surgical valve replacement due to patient interaction and/or healing response with the surgical valve.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6146809
• MDR Text Key: 61491135
• Report Number: 2025587-2016-01925
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2017

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: 310CJ
• Device Catalogue Number: 310CJ25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided; 04/24/2017
• Supplement Dates FDA Received: 04/26/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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: 72 YR