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

Model Number 305U

Device Problem Hole In Material (1293)

Patient Problem No Code Available (3191)

Event Date 02/20/2017

Event Type  Injury  

Manufacturer Narrative

The patient information and the device serial number have not been reported.Without more information, the device manufacturing and expiration date may not be obtained.Additional information has been requested, but no additional information has been received.The device has not been received for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 this bioprosthetic valve was explanted due to clot formation on the ventricular side and a leaflet hole.Prior to the replacement procedure, the patient was symptomatic.The device implant duration was not reported.No other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this device was implanted for one year, eight months before being explanted.

Manufacturer Narrative

Product analysis: the device was received at medtronic in a clear 10% formalin solution in a small specimen container enclosed in a small biohazard bag.A visual examination of the returned device was performed upon receipt.The stent posts appeared deflected.Stent post measured lr= 12°, rnc= -2°, ncl= 9°.All leaflets appeared slightly stiff but flexible except where host tissue extended on the inflow and/or outflow of the non-coronary cusp.Tears or abrasions through the free margin and lunula of all cusps appeared to be associated with contact with the bias cloth or possible long suture tails, or a combination of the two.Tiny tears in the left right commissure appeared to have occurred during explant.The right non-coronary and non-coronary left commissures appeared intact.Glistening off-white pannus remained attached to the sewing ring on the inflow adjacent to the right and non-coronary cusps, extending to the tissue and base stitching, to the right non-coronary and non-coronary left inferior coaptive areas and 1 to 3 mm onto all cusps showing a reduced inflow orifice area.Pannus on the outflow lines the sewing ring on the outflow, extending partially onto the left right and right non-coronary commissures.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.Radiography showed trace mineralization in the host tissue along the outflow rail adjacent to the non-coronary and left cusps.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.Conclusion: pannus overgrowth is associated with surgical valve replacement due to patient interaction and healing response with the surgical valve.The pannus overgrowth on the inflow appears to have extended several millimeters out onto the leaflet which would have significantly impaired the leaflet mobility.The impairment of leaflet mobility may have led to the thrombus formation on the outflow of the valve.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.

Manufacturer Narrative

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

• Brand Name: MOSAIC AORTIC 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: 6401361
• MDR Text Key: 69839663
• Report Number: 2025587-2017-00396
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/08/2019
• Device Model Number: 305U
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/24/2014
• 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: 60 YR