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

Model Number 310C

Device Problems Hole In Material (1293); Incomplete Coaptation (2507)

Patient Problem No Code Available (3191)

Event Date 02/17/2017

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.Additional information has been requested, but no new information has been received to date.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 one year, nine months following the implant this bioprosthetic valve, this valve was explanted due to clot formation on the ventricular side, which was causing the leaflet to not close, and a leaflet hole.Prior to the replacement procedure, the patient was symptomatic.No other adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that this device was implanted for one year, six months, and not one year, nine months as initially indicated.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, pieces of the sewing ring, host tissue and pledgets were received with the valve for analysis.The valve appeared distorted; oval shaped.Two pledgets remained attached to the sewing ring on the inflow.The non-coronary and left cusps were stiff due to host tissue on the outflow.The left cusp appeared slightly stiff but flexible.All leaflets appeared intact.The free margin of the left cusp appeared to fold back and adhere to the host tissue on the outflow.All commissures appeared intact.Traces of pannus remained attached to the sewing ring on the inflow.Remnants of pannus were observed on the outflow rail adjacent to the right and non-coronary cusps, extending to the commissural area, partially covering the top of the commissure and slightly onto the free margins.Tan to brown thrombotic appearing host tissue filled and stiffened the non-coronary and left cusps on the outflow.An unknown amount of pannus appeared to have been removed on the inflow and/or outflow during explant.Radiography showed no evidence of mineralization on the valve and/or host tissue.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.A visual examination of the returned device was performed upon receipt.The device was distorted (oval shaped).The reported "leaflet hole" was not observed; it could have referred to the gaps between the leaflets.An unknown amount of pannus appeared to be removed on the inflow and outflow during explant.The pannus overgrowth on the inflow / outflow could have significantly impaired the leaflet mobility.The impairment of leaflet mobility may have led to the thrombus formation on the outflow of the valve causing the leaflet coaptation issue.Distortion of the annular ring can also restrict the leaflets from fully opening and potentially affecting the coaptation.Pannus overgrowth is associated with surgical valve replacement due to patient interaction and/or healing response with the surgical valve.Pannus overgrowth has been an inherent risk of surgical valve replacement.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.

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 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 HEART VALVES DIVISION; 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: 6407276
• MDR Text Key: 70016472
• Report Number: 2025587-2017-00405
• 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: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2020
• Device Model Number: 310C
• Device Catalogue Number: 310C27
• 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: 05/18/2015
• 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: 69 YR