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

Model Number 310_MOSAIC

Device Problems Material Deformation (2976); Insufficient Information (3190)

Patient Problems Corneal Pannus (1447); Hematoma (1884); Mitral Regurgitation (1964); Thrombus (2101); Regurgitation (2259)

Event Date 09/07/2018

Event Type  Injury  

Manufacturer Narrative

The device evaluation is anticipated but has not yet begun.A supplemental report will be filed upon completion of the device evalua tion.No unique device identifier (model/serial) was provided.The model and catalog number in section d.4.Was arbitrarily chosen based on the available information provided.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 14 years and 1 month post implant of this mitral bioprosthetic valve of unknown size, it was explanted due to regurgitation.The valve was replaced with a 27mm valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual inspection identified damage along the sewing ring of the valve, likely caused during the explant procedure.The valve was slightly distorted (oval shaped).All leaflets were in the closed position with wavy free margins.All leaflets were flexible except on areas where pannus was observed.From the outflow view, tan thrombotic host tissue was observed along the margin of attachment of the left cusp (lc).Tear abrasion through the lunula of the right cusp (rc) was consistent with contact with the bias cloth.A smaller abrasion, approximately 1mm, was also noted on the lunula of the rc.From the inflow view, the left cusp (lc) exhibited an intracuspal hematoma along the margin of attachment, extending onto the inferior coaptive area between the lc and rc.Due to the dehisced right non-coronary commissure, the rc was prolapsed.The right non-coronary commissure was dehisced.The detachment was noted at the superior coaptive area.The detachment did not expose the aortic wall; therefore, manufacturing sutures could not be assessed.The right non-coronary commissure and left non-coronary commissure were intact, with no commissure dehiscence noted.White pannus encroached up to 9mm of the non-coronary cusp (inflow).A layer of white pannus lined the outflow rail adjacent to the nc and lc cusps, extending onto the back of the left non-coronary stent post.White pannus was noted on the back of the left right commissure stent post.An unknown amount of pannus appears to have been removed during explant.Radiography showed no evidence of calcification on the leaflets.Conclusion: based on the product analysis, pannus overgrowth covering the commissure/stent post could create additional stress during valve closure by limiting the deflection of the stent posts.For this event, pannus overgrowth may be a contributing factor to the commissure dehiscence.The right non-coronary commissure dehiscence may have caused the right cusp prolapse and led to incomplete coaptation, causing the regurgitation.The distortion of the annular ring (oval shape) may have altered the stress placed on the commissures and leaflets of the valve.The alteration of stress may have played a role in dehiscence of the commissure.Commissure dehiscence is a known risk is for valve failure.Reduced performance of the valve is attributed to host tissue overgrowth.This finding is generally considered a patient-related condition.Updated codes in section.Updated serial number and expiration date in section.Updated device manufacture date in section.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The reason for follow-up on report number 2025587-2018-02612, follow-up 001, was due to device evaluation.The follow-up type was corrected to 'device evaluation'.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Added expiration date, added device manufacture date.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: 7926776
• MDR Text Key: 122360088
• Report Number: 2025587-2018-02612
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2007
• Device Model Number: 310_MOSAIC
• Device Catalogue Number: 310_MOSAIC
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2004
• 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