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

Model Number T505C227

Device Problems Calcified (1077); Structural Problem (2506); Detachment of Device or Device Component (2907); Material Distortion (2977)

Patient Problems Corneal Pannus (1447); Calcium Deposits/Calcification (1758); No Code Available (3191)

Event Date 11/06/2017

Event Type  Injury  

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that an 12 years and 3 months post implant of this 23 mm bioprosthetic valve, the valve was explanted and replaced with a 27 mm valve of a different model due to cuspal tear.No additional adverse patient effects were reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was slightly distorted.The right left commissure and the non-coronary right commissures were detached.All leaflets were in the closed position, however, due to dehiscence at the right non-coronary stent post and left right stent post, the right cusp was crowded and folded within itself.All leaflets were slightly stiff but flexible.No cuspal tear was observed.All leaflets were intact except where the commissure was detached/dehisced.The right cusp and left cusp were slightly prolapsed due to the detached/dehisced commissures.The non-coronary left commissure was intact.The left right commissure and non-coronary right commissure were dehisced, possibly related to separation of the layers of aortic wall behind the commissure.The sutures holding the aortic wall to the stent post were intact.Remnants of pannus were observed on the non-coronary right commissure.Remnants of pannus were also observed on some areas of the sewing ring (outflow).Pannus was attached to the tissue of both dehisced commissures and a thin layer of pannus lined the margin of attachment of all leaflets at the inflow aspect, encroaching approximately 1 mm to the leaflets and into all inferior coaptive area.An unknown amount of pannus appeared to have been removed on the inflow during explant.Radiography revealed calcification at the left right commissure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Added manufacture date.Added expiration date.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVE 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: 7063191
• MDR Text Key: 93070378
• Report Number: 2025587-2017-02284
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/20/2017

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 Expiration Date: 07/11/2010
• Device Model Number: T505C227
• Device Catalogue Number: 305C23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2017
• Initial Date FDA Received: 11/28/2017
• Supplement Dates Manufacturer Received: 11/07/2017; 11/29/2017; 12/15/2017; 12/15/2017
• Supplement Dates FDA Received: 12/06/2017; 12/11/2017; 12/18/2017; 12/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2005
• 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: 71 YR
• Patient Weight: 77