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

Model Number 305U

Device Problem Structural Problem (2506)

Patient Problem Aortic Regurgitation (1716)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information that two years, ten months post implant of this bioprosthetic aortic valve, it was replaced due to central regurgitation.Upon removal, a tear was found in the non-coronary leaflet.No adverse patient effects were reported.

Manufacturer Narrative

Analysis: the device was returned for analysis.A visual examination of the device was performed upon receipt.A remnant of glistening off-white pannus remained attached to the tissue and base stitching adjacent to the right cusp extending on the cusp showing possible evidence of a reduced inflow orifice area.Traces of pannus lined the inflow margin of attachment adjacent to all cusps extending onto the tunica into the right non-coronary inferior coaptive area.Remnants of pannus remained attached to the outflow adjacent to all stent posts and outflow rails adjacent to all cusps and along the sewing ring.An unknown amount of pannus appeared to have been removed on the inflow and outflow during explant.The leaflets appeared to have been excised for histopathology samples.The analysis of the device showed tears and abrasions through the free margin or lunula of the left and right cusps.Abrasions on the lunula of the non-coronary cusp appeared to be due to contact with the bias cloth along the outflow rail.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: based on the received information and the returned product analysis, the reported regurgitation is most likely due to the cuspal tears.The leaflets contacting with the bias cloth could be the potential cause of the tears.Cuspal tear due to contacting with bias cloth is a known potential risk and is addressed in the current risk management file.

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): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5389784
• MDR Text Key: 36850668
• Report Number: 2025587-2016-00087
• 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
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 305U
• Device Catalogue Number: 305U225
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2012
• 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: 00065 YR