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

Model Number 305C23

Device Problems Occlusion Within Device (1423); Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2017

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 11 years and 7 months post implant of this 23 mm bioprosthetic valve, the valve was explanted and replaced with a 27 mm bioprosthetic valve of the same model. the reason for the explant was not reported.  no adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the 23mm aortic bioprosthetic valve was explanted and replaced with another manufacturer's 21mm valve due to stenosis and insufficiency.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction report to add patient and device codes which were inadvertently left off supplemental report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Aware date on previously submitted supplemental report was incorrect.Aware date should be (b)(6) 2018.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 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: 7168276
• MDR Text Key: 96502821
• Report Number: 2025587-2018-00070
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00721902694745
• UDI-Public: 00721902694745
• 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
• Report Date: 03/14/2018

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: 11/02/2010
• Device Model Number: 305C23
• Device Catalogue Number: 305C23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 02/20/2018; 02/20/2018
• Supplement Dates FDA Received: 03/13/2018; 03/13/2018; 03/14/2018
• Date Device Manufactured: 11/02/2005
• 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: 66 YR