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

Model Number 305U

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Calcium Deposits/Calcification (1758); No Information (3190)

Event Date 11/17/2016

Event Type  Injury  

Manufacturer Narrative

This device remains implanted and will not be returned for analysis.Without the return 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.

Event Description

Medtronic received information that four years and eleven months post implant of this bioprosthetic valve, this valve was replaced v alve-in-valve.The failure mechanism was not provided.No other adverse patient effects were reported.

Manufacturer Narrative

Additional information was received indicating that this bioprosthetic valve was replaced due to calcification.No other adverse patient effects were reported.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

Medtronic received additional information that indicating that this bioprosthetic valve was explanted due to calcification.No other adverse patient effects were reported.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.The medtronic transcatheter valve can be found in regulatory report #2025587-2018-00986.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 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: 6155287
• MDR Text Key: 61805995
• Report Number: 2025587-2016-01959
• 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: 04/26/2018

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: 10/13/2016
• Device Model Number: 305U
• Device Catalogue Number: 305U223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/08/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 12/20/2016; 12/20/2016
• Supplement Dates FDA Received: 12/08/2016; 12/20/2016; 09/27/2017; 04/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/28/2011
• 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: 28 YR