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

Model Number 305C27

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 03/15/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: 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 an unknown duration post implant of this aortic bioprosthetic valve, a transcatheter valve was implanted valve-in-valve due to a torn leaflet.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the aortic bioprosthetic valve was replaced valve-in-valve 11 years and 9 months post implant.Patient information updated.Device information updated.Device implant date updated.Device mfg date added.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC PORCINE HEART VALVE
• 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: 7393059
• MDR Text Key: 104199486
• Report Number: 2025587-2018-00758
• 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
• Report Date: 05/21/2018

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: 02/08/2011
• Device Model Number: 305C27
• Device Catalogue Number: 305C27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2018
• Initial Date FDA Received: 04/03/2018
• Supplement Dates Manufacturer Received: 05/01/2018
• Supplement Dates FDA Received: 05/21/2018
• Date Device Manufactured: 02/08/2006
• 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: 64 YR