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

Model Number 305C

Device Problems Structural Problem (2506); Insufficient Information (3190)

Patient Problems Fainting (1847); Bone Fracture(s) (1870); No Information (3190)

Event Date 03/08/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt 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.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.

Event Description

Medtronic received information that four years, nine months post implant of this aortic bioprosthetic valve, this valve was explanted and replaced.No failure mechanism and no other adverse patient effects were reported.

Manufacturer Narrative

Patient information, weight in lbs has been updated.Additional narrative has been received; therefore sections have been updated.

Event Description

Additional information was received indicating that 4 years and 9 months post implant of this aortic bioprosthetic valve, it was explanted and replaced due to torn leaflets.Preoperatively, the patient fainted and suffered a clavicle fracture and a femur fracture.It was reported that the syncope was possibly valve related.

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): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 5773782
• MDR Text Key: 48916854
• Report Number: 2025587-2016-00988
• 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: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• Device Model Number: 305C
• Device Catalogue Number: 305C219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2010
• 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: 51 YR
• Patient Weight: 64