MAUDE Adverse Event Report: HEART VALVES SANTA ANA MOSAIC AORTIC BIOPROSTHETIC HEART VALVE; TIMER, CLOT, AUTOMATED

Model Number 305C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aortic Insufficiency (1715); Aortic Valve Stenosis (1717)

Event Date 01/24/2017

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.The device serial number has not been received.Without the serial number, the device manufacturing date, expiration date, and the unique device identifier may remain unknown.

Event Description

Medtronic received information that post implant (duration unknown) of this bioprosthetic valve, it was explanted and replaced due to continued aortic insufficiency and stenosis.No other adverse patient effects were reported.

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: TIMER, CLOT, AUTOMATED
• 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: 6327791
• MDR Text Key: 67319775
• Report Number: 2025587-2017-00236
• Device Sequence Number: 1
• Product Code: GKN
• 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: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305C
• Device Catalogue Number: 305C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: No
• 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: 86 YR
• Patient Weight: 87