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

Model Number 305U227

Device Problem Torn Material (3024)

Patient Problem Aortic Regurgitation (1716)

Event Date 10/13/2014

Event Type  Injury  

Event Description

Medtronic received information that during the implant of this bioprosthetic valve, an echocardiogram showed severe central regurgit ation and a cuspal tear of the non-coronary leaflet.The valve was explanted and replaced with another manufacturer's device.No further adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, a visual examination of the device was performed, and showed that one stent post was slightly deflected.Device analysis confirmed the cuspal tears.Multiple tears and abrasions appeared consistent with a puncture or laceration by a sharp instrument such as a forceps.Also, minor damage or imprints on the top of the non-coronary left commissure appeared consistent with marks from forceps.Intracuspal hematomas were observed on the inflow of all cusps.All commissures were intact.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Based on the received information and the returned product analysis, the definitive cause of the severe aortic insufficiency could not be determined.However, the cuspal tears (which appeared to have occurred during the implant procedure due to contact with a sharp instrument) and stent distortion could be the contributing causes to the severe regurgitation.Regurgitation-related failure modes are addressed in the current device risk management files.

Manufacturer Narrative

The product has been returned and analysis is in progress.Upon completion of analysis, a supplemental report will be submitted.(b)(4).

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): MEDTRONIC HEART VALVES DIVISION; 1851 e. deere ave.; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4232629
• MDR Text Key: 4977020
• Report Number: 2025587-2014-00850
• 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: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2018
• Device Model Number: 305U227
• Device Catalogue Number: 305U227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/11/2013
• 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: 00061 YR
• Patient Weight: 113