MAUDE Adverse Event Report: MEDTRONIC ATS MEDICAL AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 505DA24

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2014

Event Type  Injury  

Event Description

Medtronic received information that during the initial implant of this mechanical heart valve, there was a visual observation of a portion of the valve housing coming free.The valve was explanted and replaced with another valve of the same model with no adverse patient effects.

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

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.Upon receipt at medtronic¿s quality laboratory, the valve orifice was returned damaged.Visual inspection showed the valve housing was broken along the outflow aspect.The leaflets were verified to be fully mobile.No as-manufactured surface finish anomalies were identified.The as-returned dimensions of the orifice and leaflets met the manufacturing and engineering specifications except for the observed damage.Based on the analysis, the damage to the orifice appears to have occurred due to mishandling during the procedure.

Manufacturer Narrative

Based on the analysis findings and device history record review, the damage to the orifice appears to have occurred due to mishandling during the procedure.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC ATS MEDICAL; 3905 annapolis lane north; minneapolis MN 55447
• 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: 3629879
• MDR Text Key: 4204942
• Report Number: 2134151-2014-00005
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2019
• Device Model Number: 505DA24
• Device Catalogue Number: 505DA24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2012
• 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: 00051 YR