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

Model Number 505DA20

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Intimal Dissection (1333)

Event Date 03/03/2014

Event Type  Injury  

Manufacturer Narrative

Conclusion: 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.The valve was verified to be manufactured as a size 20mm valve.From the available information, a conclusive cause of the sizing discrepancy could not be determined as the valve was implanted and the sizer was not returned.It was reported that the appropriate blue handled medtronic 20mm sizer for the ap 360 valve from the accessory kit was used and passed through the annulus without any resistance.However, the aorta tore when a 20mm valve was passed through the sinotubular junction.The valve was implanted and the tear was surgically repaired with a suture.The valve remains implanted at this time.

Event Description

Medtronic received information that during the implant of this mechanical aortic bioprosthesis the aorta was torn when the 20 millimeter (mm) valve was passed through the sino tubular junction.It was reported that the 20 mm sizer from the associated accessory kit was used and passed through the annulus without any resistance.After the valve was implanted, the tear was surgically repaired with a suture.No additional adverse patient effects were reported.

Manufacturer Narrative

The device remains implanted.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.A supplemental report will be filed if additional information is received or when the investigation is completed.(b)(4).

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: mike gaffney ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635265629
• MDR Report Key: 3701038
• MDR Text Key: 11732432
• Report Number: 2134151-2014-00010
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• 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: 05/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2015
• Device Model Number: 505DA20
• Device Catalogue Number: 505DA20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/31/2012
• 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: 00035 YR
• Patient Weight: 120