MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995-27

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2014

Event Type  No Answer Provided  

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.The freestyle instructions for use (ifu) states: ¿appropriate inventory control should be maintained so that bioprostheses with earlier use by dates are preferentially implanted and expiration is avoided.¿ the ubd reflects a 5-year shelf life that has been validated by medtronic and approved by the fda; this validation process only reflects the length of the testing by medtronic ¿ it is not necessarily an end point for sterility or integrity of the product.However, medtronic does not recommend or endorse the practice of implanting a heart valve beyond its posted shelf life.

Event Description

Medtronic received information that this bioprosthetic valve was implanted five days after the use before date (ubd).This was realized prior to the implant procedure by the physician and the physician decided to implant the valve.It was noted that the valve was implanted due to the patient's urgent need and declining condition, the physician felt there was no other option.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the product remains implanted, therefore no product analysis can be performed.Conclusion: it was reported by the physician that the valve was implanted due to the patient's urgent need and declining condition.No adverse patient effects were reported.(b)(4).

Manufacturer Narrative

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

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 4209730
• MDR Text Key: 12541785
• Report Number: 2025587-2014-00811
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• 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: 11/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2014
• Device Model Number: FR995-27
• Device Catalogue Number: FR995-27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/15/2009
• 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 Age: 00074 YR