MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 505

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

Patient Problem Cardiac Arrest (1762)

Event Date 04/24/2014

Event Type  Injury  

Event Description

Medtronic received information that following the implant of this mechanical valve, the heart would not resume beating.The valve was explanted, and a second valve was implanted, with success and the heart resumed beating.It was noted that the physician is not stating any allegation of malfunction against the mechanical valve.The explanted valve will be returned for analysis.

Manufacturer Narrative

The product has been returned and analysis results are pending.Upon completion of the analysis investigation, a supplemental report will be filed.(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.From the available information, a conclusive cause of the reported clinical observation could not be determined.However, the analysis and investigation results confirmed the clinical observation that there was no malfunction of this device.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the valve was visually inspected with no anomalies noted.The serial number was verified to be correct.The valve leaflets were fully mobile.The valve was inspected and functionally tested per manufacturing procedure and met specifications.The carbon components and stiffening ring were dimensionally inspected and met engineering specifications.The sewing ring was examined and met specifications for stitching and back-stitching.The analysis confirmed the clinical observation that there was no device malfunction.

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; 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: 3824856
• MDR Text Key: 4501722
• Report Number: 3008592544-2014-00025
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 08/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2019
• Device Model Number: 505
• Device Catalogue Number: 505DA18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/14/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2012
• 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: 00056 YR