MAUDE Adverse Event Report: MEDTRONIC ATS MEDICAL OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505DM28

Device Problems Incomplete Coaptation (2507); Mechanical Jam (2983)

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

Event Date 02/26/2014

Event Type  Injury  

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 tissue annulus diameter of the valve was measured and confirmed to be within specification.The roundness of the stiffening ring was measured and assessed, and found to be within the engineering specifications.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 available information and returned product analysis, it is likely that the clinical observation was due to a patient anatomy issue that was not detected until after device implant.

Event Description

Medtronic received information that this mechanical heart valve was implanted anatomically in a supra-annular position with no issues and proper leaflet motion.However, after closing the left atrium, the transesophageal echocardiogram (tee) showed that one leaflet was stuck in the closed position.The left atrium was reopened and the valve was rotated 90 degrees.The leaflets again showed proper movement until the left atrium was closed.Tee again showed one leaflet was stuck in the closed position.The valve was then removed and successfully replaced with a non-medtronic 29mm valve in a supra-annular position.The physician noted that this was a reoperation and that removal of remnant tissue seemed more difficult than usual.Although there was no tissue found in the orifice, there was a concern that an invasion of tissue in the orifice might occur because this valve was sutured more closely to the left atrium than the first implant.The physician speculated that there may have been an undetected interference by tissue in the orifice area during left ventricle systole due to insufficient pressure to open a leaflet with pushing the remnant backward during left atrium systole, therefore possibly causing the leaflet to be stuck in the closed position.No subsequent adverse patient effects were reported beyond the reoperation/replacement.

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: OPEN PIVOT AP360 HEART VALVE
• 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: 3705861
• MDR Text Key: 12087089
• Report Number: 2134151-2014-00011
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/27/2020
• Device Model Number: 505DM28
• Device Catalogue Number: 505DM28
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention