MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500

Device Problem Leak/Splash (1354)

Patient Problem Mitral Regurgitation (1964)

Event Date 02/29/2016

Event Type  Injury  

Manufacturer Narrative

Product analysis: 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 explanted device was not returned for analysis and a detailed investigation could not be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.However, based on the received information, the leak could be due to the patient¿s anatomy.(b)(4).

Event Description

Medtronic received information that immediately following the implant of this 29mm mechanical mitral valve, the valve was explanted and replaced with a 27mm mechanical mitral valve because the transesophageal echocardiogram (tee) showed severe central regurgitation with normal leaflet motion.The physician reported that prior to the implant of this replacement valve, "the tissue along [the] posteromedial portion was somewhat friable and thin, and was also abutting up on to the aortic valve leaflet." the physician also reported that the "leaflets were functioning normally" following implant of this valve.No other adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5532888
• MDR Text Key: 41417046
• Report Number: 3008592544-2016-00018
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/29/2017
• Device Model Number: 500
• Device Catalogue Number: 500DM29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Date Device Manufactured: 06/29/2012
• 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: 00059 YR