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

Model Number 500DM33

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

No product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Only year valid.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from the patient that approximately 4 years post implant of this 33mm mechanical valve, it was explanted and replaced with an unknown valve.The reason for replacement is unknown.No additional adverse patient effects were reported. .

• 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 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 9929368
• MDR Text Key: 186743458
• Report Number: 3008592544-2020-00027
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 00613994960283
• UDI-Public: 00613994960283
• Combination Product (y/n): N
• Reporter Country Code: RQ
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/26/2016
• Device Model Number: 500DM33
• Device Catalogue Number: 500DM33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2020
• 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: 39 YR