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

Model Number 500DM33

Device Problem Structural Problem (2506)

Patient Problem No Information (3190)

Event Date 11/25/2018

Event Type  Injury  

Manufacturer Narrative

Conclusion: without the return of the products, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant procedure of these 3 mechanical valves in 3 different patients, the physician stated that there was "leaflet breakdown" and explanted and successfully replaced the valves.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that there was only 1 device in question with "leaflet breakdown" which the physician meant to be detached leaflet.No additional adverse patient effects were reported.Added patient initial, added patient weight, updated device quantity from 3 to 1.Added device serial # ,added unique identifier (udi) #: added expiration date, added device mfg date: if information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The valve was not returned for analysis.Without return for the device, the root cause of the reported issue could not be verified.Medtronic could not identify the cause for the leaflet detachment during implant.A review of the device history record (dhr) was performed for this valve.This device was manufactured per approved and released manufacturing processes and met all applicable manufacturing specifications prior to release for distribution.Updated eval code results updated eval code conclusion.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 HEART VALVE DIVISION; 3800 annapolis lane; minneapolis CA 55447
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis CA 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8154871
• MDR Text Key: 130040992
• Report Number: 2184009-2018-00043
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: AG
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2022
• Device Model Number: 500DM33
• Device Catalogue Number: 500DM33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2019
• Date Device Manufactured: 05/18/2017
• 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: 63 YR
• Patient Weight: 72