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

Model Number 500DM33

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 04/21/2018

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, 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 implant of this mitral 33mm mechanical valve, it was noted that one of the leaflets was detached.The valve was not used and another valve was successfully implanted in its place.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that during implant one of the mechanical valve leaflets detached and fell into the patients left ventricle.Both the valve and the leaflet were removed from the patient and a new mechanical valve was successfully implanted in its place without issue.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Submitting this report as it was determined after additional information was obtained, to be a duplicate complaint record.That duplicate record resulted in a regulatory report being sent.That previously submitted mfr report number: is 3008592544-2018-00018.All information is and will be contained in that complaint record as necessary going forward.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 VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7519918
• MDR Text Key: 108449067
• Report Number: 2025587-2018-01155
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500DM33
• Device Catalogue Number: 500DM33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2018
• 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