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

Model Number 500DM29

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems Foreign Body In Patient (2687); No Information (3190)

Event Date 05/03/2018

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 immediately post implant of this mechanical valve, both valve leaflets broke and the valve was removed.A new valve was implanted with no issues.No additional adverse patient effects were reported. .

Manufacturer Narrative

Medtronic received additional information that the broken leaflets fell into the ventricle and were removed.No additional adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: medtronic received photographs of the explanted valve.The valve was not returned to medtronic for analysis.Based on review of the photographs, both leaflets were detached from the orifice and the orifice of the valve appeared damaged.With the available images, no fracture or damage on the leaflets were observed, and there was not enough information to evaluate the damaged orifice.The observed damage on the orifice may have been caused during handling/implant or attempting to retrieve the detached leaflets from the ventricular cavity.A conclusive cause of the reported broken leaflets could not be determined based on the limited information received.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.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: 7542448
• MDR Text Key: 109193907
• Report Number: 2025587-2018-01299
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2022
• Device Model Number: 500DM29
• Device Catalogue Number: 500DM29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2018
• Date Device Manufactured: 03/03/2017
• 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