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

Model Number 500DM

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, no definitive conclusion can be made regarding the clinical observation.

Event Description

Medtronic received information that during the implant of this mechanical mitral valve, a valve leaflet broke into pieces while the valve was being rotated, after the valve was sutured in place.The device was explanted and replaced during the procedure.No other adverse patient effects were reported.

Manufacturer Narrative

Product analysis: received dry with no solution in a plastic bag.One leaflet was received detached and broken in pieces.The valve was discolored showing evidence of blood contact.One leaflet appeared intact with no evidence of damage such as cracks or surface anomalies.The other leaflet was broken in four pieces.Both inflow and outflow valve hinge mechanisms appeared intact.The inflow and outflow orifices appeared intact with no evidence of damage.Using a blue actuator to test leaflet movement, the attached leaflet appears to move without difficulty.The valve was rinsed under tap water and it was verified that the carbon subassembly rotated in the sewing ring.

Manufacturer Narrative

Conclusion: medtronic received information that during the implant of this mechanical mitral valve, a valve leaflet broke into pieces while the valve was being rotated, after the valve was sutured in place.No other adverse patient effects were reported.The device was returned for analysis.One of the leaflets was received detached and broken in pieces.The valve was visually inspected.The leaflet fractures are confirmed.The hinge mechanisms and orifices appeared intact with no evidence of damage.The device history record was reviewed.The valve was built to specification and met all inspection and acceptance criteria.Based on the analysis and the reported information, a conclusive cause of the leaflet fractures cannot be determined.There are several potential causes could cause the leaflet fracture / damage: using other instruments for valve rotation; applied excessive force while rotating the valve leaflets; rotated the valve using the leaflet rather than using the rotator and the twisting of the leaflet broke the leaflet.

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 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5651527
• MDR Text Key: 45091013
• Report Number: 3008592544-2016-00030
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: ID
• 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,Followup
• Report Date: 03/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Model Number: 500DM
• Device Catalogue Number: 500DM31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/14/2016
• 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: 49 YR
• Patient Weight: 50