MAUDE Adverse Event Report: MEDTRONIC, INC. MITRAL AP MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number	501
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	Mitral Regurgitation (1964)
Date of Event	11/09/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product analysis: the product specimen will not be returned for device analysis.Conclusion: multiple attempts to gather additional information have been made; however, these attempts have been unsuccessful.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the implant of this mechanical mitral valve, the physician was unable to rotate the device into an ant-anatomical position after a considerable amount of time and effort.After the heart was closed and while attempting to wean the patient off of cardiopulmonary bypass (cpb), a transesophageal echocardiogram (tee) showed that one of the mitral valve leaflets was not moving, resulting in severe regurgitation.The patient was returned to cpb, and the physician unsuccessfully attempted to rotate the device into a more optimal position.The physician explanted the device, debrided the annulus of excess tissue, and implanted a 24mm mechanical valve.Post-operatively, the patient was placed on extracorporeal membrane oxygenation (ecmo) and transferred to the intensive care unit.Two days later, the patient died.
Additional Manufacturer Narrative
Additional information received from the physician indicated that the physician was unable to rotate the device due to severe calcification throughout the heart.The cause of death was right ventricular failure.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.
Additional Manufacturer Narrative
Analysis: the device will not be returned for analysis.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.Neither autopsy nor explant information was reported.Conclusion: based on the received information, the reported leaflet motion probably lead to regurgitation, and the potential cause of the observed leaflet motion was calcification.Calcification is an inherent risk of surgical valve replacement.With the limited information available, a relationship between the device and the death could not be established.
Additional Manufacturer Narrative
Corrected information.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MITRAL AP MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 6139699
• Report Number: 3008592544-2016-00063
• Device Sequence Number: 13649946
• Product Code: LWQ
• UDI-Device Identifier: 00643169334823
• UDI-Public: 00643169334823
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P990046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/20/2018
• Device Model Number: 501
• Device Catalogue Number: 501DM26
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/10/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 02/08/2017
• Initial Report FDA Received Date: 12/01/2016
• Supplement Report FDA Received Date: 12/05/2016; 02/09/2017; 09/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 55 YR