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

Model Number 505DA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Rupture (2208)

Event Date 02/11/2017

Event Type  Death  

Manufacturer Narrative

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

Medtronic received information that this patient was implanted with an aortic mechanical valve and a mitral mechanical valve during an emergency procedure.After the operation, the patient presented with elevated blood pressure for unknown reasons.Two day post-implant, the patient had a sudden change in health due to a rupture in the left ventricle.The physician performed a reoperation to implant a pericardial patch at the site of the rupture.During the procedure, the physician explanted the valves, checked the valves, and re-implanted them.The patient was taken to the intensive care unit.Four days post-implant, the patient died.No other adverse patient effects were reported.

Manufacturer Narrative

Additional information received indicated that the physician did not consider the rupture of the left ventricle to be caused by the patient's mechanical valves.It was presumed that the elevated blood pressure caused the ventricular rupture.Additionally, the physician noted that the patient's annulus was fragile and that there was difficulty stopping bleeding.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.

Manufacturer Narrative

Analysis: the device has not been received for analysis.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: with the limited information available, a relationship between the device and the death could not be established.No allegations were made relating the valve or its function to the death.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.

Manufacturer Narrative

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: AORTIC AP
• 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: 6447405
• MDR Text Key: 71300534
• Report Number: 3008592544-2017-00013
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2022
• Device Model Number: 505DA
• Device Catalogue Number: 505DA22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/13/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/29/2015
• 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
• Treatment: 500DM29 (SERIAL NUMBER (B)(4))
• Patient Outcome(s): Death; Required Intervention