MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO R DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	ENVEOR-N-US
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Aortic Dissection (2491)
Date of Event	06/21/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product analysis: the device was discarded, therefore no product analysis can be performed.Conclusion: 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 or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, via right femoral access with previous bilateral femoral stents, the patient died during the procedure due to an aortic dissection.A closure device was used prior to noting the injury.No autopsy was reported.The physician did not attribute the dissection to the delivery catheter system (dcs).
Additional Manufacturer Narrative
Additional information was received that during deployment, the physician pushed on the delivery catheter system (dcs) and the wire, per usual process, and as the valve was about to be released, the patient's pressure dropped.The patient was placed on cardiopulmonary bypass (cpb), the case switched to an open procedure, and cardiopulmonary resuscitation (cpr) was performed.The physician did not attribute the dissection to the valve but rather the movement of calcium released in the annulus that tore the fragile tissue in the aortic sinus.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENVEO R DELIVERY SYSTEM
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7695570
• Report Number: 2025587-2018-01771
• Device Sequence Number: 16420971
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/03/2018

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: 01/03/2019
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008938617
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 07/23/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 07/30/2018; 10/02/2018; 10/03/2018
• 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