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

Model Number	ENVEOR-N-US
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Codes	Death (1802); Hemorrhage/Blood Loss/Bleeding (1888); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/08/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains implanted, therefore no product analysis can be performed.Without return of the device, a conclusive cause cannot be determined.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the attempted implant of this transcatheter bioprosthetic valve with this delivery catheter system (dcs), multiple attempts to cross the annulus were unsuccessful.The native aortic valve was never successfully crossed with the dcs and the valve was never deployed, resheathed or recaptured.When hypotension was noted, the attempts to cross the native valve were aborted, the dcs was removed, and resuscitative measures were administered.Ongoing transesophageal echocardiogram (tee) was performed during the entire procedure and the implanting team suspected a major vascular complication after the patient¿s abdomen was noted to be ¿enlarged and hard,¿ due to severe internal bleeding.The patient died the same day.

• 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: 7383044
• Report Number: 2025587-2018-00737
• Device Sequence Number: 13801198
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Date (Section B): 03/29/2018

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: 12/07/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008911900
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 03/29/2018
• 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
• Patient Age: 88 YR