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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Low Blood Pressure/ Hypotension (1914); Rupture (2208)
Date of Event	03/29/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product analysis: the product was discarded by the customer; therefore, no product analysis can be performed.  conclusion: without return of the product, no definitive conclusions could be drawn 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, the valve dislodged.During the im plant of as second transcatheter valve, as the device passed through the aortic arch, hypotension and an ascending aortic rupture were noted.The rupture was not able to be repaired.Subsequently, the patient died.Per the physician, it was suspected that the rupture occurred as the first valve crossed the arch and was due to poor tissue condition and the narrow annulus.Due to the narrow annulus, a "little push" was required to cross.It was reported that the iliac arteries were a slightly tortuous, but that no resistance was met when advancing or inserting the delivery catheter system.

• 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: 7452187
• Report Number: 2025587-2018-00949
• Device Sequence Number: 16546109
• 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): 04/23/2018

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: 12/14/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008921476
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/23/2018
• 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 Weight: 53