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	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Aortic Regurgitation (1716); Death (1802); Low Blood Pressure/ Hypotension (1914); Occlusion (1984)
Date of Event	04/12/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Other relevant device(s) are: product id: ev olutpro-26-us, serial/lot #: (b)(4), ubd: 03-nov-2019, udi#: (b)(4); product id: evolutpro-26-us, serial/lot #: (b)(4), ubd: 19-sep-2019, udi#: (b)(4).The device was not returned, 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 implant of this transcatheter bioprosthetic valve, the valve dislodged.Subsequently, a second transcatheter bioprosthetic aortic valve was implanted.As the delivery catheter system (dcs) was removed, the nose cone caught the outflow portion of the valves near the tabs and caused a dislodgement.It was reported the nosecone caught the valves due to the tortuous aortic arch.An attempt to snare the valves was made, however hypotension occurred due to severe central aortic insufficiency.A third transcatheter bioprosthetic valve was positioned, but at 80% deployment caused a coronary occlusion, as the three valves together created a ¿tube graft¿.The third valve was recaptured and removed from the patient.Aortic insufficiency and hypotension persisted and cardiopulmonary resuscitation (cpr) was initiated.The patient was placed on extracorporeal membrane oxygenation (ecmo) and several unsuccessful attempts were made to snare the valves.Per the family¿s request further measures were not taken and the patient expired.Per the physician, the cause of death was related to coronary ischemia, coronary occlusion, and valve embolization.

• 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: 7487321
• Report Number: 2025587-2018-01059
• Device Sequence Number: 1963265
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 05/04/2018

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: 11/17/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008886109
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2018
• Initial Report FDA Received Date: 05/04/2018
• 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: 87 YR