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 Code	Death (1802)
Date of Event	09/27/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that two days prior to the implant of a transcatheter bioprosthetic valve with this delivery catheter system (dcs), a non-medtronic surgical valve was implanted into a native bicuspid valve with severe aortic insufficiency.One day following implant of the surgical valve, severe paravalvular leak (pvl) was noted.It was decided to treat with a valve-in-valve using a transcatheter bioprosthetic valve.Two days following the implant of the surgical valve, a transcatheter bioprosthetic valve was attempted to be implanted.While positioning this delivery catheter system (dcs), the surgical valve was dislodged and pushed into the ventricle.Subsequently, the transcatheter and surgical valves were removed and a surgical aortic valve replacement (avr) using a non-medtronic product was performed.Two days after attempted implant of the transcatheter valve, the patient died.Per the physician, the cause of death was severe aortic insufficiency of the previously placed surgical valve.Per the physician, the dcs did not cause or contribute to the death.
Additional Manufacturer Narrative
Additional information was received that the surgical aortic valve replacement product was a medtronic mosaic surgical valve, not a non-medtronic valve as previously reported.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: 7978409
• Report Number: 2025587-2018-02773
• Device Sequence Number: 16401351
• Product Code: NPT
• UDI-Device Identifier: 00643169800939
• UDI-Public: 00643169800939
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 11/11/2020

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: 0008921475
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 09/27/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 11/11/2020
• 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: 41 YR
• Patient Weight: 87