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	Low Blood Pressure/ Hypotension (1914); Left Ventricular Failure (1948); Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	01/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was not returned, therefore no product analysis can be performed.A good faith effort will be made to obtain the applicable information relevant to the report.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, upon deployment the valve moved aortic and out of the annulus.The valve was recaptured and repositioned.The blood pressure dampened and remained low throughout the second deployment attempt.The valve was implanted with good result.The blood pressure remained low and cardiopulmonary resuscitation (cpr) was initiated.An impella device was inserted and utilized for left ventricle support.An echocardiogram confirmed the pre-existing left ventricle effusion had worsened and a pericardiocentesis was performed.The effusion improved and the patient was stable.Exploratory surgery was performed and three perforations were repaired: one in the right ventricle and 2 in the left ventricle.The physician stated the patient had friable pericardial tissue which most likely resulted in a wire perforation during the valve procedure.It could not be determined when a wire perforation occurred, but there was a reported possibility the perforation occurred during positioning or deployment of the valve.The patient was stable on a ventilator.The impella device was removed and the valve was functioning well.No additional adverse patient effects were reported.

• 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: 7225074
• Report Number: 2025587-2018-00230
• Device Sequence Number: 16437625
• Product Code: NPT
• UDI-Device Identifier: 00643169956193
• UDI-Public: 00643169956193
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/29/2018

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: 07/14/2019
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008714262
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2018
• Initial Report FDA Received Date: 01/29/2018
• 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: Required Intervention
• Patient Age: 82 YR