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	Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)
Date of Event	02/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product will not be returned, therefore no product analysis would be performed.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, a non-medtronic sheath was introduced to the patient.A pre-balloon aortic valvuloplasty (bav) was performed and the valve was advanced.The valve would not cross the annulus.The valve was removed and a bav was performed.The valve was re-advanced, however, the valve would not cross the annulus.The valve was removed and a bav was performed.The valve was advanced and would not cross the annulus again.As the valve was attempting to be advanced, the patient's pressure dropped to 20mmhg.The patient was placed on cardio pulmonary bypass.There was no annulus or arch dissection.It was reported that there was an abdominal aortic aneurysm (aaa) dissection and a stent was placed.It was reported the dissection occurred due to the non-medtronic sheath and dcs passing the aaa so many times.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: 7345208
• Report Number: 2025587-2018-00586
• Device Sequence Number: 592046
• Product Code: NPT
• UDI-Device Identifier: 00643169640337
• UDI-Public: 00643169640337
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 03/16/2018

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: 11/13/2018
• Device Model Number: ENVEOR-N-US
• Device Catalogue Number: ENVEOR-N-US
• Device Lot Number: 0008876401
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 03/16/2018
• 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