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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV Back to Search Results
Model Number D-EVPROP34US
Device Problem Failure to Advance (2524)
Patient Problems Cardiac Arrest (1762); Perforation (2001)
Event Date 08/17/2022
Event Type  Death  
Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 Description
Medtronic received information that during implant of this transcatheter bioprosthetic valve, into a patient with type 0 bicuspid sievers valve with stenosis and aortic tortuosity, the valve was loaded successfully.A pre-balloon aortic valvuloplasty (bav) was performed with a 20 millimeter (mm) balloon.The balloon had to be positioned twice for optimization.The delivery catheter system (dcs) was advanced over the aortic arch with some resistance however tracking appeared reasonable to advance and position into the ascending aorta just superior to the annulus.The valve was advanced to the annulus with an attempt to cross however resistance was met as the nose cone was trying to negotiate a mild/moderate turning course at the annulus without tracking success and created tension in the catheter.Multiple forward attempts were made without success.The valve was withdrawn from the annulus and back across the aortic arch.The valve was positioned into the descending aorta and fluoroscopy visually inspected the valve and nose cone which appeared normal.The patient remained stable.The dcs was rotated 90 degrees and re-advanced.Multiple forward attempts were made again w without success.It was determined to abort the case.The patient remained hemodynamically stable.The valve and dcs were withdrawn into the superior ascending aorta while optimally managing the stiff wire position in the left ventricle when the arch abruptly moved and changed its position taking the dcs it the movement.The valve was withdrawn to the descending aorta in preparation for removal.The patient became hemodynamically unstable with no pulse pressure and chest compressions were initiated.An ultrasound echocardiogram was performed quickly to determine a pericardial effusion however imaging was sub-optimal.Cardiopulmonary resuscitation (cpr) persisted for up to 20 minutes in preparation for surgical conversion however the patient died.Per the physician, the cause of death was an aortic perforation near the superior ascending aorta/arch transition area.It was noted that the patient had thin vessel tissue.
 
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Brand Name
EVOLUT PRO PLUS DCS
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
Manufacturer (Section D)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer (Section G)
MEDTRONIC HEART VALVES DIVISION
1851 e deere ave
santa ana CA 92705
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key15297310
MDR Text Key298652282
Report Number2025587-2022-02371
Device Sequence Number1
Product Code NPT
UDI-Device Identifier00763000207861
UDI-Public00763000207861
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P130021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberD-EVPROP34US
Device Catalogue NumberD-EVPROP34US
Device Lot Number0011254285
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/17/2022
Date Device Manufactured06/08/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age73 YR
Patient SexFemale
Patient Weight61 KG
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