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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-EVPROP2329US
Device Problem Failure to Advance (2524)
Patient Problems Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130); Cardiovascular Insufficiency (4445)
Event Date 04/23/2021
Event Type  Injury  
Event Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve into a patient with a previously implant surgical aortic valve (sav), while attempting to advance the delivery catheter system (dcs) through the previous sav at the annulus, hemodynamic breakdown occurred.The dcs was not able to be advanced.It was reported that the dcs was an indirect cause of the hemodynamic breakdown.It was reported that the patient's blood pressure decreased, and acute aortic regurgitation (ar) occurred.The direct cause of the ar was an unknown guidewire.Ventricular fibrillation also occurred.The heart became intolerant to the exacerbation of ar.As a result, percutaneous cardiopulmonary support was introduced, and cardiopulmonary resuscitation (cpr) was initiated.The recovery of the patient was prioritized, and the valve implant attempt was aborted.Of note, it was reported that prior to the valve implant procedure, the patient's hemodynamics were originally poor.No additional adverse patient effects were reported.
 
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.If information is provided in the future, a supplemental report will be issued.
 
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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 Key13771794
MDR Text Key287246101
Report Number9612164-2022-01022
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P130021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/15/2022
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
Device Operator Health Professional
Device Expiration Date11/11/2022
Device Model NumberD-EVPROP2329US
Device Catalogue NumberD-EVPROP2329US
Device Lot Number0010451636
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/18/2022
Initial Date FDA Received03/15/2022
Date Device Manufactured11/11/2020
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) Life Threatening; Required Intervention;
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