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U.S. Department of Health and Human Services

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

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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED Back to Search Results
Model Number EVPROPLUS-26US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Ventricular Tachycardia (2132); Vascular System (Circulation), Impaired (2572)
Event Date 08/31/2020
Event Type  Injury  
Manufacturer Narrative
Product analysis: the device remains implanted, therefore no product analysis can be performed.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.
 
Event Description
Medtronic received information that during the implant of this 26mm transcatheter bioprosthetic valve, into an existing medtronic valve with severe central aortic regurgitation, at 80% deployment and immediately after the valve was released from the delivery catheter system (dcs) ¿some¿ left coronary artery flow was noted.However, the patient's pressures began to drop and the patient went into ventricular tachycardia.The patient was defibrillated, cardiopulmonary resuscitation was initiated, and placed on cardiopulmonary bypass (cpb).A left main coronary artery occlusion was noted due to the previous medtronic valve leaflet.A computed tomography showed the leaflet was long and the coronary height was low at less than 10mm.A stent was placed which restored flow to left main coronary artery.The patient was weaned off cpb and was stable.No additional adverse patient effects were reported.
 
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Brand Name
EVOLUT PRO PLUS VALVE
Type of Device
AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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
paula bixby
8200 coral sea street ne
mounds view, MN 55112
7635055378
MDR Report Key10567839
MDR Text Key207962642
Report Number2025587-2020-02890
Device Sequence Number1
Product Code NPT
UDI-Device Identifier00763000211110
UDI-Public00763000211110
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 09/22/2020
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
Device Operator Health Professional
Device Expiration Date02/22/2022
Device Model NumberEVPROPLUS-26US
Device Catalogue NumberEVPROPLUS-26US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2020
Initial Date FDA Received09/22/2020
Date Device Manufactured03/10/2020
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) Required Intervention;
Patient Age85 YR
Patient Weight90
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