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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 DELIV
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MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV Back to Search Results
Model Number EVPROPLUS-34
Device Problems Material Invagination (1336); Device Dislodged or Dislocated (2923)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/04/2024
Event Type  malfunction  
Manufacturer Narrative
Updated: b5, h6, h11.Corrected: h11 implant/explant dates n/a.Continuation of d10:  product id unknown balloon (lot/serial: unknown); product type: aortic valvuloplasty balloon; implant date n/a; explant date n/a product id l-evprop34 (lot: 0012056291); product type: 0195-heart valves; implant date n/a; explant date n/a this is a system report.The section d information is for the primary device, which was in use with the following: product id d-evprop34 (lot: 0011916507); product type: 0195-heart valves; implant date n/a; explant date n/a medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Event Description
Medtronic received information that during implant of this transcatheter bioprosthetic valve, no misloads occurred before the procedure.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 23mm balloon, due to severe annular calcification extending to the left ventricular outflow tract (lvot).When deployment was attempted, the valve was recaptured once or twice due to unstable positioning/parachute.Upon recapture, the valve infolded.The valve was withdrawn from the patient.A new valve and delivery catheter system (dcs) were used to successfully complete the implant procedure.No adverse patient effects were reported.Additional information was received that the recapture performed was due to valve dislodgement.The infold was first noticed during the second deployment attempt which resulted in a procedure delay.A pre-implant bav was performed during the procedure.
 
Event Description
Medtronic received information that during implant of this transcatheter bioprosthetic valve, no misloads occurred before the procedure.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 23mm balloon, due to severe annular calcification extending to the left ventricular outflow tract (lvot).When deployment was attempted, the valve was recaptured once or twice due to unstable positioning/parachute.Upon recapture, the valve infolded.The valve was withdrawn from the patient.A new valve and delivery catheter system (dcs) were used to successfully complete the implant procedure.No adverse patient effects were reported.
 
Manufacturer Narrative
Continuation of d10:  product id d-evprop34 (lot: 0011916507); product type: 0195-heart valves; implant date (b)(6) 2024; explant date (b)(6) 2024 product id l-evprop34 (lot: 0012056291); product type: 0195-heart valves; implant date (b)(6) 2024; explant date (b)(6) 2024 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
Manufacturer Narrative
Upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with a valve loaded within the capsule.The dcs was received with the capsule fully closed.There was a slight bend to the capsule.Delamination was observed over the nitinol reinforcing frame along the mid-section to the proximal end of the capsule.There was a bend to the proximal section of the stability shaft.The handle appeared intact.The device was returned with the end cap/screw gear snap fit connected.On retraction of the capsule via the rotation of the deployment knob, the original valve deployed with an infold.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The inner member shaft and spindle hub appeared intact with no evidence of damage.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
 
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Brand Name
EVOLUT PRO PLUS VALVE
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 Key19059900
MDR Text Key340251396
Report Number2025587-2024-02148
Device Sequence Number1
Product Code NPT
Combination Product (y/n)N
Reporter Country CodeEZ
PMA/PMN Number
P130021
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEVPROPLUS-34
Device Catalogue NumberEVPROPLUS-34
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/10/2024
Date Device Manufactured11/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
SEE H11...
Patient SexMale
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