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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-29US
Device Problem Difficult or Delayed Positioning (1157)
Patient Problems Obstruction/Occlusion (2422); Low Cardiac Output (2501)
Event Date 10/12/2022
Event Type  Injury  
Event Description
Medtronic received information that prior to the attempted implant of a transcatheter bioprosthetic valve (tav), into a previously implanted surgical aortic valve, the physician expressed concern the patient may experience coronary obstruction from the transcatheter bioprosthetic valve causing the surgical valve leaflets to obstruct the coronary arteries.In addition, it was noted the physician sized the patient for a 26 mm tav, while medtronic sized for a 29 mm tav.A decision was made to implant a 29 mm valve.During the first implant attempt, while at 80% deployed, the right coronary artery (rca) became occluded which caused a low grade flow; the left main coronary artery, left anterior descending artery, and the circumflex artery were observed to have normal flow.The 29 mm valve was recaptured and pulled back into the descending aorta as the rca filled without issue.Another attempt to implant the 29 mm valve was made with the same result as the first attempt.The 29 mm valve was withdrawn from the patient.The physician then attempted implant with the smaller 26 mm valve.Again, when the valve was deployed to 80%, a low grade flow to the rca was observed.The 26 mm valve was recaptured and withdrawn from the patient and the procedure was aborted.No transcatheter bioprosthetic valve was implanted.The patient was stable.No adverse patient effects were reported.
 
Manufacturer Narrative
Concomitant medical products: other relevant device is: product id: evproplus-26us, serial#: (b)(4), ubd: 02-apr-2023, udi#: (b)(4).Product analysis: both of the devices associated with the event were discarded and no procedural images were submitted for review; therefore, no product analysis can be performed.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.
 
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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 Key15831085
MDR Text Key303993666
Report Number2025587-2022-03239
Device Sequence Number1
Product Code NPT
UDI-Device Identifier00763000211127
UDI-Public00763000211127
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 11/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date10/14/2023
Device Model NumberEVPROPLUS-29US
Device Catalogue NumberEVPROPLUS-29US
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/27/2022
Date Device Manufactured10/14/2021
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;
Patient Age77 YR
Patient SexFemale
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