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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 Problem Vascular Dissection (3160)
Event Date 12/31/2021
Event Type  Injury  
Event Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, in a patient with a horizontal aorta with an angle of 69-70 degrees, an annulus perimeter of 67 millimeters (mm) and a type 0 bicuspid valve, a non-medtronic guidewire was used in reverse position and advanced to the left ventricle.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 20 mm balloon.The delivery catheter system (dcs) was attempted to be advanced through the valve, but was unable to advance past the sinus of valsalva on the greater curvature side.The dcs was removed.An echocardiogram and aortography revealed a flap on the ascending aorta and contrast confirmed a dissection.It was reported that the dissection was caused by the dcs.The procedure was converted to thoracotomy and ascending aorta replacement and aortic valve replacement (avr) were performed successfully.No additional adverse patient effects were reported.
 
Manufacturer Narrative
Product analysis: the device was discarded, 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.
 
Manufacturer Narrative
Conclusion: the subject delivery catheter system (dcs) was not returned, and as such no analysis could be performed.No procedural images were provided for review.Difficulties advancing the dcs is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity, etc.).In this case, it was noted that the patient presented with a horizontal aorta with an angle of 69-70 degrees, an annulus perimeter of 67 millimeters (mm) and a type 0 bicuspid valve.This indicates that the probable cause of the advancement difficulties was patient anatomy.Without procedural images for review and evidence available, an assignable root cause could not be determined and a relationship to the dcs could not be established.The evolut system instructions for use (ifu) instructs if there is a significant increase in resistance, stop advancement and investigate the cause of the resistance (for example, magnify the area of resistance) before proceeding.Do not force passage.Forcing passage could increase the risk of vascular complications (for example, vessel dissection or rupture).Vascular access related complications, such as dissection, are known potential adverse patient effects per the ifu and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).However, based on the information available, an assignable root cause of the dissection could not be determined.A device history record (dhr) review was performed on the dcs and there were no correlations or issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.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.
 
Manufacturer Narrative
Additional information was received that hemodynamic collapse occurred prior to identifying the aortic dissection.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 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 Key13225688
MDR Text Key283601253
Report Number2025587-2022-00074
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,Followup,Followup
Report Date 03/17/2022
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 Date08/19/2023
Device Model NumberD-EVPROP2329US
Device Catalogue NumberD-EVPROP2329US
Device Lot Number0010810983
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/31/2021
Initial Date FDA Received01/11/2022
Supplement Dates Manufacturer Received01/26/2022
03/08/2022
Supplement Dates FDA Received02/01/2022
03/18/2022
Date Device Manufactured08/19/2021
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) Required Intervention;
Patient Age82 YR
Patient SexFemale
Patient Weight48 KG
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