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

Model Number D-EVPROP23-29

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923); Activation Failure (3270); Patient Device Interaction Problem (4001)

Patient Problems Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2023

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: section d information references the main component of the system.Other relevant device(s) are: product id: evproplus-26, serial/lot #: (b)(4), ubd: 05-dec-2023, udi#: (b)(4) ; product id: d-evprop23-29, serial/lot #: (b)(4), ubd: 09-dec-2023, udi#: (b)(4) product analysis: the valve remains implanted and the delivery catheter systems (dcss) were 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.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.

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, it was noted that the patient had a severely calcified bicuspid aortic valve with left coronary cusp (lcc)-right coronary cusp (rcc) raphe, a highly calcified non-coronary cusp (ncc) leaflet, and a horizontal aorta.The valve was fully deployed in a high position.As the delivery catheter system (dcs) was withdrawn, the valve dislodged.Several attempts were made to reposition the valve using a snare, however, this was unsuccessful.The valve was positioned safely above the sinotubular junction.An attempt was made to implant a second valve, however, the second dcs was unable to cross the dislodged valve.Subsequently, a dissection in the ascending aorta was noted.It was suspected that while attempting to cross the dislodged valve, pushing the second dcs inside the valve had caused the dissection.The patient was subsequently transferred to surgery.The patient was reported to be alive and hemodynamically stable.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated b5.Updated h6.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.

Event Description

Additional information was received which reported that 2 pre-implant balloon aortic valvuloplasties (bav) were performed using 20 mm vacs ii balloons.It was reported that the valve was intentionally implanted at a high depth due to the raphe-dominant configuration of the bicuspid aortic valve.According to the physician, the under expansion of the valve due to very calcified bicuspid anatomy, in combination with high implant depth resulted in the dislodgement of the valve.During the surgery, the dissection was repaired and the dislodged valve was explanted.A surgical valve was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the subject delivery catheter systems (dcs)s were discarded by the customer and therefore was unable to be returned for analysis.The valve remained implanted and therefore was unable to be returned for product analysis.Procedural images were provided for review.According to the image review, pre-implant computed tomography (ct) images were provided.Perimeter and perimeter derived diameters were 74.8 mm/23.8 mm, suggesting a 29 mm evolut.Aortic root angle is approximately 63°.Patient appeared to have a sievers 1 bicuspid aortic valve with fusion of the right coronary cusp (rcc) and left coronary cusp (lcc).Aortic valve leaflets and rcc/lcc raphe appear heavily calcified.Calcium seen in aortic annulus under left coronary cusp (lcc) extending into the left ventricular outflow tract (lvot).Possible left atrial appendage thrombus vs.Inadequate contrast filling.No ascending aorta dissection or aneurysm.The images provide evidence of a balloon rupture during a pre-balloon aortic valvuloplasty (bav).A pre bav balloon appears to have a ¿dog boning¿ shape which means it is not fully inflated, with a subsequent balloon rupture.A failed pre bav would warrant a second attempt at pre dilatation.Images show that the valve was proceeded to be implanted and appeared to be significantly under expanded, in a cusp overlap view.The reported dislodgement due to dcs interaction cannot be seen in the images provided.Dislodgement of the valve by the dcs is related to operator technique or experience.The evolut pro plus system instructions for use (ifu), instructs ¿under fluoroscopic guidance, confirm that the catheter tip is coaxial with the inflow portion of the bioprosthesis¿ prior to drawing the dcs tip through the valve.Events of this type do not indicate a device malfunction or a failure to meet manufacturing specifications.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that the patient had a severely calcified bicuspid aortic valve with left coronary cusp (lcc)-right coronary cusp (rcc) raphe, a highly calcified non-coronary cusp (ncc) leaflet, and a horizontal aorta.This indicates that the probable cause of the advancement difficulties was patient anatomy.Vascular access related complications, such as bleeding and dissection, are a known potential adverse patient effect per the evolut system ifu and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).It was suspected that while attempting to cross the dislodged valve, pushing the second dcs inside the valve had caused the dissection.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.A medical safety assessment (msa) was carried out for this complaint.Upon review of the information provided, the primary event of valve dislodgement, leading to an unsuccessful 2nd valve implant attempt and unplanned surgical valve placement intervention, is assessed as likely related to the evolut pro+ dcs and valve as upon removal of the dcs the valve dislodged.Per image review, contributing factors may have been the patients anatomy including raphe leaflet configuration with severe calcification leading to an intentional high implant.Also of note, a pre-bav was done but it appears there was a balloon rupture and balloon was fully expanded and another bav attempt was not performed prior to tav implant.Upon review of the information provided, the secondary event of aortic dissection, leading to surgical repair, is assessed as likely related to the evolut pro+ dcs as it was suspected that while attempting to cross the dislodged valve, pushing the second dcs inside the valve had caused the dissection.Review of the device history record (dhr) and frame record for the valve was performed.Based on the dhr review, all process parameters were within specification as outlined in applicable procedures and specifications.All materials used were as per the requirements of the dhr.All processes were carried out as per relevant procedures and met specification.A dhr was not performed on either dcs.Updated h6.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.

• 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 92705 ; CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana 92705 ; CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16532058
• MDR Text Key: 311217951
• Report Number: 9612164-2023-01112
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D-EVPROP23-29
• Device Catalogue Number: D-EVPROP23-29
• Device Lot Number: 0011527043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: "SEE H10....".
• Patient Outcome(s): Required Intervention