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

Model Number EVOLUTFX-34

Device Problems Perivalvular Leak (1457); Material Split, Cut or Torn (4008)

Patient Problems Cusp Tear (2656); Valvular Insufficiency/ Regurgitation (4449)

Event Date 11/27/2023

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id: d-evolutfx-34 (lot: unknown), product type: 0195-heart valves; product id: l-evolutfx-34 (lot: unknown), product type: 0195-heart valves; 25mm semi-complaint non-medtronic (cristal) balloon 28mm, semi-complaint non-medtronic (cristal) balloon.Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.  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 following the implant of this transcatheter bioprosthetic valve into a patient with a challenging and heavily calcified aortic annulus, moderate paravalvular leak (pvl) was observed.A post-implant balloon aortic valvuloplasty (bav) was performed using a 25 millimeter (mm) semi-compliant non-medtronic (cristal) balloon.Angiogram showed that moderate pvl remained.Therefore, a second bav was performed using a 28mm semi-compliant non-medtronic (cristal) balloon.Following the second bav, moderate pvl remained.The procedure was subsequently completed.Ten days following the valve implant, transesophageal echocardiogram (toe) revealed a possible commissure rupture of the transcatheter valve.A non-medtronic (26mm sapien s3 ultra) was subsequently implanted valve-in-valve.No additional adverse patient effects were reported.

Event Description

Additional information was received indicating that for both the first and second balloon aortic valvuloplasty (bav), one inflation was performed for 5 seconds using a syringe inflation device.

Manufacturer Narrative

Updated: b5 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

Corrected data: additional code - img component code updated data: h6 - method, result and conclusion codes conclusion: the device history record was reviewed and showed this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Paravalvular leak can be caused by a variety of factors, including valve positioning, patient anatomy, calcification level or presence of pre-existing patient conditions.In this case, two post balloon aortic valvuloplasties (bav) were performed.The instructions for use (ifu) states: " if valve function or sealing is impaired due to excessive calcification, bicuspid nature, incomplete expansion or infolding, a post-implant balloon dilatation (pid) of the bioprosthesis may improve valve function and sealing." after post bav(s), moderate paravalvular leak (pvl) remained.A medical safety assessment was performed.In summary, the assessment states, the primary event of pvl, treated with two balloon aortic valvuloplasties was likely related to the fx valve as it did not provide an adequate seal.It was also likely that heavily calcified aortic annulus contributed to the leak.The secondary event of the prosthetic valve commissure rupture (10 days post implant), treated with a valve in valve procedure was likely related to the post implant balloon aortic valvuloplasties.As it was stated that the user used a "semi-compliant" balloon.Per ifu, "caution: overexpansion of the narrowest portion (waist) of the evolut fx tav beyond the levels set forth in table 4 has been demonstrated through bench data to cause damage to the bioprosthetic leaflets.Complaints of damage to the bioprosthetic leaflets.During post-implant balloon dilatation have been reported in some clinical cases, resulting in moderate to severe aortic insufficiency, which may be detected acutely or during follow-up." table 4 (ifu): tav waist diameter (in mm) for evolut fx 34 millimeter (mm), is 24mm.Post-implant balloon dilatation sizing, the maximum balloon diameter (in mm) for compliant and semi-compliant balloons for evolut fx 34mm, is 26, 27, or 28mm with an applied inflation pressure of no greater than 2 atm.In this case, it indicates that the balloon size for the post bav(s) are 25mm and 28mm; however, the tav waist diameter and the inflation pressure were not provided.Based on the event description information and medical safety assessment, the heavily calcified aortic annulus may have been the con tributing factor for the pvl.The post bav may related to the commissure rupture/tear.This event does not indicate device misuse or malfunction.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 FX 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 Key: 18328789
• MDR Text Key: 330549328
• Report Number: 2025587-2023-05219
• 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: 02/19/2024

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 Model Number: EVOLUTFX-34
• Device Catalogue Number: EVOLUTFX-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/18/2023; 02/16/2024
• Supplement Dates FDA Received: 12/20/2023; 02/19/2024
• Date Device Manufactured: 10/18/2023
• 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
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 86 YR
• Patient Sex: Male