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

Model Number D-EVOLUTFX-2329

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2022

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant medical products: the main component of the system.Other relevant device(s) are: product id: evolutfx-29, serial/lot #: (b)(4), ubd: 2023-11-24, udi#: (b)(4).Product analysis: the valve remains implanted and the dcs was not returned, therefore no product analysis can be performed.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 during implant of this transcatheter bioprosthetic valve, the patient's aortic valve was pre-ballooned with a 20 millimeter (mm)  balloon and then with a 22 mm balloon.The initial deployment of the valve was performed in the cusp overlap view.At 80% deployment, the depth was 3-4 mm on the non-coronary cusp (ncc) and 2-3 mm on the left coronary cusp (lcc).The valve appeared constrained at 80% deployed in the cusp overlap view but well expanded in the left anterior oblique view.Multiple projections were made to confirm there was no infold of the valve.The valve did not appear to be infolded, but was constrained by the calcium which was confirmed with the physician.The valve was released and both tabs of the delivery catheter system (dcs) were released and confirmed under x-ray.As the dcs was removed slowly with the paddle pockets still up in the crown, the valve appeared to move aortic.The removal of the dcs was stopped and reassessed.The dcs was then turned and removed through the valve and pulled into the descending thoracic aorta.Fluoroscopy revealed that the valve had dislodged into the ascending aorta.There was a discussion between the physician and patient and they decided to proceed with a surgical aortic valve replacement (savr) instead of attempting a second transcatheter bioprosthetic valve.Per the physician, it was unclear if the delivery catheter system (dcs) dislodged the valve, if the valve was under expanded and dislodged or a combination or both.No additional adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device history record was reviewed for the valve and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.It was reported that during implant of this valve, at 80% deployment, the valve appeared constrained in the cusp overlap view but well expanded in the left anterior oblique view.Per the device instructions for use (ifu), in the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a post-implant balloon dilation of the bioprosthesis may improve valve function and sealing.To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation.The balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus.Refer to the specific balloon catheter manufacturer's labeling for proper instruction on the use of balloon catheter devices.In this case, a pre-implant bav was completed prior to the reported frame expansion issue.It was reported that the valve was constrained by calcium, however this cannot be conclusively confirmed with the limited information available and without procedural images for review.The reported event indicates that after the valve was released, as the delivery catheter system (dcs) was removed with the paddle pockets still up in the crown, the valve appeared to move aortic.Fluoroscopy revealed that the valve had dislodged into the ascending aorta.Dislodgement of the valve by the dcs is related to operator technique or experience.The evolut fx instructions for use instruct ¿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.With the limited information available and without procedural images for review, a conclusive root cause of the dislodgement event cannot be determined.Per the physician, it was unclear if the dcs dislodged the valve, if the valve was under expanded and dislodged or a combination or both.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

Product analysis: the delivery catheter system (dcs) and explanted valve were discarded, therefore no product analysis can be performed.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 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 Key: 15722774
• MDR Text Key: 303032686
• Report Number: 2025587-2022-03067
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/24/2023
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0011371602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2022
• Date Device Manufactured: 11/24/2021
• 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
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 91 KG