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

Model Number EVOLUTFX-23

Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923); Activation Failure (3270); Patient Device Interaction Problem (4001); Central Regurgitation (4068)

Patient Problems Low Blood Pressure/ Hypotension (1914); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10:  product id evolutfx-23 (serial: f563161); product type: 0195-heart valves; implant date (b)(6) 2024; product id d-evolutfx-2329; product type: 0195-heart valves; product id l-evolutfx-2329; product type: 0195-heart valves; implant date n/a; explant date n/a 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 during implant of this transcatheter bioprosthetic valve, the valve dislodged.A second valve was implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Updated data: continuation of d10:  product id 20 mm true balloon (lot#: ); product type: dilation balloon; implant date ; explant date product id 14 fr sheath (lot#: ); product type: sheath.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received that following the valve implant, after the valve was implanted, a 20 mm non-medtronic balloon(true) was used for the balloon aortic valvuloplasty (bav).While attempting to remove the non-medtronic balloon, the balloon became stuck in the valve frame.As the physician attempted to maneuver the balloon, the valve was pulled and dislodged aortic as the balloon remained stuck in the valve frame.After the valve dislodged, the patient started to decompensate and became hypotensive with aortic insufficiency.Cardiopulmonary resuscitation (cpr) was initiated while the second valve was being prepared.After the second valve deployment, cpr was stopped and the patient had pulsatile flow.A 14 french(fr) sheath was used to remove the non-medtronic balloon that was stuck to the first valve.The patient had stable blood pressure at the end of the procedure.

Manufacturer Narrative

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

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 that following implant of the valve, inside a previously implanted valve, a post-implant balloon aortic valvuloplasty (bav) was performed due to the valve being constrained.The guidewire and post-implant bav were inadvertently passed through and entangled with the valve frame.The valve subsequently dislodged upon withdrawal of the bav.A pre-implant bav was not performed.Patient anatomy did not contribute to the dislodge.The deployment starting point was at the bottom of the pigtail catheter and the direction of the dislodge was aortic.Prior to valve dislodgement, the implant depth on the non-coronary cusp (ncc) and left coronary cusp (lcc) were 4 millimeter¿s (mm).Following dislodgement, the valve was up near the aortic arch.Additionally, a non-medtronic (lunderquist) guidewire was used.No additional adverse patient effects were reported.

Event Description

Additional information was received indicating that after the valve dislodged, severe central regurgitation was observed.

Manufacturer Narrative

Updated: b5, h6 medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Image review: four static images and two media files were provided for review of the event.The patient¿s executive summary was not provided for anatomical review.It was reported that a post implant dilatation was warranted due to the valve being constrained, and that the guidewire and balloon inadvertently entangled with the valve frame.Reinsertion of the guidewire and advancement of the balloon were not saved on fluoroscopy.However, evidence shows that during post implant dilatation, the balloon interacted with the outflow, specifically one of the paddles, of the evolut frame which would validate the statement above.Subsequently, it was reported that during removal of the balloon, the valve dislodged aortic.The dislodged valve remained in the ascending aorta, and a second valve was implanted.Updated: h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18859853
• MDR Text Key: 337160132
• Report Number: 2025587-2024-01458
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370688
• UDI-Public: 00763000370688
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/21/2024

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?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-23
• Device Catalogue Number: EVOLUTFX-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/07/2024
• Supplement Dates Manufacturer Received: 03/07/2024; 03/07/2024; 03/07/2024; 03/27/2024; 05/20/2024
• Supplement Dates FDA Received: 03/08/2024; 03/15/2024; 03/27/2024; 04/09/2024; 05/21/2024
• Date Device Manufactured: 02/21/2023
• 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 H11; SEE H11...
• Patient Outcome(s): Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female
• Patient Weight: 32 KG