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

Model Number D-EVOLUTFX-2329

Device Problems Difficult to Advance (2920); Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/19/2024

Event Type  Death  

Manufacturer Narrative

Continuation of d10: product id: evolutfx-26;,product type: 0195-heart valves.Product id l-evolutfx-2329, product type: 0195-heart valves.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.

Event Description

Medtronic received information that prior to the attempted implant of this transcatheter bioprosthetic valve, the patient¿s annulus measured 21.8mm x 27.2mm, with a perimeter of 78mm.It was noted that the patient had a severely kinked and hostile calcified infra-renal aneurysmatic aorta.An 18 french (fr) (sentrant) sheath was used during the procedure.After difficulty crossing the valve, pre-implant balloon aortic valvuloplasty (bav) was performed using a 24mm non-medtronic (true) balloon.The delivery catheter system (dcs) was inserted inside the 18fr sheath.Some resistance was noted.While advancing the dcs, the patient¿s blood pressure quickly dropped.Cardiopulmonary resuscitation (cpr) was initiated.After ten minutes of cpr, the patient subsequently died.The cause of death was not received.

Event Description

Additional information was received indicating that according to the physician, it was "most obvious, but not clear" if the sentrant sheath caused of contributed to the death.No further information was able to be obtained.

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

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received without a valve loaded within the capsule.The device was received with the capsule partially opened.Delamination was observed over the nitinol reinforcing frame to the proximal end of the capsule.There were bends to the stability shaft and outer shaft.There were slight ridges formed on one side of the outer shaft.The handle was intact.The device was returned with the end cap/screw gear snap fit connected.The deployment knob retracted and advanced the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism was intact.The inner member shaft and spindle hub appeared intact with no evidence of damage.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: procedural images were provided for review.Imaging confirmed that no misload was present.Imaging showed an overview of the infra-renal aneurysm with the two renal artery take-offs dyed with contrast.It also featured an introducer sheath which reached up to a few centimeters below the renal take-offs.Imaging showed the evolut delivery catheter system (dcs) with the loaded valve, likely in the descending aorta.A pigtail (possibly a ¿buddy¿ pigtail), located parallel to the dcs and the guidewire (possibly a lunderquist) are also visible in the image.There were no images provided showing the reported event.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 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: 18750063
• MDR Text Key: 335891499
• Report Number: 2025587-2024-01039
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/14/2024

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: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0012021814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 02/24/2024; 03/15/2024; 05/01/2024
• Supplement Dates FDA Received: 02/27/2024; 04/10/2024; 05/14/2024
• Date Device Manufactured: 11/01/2023
• 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): Death; Required Intervention
• Patient Sex: Male