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

Model Number D-EVOLUTFX-2329

Device Problems Failure to Advance (2524); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Pain (1994); Vascular Dissection (3160)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10:  product id evolutfx-23 (serial: (b)(6))product type: 0195-heart valves; product id non-medtronic valve; product type: balloon expandable valve; implant date (b)(6) 2024.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 the attempted implant of this transcatheter bioprosthetic valve, inside a previously implanted non-medtronic surgical valve, the delivery catheter system (dcs) was unable to cross the surgical valve due to limitations with the dcs.The system was withdrawn, and a non-medtronic balloon expandable valve (bev) was used.The bev was unable to cross the surgical valve after multiple attempts.The decision was made to perform a pre-implant balloon aortic valvuloplasty (bav) with wire exchange.Subsequently, the patient began complaining of intense pain.Pulseless electrical activity (pea) was observed and the patient arrested.Cardiopulmonary resuscitation (cpr) was performed and return of spontaneous circulation (rosc) was achieved with several rounds of cpr.The patient was intubated and placed on extracorporeal membrane oxygenation (ecmo).An echocardiogram and angiogram was performed that revealed an ascending and descending type b aortic dissection.The bav was performed and the non-medtronic bev was implanted.The dissection was repaired by vascular surgery with stent grafts.The patient also suffered a dissection in the right iliac artery which was also stented.The patient remained stable.No additional adverse patient effects were reported.

Event Description

Additional information was received that during the valve implant, the right access site was used and a minimum access vessel greater than 5.0 millimeter (mm) was reported.Per the physician, it was unknown when the dissection occurred as the patient became symptomatic after the delivery catheter system (dcs) was already removed from the body and an several attempts to cross the aortic valve were made with a non-medtronic balloon expandable valve (bev).It was believed that the multiple attempts with both valve systems and guidewires to traverse the arch may have contributed to the event.The cause of the pulseless electrical activity (pea)/cardiac arrest was attributed to the dissection.Per the physician, the delivery catheter system (dcs) did not cause or contribute to the pea/cardiac arrest or dissection.Of note, the patient had a previous surgical replacement of their aortic arch which may have contributed to the dissection and advancement difficulty.

Manufacturer Narrative

Device manufacture date.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: 18725314
• MDR Text Key: 335700898
• Report Number: 2025587-2024-00950
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: 0012063623
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2024
• Date Device Manufactured: 12/04/2023
• 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...
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 45 KG