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 Low Blood Pressure/ Hypotension (1914); Rupture (2208)

Event Date 03/14/2024

Event Type  Death  

Manufacturer Narrative

Continuation of d10:  product id evolutfx-23 (serial: (b)(6); product type: 0195-heart valves; implant date n/a; explant date n/a product id l-evolutfx-2329 (serial: unknown); 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 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

Medtronic received information that prior to the attempted implant of this transcatheter bioprosthetic valve, inside a previously implanted surgical aortic valve, while attempting to navigate the delivery catheter system (dcs) through the patients calcified and tortuous anatomy, resistance was felt.It was decided to exchange the non-medtronic (safari) guidewire for a different non-medtronic ( lunderquist) guidewire to gain stability for the dcs.The external sheath was also upsized to an 18 french sheath for added stability.It was re-attempted to advance the dcs, however, the patient's blood pressure dropped and a dissection was suspected.An angiogram was performed that revealed a large aortic dissection.The procedure was aborted and the patient subsequently died.Per the physic ian, the cause of death was aortic rupture, and the patients tortuous and calcified anatomy contributed to the aortic rupture and subsequent death.

Manufacturer Narrative

Updated data: a3b b5 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.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received that the previously implanted surgical valve was not a medtronic valve.

• 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: 18955627
• MDR Text Key: 338301993
• Report Number: 2025587-2024-01834
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000365677
• UDI-Public: 00763000365677
• 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
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 0011916508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2024
• Date Device Manufactured: 08/18/2023
• 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): Death
• Patient Age: 93 YR
• Patient Sex: Female