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

Model Number D-EVOLUTFX-2329

Device Problems Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)

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

Event Date 03/06/2024

Event Type  malfunction  

Event Description

Medtronic received information that during implant of this 29 millimeter (mm) transcatheter bioprosthetic valve (j084159), three deployment attempts were made as the valve consistently dislodged into the left ventricle.The valve was recaptured two times due to deep implant position.It was also reported that another 29 mm valve (j084155) was had a bent valve crown.Subsequently a 34 mm valve was used and was implanted.A procedural delay of approximately 5 minutes was reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Continuation of d10: product id evolutfx-29 (serial: (b)(6)); product type: 0195-heart valves; implant date ; explant date product id evolutfx-34 (serial: (b)(6)); product type: 0195-heart valves; implant date 2024-03-06; explant date product id evolutfx-29 (serial: (b)(6) ); product type: 0195-heart valves; implant date ; explant date product id l-evolutfx-2329 (lot: 0012021824); product type: 0195-heart valves; implant date ; explant 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.

Manufacturer Narrative

Updated data: 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.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 as received that a misload was identified on the delivery catheter system (dcs) that was used with the valve that had the bent crown.The misloaded dcs was not used for implant, and a new dcs was used.The misload was not due to a new valve loader.No additional adverse patient effects were reported.

Manufacturer Narrative

Event description continuation of d10: product id safari (lot number: ); product type: guidewire; product id d-evolutfx-2329 (lot: 0012045195); product type: 0195-heart valves; product id d-evolutfx-2329 (lot: ); product type: 0195-heart valves; device and method code additional codes - imf health impact and img component codes 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 during the valve implant, the deployment starting point was 3-5 millimeter (mm) below the pigtail on the non-coronary cusp (ncc).After the valve dislodged, the implant depth was greater than 10 mm.A non-medtronic guidewire (safari) was used.While loading of the 29 mm valve (j084155), the bent valve crown was visually observed during loading and the valve was not used.Subsequently the larger 34 mm valve was used as the 29 mm valve kept dislodging into the left ventricle.

• 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: 18896487
• MDR Text Key: 337697381
• Report Number: 2025587-2024-01618
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D-EVOLUTFX-2329
• Device Catalogue Number: D-EVOLUTFX-2329
• Device Lot Number: 0012045195
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: 03/13/2024; 03/20/2024
• Supplement Dates FDA Received: 03/20/2024; 04/02/2024
• 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 Age: 68 YR
• Patient Sex: Male