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

Model Number EVPROPLUS-26

Device Problems Fluid/Blood Leak (1250); Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Obstruction/Occlusion (2422); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/07/2024

Event Type  Death  

Manufacturer Narrative

Continuation of d10: product id: d-evprop23-29 (lot: 0011966159); product type: 0195-heart valves; product id: l-evprop23-29 (lot: 0011945516); product type: 0195-heart valves; product id: d-evprop23-29 (lot: 0011966159); product type: 0195-heart valves; product id: l-evprop23-29 (lot: 0011837018); product type: 0195-heart valves; section d references the main component of the system.Other medical products in use during the event include: brand name evolut pro plus valve; product id: evproplus-26 (serial: (b)(6); product type: 0195-heart valves; implant date: on (b)(6) 2024.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 during implant of this transcatheter bioprosthetic valve (b)(6), the valve was released and aortic insufficiency was observed.It was decided to post dilate the valve and during the dilation the valve dislodged.A second valve (b)(6) was implanted and aortic insufficiency was also observed.Another post implant dilation was performed and during the dilation, tamponade was observed.Cardiopulmonary resuscitation (cpr) and coronary recanalization were attempted.Subsequently the patient died.The cause of death was  tamponade.

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.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 a pre-balloon aortic valvuloplasty (bav) was performed.The aortic insufficiency after the first valve was moderate.It was reported that no cardiac tamponade was observed, however, a coronary occlusion occurred due to the valve dislodgement and second valve.After the second valve was implanted the aortic insufficiency decreased to mild.Per the physician, the cause of death was the coronary occlusion.

Manufacturer Narrative

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

The physician confirmed the aortic insufficiency was classified as paravalvular leak (pvl).

Manufacturer Narrative

Updated: b1, 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: images were submitted to medtronic for review.Intra procedural fluoroscopic images and a mpxr questionnaire were provided for review.The patient¿s executive summary was provided for anatomical review.The patient¿s annulus perimeter measured 69.2mm with a perimeter derived diameter of 22mm suggesting a size 26mm evolut valve.The aortic valve leaflets appeared to be significantly calcified; however, there was no evidence that a pre balloon aortic valvuloplasty was performed prior to the valve implant.The valve was deployed to just prior the point of no recapture and depth assessment was performed.The depth at the non-coronary cusp was approximately 1mm in the cusp overlap view and 3mm at the left-coronary cusp in the left anterior oblique view.The valve appeared to be under expanded/constrained in the cusp overlap view which would warrant a recapture.The valve was released which resulted in dislodgment to the level of the sinuses.There is no evidence that snaring the dislodged valve was attempted, which resulted in complete occlusion of the coronary arteries when the second valve was implanted, as evident by the reviewed images.It was also reported that tamponade was observed, but it is not possible to confirm on the fluoroscopic images provided.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 PRO PLUS 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: 18882899
• MDR Text Key: 337402298
• Report Number: 2025587-2024-01530
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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,Followup
• Report Date: 05/29/2024

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: EVPROPLUS-26
• Device Catalogue Number: EVPROPLUS-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2024
• Initial Date FDA Received: 03/11/2024
• Supplement Dates Manufacturer Received: 03/15/2024; 03/15/2024; 05/23/2024; Not provided
• Supplement Dates FDA Received: 03/18/2024; 03/21/2024; 05/23/2024; 05/29/2024
• Date Device Manufactured: 11/16/2023
• 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): Death; Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 55 KG