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

Model Number D-EVPROP2329US

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Vascular Dissection (3160)

Event Date 03/31/2023

Event Type  Death  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 implant of this transcatheter bioprosthetic valve, the patient suffered an aortic dissection by the catheter, during an attempt to advance across the aortic arch.The patient died as a result.Further details were not provided.

Manufacturer Narrative

Additional information was received that the delivery catheter system (dcs) could not pass the aortic arch due to calcification and angulation.The safari guidewire was changed to a lunderquist guidewire to try to improve the angulation.A second lunderquist guidewire was placed in a pigtail in the aortic arch.After trying to reposition the system, the dcs still could not pass the aortic arch.The system was removed from the patient.While removing the system, the systolic pressure dropped from 140 mmhg to 45 mmhg.A contrast injection was performed and a dissection was noted with blood escaping the aorta.Per the physician, the dissection was caused by trying to push the system in the aortic arch and then pulling it.A balloon was placed in the aortic arch to reduce the leak while an emergency team was called.A covered stent was placed which successfully repaired the aorta.However, after thirty minutes while cardiopulmonary resuscitation (cpr) was performed, the patient did not recover and died.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

Conclusion: the subject delivery catheter system (dcs) was discarded by the customer and as such no analysis could be performed.An image of the aortic arch was provided which revealed calcification in the aortic arch.Images of the reported dissection were not provided for review.The reported event indicates that the dcs could not pass the aortic arch due to calcification and angulation.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique.In this case, it was noted that there was calcification and angulation of the aortic arch.This indicates that the probable cause of the advancement difficulties was patient anatomy.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.While removing the system, the systolic pressure dropped from 140 mmhg to 45 mmhg.Hypotension is a known potential adverse effect per device instructions for use (ifu).A medical safety assessment was performed, and upon review of the information provided, the primary event of aortic dissection, causing death, is assessed as likely related to the evolut pro+ dcs.Per the physician, the dissection was caused by trying to push the system in the aortic arch and then pulling it.Contributing factors may have been the patient's aortic arch being calcified and angulated.Aortic dissection and death are known potential risks associated with the implantation of the evolut pro+ valve and all reported adverse events and severities are documented in our risk files and instructions for use.No further safety assessment is required at this time.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications.Updated h6.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 PRO PLUS 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: 16682228
• MDR Text Key: 312696996
• Report Number: 2025587-2023-01366
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 06/30/2023

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-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 04/05/2023
• Supplement Dates Manufacturer Received: 04/06/2023; 06/26/2023
• Supplement Dates FDA Received: 04/11/2023; 06/30/2023
• 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: 89 YR
• Patient Sex: Female