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

Model Number D-EVPROP23-29

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Great Vessel Perforation (2152)

Event Date 08/25/2022

Event Type  Death  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, while crossing a calcified aortic arch, it became difficult to advance the delivery catheter system (dcs).Three attempts were made to advance the dcs.The dcs perforated the aortic arch and the blood pressure decreased.Cardiopulmonary resuscitation (cpr) was initiated.The patient noted they did not want open heart surgery performed.As a result, no treatment options were available.Subsequently, the patient died.Per the physician, the cause of death was hypotension caused by bleeding.

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.

Manufacturer Narrative

Conclusion: the delivery catheter system (dcs) was discarded by the customer and as such no analysis could be performed.Procedural images were not provided for review.A device history record (dhr) review of the dcs noted no correlations/issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The dhr review did not show any findings related to this event.The reported event indicated that while crossing a calcified aortic arch, it became difficult to advance the dcs.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 of the aortic arch.This indicated 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.Three attempts were made to advance the dcs.The dcs perforated the aortic arch and the blood pressure decreased.Vascular access related complications, such as perforation, are known potential adverse patient effects per the evolut pro+ system instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Hypotension is a known potential adverse effect per device ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally functioning device or model implant procedure.Death is a known potential adverse patient effect per the evolut pro+ system ifu and is typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Per the physician, the cause of death was hypotension caused by bleeding.There was no information to suggest a device malfunction or a failure to meet specifications that may have caused or contributed to this event.Updated data: h6 method, result, conclusion codes 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.

• 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: 15334750
• MDR Text Key: 299047603
• Report Number: 2025587-2022-02432
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2023
• Device Model Number: D-EVPROP23-29
• Device Catalogue Number: D-EVPROP23-29
• Device Lot Number: 0011248723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2022
• Date Device Manufactured: 06/05/2022
• 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; Life Threatening
• Patient Age: 84 YR
• Patient Sex: Female