MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number ENVPRO-16

Device Problem Failure to Advance (2524)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Vascular Dissection (3160)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device was discarded, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the left femoral artery was dilated with a 14 french(fr) sheath.The delivery catheter system (dcs) was unable to advance through the left femoral artery.The left femoral artery was dilated with a 16fr sheath, but the dcs was still not able to be advanced.The patient began to bleed and had six cardiac arrests.Medication was administered.An iliac-femoral dissection was found.Two stents were implanted and the bleeding was stopped.No additional adverse patient effects were reported.

Manufacturer Narrative

Additional information was received that the minimum access vessel diameter was 5.8 mm.Per the physician, calcium and a small vessel diameter contributed to the injury.Per the physician, the delivery catheter system (dcs) caused or contributed to the injury."cardiopulmonary" resuscitation (cpr) was performed during the procedure.After the stents were implanted, the procedure was aborted.A valve was never implanted.No additional adverse patient effects were reported.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 not returned to medtronic, and as such no analysis could be performed.No procedural images were provided for review.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.It was reported that during the implant of this transcatheter bioprosthetic valve, the dcs was unable to advance through the left fe moral artery.Difficulties advancing the dcs is known to be related to procedural factors, user technique, and/or patient anatomy (angulation, calcification, tortuousity, etc.).In this case, it was reported that the patient presented with calcium and a small vessel diameter.This indicates the probable cause of the advancement issues was patient anatomy.However, with the limited information available, the cause of the difficulty advancing the dcs could not be determined and a relationship to the dcs cannot be established.The patient began to bleed and had six cardiac arrests.Medication was administered and an iliac-femoral dissection was found, leading to the implant of two stents which stopped the bleeding.Vascular complications, such as bleeding and dissection, are known potential adverse patient effects per the evolut 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.).Based on the limited information available, an assignable root cause of the vascular complication cannot be determined and the relationship to the dcs could not be established.Cardiac arrest is known potential adverse effect per the evolut system instructions for use (ifu).These events may be related to patient medical condition, comorbidities, and/or procedural factors.Based on the limited information available, an assignable root cause of the cardiac arrest cannot be determined and the relationship to the device could not be established.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Updated data: h6 - eval method code, eval results code, eval conclusion code additional codes - img component code.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: ENVEO PRO DELIVERY SYSTEM
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 12287340
• MDR Text Key: 265369466
• Report Number: 2025587-2021-02478
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2022
• Device Model Number: ENVPRO-16
• Device Catalogue Number: ENVPRO-16
• Device Lot Number: 0010402254
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention