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

Model Number D-EVPROP34US

Device Problem Failure to Advance (2524)

Patient Problem Vascular Dissection (3160)

Event Date 04/22/2022

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.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 physician was unable to advance the delivery catheter system (dcs) up the left femoral artery.The access was moved to the right sided and the physician was unable to advance up the right femoral artery.A dissection of the right external iliac was observed and two covered stents were implanted.A vessel was dissected lower and the physician was unable to fix the dissection.Subsequently the patient died.

Manufacturer Narrative

Additional information was received that the minimum access vessel diameter was 6 mm with minimal calcium and no tortuosity.A dissection was noted on computed tomography (ct) prior to the procedure.Per the physician, the cause of death was right femoral dissection possibly caused by the delivery catheter system (dcs) advancing through the anatomy.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 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 the physician was unable to advance the delivery catheter system (dcs) up the left femoral artery.The access was moved to the right side and the physician was unable to advance up the right femoral artery.Difficulties advancing the dcs through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, a cause of the advancement difficulties was unable to be determined given the limited information available.It was reported that a dissection of the right external iliac was observed and two covered stents were implanted.A vessel was dissected lower and the physician was unable to fix the dissection.Vascular access related complications, such as dissection, are a known potential adverse patient effect per the evolut pro plus 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.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.It was noted that the minimum diameter of the access vessel was 6 mm.Per the ifu ¿patients must present with transarterial access vessels with diameters that are =6.5 mm when using model d-evprop34us¿.This indicates use error.Subsequently, the patient died.Patient death is a known potential adverse patient effect per the evolut pro plus system instructions for use (ifu), and 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 right femoral dissection possibly caused by the dcs advancing through the anatomy, but this cannot be conclusively confirmed without procedural images for review and based on the limited information available.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: 14318155
• MDR Text Key: 291191672
• Report Number: 2025587-2022-01286
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207861
• UDI-Public: 00763000207861
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2022

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 Expiration Date: 11/01/2023
• Device Model Number: D-EVPROP34US
• Device Catalogue Number: D-EVPROP34US
• Device Lot Number: 0010920221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 05/09/2022; 07/14/2022
• Supplement Dates FDA Received: 05/20/2022; 07/18/2022
• Date Device Manufactured: 11/01/2021
• 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; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male