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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 06/06/2022

Event Type  Injury  

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, calcification was observed in the iliac and femoral arteries on both lower limbs.The blood vessel diameter was not maintained.The left subclavian artery diameter was less that 5 mm so it was not an option as an access site.In order to avoid the narrow region of the femoral artery, an access approach was made by a cut-down from high in the left external iliac artery.A 14 fr non-medtronic introducer (dryseal) sheathe was inserted and advanced.The 14 fr inline sheath did not advance however.An 18 fr non-medtronic introducer (dryseal) sheath was attempted but it would also not advance.The artery was inflated with a percutaneous transluminal angioplasty (pta) balloon.Both the 18 fr sheath and 14 fr sheath were attempted to be advanced again, but did not pass.The apical non-medtronic (safari) guidewire was removed and changed for another non-medtronic (lunderquist) guidewire.The inline sheath was attempted again with this wire, but it was not successful.Access approach from the right leg was suggested, but was rejected, therefore the procedure was aborted and the valve was not implanted.A balloon aortic valvuloplasty (bav) was performed instead.It was reported that following, vascular damage to the left external iliac artery access site was observed.The damage was sutured.No other treatment was reported.No additional adverse patient effects were reported.Additional information was received that during the implant of the valve, an intimal delamination at the femoral artery insertion site was observed.Blood flow improved by end to end anastomosis with a synthetic graft.Four days following the valve implant, the patient had a cranial ulcer and developed symptoms.Per the physician, there was no causal relationship between the valve or implant procedure.No additional adverse patient effects were reported.

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.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

Corrected data: h6 - device code updated data: h6 - method, results and conclusion codes 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.The reported event indicates that the access approach from the right leg was suggested, but was rejected, therefore the procedure was aborted, and the valve was not implanted.Difficulties advancing the delivery catheter system (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, it was noted that calcification was observed in the iliac and femoral arteries on both lower limbs.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.It was reported that following, vascular damage to the left external iliac artery access site was observed.Vascular related complications are a known potential adverse patient effect 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.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.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: 16710815
• MDR Text Key: 313007089
• Report Number: 2025587-2023-01434
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2024
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0011051603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2023
• Date Device Manufactured: 02/03/2022
• 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): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 34 KG