MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVOLUTR-34

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of concomitant medical products: the main component of the system.Other relevant device(s) are: product id: envpro-16, serial/lot #: (b)(4), ubd: 19-jan-2024, udi#: (b)(4).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 in a patient with severe calcification on the iliac artery, prior to removing the valve from the packaging, peripheral shockwave was performed.Peripheral intravascular ultrasound confirmed the success of the treatment, so the physician proceeded with the implant of the valve.However, the delivery catheter system (dcs) was unable to pass over focal calcification on the common iliac.After several attempts, during the check of the system, the specialist noted a possible piece of valve pericardium on the loading bath.It is suspected that when pushing the dcs against the calcification in the iliac artery, the capsule "oversheathed" and calcium entered in the capsule, which may have damaged the pericardium in the valve inflow.Subsequently, the system was exchanged with a new valve and a new dcs.After another cycle of peripheral shockwave and percutaneous transluminal angioplasty with non-compliant balloons of increasing size, the new valve was successfully implanted.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis of primary pli (valve): upon receipt at medtronic¿s quality laboratory, the device was received via tnt in packaging of serial number (b)(6), the replacement valve, with patient registration labels for serial number (b)(6).All leaflets were flexible and intact; no tears or damages were noted.Marginal blood remnants were noted on the free margins of leaflets 2 and 3.The cuspal tear allegation could not be confirmed.All leaflets were in the closed position with a small gap at the point of coaptation.All commissures were intact.Two small tissue fragments were returned with the valve inside the jar.One (a) tissue fragment measured approximately 3 mm x 2.5 mm with a focal thick region and thin glistening irregular shaped edges.Second (b) tissue fragment measured approximately 5 mm x 3 mm with thin glistening surfaces on both sides and irregular shaped edges.The valve was inspected; appeared intact, no tears or missing pieces wer e noted on the valve.Evolutr pericardial tissue has a fibrous side and serous side.The characteristics of the tissue fragments are suggestive of possible native tissue caught during the valve recapture.Conclusion: the valve was received for analysis.The subject delivery catheter system (dcs) was discarded by the customer and therefore was unable to be returned for analysis.No additional procedure images were provided.Per the device instructions for use (ifu), in the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a post-implant balloon dilation of the bioprosthesis may improve valve function and sealing.To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation.¿ the balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus.Refer to the specific balloon catheter manufacturer's labeling for proper instruction on the use of balloon catheter devices.In this case, there was no bav performed.Based on the product analysis, a cuspal tear could not be confirmed as the valve was returned to the analysis lab intact.Rather, the received pericardium tissue is indicative of native tissue caught during the valve recapture.Thus, this was identified as a procedural error.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, it was noted that the patient had severe calcification on the iliac artery.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.A device history record (dhr) review was not required for the dcs.A dhr review was performed on the valve and all process parameters were within specification as outlined in applicable procedures and specifications.All materials used were as per the requirements of the dhr.All processes were carried out as per relevant procedures and device met specifications.No deviations referenced on the dhr were identified.Dhr review did not show any deviations in the manufacturing process.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.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 R TRANSCATHETER AORTIC VALVE
• 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: 16281426
• MDR Text Key: 308625576
• Report Number: 2025587-2023-00370
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2023
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2022
• 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 Sex: Male