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

Model Number D-EVPROP2329US

Device Problems Device Damaged Prior to Use (2284); Detachment of Device or Device Component (2907)

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

Event Date 09/03/2021

Event Type  malfunction  

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the delivery catheter system (dcs) was unpacked, and the rinsing tray was found to be deformed.It was noted that the dcs was stored in the distributor warehouse, was taken out the day of the case and opened just before the procedure.The dcs was not used and a new one was used for implant.It was unknown if the dcs was defective.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the rinsing tray was returned with the proximal and loading tray, tray clips, delivery catheter system (dcs), pouch, into the original medtronic shelf carton.There was no evidence of damage to the shelf carton, pouch and labels returned.The proximal and distal loading trays appeared intact.The four tray clips were returned on the loading tray.The four tray clips appeared deformed and were removed from the tray.Clip # 3 was also deformed and could not be removed from the tray.The rinsing tray was returned loaded on the distal loading tray, and was noted to be deformed.The rinsing tray was removed from the distal loading tray and the deformation was noted to affect the whole rinsing tray.The reflective material on the distal tray seemed in place and with no evidence of damage.The dcs returned was analyzed.The device was received with the handle components detached from the dcs.During analysis the actuator components separated.Tab 3 and 4 of the left actuator component appeared intact.The left actuator component was inspected and confirmed to be a new actuator design.A smooth transition was noted between the face of the tab and the main body of the actuator.The device was received with the capsule partially opened.The capsule appeared intact with no evidence of damage.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The device was returned with the end cap/screw gear snap fit connected.The inner member shaft and spindle hub appeared intact with no evidence of damage.The returned rinsing tray was deformed, therefore confirming the reported event.Conclusion: the investigation is still in progress.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Conclusion: a device history record (dhr) review was performed on the dcs and there were 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.Futher investigation was performed by packaging and labelling (p <(>&<)>l) engineering.The results of the investigation showed that the gross tray deformation noted was most likely to have been caused by elevated temperatures (approx.55- 57 °c) and high humidity through transport and/or storage, prior to reaching the end user.During analysis, it was noted that actuator components separated from the delivery catheter system (dcs).As this was not reported in the description of the event, the actuator components may have separated during manipulation either removing or returning the dcs into the tray.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.Based on the limited details available, an assignable root cause for the actuator separation cannot be determined.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: 12722014
• MDR Text Key: 280470862
• Report Number: 2025587-2021-03302
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2023
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010688626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2021
• 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 Age: 80 YR
• Patient Sex: Female
• Patient Weight: 48 KG