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

Model Number D-EVPROP2329US

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/30/2020

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received with the handle components and the carriage components detached from the dcs.The capsule was partially opened and 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 was intact with no evidence of damage.One tab was observed to have detached from the male actuator component.Another tab was observed to be hinged inward.Conclusion: the investigation is in progress.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that prior to the implant of a transcatheter bioprosthetic valve, during loading, the deployment knob of the delivery catheter system (dcs) separated at the seam.The separation occurred prior to fully loading the valve into the capsule on the dcs, therefore the load was aborted.The dcs was not used for implant.The dcs was replaced and the valve was then successfully loaded.There was no patient involved in this event; therefore no adverse patient effects were reported.

Manufacturer Narrative

Conclusion: the device was received with the handle components and carriage components detached from the dcs which confirmed the reported event.The snap fit tabs of the actuator were observed to be damaged.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.A device history record (dhr) review was performed on the delivery catheter system (dcs) and there were no correlations or issues id entified regarding manufacturing.The device was manufactured per approved and released manufacturing processes.The device met all applicable manufacturing specifications prior to release for distribution.Updated codes section h.6: patient codes, health impact code, eval code method, eval code results and eval code conclusion.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

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 DELIVERED
• 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: toni o'doherty ; parkmore business park west; galway, MN ; EI ; 7635055378
• MDR Report Key: 10703936
• MDR Text Key: 212095055
• Report Number: 2025587-2020-03159
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000207854
• UDI-Public: 00763000207854
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2022
• Device Model Number: D-EVPROP2329US
• Device Catalogue Number: D-EVPROP2329US
• Device Lot Number: 0010182735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2022
• Date Device Manufactured: 03/19/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 2025587-05-28-2021-001-R
• Patient Sequence Number: 1
• Patient Age: 89 YR
• Patient Sex: Female