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

Model Number D-EVPROP34US

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/13/2021

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the delivery catheter system (dcs) was not returned, therefore no product analysis can be performed.Conclusion: without 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 prior to the implant of a transcatheter bioprosthetic valve, while loading, just before marrying the valve with manual force, the delivery catheter system (dcs) handle broke and was not able to be put back together.A non-medtronic valve was subsequently implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at medtronic¿s quality laboratory, the handle appeared intact.The capsule appeared intact with no evidence of damage.The device was received with the capsule fully opened.The deployment knob appeared to retract and advance the capsule.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact.The inner member shaft and spindle hub appeared intact with no evidence of damage.The device was returned with the end cap/screw gear snap fit connected.The actuator components were loose and separated during the retraction of the capsule.Tab 3 of the actuator component was observed to have a hairline fracture at the point where the tab protrudes from the component.Tab 4 of the actuator component was observed to have a stress mark at the point where the tab protrudes from the male actuator component.The reported event for actuator component separation could be confirmed in the analysis.However, the delivery catheter system (dcs) was received with the actuator component put back together on the dcs.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.The subject dcs was returned to medtronic for analysis.The actuator components were loose and separated during the retraction of the capsule, confirming the reported event.Tab 3 of the actuator component was observed to have a hairline fracture at the point where the tab protrudes from the component and tab 4 of the actuator component was observed to have a stress mark at the point where the tab protrudes from the male actuator component.No procedural images were provided for review.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.A second dcs was used to load the valve.Capa 408848 was initiated to investigate the root cause of actuator separation events; the risk analysis and the manufacturing lot relationship will be reviewed as a part of this capa.Updated data: method code, results code, conclusion code.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 ; EI ; 091708734
• MDR Report Key: 11286341
• MDR Text Key: 230519307
• Report Number: 2025587-2021-00456
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2021
• Device Model Number: D-EVPROP34US
• Device Catalogue Number: D-EVPROP34US
• Device Lot Number: 0010161318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female