MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number ENVPRO-16-US

Device Problems Material Separation (1562); Positioning Problem (3009)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was recaptured twice.After the second recapture, the capsule of the delivery catheter system (dcs) separated.Subsequently, the valve was recaptured and the dcs was withdrawn from the patient without any issue.A new valve and a new dcs were used for successful implant.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: no product was returned and no procedural images were submitted for review; 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

Updated data: d9.H3.Dev ret to mfr h6.Eval code method and eval code conclusion product analysis: upon receipt at medtronic¿s quality laboratory, the device was received with the capsule partially opened and the end cap/screw gear snap fit connected.Upon visual inspection, a break observed in the capsule nitinol reinforcing frame near the proximal end of the capsule.The separation site was observed to be jagged and uneven.There was damage observed on the threading of the screw gear.During functional testing, the handle appeared intact.The trigger moved to fully advanced and retracted positions and locked in place when released.The tip-retrieval mechanism appeared intact but could not retract the capsule due to the separation.The deployment knob could not retract and advance the full capsule due to the separation.The reported event for separation of components could be confirmed in the analysis.No procedural images or fluoroscopic load check images were submitted for review.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 device was returned to medtronic for analysis.Damage was observed on the threading of the screw gear.This damage is consistent with the increased forces in the system.High forces in the handle may cause the threading of the screw gear to become worn and damaged.The device was received with the capsule separated, confirming the reported event.Capsule separation occurs due to excessive compressive forces applied to the capsule.Forces in the system is a cumulative effect that may be increased by factors such as tortuous anatomy and load quality.The cause of the capsule separation cannot be determined based on the information available.Recapturing is a feature of the device that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.There is no information to suggest a device quality deficiency that may have caused or contributed to this event, but the cause of the positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.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 the implant of this transcatheter bioprosthetic valve, the valve was recaptured twice.After the second recapture, the capsule of the delivery catheter system (dcs) separated.Subsequently, the valve was recaptured and the dcs was withdrawn from the patient without issue.A new valve and a new dcs were used for successful implant.No adverse patient effects were reported.

• Brand Name: ENVEO PRO DELIVERY SYSTEM
• 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: 15785720
• MDR Text Key: 304788343
• Report Number: 2025587-2022-03169
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00643169987210
• UDI-Public: 00643169987210
• 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
• Type of Report: Initial,Followup
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: ENVPRO-16-US
• Device Catalogue Number: ENVPRO-16-US
• Device Lot Number: 0010961466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2021
• 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 Outcome(s): Other
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 111 KG