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

Model Number	ENVPRO-14-US
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is being submitted as part of remediation activities associated with capa 643143, addressing mdr reporting guidance from the fda¿s 1995 preamble, which ensures complaints related to corrections and recalls previously reported to the fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.Product analysis: upon receipt of the suspect complaint device at medtronic¿s quality laboratory, visual analysis showed the handle appeared intact.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 device was received with the capsule fully closed.The device was returned with the end cap/screw gear snap fit connected.The capsule appeared intact with no evidence of damage.The inner member shaft and spindle hub appeared intact with no evidence of damage.When retracting the capsule, the actuator components started to separate.At this point, the actuator handles were fully removed from the dcs by the analysis technician.A stress mark was observed on the actuator tab at the point where the tab protruded from the actuator.A crack was observed on the actuator tab at the point where the tab protruded from the actuator.Conclusion: the device history record was reviewed and showed 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 for analysis.When retracting the capsule, the actuator components started to separate.At this point, the actuator handles were fully removed from the dcs by the analysis technician.A stress mark was observed on the actuator tab at the point where the tab protruded from the actuator.A crack was observed on the actuator tab at the point where the tab protruded from the actuator.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, due to patient anatomy, the valve had to be individually sized.Based on sinus of valsalva (sov) diameter of greater than 29 mm and an average diameter of 23.5 mm, a 29mm valve was chosen for implant.During the loading of this valve, it was reported by both the loader and the medtronic rep that the blue plastic shell on the deployment knob was beginning to separate.This separation was most prominent past the 80% load phase.The valve was never fully loaded and this delivery catheter system (dcs) was not used in the patient.During two attempted deployments, the valve was reported to have moved ventricular.The physician decided this valve was to large to be implanted.The valve was recaptured and removed from the patient.A 26 mm valve was successfully implanted with a negligible gradient and no paravalvular leak (pvl) reported.No adverse patient effects were reported.

• Brand Name: ENVEO PRO DELIVERY SYSTEM
• Common Device Name: 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: 22480594
• Report Number: 2025587-2025-04940
• Device Sequence Number: 8554393
• Product Code: NPT
• UDI-Device Identifier: 00643169987203
• UDI-Public: (01)00643169987203(17)210212(10)0009590358
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: ENVPRO-14-US
• Device Catalogue Number: ENVPRO-14-US
• Device Lot Number: 0009590358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2025587-05-28-2021-001-R
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 136 KG