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 Codes	Detachment of Device or Device Component (2907); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2019
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.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 (b)(6) into a failed 27 millimeter (mm) medtronic surgical valve, the root angle was 44 degrees but the prior surgical valve (sav) seemed canted in annulus.The sinus of valsalva (sov) was much larger, so it was planned to utilize snare to assist with crossing into the sav frame.It was reported that the patient had a tortuous anatomy.A confida guidewire was used.An 18 fr (gore) introducer sheath was used.The first attempt, the nosecone was snared in descending aorta and advanced the device and snare together without issue.The sav was able to be crossed with minor assistance from the snare.The snare was then pulled back along delivery catheter system (dcs) (0009583098) into the arch.The valve was attempted to be deployed with controlled pacing, however the valve was too deep at 10 mm on the non-coronary cusp (ncc) and 16 mm on the left coronary cusp (lcc).The valve was recaptured and re-deployed a second time.However, the dcs was unable to come off inner curve.After 4-5 attempts and uneven depths, the dcs was removed to exchange the confida guidewire with a double curve non-medtronic wire(lunderquist) to support the greater curve.A second dcs (0009598230) was opened and loaded a second valve (b)(6).This time the dcs was more centralized but the first implant attempt was too high.The valve was released on the second attempt without issues.It was reported that after the valve deployment, the dcs deployment handle was started to separate at opposite side of arrows along the crease while closing the capsule to the nose cone.After the dcs was removed from the body, the handle was examined and it separated completely.The deployed valve seemed somewhat constrained, so the decision was made to post dilate the valve and possibly fractured the sav.A 25 mm non-medtronic balloon was used, and was advanced in to place with the patient paced at 180 beats per minute (bpm).The balloon ended up rupturing during balloon aortic valvuloplasty (bav).The balloon was pulled down to the sheath, but was unable to be removed from the sheath.Eventually both were removed over the wire without issue.A post implant transesophageal echocardiogram (tee) revealed mild paravalvular leak (pvl) around one of the leaflets of the transcatheter valve.The plan is to monitor the pvl and do a follow up echocardiogram.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: 22440053
• Report Number: 2025587-2025-04829
• Device Sequence Number: 4708404
• Product Code: NPT
• UDI-Device Identifier: 00643169987203
• UDI-Public: (01)00643169987203(17)210217(10)0009598230
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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: 02/17/2021
• Device Model Number: ENVPRO-14-US
• Device Catalogue Number: ENVPRO-14-US
• Device Lot Number: 0009598230
• Was Device Available for Evaluation?: No
• 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: 07/08/2025
• Date Device Manufactured: 02/18/2019
• 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: 84 YR
• Patient Sex: Male