MAUDE Adverse Event Report: MEDTRONIC IRELAND HARMONY DELIVERY CATHETER SYSTEM; PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI

Model Number	HARMONY-DCS
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant of a transcatheter valve, the right pulmonary artery (rpa) wire position was used during deployment using a non-medtronic guidewire.The "carrot" was launched deep into the rpa sub branch.The delivery catheter system (dcs) was pulled and the valve was covered back towards the main pulmonary artery until the radiographic marker band of the dcs was noted to "flop" over from the rpa ostium to the middle of the bifurcation roof.After uncovering rows 1-2 of the valve frame, one of the crowns of the right side of the valve frame "slipped" down below the "armpit" of the rpa.Additionally, inadvertent uncovering of row 3 occurred, and the frame outflow rested in a "kinked" position.Subsequently, the valve was resheathed using a 26 french non-medtronic introducer sheath due to the low and tilted position of the patient's anatomy.A new valve and new dcs were used to successfully complete the procedure.Per the physician, the depth of implant contributed to the event.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id harmony-25 (k041359); product type: 0195-heart valves; implant date n/a; explant date n/a 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.
Additional Manufacturer Narrative
Updated data: b5.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
Additional information was received that the valve was still attached to the dcs coil and was partially recaptured in the capsule when the valve frame slipped down.
Additional Manufacturer Narrative
Image review: the initial harmony deployment attempt resulted in the distal end dropping below the right pulmonary artery (rpa) ostium.Although off-label, the implanters chose to bail out by retrieving the valve into the non-medtronic sheath.During the second deployment attempt, they were able to keep the valve higher against the roof of the bifurcation.A faster uncovering allowed the distal end to stay higher, in their desired position.To retrieve or reposition the harmony® tpv valve and once the struts have made contact with the anatomy during deployment it is not recommended.This is listed as a warning/precaution.Product analysis: upon receipt of the suspect complaint device at medtronic¿s quality laboratory, the delivery catheter system (dcs) was received without a valve loaded within the capsule.The device was received with the capsule fully opened.Deformation was evident to the capsule.The device was received with the nosecone detached.A kink was observed in the peek inner shaft just proximal to the handle edge.A kink was also observed on the proximal peek inner shaft.The device was received with the peek inner shaft partially advanced, and the holding coil was partially retracted.The peek inner shaft could be advanced and retracted with resistance due to the kinks on the peek inner shaft.The tuohy borst body appeared to rotate the holding coil when rotated.The hemostasis valve actuator appeared to lock when rotated clockwise and unlock when rotated counterclockwise.The proximal handle actuator appeared to lock when rotated clockwise and unlock when rotated counterclockwise.A harmony tpv-25 valve was successfully loaded onto the dcs with slight resistance.On retraction of the capsule via retraction of the haemostasis valve body, the valve deployed with slight resistance.The valve was released from the holding coil via rotation of the tuohy borst body without issue.The reported event for positioning difficulty could not be confirmed in the analysis.The reported event for dislodged dcs could not be confirmed in the analysis.Updated data: b5., d9., h3., h6.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
Additional information was received that a a nose cone separation was not noted during the implant procedure and that the entire delivery catheter system (dcs) was intact.
Additional Manufacturer Narrative
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.

• Brand Name: HARMONY DELIVERY CATHETER SYSTEM
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24334411
• Report Number: 9612164-2026-00811
• Device Sequence Number: 4771012
• Product Code: NPV
• UDI-Device Identifier: 00763000341367
• UDI-Public: (01)00763000341367(17)260520(10)0012824770
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P200046
• 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
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/27/2026

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: 05/20/2026
• Device Model Number: HARMONY-DCS
• Device Catalogue Number: HARMONY-DCS
• Device Lot Number: 0012824770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 02/18/2026; 03/25/2026; 04/24/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 03/13/2026; 04/24/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 22 KG