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

Model Number	HARMONY-DCS
Medical Device Problem Codes	Difficult to Open or Close (2921); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemoptysis (1887); Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id harmony-25 (serial: (b)(6)); product type: 0195-heart valves; implant date na; explant date na product id harmony-dcs (lot: 0012642959); product type: 0195-heart valves; implant date na ; explant date na product id lunderquist guidewire (lot: unknown); product type: guidewire; implant date na; explant date na product id gore dryseal sheath (lot: unknown); product type: sheath; implant date na; explant date na 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
It was reported that during the implant procedure of a transcatheter bioprosthetic pulmonary valve with experienced implanters, the intent was to used right pulmonary artery (rpa) guidewire position with a non-medtronic guidewire.The delivery catheter system (dcs) was advanced and the nose cone was launched into the rpa.As the rows 1-3 were being uncovered at the roof of the bifurcation according to the pre-case planning, the guidewire "jumped" from the rpa to the left pulmonary artery (lpa).This re-oriented the valve and forced it to move lower than was planned.As result, the deployed valve, which was not yet released, was recaptured through the 26 fr 65 centimeter (cm) non-medtronic sheath.Difficulty to recapture was reported.Guidewire perforation of the distal right pulmonary artery with hemoptysis and bleeding from the endotracheal (et) tube occurred.This required cold saline irrigation, continued intubation, and admission to the pediatric cardiac intensive care unit.The hemoglobin level pre-implant measured 13.1 grams per deciliter (g/dl).The hemoglobin level post valve implant measured 10.6 g/dl.The perforation resulted in prolonged hospitalization.A new guidewire, dcs and valve were then used without issue and this different valve was successfully implanted.As reported, there was no delay in the procedure.The physician indicated that the events of valve placement, reorientation, perforation, and hemoptysis were possibly related to the dcs and causal to the implant procedure.The perforation was reported as recovered with sequelae on the same date as the implant procedure.
Additional Manufacturer Narrative
Updated data: b5.A second paragraph was added.H6.Eval code method was updated.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
It was reported that during the implant procedure of a transcatheter bioprosthetic pulmonary valve with experienced implanters, the intent was to used right pulmonary artery (rpa) guidewire position with a non-medtronic guidewire.The delivery catheter system (dcs) was advanced and the nose cone was launched into the rpa.As the rows 1-3 were being uncovered at the roof of the bifurcation according to the pre-case planning, the guidewire "jumped" from the rpa to the left pulmonary artery (lpa).This re-oriented the valve and forced it to move lower than was planned.As result, the deployed valve, which was not yet released, was recaptured through the 26 fr 65 centimeter (cm) non-medtronic sheath.Difficulty to recapture was reported.Guidewire perforation of the distal right pulmonary artery with hemoptysis and bleeding from the endotracheal (et) tube occurred.This required cold saline irrigation, continued intubation, and admission to the pediatric cardiac intensive care unit.The hemoglobin level pre-implant measured 13.1 grams per deciliter (g/dl).The hemoglobin level post valve implant measured 10.6 g/dl.The perforation resulted in in prolonged hospitalization.A new guidewire, dcs and valve were then used without issue and this different valve was successfully implanted.As reported, there was no delay in the procedure.The physician indicated that the events of valve placement, reorientation, perforation, and hemoptysis were possibly related to the dcs and causal to the implant procedure.The perforation was reported as recovered with sequelae on the same date as the implant procedure.Additional information was received from the physician: "the wire perforation was not a unique risk to the medtronic equipment; it's related to the positioning of the lunderquist wire.It has nothing to do with medtronic equipment.The ventricular ectopy post implant is typical of harmony valve implantations (the graft touching right ventricular outflow tract myocardium) and we have seen it before, nothing unique to this case." on the first post-operative day, premature ventricular contractions were noted.The patient was started on a beta blocker medication.
Additional Manufacturer Narrative
Updated data: d4 h6 - annex b, annex c.Image review analysis: unfortunately, in the images provided it was not possible to appreciate the switch or change of the wire position during the deployment described as the possible reason of the perforation.Perforation is listed as a potential complications or adverse event.Also, the instructions for use (ifu) recommend a surveillance of the wire during all time of the procedure as during the implantation the advance of the delivery catheter system (dcs) the manipulation of the wire is needed.The images provided showed 2 deployments or attempts of deployment.In the first images we were able to view the dcs forward distal movement into the rpa, (rows 1 to 5).Following by a standard deployment in a proper position.The attempted release of the wire into the lpa just showed the release until row 6 but not the recovery of the valve.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.A third paragraph was added.Corrected data: d.Suspect medical device: manufacturer name and address full udi#.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
It was reported that during the implant procedure of a transcatheter bioprosthetic pulmonary valve with experienced implanters, the intent was to use right pulmonary artery (rpa) guidewire position with a non-medtronic guidewire.The delivery catheter system (dcs) was advanced and the nose cone was launched into the rpa.As the rows 1-3 were being uncovered at the roof of the bifurcation according to the pre-case planning, the guidewire "jumped" from the rpa to the left pulmonary artery (lpa).This re-oriented the valve and forced it to move lower than was planned.As result, the deployed valve, which was not yet released, was recaptured through the 26 fr 65 centimeter (cm) non-medtronic sheath.Difficulty to recapture was reported.Guidewire perforation of the distal right pulmonary artery with hemoptysis and bleeding from the endotracheal (et) tube occurred.This required cold saline irrigation, continued intubation, and admission to the pediatric cardiac intensive care unit.The hemoglobin level pre-implant measured 13.1 grams per deciliter (g/dl).The hemoglobin level post valve implant measured 10.6 g/dl.The perforation resulted in in prolonged hospitalization.A new guidewire, dcs and valve were then used without issue and this different valve was successfully implanted.As reported, there was no delay in the procedure.The physician indicated that the events of valve placement, reorientation, perforation, and hemoptysis were possibly related to the dcs and causal to the implant procedure.The perforation was reported as recovered with sequelae on the same date as the implant procedure.Additional information was received from the physician: "the wire perforation was not a unique risk to the medtronic equipment; it's related to the positioning of the lunderquist wire.It has nothing to do with medtronic equipment.The ventricular ectopy post implant is typical of harmony valve implantations (the graft touching right ventricular outflow tract myocardium) and we have seen it before, nothing unique to this case." on the first post-operative day, premature ventricular contractions were noted.The patient was started on a beta blocker medication.Additional information was received to correct the previously documented narrative to note the right pulmonary artery perforation was resolved two days after onset.The ventricular premature beats was resolved approximately five months, one week after onset.

• Brand Name: HARMONY DELIVERY CATHETER SYSTEM
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway CA ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway CA ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21969621
• Report Number: 2025587-2025-03446
• Device Sequence Number: 12792915
• Product Code: NPV
• UDI-Device Identifier: 00763000341367
• UDI-Public: (01)00763000341367(17)250926(10)0012463874
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/26/2025
• Device Model Number: HARMONY-DCS
• Device Catalogue Number: HARMONY-DCS
• Device Lot Number: 0012463874
• 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: 04/08/2025
• Supplement Date Received by Manufacturer: 05/07/2025; 07/24/2025; 10/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/31/2025; 07/25/2025; 11/10/2025
• Date Device Manufactured: 09/26/2024
• 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.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American