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

Model Number	HARMONY-DCS
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that one day following the implant of this transcatheter bioprosthetic valve, the patient was discharged, and a right groin bleed occurred that required rehospitalization.Telemetry observation was required.Ultrasound showed no expanding hematoma, and no treatment was administered.The patient was required to lay flat for a period of time.The bleed resolved one day after onset, and the patient was discharged.Per the physician, the event was not related to the valve or the delivery catheter system (dcs) but was related to the procedure.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.  continuation of d10: product id: harmony-25, product lot/serial number: (b)(6), product type: transcatheter aortic valve (tavr), implant date: (b)(6) 2023.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 received indicated that the delivery catheter system (dcs) was access via the right femoral access site.
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.
Event or Problem Description
Additional information received that the 26fr non-medtronic sheath was the largest size.There was no difficulty with insertion, advancement, nor issue at the end of the transcatheter bioprosthetic pulmonary valve procedure.Patient anatomy features were not a concern.Two figure 8 sutures were used at end of the implant procedure with good hemostasis.The patient was observed for over 6 hours after removal of the sutures the following day.At that time, there was no bleeding.Bleeding was first observed as the patient took 3-5 steps out of hospital.As result, the patient immediately returned to the emergency room.Other than manual compression, no other interventions were required.Overnight observation was required.As reported, there was no injury observed.Rather the patient simply bled from access site the day after the procedure.

• Brand Name: HARMONY DELIVERY CATHETER SYSTEM
• Common Device Name: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI
• 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: 19740380
• Report Number: 2025587-2024-03960
• Device Sequence Number: 19755382
• Product Code: NPV
• UDI-Device Identifier: 00763000341367
• UDI-Public: 00763000341367
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 08/19/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/01/2024
• Device Model Number: HARMONY-DCS
• Device Catalogue Number: HARMONY-DCS
• Device Lot Number: 0011754548
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/07/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/23/2024; 08/20/2024
• Date Device Manufactured: 05/02/2023
• 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
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian