MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GWBC30
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id evproplus-26 (b)(6); product type: 0195-heart valves; implant date (b)(6) 2025 select patient information cannot be included in the regulatory report due to regional privacy regulations.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 of this transcatheter bioprosthetic valve, following full deployment, a post-implant balloon dilation was performed using a 22 mm balloon.Upon removal, the balloon interacted with the medtronic (confida) guidewire.This interaction caused the valve to dislodge from position.Subsequently, a second valve was implanted in the patient.
Event or Problem Description
It was reported that during the implant of this transcatheter bioprosthetic valve, following full deployment, a post-implant balloon dilation was performed using a 22 mm balloon.Upon removal, the balloon interacted with the medtronic guidewire.This interaction caused the valve to dislodge from position.Subsequently, a second valve was implanted in the patient.Additional information was received indicating that the post-dilation was performed due to a paravalvular leak.The patient was rapid paced during the post-implant balloon dilation.The valve implant depth was originally 4 mm, but it dislodged in the aortic direction.The second valve was implanted at a depth of 3 mm on the non-coronary cusp and left coronary cusp.
Additional Manufacturer Narrative
Updated data: b5.Added second paragraph.D4.H4.H6.Corrected data: b2.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: b2.B5.Added second paragraph.Corrected data: b2.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 of this transcatheter bioprosthetic valve, following full deployment, a post-implant balloon dilation was performed using a 22 mm balloon.Upon removal, the balloon interacted with the medtronic guidewire.This interaction caused the valve to dislodge from position.Subsequently, a second valve was implanted in the patient.Additional information was received indicating that the post-dilation was performed due to a paravalvular leak.The patient was rapid paced during the post-implant balloon dilation.The valve implant depth was originally 4 mm, but it dislodged in the aortic direction.The second valve was implanted at a depth of 3 mm on the non-coronary cusp and left coronary cusp.Additional information was received that the valve dislodged to a depth of 4 mm.The paravalvular leak was severe.

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 22542863
• Report Number: 2025587-2025-05141
• Device Sequence Number: 15197339
• Product Code: DQX
• UDI-Device Identifier: 00763000060886
• UDI-Public: (01)00763000060886(17)251231(10)92206676
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: K132623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/28/2025

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: 12/31/2025
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 92206676
• 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: 07/15/2025
• Supplement Date Received by Manufacturer: 07/22/2025; 07/25/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 07/23/2025; 07/28/2025
• Date Device Manufactured: 12/31/2022
• 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: Life Threatening; Required Intervention
• Patient Sex: Female
• Patient Weight: 70 KG