MAUDE Adverse Event Report: MEDTRONIC IRELAND CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GWBC30
Medical Device Problem Codes	Difficult to Advance (2920); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	11/03/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of d10: product id {evproplus-29}; product lot/serial number (b)(6); product type: {0195-heart valves}; implant date (b)(6) 2025; product id {d-evprop23-29}; product lot/serial number (b)(6); product type: {0195-heart valves}; 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 procedure of a transcatheter valve, during delivery catheter system (dcs) advancement, the dcs was difficult to advance through the patient's heavily calcified aortic arch.After several attempts, the dcs was able to pass and the valve was implanted.Following the implant procedure, the patient experienced a stroke and received treatment; however, the patient died.Additional information was received that following the valve implant, the stroke was hemorrhagic and confirmed by patient symptoms (loss of consciousness and hemiparesis) and computed tomography (ct).Per the physician, the valve did not contribute to the stroke but due to various attempts to cross the calcified aortic arch the delivery catheter system (dcs) may have contributed to calcium displacement.The cause of the stroke was calcium displacement from the aortic arch.The patient was hospitalized and medical management was used to treat the stroke.The cause of death was due to the stroke.

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 24067535
• Report Number: 9612164-2026-00231
• Device Sequence Number: 10282302
• Product Code: DQX
• UDI-Device Identifier: 00763000758646
• UDI-Public: (01)00763000758646(17)280831(10)92402847(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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
• Report Date (Section B): 01/14/2026

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 Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 92402847
• 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: 12/17/2025
• Initial Report FDA Received Date: 01/14/2026
• Date Device Manufactured: 08/31/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization; Death
• Patient Sex: Male
• Patient Weight: 70 KG