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

Model Number	GWBC30
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	10/27/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Select patient information cannot be included in regulatory report due to regional privacy regulations.Continuation of d10: product id: evproplus-26 (serial: (b)(6); product type: 0195-heart valves; implant date: n/a; explant date: n/a; product id: d-evprop23-29 (lot: 0012864348); 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.
Event or Problem Description
It was reported that during the attempted implant of a transcatheter valve, the valve was recaptured to reposition it; however, the patient began to decompensate.Subsequently, cardiac massage and cardiopulmonary resuscitation (cpr) were initiated.An echocardiogram was performed that revealed a pericardial effusion, and a perforated/torn ventricle by the medtronic (confida) guidewire.Subsequently, surgical repair was performed; however, the patient died during the procedure.Per the physician, the cause of death was due to complications with the pericardial effusion.It was noted that the transcatheter valve did not contribute to the death, and was never implanted.
Additional Manufacturer Narrative
Updated data: a1 b5 h2 h3 h6.Image review: pre-implant computed tomography (ct) images were.Suboptimal imaging due to noise and motion/blurring artifact, consider measurements estimates.Aortic valve is trileaflet.Aortic valve leaflets appear moderately calcified.The annulus perimeter is 65.3 and perimeter derived is 20.8 suggesting a 26 millimeter (mm) evolut per sizing matrix.Left ventricular outflow tract (lvot) perimeter and perimeter derived diameter 66.6 mm / 21.2 mm.Protruding calcium seen in aortic annulus under non-coronary cusp (ncc) commissure and extending into left ventricular outflow tract (lvot).All sinus of valsalva (sov) diameters, sinus heights, and coronaries are within recommended ranges.Annular angulation 41°.Normal aortic arch anatomy.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 during the valve implant, the guidewire was inspected prior to use and no damage was observed.The guidewire was introduced into the ventricle through a pigtail catheter that was already positioned in the ventricle and was placed in the apex of the left ventricle.The guidewire was monitored during the implant procedure but after verifying post patient complications it was confirmed that the guidewire had lost its initial position at the moment the valve was released as it moved forward.The guidewire was repositioned before the pre-implant balloon dilation.It was noted that the guidewire was not twisted or torqued and was monitored using two projections.Per the physician, the patient's friable tissue contributed to the perforation.
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 during the valve procedure, the guidewire was not manipulated prior to use.Per the physician, the delivery catheter system (dcs) did not contribute to the ventricular perforation.The cause of death was ventricular perforation.
Additional Manufacturer Narrative
Updated data: h2.H6.Conclusion: a medical safety assessment was performed for this event.In summary, the medical safety assessment concluded that based on the event description, and medical expertise, hemodynamic decompensation, pericardial effusion, ventricular perforation and death were likely related to the guidewire and not related to the valve or delivery system.The patient's friable tissue likely contributed to the perforation.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: 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: 23428215
• Report Number: 9612164-2025-05338
• Device Sequence Number: 8252770
• Product Code: DQX
• UDI-Device Identifier: 00763000758646
• UDI-Public: (01)00763000758646(17)280630(10)92402833(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/12/2026

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: 92402833
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 11/06/2025; 11/27/2025; 12/31/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 11/20/2025; 12/04/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/30/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 78 YR
• Patient Sex: Female