| Model Number EVOLUTFX-26 |
| Device Problem
Patient Device Interaction Problem (4001)
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| Patient Problems
Non specific EKG/ECG Changes (1817); Heart Block (4444)
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| Event Date 04/15/2024 |
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Event Type
Injury
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Manufacturer Narrative
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Continuation of d10: product id d-evolutfx-2329; product lot/serial number (b)(6) ; product type: delivery catheter system; implant date: na; explant date: na product id d-l-evolutfx-2329; product lot/serial number (b)(6); product type: catheter loading system; implant date na; explant date na product id unknown guidewire; product lot/serial number unknown; product type: vascular guidewire; implant date: na; explant date: na additional information was requested for this reportable event.Should additional reportable information be received, a supplemental regulatory report will be submitted. 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.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve complete atrio-ventricular block d eveloped after positioning an unspecified guidewire in the left ventricle.A temporary pacemaker via the left femoral was placed.A gradual recovery of the conduction issue occurred after valve deployment, with residual first degree atrio-ventricular block.The t emporary pacemaker was left in place and the rhythm was monitored.Paroxysmal unspecified atrio-ventricular block occurred, and a permanent pacemaker was implanted the day following the valve implant.Prolonged hospitalization was required, and the patient was discharged 2 days following the valve implant.Outcome reported as resolved.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Updated data: b5.Second paragraph was added.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.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, complete atrio-ventricular block d eveloped after positioning an unspecified guidewire in the left ventricle.A temporary pacemaker via the left femoral was placed.A gradual recovery of the conduction issue occurred after valve deployment, with residual first degree atrio-ventricular block.The t emporary pacemaker was left in place and the rhythm was monitored.Paroxysmal unspecified atrio-ventricular block occurred, and a permanent pacemaker was implanted the day following the valve implant.Prolonged hospitalization was required, and the patient was discharged 2 days following the valve implant.Outcome reported as resolved.No additional adverse patient effects were reported.Additional information was reported to clarify there was no "paroxysmal unspecified atrio-ventricular block" that occurred.It was clearly documented residual first-degree atrio-ventricular block occurred which required a permanent pacemaker.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, complete atrio-ventricular block developed after positioning an unspecified guidewire in the left ventricle.A temporary pacemaker via the left femoral was placed.A gradual recovery of the conduction issue occurred after valve deployment, with residual first degree atrio-ventricular block.The temporary pacemaker was left in place and the rhythm was monitored.Paroxysmal unspecified atrio-ventricular block occurred, and a permanent pacemaker was implanted the day following the valve implant.Prolonged hospitalization was required, and the patient was discharged 2 days following the valve implant.Outcome reported as resolved.No additional adverse patient effects were reported.Additional information was reported to clarify there was no "paroxysmal unspecified atrio-ventricular block" that occurred.It was clearly documented residual first-degree atrio-ventricular block occurred which required a permanent pacemaker.Additional information was received that three weeks following valve implant the patient developed intense chest and shoulder pain.The next day, the patient was transported to the hospital via emergency medical services.Diagnostic tests were performed and demonstrated pre-tamponade with significant compression of the right atrium.A computed tomography was also performed and confirmed perforation of the right ventricle extending from the ventricular apex to the pericardium caused by the ventricular pacemaker electrode.The patient was taken to the operating room for pericardial puncture with drainage of 400cc of blood, replacement of the pacemaker unit and faulty lead, and addition of a right ventricular lead.The patient was then transferred to the coronary care unit for a few hours and subsequently to an intermediate care for monitoring the same day.The patient was transferred to general cardiology two days later.A transthoracic echocardiogram was performed the next day with no sign of tamponade or compression on the heart.There was a lateral effusion of 7mm and the mean aortic bioprosthesis gradient was 3.8 mmhg.The patient remained hospitalized four days after admission.
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Manufacturer Narrative
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Updated data: b5.Third paragraph was added.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.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Continuation of d10: product id cordis j 0.035; product lot/serial number (b)(6) ; product type: guidewire; implant date na; explant date na product id argon j 0.035; product lot/serial number (b)(6); product type: guidewire; implant date na; explant date na product id argon drt 0.035; product lot/serial number (b)(6) product type: guidewire; implant date na; explant date na product id safari; product lot/serial number unknown; product type: guidewire; implant date na; explant date na product id cordis jr4 sf; product lot/serial number (b)(6) product type: guidewire; implant date na; explant date na product id cordis; product lot/serial number (b)(6) product type: pig tail droit; implant date na; explant date na product id ingevity+; product lot/serial number unknown; product type: pacemaker electrode; implant date (b)(6); explant date unknown updated data: b5, d10.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.
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Event Description
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Additional information indicated the guidewires used during the procedure were non-medtronic guidewires.The paroxysmal atrio-ventri cular (av) block was further defined as a 1:1 av conduction which changed to complete heart block.At discharge of the valve implant procedure, the hemoglobin measurement was 103 grams per liter (g/l).Upon the readmission of the patient the hemoglobin was 89 g/l.Lowest was 76 g/l.Blood transfusions were required.The specific number of transfusions was not available.The physician indicated the pre-tamponade was causal to the procedure and unrelated to the delivery catheter system (dcs).The ventricular pacemaker electrode which caused the perforation was a non-medtronic electrode.The maximum aortic gradient measured 7.1 millimeters of mercury (mm hg).The patient remained hospitalized 10 days following re-admission.
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Event Description
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Additional information received indicated the patient was discharged from the hospital 11 days following the readmission.
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Manufacturer Narrative
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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.
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Event Description
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Additional information received indicated the pre-tamponade event was resolved on the date of hospital discharge.
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Manufacturer Narrative
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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.
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