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On-x ascend study patient 1215 experienced ischemic stroke and cardiac arrhythmia* on (b)(6) 2020 which led to a serious deterioration in the health of the patient and prolonged their hospitalization.A head ct without contrast demonstrated multi focal acute to subacute infarct of the primary motor cortex of the arm/hand region right greater than left and the bilateral occipital lobes.This resolved on (b)(6) 2020.The cardiac arrhythmia resolved on (b)(6) 2021.* cardiac arrhythmia was incorrectly entered as cardiac arrest.Additional information received is as follows: (b)(6) 2021 - impression: atrial fibrillation no clinical recurrences; no need for medication; continue warfarin for mechanical valve.Bradycardia - modest bradycardia; no attributable symptoms; average ventricular rate=59 bpm.No indication for pacemaker.(b)(6) 2020 - multiple infarcts seen on noncontrast head ct earlier this morning; low gfr of 38; cta of head & neck approved.Vitals: wt=65.2kg, bmi=22.06kg/m2, bsa=1.76m2.65yr old male with a past medical history of hypertension, hyperlipidemia, polycystic kidney disease, ckd stage iii, multi-vessel cad/nstemi, afib w/ cardioversion in 7-2020.A-fib w/ rvr and an anteroseptal q-wave mi by ecg.(b)(6) 2020 underwent tee and had successful cardioversion to sinus rhythm.
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The study patient experienced ischemic stroke and cardiac arrhythmia on (b)(6) 2020 which led to a serious deterioration in the health of the patient and prolonged their hospitalization.A head ct without contrast demonstrated multi focal acute to subacute infarct of the primary motor cortex of the arm/hand region right greater than left and the bilateral occipital lobes.This resolved on (b)(6) 2020.The cardiac arrhythmia resolved on (b)(6) 2021.Additional information received is as follows: (b)(6) 2021 - impression: atrial fibrillation no clinical recurrences; no need for medication; continue warfarin for mechanical valve.Bradycardia - modest bradycardia; no attributable symptoms; average ventricular rate=59 bpm.No indication for pacemaker.(b)(6) 2020 - multiple infarcts seen on noncontrast head ct earlier this morning; low gfr of 38; cta of head & neck approved.Vitals: wt=65.2kg, bmi=22.06kg/m2, bsa=1.76m2 65yr old male with a past medical history of hypertension, hyperlipidemia, polycystic kidney disease, ckd stage iii, multi-vessel cad/nstemi, afib w/ cardioversion in 7-2020.A-fib w/ rvr and an anteroseptal q-wave mi by ecg.(b)(6) 2020 underwent tee and had successful cardioversion to sinus rhythm.
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The study patient experienced ischemic stroke and cardiac arrhythmia on (b)(6) 2020 which led to a serious deterioration in the health of the patient and prolonged their hospitalization.A head ct without contrast demonstrated multi focal acute to subacute infarct of the primary motor cortex of the arm/hand region right greater than left and the bilateral occipital lobes.This resolved on (b)(6) 2020.The cardiac arrhythmia resolved on (b)(6) 2021.Additional information received is as follows: (b)(6) 2021 - impression: atrial fibrillation no clinical recurrences; no need for medication; continue warfarin for mechanical valve.Bradycardia - modest bradycardia; no attributable symptoms; average ventricular rate=59 bpm.No indication for pacemaker.(b)(6) 2020 - multiple infarcts seen on noncontrast head ct earlier this morning; low gfr of 38; cta of head & neck approved.Vitals: wt=65.2kg, bmi=22.06kg/m2, bsa=1.76m2 65yr old male with a past medical history of hypertension, hyperlipidemia, polycystic kidney disease, ckd stage iii, multi-vessel cad/nstemi, afib w/ cardioversion in 7-2020.A-fib w/ rvr and an anteroseptal q-wave mi by ecg.10-jul-2020 underwent tee and had successful cardioversion to sinus rhythm.This investigation is relegated to onxaap-23 serial number (sn) (b)(6).A sample evaluation was not performed as the product remains implanted.The manufacturing records for onxaap-23, sn (b)(6) were reviewed, and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted.Document change orders le17682 and le17686 were issued for leaflet tuning as a part of the standard manufacturing process.An onxaap 23 with serial number (b)(6) was implanted on (b)(6) 2020 with a concomitant cabg x 2, aortic root and ascending aorta replacement in a 65-year-old male with a past medical history of nstemi and atrial fibrillation requiring cardioversion in (b)(6) 2020.Ascending aortic dilation measuring 5.0 x 4.7 cm, mild aortic insufficiency, and reversible myocardial defect involving the inferoseptum per a cmri performed on (b)(6) 2020 and hypertension, hyperlipidemia, polycystic kidney disease and chronic kidney disease stage iii.The subject was enrolled in the study and this event refers to the study patient.On (b)(6) 2020 (1-day post implant) the patient experienced two adverse events.Event one was an ischemic stroke with a listed resolution date of (b)(6) 2020 without sequelae.On (b)(6) 2020 once extubated the patient complained of bilateral upper extremity tingling however, routine neurological exams showed no deficits.The morning of (b)(6) 2020 the physical therapist reported left upper and lower extremity weakness and that the left upper extremity had markedly decreased motor function and decreased sensation was reported by the patient.A neuro consult was ordered, and the patient sent for a non-contrast head ct that showed infarcts to bilateral occipital poles and an infarct in the right cerebellar hemisphere.Further studies were ordered at that time; an ct angiogram of the head and neck, bilateral carotid doppler and a tte (transthoracic echocardiogram).The preliminary cta report showed no apparent large vessel disease and the tte reported a normal functioning valve with a mean gradient of 17 mmhg.A subsequent follow up tee (transesophageal echocardiogram) performed on (b)(6) 2020 reported no thrombus and the valve was stable and functioning normally.The final reports for the ct, cta and bilateral doppler were not included with the provided medical records.Event two was a report of cardiac arrythmia, per the adverse event reporting form the start date was listed as (b)(6) 2020 with a resolution date of (b)(6) 2021 without sequelae.Upon review of the medical records provided the first reported incidence of atrial fibrillation was on (b)(6) 2020, ¿the patient has been in a fib, continue rate control and increase metoprolol to 37.5mg po bid¿.No further mention was noted until a follow up progress note dated (b)(6) 2021 ¿a fib with no clinical reoccurrences, no need for antiarrhythmic medication¿ and bradycardia ¿modest bradycardia with no attributable symptoms¿ average ventricular rate of 59, low of 48, high of 119¿no indication for a pacemaker at this time.¿ the instructions for use [ifu] for the aap valve lists the possibilities of stroke and thromboembolism as potential complications of prosthetic heart valve replacement with te occurring at a historical rate of 1.6 %/patient-year [iso 5840:2021].The instructions for use [ifu] for the aap valve list cardiac arrhythmia as a potential adverse event for mechanical prosthetic valve recipients.Ischemic stroke and cardiac arrhythmia are known potential complications.The event of stroke is possibly related to the on-x aap device, however with the patient¿s history of atrial fibrillation, hypertension and hyperlipidemia the causative factor cannot be known for certain.In addition, there is no indication that the on-x aap device contributed in any way to the reported episode of cardiac arrythmia and the arrythmia is more likely a complication related to the surgical procedure itself rather than the valve.The risk management file for the on-x ascending aortic prosthesis was reviewed.Ischemic stroke and cardiac arrhythmia are known potential complications.The event of stroke is possibly related to the on-x aap device, however with the patient¿s history of atrial fibrillation, hypertension and hyperlipidemia the causative factor cannot be known for certain.In addition, there is no indication that the on-x aap device contributed in any way to the reported episode of cardiac arrythmia and the arrythmia is more likely a complication related to the surgical procedure itself rather than the valve.The patient is part of the ascend study and there is not enough data to determine the root cause for the events; thus, severity and occurrence is not evaluated.The instructions for use [ifu] for the aap valve lists the possibilities of stroke and thromboembolism as potential complications of prosthetic heart valve replacement with te occurring at a historical rate of 1.6 %/patient-year [iso 5840:2021].The instructions for use [ifu] for the aap valve also list cardiac arrhythmia as a potential adverse event for mechanical prosthetic valve recipients.Ischemic stroke and cardiac arrhythmia are known potential complications.The event of stroke is possibly related to the on-x aap device, however with the patient¿s history of atrial fibrillation, hypertension and hyperlipidemia the causative factor cannot be known for certain.In addition, there is no indication that the on-x aap device contributed in any way to the reported episode of cardiac arrythmia and the arrythmia is more likely a complication related to the surgical procedure itself rather than the valve.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.H10: the following did not show on the initial report - this investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.
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