HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSIST) BYPASS
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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Muscle Weakness (1967); Tachycardia (2095); Ventricular Tachycardia (2132); Weakness (2145); Dizziness (2194)
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Event Date 07/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac trans plantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: video assisted thoracoscopic sympathectomy for intractable recurrent vt after minimal-invasive lvad implantation.Journal of cardiac surgery, july 2020; 35(7):1708-1710.Doi: 10.1111/ jocs.14639 additional information has been requested regarding the cause of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A journal article was reviewed which contained information regarding ventricular assist devices (vads).The article was a case report on using a surgical treatment to eliminate intractable ventricular tachycardia (vt) in a patient implanted with a left vad.The patient's post-operative course was complicated by the development of recurrent vt approximately seven weeks post-implant.The patient¿s implantable cardioverter defibrillator (icd) delivered shocks which terminated each episode of vt, but this resulted in multiple hospitalizations.The patient later developed vt storm, requiring another hospitalization, where the patient underwent endocardial catheter ablation and oral anti-arrhythmic medication adjustment.After further episodes of vt involving weakness and dizziness, left-sided video-assisted thoracoscopic sympathectomy/ denervation of the heart was performed.The patient experienced one later run of vt episodes, which were terminated by icd shocks, then remained symptom-free.The vad remains in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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A supplemental report is being submitted for investigation completion.Product event summary: one pump with unknown serial number was not returned for evaluation.This complaint is associated with a clinical adverse event.Based on the available information, there is no evidence to indicate that a device malfunction or performance issue caused or contributed to the reported event.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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