HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1104 |
Device Problems
Increase in Suction (1604); Adverse Event Without Identified Device or Use Problem (2993); Pumping Problem (3016)
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Patient Problems
Sepsis (2067); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 12/18/2020 |
Event Type
Death
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Event Description
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It was reported that post implant the patient had a pulmonary infection with increasing infection parameters.A computed tomography (ct) scan confirmed inflammatory lung changes in the lower lobes.The patient was started on oral and intravenous medication and condition improved initially.A second ct scan revealed respiratory condition worsening with increasing inflammatory parameters along with sepsis and multiple organ failure.It was further noted that the patient had severe right heart failure was hemodynamically unstable, and respiratory insufficient.The patient¿s condition deteriorated significantly and subsequently died.
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Manufacturer Narrative
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This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: the ventricular assist device (vad) (b)(4) was not returned for evaluation.This complaint is associated with a clinical adverse event.Review of the sterility certificate confirmed that the associated device met all requirements for release.Information received from the site indicated that post implant the patient had a pulmonary infection with increasing infection parameters.A computed tomography (ct) scan confirmed inflammatory lung changes in the lower lobes.The patient was started on oral and intravenous medication and condition improved initially.A second ct scan revealed respiratory condition worsening with increasing inflammatory parameters along with sepsis and multiple organ failure.It was further noted that the patient had severe right heart failure was hemodynamically unstable, and respiratory insufficient.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, infection, respiratory dysfunction and right ventricular failure are known potential complications associated with the implantation of a vad.There was no evidence the patient had a history of similar adverse events.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 an tiplatelet 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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was further reported that the ventricular assist device (vad) had multiple suction alarms and a low flow alarm.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information to: b1: adv evnt/prod prob b5: desc evt problem h2: device codes (fdd/annex a) additional codes: img (annex g) component.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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