HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT; VENTRICULAR (ASSISST) BYPASS
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Device Problem
Obstruction of Flow (2423)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one-to-one correlation could not be made with unique product serial/lot numbers.The baseline age characteristics is 63 years old.The model listed in the report is a representative of the model family, as there is no specific model listed.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: providing end-of-life care for patients with left ventricular assist devices: experience of a hospice agency.Journal of pain and symptom management.May 2021.Vol.61 no.5.891-897.Doi.Org/10.1016/j.Jpainsymman.2020.10.003 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 that contained information regarding hospice experience with left ventricular assist device (vad) implanted patients.The article reports patients that were enrolled in hospice care that were implanted with a vad.The patients were all multimorbid as moderate or severe and receiving oxygen, warfarin, and aspirin.There was one patient who experienced an outflow graft obstruction.The status/disposition of the vad is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.
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Manufacturer Narrative
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A supplemental report is being submitted for investigation completion.Product event summary: one (1) outflow graft with unknown lot number was not returned for evaluation.Review of the controller log files could not be performed since log files were not available for analysis.The reported outflow graft obstruction event could not be confirmed due to insufficient evidence.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.
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