HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSISST) BYPASS
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Model Number 1103 |
Device Problems
Obstruction of Flow (2423); Pumping Problem (3016)
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Patient Problems
Stroke/CVA (1770); Brain Injury (2219); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
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Event Date 01/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Investigation of this event is pending and a supplemental report will be sent upon its completion.
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Event Description
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It was reported that the patient was hospitalized for two months due to the ventricular assist device (vad) being "bad".The patient received a heart transplant, and following the transplant was reported by the patient's sibling to have blood clots and brain damage.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: (b)(6) was not returned for evaluation.Review of the controller log files was not performed since log files were not available for analysis.There is insufficient information regarding the ventricular assist device (vad) being "bad" event.As a result, the reported "ventricular assist device (vad) being "bad" event could not be confirmed.Information received from the site indicated that the patient received a heart transplant, and following the transplant was reported by the patient's sibling to have blood clots and brain damage.Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, neurological dysfunction is a known potential complication associated with the implantation of a vad.There was no evidence that 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 antiplatelet medications and the patient's complex post-operative cour se.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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Manufacturer Narrative
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A supplemental report is being submitted for additional event details and event date.Investigation of this event is pending and a supplemental report will be sent upon its completion.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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Event Description
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It was further reported that the patient had several cerebrovascular accident (cva).
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Manufacturer Narrative
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A supplemental report is being submitted for an updated investigation completion.A2 age at event was corrected from 49 to 48 ye ars.Product event summary: (b)(6) was not returned for evaluation.Review of the controller log files was not performed since log files were not available for analysis.There is insufficient information regarding the ventricular assist device (vad) being "bad" event.As a result, the reported "ventricular assist device (vad) being "bad" event could not be confirmed.Information received from the site indicated that the patient received a heart transplant, and following the transplant was reported by the patient's sibling to have blood clots and brain damage.It was further reported that the patient had several cerebrovascular accident (cva).Based on the available information, the device may have caused or contributed to the reported event.Per the instructions for use, neurological dysfunction is a known potential complication associated with the implantation of a vad.There was no evidence that 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 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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