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| Model Number 1103 |
| Device Problems
Pumping Stopped (1503); Device Issue (2379); Obstruction of Flow (2423); Material Integrity Problem (2978); Pumping Problem (3016)
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| Patient Problems
Death (1802); Hemolysis (1886); Intracranial Hemorrhage (1891); High Blood Pressure/ Hypertension (1908); Neurological Deficit/Dysfunction (1982); Renal Failure (2041); Thrombus (2101); Confusion/ Disorientation (2553); Hematuria (2558); Lactate Dehydrogenase Increased (4567)
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| Event Date 04/19/2017 |
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Event Type
Death
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Manufacturer Narrative
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Other devices involved in this event: con096331 - controller / catalog number 1403us / expiration date: 08/31/2015.Udi #: unk.(b)(4).The 1001883426 - outflow graft / catalog number 1125 / expiration date: 04/30/2019.Udi #: unk.(b)(4).Unk-battery - battery / catalog number 1650 / expiration date: unk.Udi #: unk.(b)(4).Unk-battery - battery / catalog number 1650 / expiration date: unk.Udi #: unk.(b)(4).The ventricular assist system is indicated for use as a bridge to cardiac transplantation 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.The hvad controller is a microprocessor unit that controls and manages the hvad system operation.It sends power and operating signals to the blood pump and collects information from the pump.The controller's internal, non-replaceable, rechargeable battery is used to power an audible "no power" alarm when both power sources are disconnected.The hvad controller requires two power sources for safe operation: either two batteries, or one battery and an ac adapter or dc adapter.The instructions for use (ifu) provides guidance regarding controller visual and auditory alarms.The "no power" alarm provides a loud continuous auditory alarm that users are unable to mute.The ifu explains that this critical alarm indicates that the controller is not providing power to the pump and that the pump has stopped.They are instructed that potential actions to resolve the issue include connecting two new power sources, exchanging the controller and contacting clinical support.Thrombus is a potential event that may be associated with use of the product.The instructions for use (ifu) and patient manual provide guidelines on proper usage of the hvad system and programming hvad pump parameters.Moreover, the ifu provides instruction to further educate the patient about product safety, alarm management, and anticoagulation recommendations.The instructions for use (ifu) addresses guidelines for optimal patient management including having adequate and stable preload available.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
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Event Description
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It was reported that, on (b)(6) 2017, the patient presented to the emergency department with possible power issues.Patient appeared to be "confused" - oriented to person and place but not time during the conversation. the patient was transported to a different hospital with advanced life support. log files were sent which reported four controller power-up and associated pump start events logged since (b)(6) 2017, indicating a loss of power to the controller. on (b)(6) 2017, they noted head computerized tomography (ct) read with concern for possible subarachnoid hemorrhage (sah) with their altered mental status.Suspected pump thrombosis in the setting of elevated lactate dehydrogenase (ldh) to 689 and plasma free hemoglobin (hgb), dark colored urine; pulsatility present on exam, intermittent vad hum present on auscultation and subtherapeutic international normalized ratio (inr) of 1.7.Heparin drip started with possible gout glare, acute kidney injury, and benign prostatic hypertrophy. on (b)(6) 2017, their ldh was 2500; gout appeared to be improved after anakinra yesterday.On (b)(6) 2017, hemolysis markers gradually improving, continued medications: amlodipine, carvedilol, hydralazine, half-dose clonidine. stable on serial head cts -therapeutic anticoagulation cleared per neurology on (b)(6) 2017, pump power decreasing on heparin drip. however, ldh was up to 1385 and 1717 on (b)(6) 2017. coke colored urine indicative of worsening hemolysis. discontinuation of lvad and outflow graft occlusion. peripherally inserted central catheter (picc) placement today in anticipation of dobutamine. on (b)(6) 2017, outflow graft angioplasty, lvad outflow graft occlusion, and vascular closure device deployment. a device exchange was performed. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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(additional information received)- it was reported from the clinical study site that the log file report with notable ventricular assist device (vad) stops and restarts.On (b)(6) 2017 it was stated that the patient hypertension (htn) resolved.It was further stated that dobutamine 2.5 mcg/kg/hr and the discontinuation of carvedilol was done before vad occlusion.It was stated that altered mental status with known mild cognitive dysfunction with superimposed subarachnoid hemorrhage (sah) was improving back to baseline.Liver function test (lft) elevation.Elevated in the setting of pump thrombosis and hemolysis, right upper quadrant (ruq) ultrasound negative, improved and stable.Atrial fibrillation doesn't appear to be documented on prior electrocardiograms (ekgs), but is normally atrial ventricular (av) paced as well, likely in context of hemolysis, stress, and suspected pump thrombosis.The patient died on (b)(6) 2017.No additional information available.Correction:it was reported by the clinical study site that the patient died on (b)(6) 2017.No additional information available.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
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Manufacturer Narrative
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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 driveline was cut.
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Manufacturer Narrative
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It was reported by the clinical study site that the device not removed but turned off.No additional information available.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
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Manufacturer Narrative
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This event was reassessed and is being updated as part of a retrospective review of events in response to an update to the mdr compl aint sources.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product event summary: (b)(4), outflow graft # (b)(4) and two batteries with unknown serial numbers were not returned for evaluation.Review of the manufacturing documentation confirmed that the associated pump, outflow graft and controller met all requirements for release.Review of the manufacturing documentation of the two batteries could not be performed due to serial number being unknown.The reported events of loss of power and high power were confirmed via log analysis which revealed 4 controller power-up and associated pump start events logged on (b)(4) since (b)(6) 2017, indicating a loss of power to the controller.Nine critical battery alarms have been logged since (b)(6) 2017 on (b)(4).These alarms occurred because the patient allowed the batteries to drain below 10% relative state of charge (rsoc).The patient likely reacted to these alarms and in an attempt to change power sources, accidentally disconnected both the power sources from the controller which led to the loss of power events.There was an increase in power consumption starting (b)(6) 2017 to parameters above the normal operating range.Eight suction alarms have been logged since april 25, 2017.One high watt alarm was logged on april 26, 2017 at 18:43:45.Of note, it was reported that the patient was treated with heparin following which the pump power decreased.It was reported that an angioplasty revealed outflow graft occlusion.Additional information received indicated that the driveline was cut; however, this event could not be confirmed since the device was not returned and no supporting evidence was provided.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the investigation conducted, the most likely root cause of the loss of power events may be attributed to disconnection of both the power sources from the controller.Based on historical review of similar high power events, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.The most likely root cause of the suction alarms may be attributed to factors such as inflow cannula thrombus (occlusion).It is likely that thrombus got ingested into the pump triggering an increase in power.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.Additional products: outflow graft/(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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It was reported by the clinical study site that the patient died on (b)(6) 2017.No additional information available.Labeling to be added: the implantation of a vad is an invasive procedure requiring general anesthesia, median sternotomy, a ventilator and cardiopulmonary bypass.A user must fully consider the risks of this device with that of other treatment modalities before deciding to proceed with device implantation.These surgical procedures are associated with numerous risks.Death and neurological dysfunction, renal dysfunction are known potential adverse event associated with the implantation of all vads as outlined in the instructions for use.After further review of additional information received sections have been updated accordingly.Heartware will submit a supplemental report when new facts arises which materially alters information submitted in a previous mdr report.
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Manufacturer Narrative
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Other devices involved in this event: controller / (b)(4).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 an update to the investigation completion.Product event summary: the pump ((b)(4)), an associated outflow graft (lot no.1001883426), one controller ((b)(4) ) and two batteries ((b)(4) and (b)(4) were not returned for evaluation.The reported loss of power, vad stops and high-power events were confirmed via log analysis which revealed four (4) controller power-up and associated motor start events logged on (b)(4), indicating a loss of power to the controller on (b)(6) 2017 at 22:18:38, on (b)(6) 2017 at 08:03:52, on (b)(6) 2021 at 23:45:31 and 23:46:47.The maximum time the controller was without power was 13 minutes 27 seconds on the first loss of power, 11 minutes 8 seconds on the second loss of power and 8 minutes 3 seconds on the third and fourth loss of power.Alarm log files revealed nine (9) critical battery alarms that have been logged since (b)(6) 2017 at 22:08:31 involving (b)(4) and (b)(4).These alarms occurred because the patient allowed the connected batteries to drain below 10% relative state of charge (rsoc) and attempted to use batteries with rsoc below 10%.Additionally, review of log files revealed an increase in power consumption starting
(b)(6) 2017 to parameters above the normal operating range.Eight (8) suction alarms have been logged since (b)(6) 2017 at 05:42:05 and one (1) high watt alarm was logged on (b)(6) 2017 at 18:43:45.The reported thrombus event could not be confirmed due to insufficient evidence.Of note, it was reported that the patient was treated with heparin following which the pump power decreased.It was reported that an angioplasty revealed outflow graft occlusion.Additional information received indicated that the driveline was cut; however, this event could not be confirmed since the device was not returned and no supporting evidence was provided.Based on the available information, the device may have caused or contributed to the reported event.Information received from the site revealed that the patient was presented to the site and appeared to be confused.A computerized head tomography (ct) revealed a possible subarachnoid hemorrhage (sah) with altered mental status.The patient was suspected of device thrombus and had plasma free hemoglobin (hgb), dark colored urine.The patient was started on heparin drip with possible gout glare, acute kidney injury, and benign prostatic hypertrophy.The patient displayed improvements on hemolysis after receiving medication.According to the neurologist the patient had stable head ct after therapeutic anticoagulation.It was stated that the patient hypertension resolved.An outflow graft angioplasty was performed.Later, the patient expired, and the cause of death was due to subarachnoid hemorrhage (sah) and pump thrombosis.Based on the available information, the device may have caused or contributed to the reported event.A possible root cause of the losses of power and vad stop can be attributed to a disconnection of both power sources and/or to an intermittent disconnection on one or both power sources.Capa pr(b)(4) is investigating controller losses of power.The most likely root cause of the critical battery alarms can be attributed to the patient allowing the batteries to deplete below 10% or the patient attempting to connect batteries with rsoc below 10%.Based on historical review of similar high power events, the most likely root cause of the high power event can be attributed to external factors such as thrombus formation/ingestion.Based on the risk documentation, possible causes of the reported suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft.Per the instructions for use, hemolysis, hypertension, renal dysfunction, device thrombus, neurological dysfunction, hypertension, and death are known potential complications associated with the implantation of an vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of hypertension.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.Additional products: heartware ventricular assist system ¿ outflow graft lot#: 1001883426.Heartware ventricular assist system ¿ controller 1.0 serial#: (b)(4).Heartware ventricular assist system ¿ battery serial#: (b)(4) heartware ventricular assist system ¿ battery serial#: (b)(4).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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Manufacturer Narrative
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Additional products: 1650/ bat114926, expiration date: 31-aug-2015, mfg date: 31-aug-2013 1650/ bat114887, expiration date: 31-aug-2015.Mfg date: 31-aug-2013.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 cause of death was due to subarachnoid hemorrhage (sah) and pump thrombosis.The cause of death was collected during a review of patient records with the healthcare facility.
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Manufacturer Narrative
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A supplemental report is being submitted for additional information and correction.Correction h4: mfg date was added.Correction h6: patient ime code(s) were updated.Additional products: d1: heartware ventricular assist system ¿ outflow graft / d4: model #: 1125 / lot#: 1001883426 / udi #: (b)(4) / h4: mfg date: 30-apr-2014 / h6: patient ime code(s): e010701, e0118, e0303, e1302, e2204, e2320 h6: imf code(s): f08, f2203, f2303 / d1: heartware ventricular assist system ¿ controller 1.0 / d4: model #: 1403 / serial#: (b)(6) / udi #: (b)(4) / h4: mfg date: 31-aug-2013 / h6: patient ime code(s): e010701, e0118, e0303, e1302, e2204, e2320 h6: imf code(s): f08, f2203, f2303 / d1: heartware ventricular assist system ¿ battery / d4: model #: 1650 / serial#: (b)(6) / h6: patient ime code(s): e010701, e0118, e0303, e1302, e2204, e2320 h6: imf code(s): f08, f2203, f2303 / d1: heartware ventricular assist system ¿ battery/ d4: model #: 1650 / serial#: (b)(6) / h6: patient ime code(s): e010701, e0118, e0303, e1302, e2204, e2320 h6: imf code(s): f08, f2203, f2303.Investigation of this event is pending and a supplemental report will be sent upon its completion.The cause of death was collected during a review of patient records with the healthcare facility.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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Search Alerts/Recalls
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