MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP; VENTRICULAR (ASSIST) BYPASS

Model Number 1103

Device Problems Increase in Suction (1604); Pumping Problem (3016); Noise, Audible (3273)

Patient Problems Stroke/CVA (1770); Headache (1880); Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891); Muscle Weakness (1967); Tachycardia (2095); Ventricular Tachycardia (2132); Weakness (2145); Thrombosis/Thrombus (4440)

Event Date 09/26/2020

Event Type  Injury  

Manufacturer Narrative

Additional information has been requested regarding the type of stroke 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.

Event Description

It was reported that the ventricular assist device (vad) exhibited low flows alarms and thrombus was suspected.Of note, the patient¿s rhythm had frequent ventricular tachycardia (v-tach) which resulted in frequent suction events.It was further reported that the patient had a severe headache which was increased from their usual.The patient recently had their pregabalin medication increased to improve their chronic headaches.Of note, the patient denied any recent fever, chills, nausea, vomiting diaphoresis or leg swelling.Upon admission, patient was administered tissue plasminogen activator (tpa) twice and on the second dose the patient had a stroke with symptoms of a headache and left sided weakness.The vad showed low flow of 1.5 liters per minute (lpm) and a hum with a raspy/grinder sound was heard.The patient¿s mean arterial pressure (map) was higher than usual.A head computerized tomography (ct) revealed negative for acute intraparenchymal hemorrhage, and a chest x-ray looked stable with no focal consolidations or effusions.The patient¿s complete blood count was stable but had elevated lactate dehydrogenase.It was further reported that due to concerns for pump thrombus, the patient was admitted to the intensive care unit (icu) for consideration of alteplase infusion versus pump exchange.Of note, the patient¿s urinalysis had hemoglobinuria.The patient was administered heparin bolus and high-intensity drip and had previously received normal saline and intravenous (iv) hydralazine without changes in pump flows.The patient was discharged and the vad remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for additional information and a correction.Additional information was received regarding patient symptoms and patient diagnosis.Correction b.2: outcome attributed to adverse event was updated to include life threatening.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.

Event Description

It was further reported that the patient was discharged with a therapeutic international normalized ratio (inr).The patient continued experiencing worsening headaches.Of note, the type of stroke was hemorrhagic.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the ventricular assist device (vad) was not returned for evaluation.The reported low flow/suction event was confirmed via review of the controller log files which revealed multiple decreases in power consumption beginning (b)(6) 2020, with subsequent increases to baseline parameters, and intermittent suction events observed within the analyzed period through (b)(6) 2020.24 low flow alarms were logged since (b)(6) 2020.Information received from the site indicated that a device thrombus was suspected, and the patient¿s rhythm had frequent ventricular tachycardia (v-tach).It was further reported that the patient had a severe headache.Upon admission, the patient was administered tissue plasminogen activator (tpa) twice, which corresponds with the increases in power consumption and flow observed in the logs, and on the second dose the patient had a hemorrhagic stroke with symptoms of a headache and left sided weakness, and the patient¿s mean arterial pressure (map) was higher than usual.The patient was administered heparin bolus and high-intensity drip and had previously received normal saline and intravenous (iv) hydralazine.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.Based on the risk documentation, possible causes of the reported low flow/suction event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, and/or inappropriate pump rotational speed.Based on risk documentation, the reported loud sound may have been caused by pump vibration, which may be attributed to multiple factors including but not limited to thrombus within the device leading to impeller imbalance or the placement of the pump which allows contact with fixed or rigid anatomical structure.Per the instructions for use, device thrombus, cardiac arrhythmias, and neurological dysfunction are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of neurological dysfunction 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.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10750218
• MDR Text Key: 213892418
• Report Number: 3007042319-2020-07098
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 49 YR
• Patient Weight: 87