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

Device Problems Increase in Suction (1604); Obstruction of Flow (2423); Pumping Problem (3016)

Patient Problems Dyspnea (1816); Hemolysis (1886); Thrombosis/Thrombus (4440); Renal Impairment (4499)

Event Date 01/31/2011

Event Type  Injury  

Event Description

A journal article was reviewed that contained information regarding the management of thrombosis using intracavitary thrombolytics.The article reports a patient who underwent ventricular assist device (vad) implantation as a bridge to transplant.Approximately five months post implant, the patient gained weight and dyspnea worsened.The patient had a subtherapeutic international normalized ratio (inr) and heparin was initiated.An admission echocardiogram revealed a midline septum, intermittently opening aortic valve, and decompressed left ventricle (lv).Right-sided heart catheterization confirmed low cardiac output and elevated filling pressures.The patient initially responded well to intravenous (iv) milrinone and diuresis.Six days later, vad flow decreased without a change in pump speed or blood pressure.Over a 24-hour period, worsening pulmonary congestion, impaired renal function, and hemolysis were observed.Logged waveform files suggested an obstructive pattern of reduced flow and increased power requirement.Maximizing pump speed did not augment flow despite an increase in power use, and the lv remained dilated, thereby confirming obstruction of pump flow.A non-contrast chest computerized tomography (ct) scan excluded outflow cannula kinking or aberrant positioning of the inflow cannula toward the septum or lv free wall.The patient was referred for intraventricular administration of thrombolytics.Ventriculography confirmed the absence of flow through the vad.Tissue plasminogen activator (tpa) was administered and after 37 minutes, lv pressure spontaneously reduced to, and vad flow improved.Over a 12-hour period, urine output increased and triggered suction events requiring fluid resuscitation and a reduction in pump speed.Decompression of the lv was confirmed with echocardiography.Three weeks later, the patient underwent successful orthotopic heart transplantation.After explant, the impeller showed no evidence of chronic thrombus.The status/disposition of the vad is unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.The event only occurred with one patient but specific details on the patient were not provided.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: management of heartware left ventricular assist device thrombosis using intracavitary thrombolytics.The journal of thoracic and cardiovascular surgery.2011;142:712-4.Doi:10.1016/j.Jtcvs.2010.11.022.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.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: one (1) pump with unknown serial number was not returned for evaluation.Log file analysis could not be performed since log files covering the reported event date were not available for analysis.As a result the reported event could not be confirmed due to insufficient evidence.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the 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, inappropriate pump rotational speed.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 (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15495858
• MDR Text Key: 300708402
• Report Number: 3007042319-2022-07839
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male