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

Model Number 1103

Device Problems Increase in Suction (1604); Pumping Problem (3016)

Patient Problems Anemia (1706); Stroke/CVA (1770); Fatigue (1849); Intracranial Hemorrhage (1891); Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Muscle Weakness (1967); Pulmonary Dysfunction (2019); Shock (2072); Dysphasia (2195); Hypovolemia (2243); Respiratory Failure (2484); Hematuria (2558); Unspecified Nervous System Problem (4426); Unspecified Mental, Emotional or Behavioural Problem (4430); Thrombosis/Thrombus (4440)

Event Date 06/11/2021

Event Type  Injury  

Event Description

It was reported that the patient presented to the emergency department with dark urine, muscle aches, and fatigue and was admitted for concern of ventricular assist device (vad) thrombus.Computed tomography angiography (cta) did not reveal a vad thrombus and symptoms were attributed to a supratherapeutic international normalized ratio (inr).Two days after admission, the patient was found to have acute neurological changes including altered mental status, non-verbal, and left arm weakness.The patient was sent for a cta and during imaging the patient experienced acute hypoxic hypercapnic respiratory failure requiring emergent intubation.During intubation, the vad exhibited a suction event.Vad speeds were reduced and the patient received intravenous fluids and epinephrine.Vad speeds were able to be increased and the patient was taken for a right middle cerebral artery thrombectomy.Following the procedure, the patient was in significant distributive shock requiring multiple vasopressors and dobutamine, which were successfully weaned six days later.Midodrine support was required for an additional seven days.The vad remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

2021-11-10: it was further reported that in the course of the prolonged hospitalization from (b)(6) 2021, the ventricular assist device (vad) patient had persistent hypercapnia and hypoxemic respiratory distress with tracheostomy placement and percutaneous endoscopic gastrostomy (peg) tube placement.Several interventions including bronchoscopy for thick secretions, steriod administration, and multiple antibiotics were given due to respiratory failure issues.The patient was diagnosed with new onset pulmonary hypertension via right heart catheterization and started on sildenafil, which was later held due to hypotension and never resumed.Hypovolemia and hypotension were an issue intermittently throughout the hospital coursethought to be due to maintenance diuretics, heart failure maintenance medications and other medications with sedative effects given throughout the hospitalization.The patient also had anemia requiring five (5) units of packed red cells over a three (3) week timespan which was thought to be dilutional anemia as bleeding workup was unremarkable.Toward the end of the hospitalization and prior to transfer to a long term care facility (ltc), the patient required a bronchoscopy for thick secretions and prior to the procedure experienced acute hemodynamic collapse with t ransient vad speed reduction, vasopressor support required and procedure abortion.Following decompensation an acute right sided weakness was noted and computerized tomography (ct) scan demonstrated a small subarachnoid hemorrhage which was treated with antiseizure medications.The patient was discharged to a ltc facility on anticoagulants, which had been given throughout the course of the hospital stay despite neurological events, in stable condition.

Manufacturer Narrative

A supplemental report is being submitted for additional event details.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: the ventricular assist device (vad) was not returned for evaluation.Log file analysis was not performed since log files were not available for analysis.As a result, the reported low flow and suction events could not be confirmed.Information provided by the site indicated that the patient presented with dark urine, muscle aches, and fatigue and was admitted for concern of thrombus; however, computed tomography angiography did not reveal a thrombus and symptoms were attributed to a supratherapeutic international normalized ratio (inr).Two days later, the patient was found to have acute neurological changes including altered mental status, non-verbal, and left arm weakness, followed by acute hypoxic hypercapnic respiratory failure requiring emergent intubation.A right middle cerebral artery thrombectomy was performed, after which the patient was in significant distributive shock requiring multiple vasopressors and dobutamine.During the patient¿s prolonged hospitalization, the patient had persistent hypercapnia and hypoxemic respiratory distress with tracheostomy placement and percutaneous endoscopic gastrostomy (peg) tube placement.Several interventions including bronchoscopy for thick secretions, steroid administration, and multiple antibiotics were given due to respiratory failure issues.The patient was diagnosed with new onset pulmonary hypertension via right heart catheterization.Hypovolemia and hypotension were an issue intermittently throughout the hospital course.The patient also had anemia, requiring several blood transfusions.Following decompensation an acute right sided weakness was noted and computerized tomography scan demonstrated a small subarachnoid hemorrhage which was treated with antiseizure medications.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 reported suction and low flow events 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.Per the instructions for use, neurological dysfunction, respiratory dysfunction, and thrombus 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.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: 12759733
• MDR Text Key: 284388109
• Report Number: 3007042319-2021-07916
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2021
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2021
• Date Device Manufactured: 06/04/2019
• 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
• Treatment: DDMB1D4 ICD, 6935M55 LEAD, 407645 LEAD
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female