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U.S. Department of Health and Human Services

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

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HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS Back to Search Results
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.
 
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Brand NameHEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Type of DeviceVENTRICULAR (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 Key12759733
MDR Text Key284388109
Report Number3007042319-2021-07916
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00888707003261
UDI-Public00888707003261
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100047
Number of Events Reported1
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 Received11/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2021
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/04/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/07/2021 Patient Sequence Number: 1
Treatment
DDMB1D4 ICD, 6935M55 LEAD, 407645 LEAD.
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