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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HEARTWARE INC. HVAD PUMP IMPLANT KIT VENTRICULAR (ASSIST) BYPASS

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HEARTWARE INC. HVAD PUMP IMPLANT KIT VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 1103
Device Problems Obstruction of Flow (2423); Material Deformation (2976); Mechanics Altered (2984); Scratched Material (3020)
Patient Problems Stroke/CVA (1770); Cognitive Changes (2551); Convulsion/Seizure (4406); Heart Failure/Congestive Heart Failure (4446)
Event Date 12/02/2021
Event Type  Death  
Event Description
(b)(6) patient developed pump thrombus, leading to death. Detail of note: pump analysis says 'external factors' deformed the pump, causing the impeller to make contact with rear housing. Treatment summary: the patient was admitted for ventricular assist device (vad) high power and suspected thrombus. In addition, the patient was showing signs and symptoms of heart failure and their international normalized ratio (inr) was 2. 6. The patient was given 2 doses of tissue plasminogen activator (tpa) to treat the thrombus. After the tpa treatment, the patient experienced changes in mental status and a hemorrhagic stroke. The patient continued to decline neurologically, and an electroencephalogram (eeg) showed continuous seizing. The decision was made to withdraw care and the patient subsequently passed away. Device analysis: analysis of the pump revealed the device did not pass visual inspection or dimensional verification. Visual examination revealed abrasions on the lower housing ceramic surface and on the inferior surface of the impeller. These mechanical abrasions of the lower housing ceramic surface and matching surface of the impeller are indicative that an external factor may have forced the impeller against the rear housing which led to scoring marks observed during visual inspection. Dimensional verification revealed the front and rear housing disc curvatures were found to be deviating from specifications.
 
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Brand NameHVAD PUMP IMPLANT KIT
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
HEARTWARE INC.
8200 coral sea street ne
mvs46
moundsview MN 55112
MDR Report Key15093562
MDR Text Key296487813
Report Number15093562
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number1103
Device Catalogue Number1103
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/18/2022
Device Age4 YR
Event Location Hospital
Date Report to Manufacturer07/25/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 07/25/2022 Patient Sequence Number: 1
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