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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106524US
Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Pneumothorax (2012); Pulmonary Edema (2020); Renal Failure (2041); Fungal Infection (2419); Respiratory Insufficiency (4462)
Event Date 04/21/2022
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient experienced bleeding during the pump implant procedure on (b)(6) 2022 that is suspected to have contributed to the development of multi-system organ failure, an aute kidney injury, and metabolic disfunction. On (b)(6) 2022 the patient required re-intubation for respiratory distress related to the metabolic dysfunction. Upon initial manual ventilation during the procedure, the patient coded and lost all flow in their left ventricular assist device (lvad) and right ventricular assist device (rvad). The patient received chest compressions. Imaging caused concern for a tension pneumothorax and bilateral chest tubes were placed. Multiple bronchoscopies showed pulmonary edema. Multiple echocardiograms confirmed the positioning of the pump in the left ventricle and the size of the patient's left ventricle was causing a flow backup into the left atrium and subsequently causing the pulmonary edema. The patient continued on lvad and rvad support as well as continuous venovenous hemofiltration (cvvh). They were sedated with 80% fraction of inspired oxygen (fio2) and on inotropic support. The patient failed to wean from ventilator support and received a tracheostomy. The patient continued to have lvad suction events and drops in flow in their rvad as they were waking up and coughing despite multiple speed changes in attempts to stop the suction events. A bronchoscopy was planned for (b)(6) 2022. The patient was not following commands or making purposeful movements, so a computed tomography (ct) scan was planned for (b)(6) 2022 to rule out ischemic injury.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
Type of DeviceVENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key14470929
MDR Text Key292387372
Report Number2916596-2022-10944
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
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 07/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/23/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number8222852
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2021
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: 05/23/2022 Patient Sequence Number: 1
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