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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 106524
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Obstruction/Occlusion (2422); Thromboembolism (2654); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577)
Event Date 06/09/2022
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted once the manufacturer¿s investigation is complete.
 
Event Description
It was reported that the patient had an auxiliary balloon pump placed on (b)(6) 2022 pre left ventricular assist device (lvad) implant on (b)(6) 2022. The patient's hemoglobin reportedly dropped and they were given 1 unit of packed red blood cells (pcrbs). On (b)(6) 2022 it was reported that the patient had venous thromboembolism revealed by ultrasound. The patient had a swollen right arm and the picc was discontinued on the right side and was moved to the left. Heparin and coumadin doses were increased. It was reported on (b)(6) 2022 that the patient was pre-op for acute blood loss anemia as well as venous thromboembolism. It was also reported that the patient continued to be supported on inotropes mere than 7 days post-op. The plan was to start slowly weaning the patient off.
 
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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 Key14882302
MDR Text Key295112289
Report Number2916596-2022-11849
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 Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number106524
Device Lot Number8465251
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2022
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: 07/01/2022 Patient Sequence Number: 1
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