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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524INT
Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)
Patient Problems Septic Shock (2068); Cardiogenic Shock (2262); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Event Date 08/20/2021
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 had a computed tomography (ct) scan that revealed a thrombus on the outflow graft. On (b)(6) 2021 a surgical procedure to correct the thrombus was performed. The driveline was cut by accident during the surgery. The patient was stable during surgery so the surgical team decided to explant the pump and observe how the patient recovers. Following the driveline cut the patient started to have cardiogenic shock and right ventricular failure. The clinical team decided to implant a biventricular centrimag.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
Type of DeviceVENTRICULAR (ASSISST) 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 Key12536717
MDR Text Key273540999
Report Number2916596-2021-05025
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2021
Device Model Number106524INT
Device Lot Number6661793
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2018
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: 09/27/2021 Patient Sequence Number: 1
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