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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 Failure to Align (2522); Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Heart Failure/Congestive Heart Failure (4446)
Event Date 04/28/2022
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 was taken back to the or (operating room) due to inflow cannula position pointed towards the septum, which was diagnosed by x-ray. The clinician observed the surgeon place sutures around the outflow bend relief and tact to diaphragm, as well as a suture in the bend relief and tack to chest wall. The clinician observed the or team utilizing echo (echocardiogram) for optimization of inflow position. The cannula was observed to be parallel with the septum in the left ventricle. The chest was closed and the patient was transferred to the intensive care unit (icu). The pump components operated as intended. It was reported on (b)(6) 2022 that the patient was improving, extubated, with stable flows. A right ventricular assist device (rvad) was implanted due to post operative rv (right ventricle) failure. The rvad was a maquet pump and circuit without an oxygenator. On (b)(6) 2022 it was reported that the patient's right heart failure improved after support, with echo showing normal values. It was also reported that the patient's rvad was discontinued the previous day due to recovery.
 
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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 Key14455413
MDR Text Key292171423
Report Number2916596-2022-10746
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
Type of Report Initial,Followup
Report Date 07/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number8341062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2022
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: 05/20/2022 Patient Sequence Number: 1
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