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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 106524INT
Device Problems Mechanical Problem (1384); Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/27/2022
Event Type  Death  
Manufacturer Narrative
(b)(4). No further information was provided. A supplemental report will be submitted once the manufacturer's investigation is complete.
 
Event Description
It was reported that recently implanted patient required a high level of vasopressor therapy and temporary device support following their left ventricular assist device (lvad) implant. The patient later experienced a severe bowel ischemia that developed into multi-system organ failure and subsequently passed away on (b)(6) 2022. The site suspected the death was related to a combination of vasoconstrictive therapy and a small thrombus formation caused by the explant of the temporary device, as part of the thrombus was seen on the pig tail of the device catheter. The patient's death was not device or therapy related and the device operated as expected.
 
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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 Key14877531
MDR Text Key295069720
Report Number2916596-2022-12015
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeGM
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 07/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number106524INT
Device Lot Number8427106
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 Manufactured04/12/2022
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: 06/30/2022 Patient Sequence Number: 1
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