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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 107801
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Septic Shock (2068); Hemorrhagic Stroke (4417); Skin Infection (4544)
Event Date 05/22/2021
Event Type  Death  
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 methicillin-resistant staphylococcus aureus (mrsa) and recurrent pseudomonas infection of the driveline exit site and chest wall as well as multiple drug-resistant organism pseudomonas bacteremia. The patient had an acute mental status change. A subdural hemorrhage and right frontal lobe intraparenchymal hemorrhage were noted. The patient developed pseudomonas septicemia with increased purulent drainage. Blood cultures taken on (b)(6) 2021 were positive for gram negative rod pseudomonas. The patient developed lactic acidosis on (b)(6) 2021. They had a supratherapeutic international normalized ratio (inr) status post vitamin k and hypotension likely related to sepsis. The patient passed away on (b)(6) 2021.
 
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Brand NameHEARTMATE II 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 Key15106423
MDR Text Key296621214
Report Number2916596-2022-12253
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/26/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/27/2022
Device Model Number107801
Device Catalogue Number107801
Device Lot Number7243375
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/25/2019
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: 07/26/2022 Patient Sequence Number: 1
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