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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Right Ventricular Dysfunction (2054); Thrombosis (2100); Tricuspid Regurgitation (2112)
Event Date 03/05/2018
Event Type  Injury  
Manufacturer Narrative
The heartmate 3 left ventricular assist system (lvas) was implanted during the (b)(6) clinical trial, ide# (b)(4). Fda approval for heartmate 3 lvas was received on 23aug2017. The gtin unique device identifier for the commercial heartmate 3 lvas is (b)(4). No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
Event details: the patient was implanted with lvad on (b)(6) 2018. Postoperatively, the patient had moderate right ventricular (rv) dysfunction and was placed on high dose inotropes. Post-implant echocardiogram revealed severe tricuspid regurgitation (tr). Post op course complicated by significant bleeding, the chest tube output was over 1500 ml. The patient required blood transfusion. On (b)(6) 2018, the patient underwent mediastinal re-exploration for bleeding/thrombosis and tricuspid valve repair. The patient had leukocytosis and was treated with vancomycin and cefepime for open chest prophylaxis. Pan cultures obtained and all came back negative on (b)(6) 2020. No further information was reported.
 
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Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
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 Key10528804
MDR Text Key206781972
Report Number2916596-2020-04592
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,study
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Model Number106524
Device Lot Number6252687
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/03/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/22/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Invalid Data

Patient Treatment Data
Date Received: 09/14/2020 Patient Sequence Number: 1
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