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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Right Ventricular Dysfunction (2054)
Event Date 02/18/2020
Event Type  Injury  
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported per the ventricular assist device (vad) coordinator, the patient underwent heart transplant. On (b)(6) 2020 patient with right ventricular (rv) dysfunction. Heart list changed to status 2. The device will not be returned for evaluation.
 
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Brand NameHEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Type of DeviceVENTRICULAR (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
Manufacturer Contact
bob fryc
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key9831707
MDR Text Key183343869
Report Number2916596-2020-01253
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011224
UDI-Public00813024011224
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
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2020
Device Model Number106015
Device Catalogue Number106015
Device Lot Number6128604
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 Received06/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/21/2017
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: 03/13/2020 Patient Sequence Number: 1
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