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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 104911
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Aortic Regurgitation (1716); Right Ventricular Dysfunction (2054)
Event Date 06/04/2020
Event Type  Injury  
Manufacturer Narrative
Event date estimated. Date of imaging used. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
(b)(6) 2020 echo revealed mild continuous aortic regurgitation. Right ventricular cavity size was mildly dilated with mildly decreased right ventricular systolic function. La moderately dilated. There was mild dilatation of the ascending aorta.
 
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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 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 Key10401313
MDR Text Key202710301
Report Number2916596-2020-03958
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011170
UDI-Public00813024011170
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 09/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2013
Device Model Number104911
Device Catalogue Number104911
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 Received08/31/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/23/2011
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: 08/13/2020 Patient Sequence Number: 1
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