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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA VENTRICULAR (ASSISST) BYPASS Back to Search Results
Catalog Number 106015
Device Problems Partial Blockage (1065); Material Twisted/Bent (2981)
Patient Problems Thrombus (2101); Heart Failure (2206)
Event Date 05/02/2018
Event Type  Injury  
Manufacturer Narrative
Approximate age of device - 2 years, 11 months. No further information was provided. A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
The patient was implanted with left ventricular assist device (lvad) on (b)(6) 2015. It was reported that patient was hospitalized with symptoms of heart failure (hf). Evaluation indicated a potential outflow graft obstruction or twist. Patient subsequently underwent pump exchange on (b)(6) 2018. A thrombus was observed inside the outflow graft. Additional information was requested but not yet provided.
 
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Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
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 95488
7818528390
MDR Report Key7577438
MDR Text Key110333500
Report Number2916596-2018-02341
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 company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date12/31/2017
Device Catalogue Number106015
Other Device ID Number813024011224(2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/07/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2015
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: 06/07/2018 Patient Sequence Number: 1
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