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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

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA Back to Search Results
Model Number 106015
Device Problems Partial Blockage (1065); Material Frayed (1262); Power Problem (3010)
Patient Problems Death (1802); Right Ventricular Failure (2055); Thrombus (2101)
Event Date 04/25/2018
Event Type  Death  
Manufacturer Narrative
Approximate age of device - 1 year, 2 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 a left ventricular assist device (lvad) on (b)(6) 2015. It was reported that the patient was admitted to the hospital with elevated lactate dehydrogenase (ldh). Additionally, on (b)(6) 2018, it was reported that the patient¿s ldh elevated during his hospitalization and was started on bivalirudin. On (b)(6) 2018, the patient passed away due to a suspected clot. The patient also had severe right sided heart failure and had renal failure that required dialysis for at least the last year. It was reported that the patient had a long history of non-compliance with medications, diet, and fluid restrictions.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system and the reported event could not conclusively be established through this evaluation. The report of the damage on the outer jacket of the driveline could not be confirmed through this evaluation. The log file contained data from (b)(6) 2018 to (b)(6) 2018. The file captured seven no external power events between (b)(6) 2018 at 02:31 to (b)(6) 2018 at 14:34. However, the pump continued to operate on controller¿s backup battery per design and vad support was not interrupted during these events. The pump remained above the low speed limit and the pump appeared to function as intended. Heartmate ii left ventricular assist system was not returned to abbott for analysis. The heartmate ii left ventricular assist system instruction for use lists device thrombosis, right heart failure and renal failure as adverse events that may be associated with the use of the heartmate ii left ventricular assists system and outlines the recommended anticoagulation therapy and inr range. This document also outlines indications of pump thrombosis, as well as how to respond to such events. The heartmate ii left ventricular assist system instruction for use and patient handbook contain sections on ¿caring for the driveline,¿ and explain that all heartmate ii lvad drivelines have the potential for breakdown to occur dependent upon length of use and patient handling.
 
Manufacturer Narrative
Correction to initial report. Approximate age of device - 3 years, 2 months. Manufacturer's aware date was inadvertently omitted from supplemental report follow-up # 1. The correct date was oct 12, 2018.
 
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Brand NameHEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
Type of DeviceLEFT VENTRICULAR ASSIST SYSTEM
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 Key7546923
MDR Text Key109351196
Report Number2916596-2018-02142
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 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Model Number106015
Device Catalogue Number106015
Other Device ID Number00813024011224
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 Received01/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/05/2015
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: 05/25/2018 Patient Sequence Number: 1
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