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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); Kinked (1339); Device Stops Intermittently (1599)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/17/2018
Event Type  Injury  
Manufacturer Narrative
Approximate age of device- 2 years and 3 months. The patient remains ongoing with the lvad device. 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) 2016. It was reported that the patient presented to the emergency room due to persistent low flow alarms which occurs while connected to battery and on the mobile power unit (mpu). The manufacturer¿s technical services representative reviewed the submitted log file and reported 232 low flow events observed. Within the log file there were also 2 pump stops and 3 low speed operations taking place on (b)(6) 2018 at 9:05, (b)(6) 2018 at 9:22, and (b)(6) 2018 11:12. During these events it appears the patient is on the power module. On (b)(6) 2018, the patient underwent an outflow graft replacement. Yellow, fibrous material was found between graft and bend relief, kink found at aortic anastamosis. Graft replaced via sternotomy and the patient¿s chest was closed. No additional information was provided.
 
Manufacturer Narrative
The report of low flow alarms was confirmed based on review of the submitted log file; however, a specific cause could not be conclusively determined through this evaluation. The report of yellow, fibrous material was found between graft and bend relief, kink found at aortic anastomosis could not be confirmed. No product was returned for analysis. Images or photographs that may have been taken by the user facility during the outflow graft replacement procedure were not provided to the manufacturer for analysis. The pump remains implanted and the patient remains ongoing on vad support. The heartmate ii lvad instructions for use (ifu) explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling, explains that pump flow is estimated from pump power, and addresses assessing pump flow. This ifu also contains important warnings regarding the prevention of outflow graft kinks and twists. A review of the device history records revealed the device met applicable specifications. No further information is available. The manufacturer is closing the file on this event.
 
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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
MDR Report Key7598825
MDR Text Key110998347
Report Number2916596-2018-02448
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011224
UDI-Public00813024011224
Combination Product (y/n)N
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2018
Device Model Number106015
Device Catalogue Number106015
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/19/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
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