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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

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THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Back to Search Results
Model Number 106524
Device Problem Partial Blockage (1065)
Patient Problems Death (1802); Thrombus (2101)
Event Date 04/25/2018
Event Type  Injury  
Manufacturer Narrative
Approximate age of device - 1 year, 6 months. No further information was provided. A supplemental report will be submitted when the manufacturer's investigation is completed.
 
Event Description
It was reported that on (b)(6) 2018 it was reported that the patient presented in clinic with a recent history of shortness of breath, a 1 liter decrease in flows and heart failure symptoms with elevated pressures on right heart catheterization. A computerized tomography that revealed a chronic thrombus in proximal aspect of outflow cannula. The thrombus was focal as well as circumferential and was narrowing the lumen up to approximately 50%. It was reported that on (b)(6) 2018, the patient expired. No additional information was provided.
 
Manufacturer Narrative
A 3rd system controller event log from after the outflow revision was submitted which captured the reported pump flow increase from the 2 lpm range to the 4-5 lpm range. Following the increase, the device appeared to be operating as expected. The patient remains ongoing on vad support. No product available for investigation. The surgical procedures section contains information on "preparing the sealed outflow graft. " the attaching the sealed outflow graft to the pump section instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight. The "de-airing the pump" section explains that when de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring. This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may to serious adverse events such as low left ventricular assist device flow and/or bleeding. The system monitor section describes the pump flow display and the hazard alarms. The ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2. 5 lpm and explains that changes in patient conditions can result in low flow. The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm. A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications. The manufacturer is closing the file on this event.
 
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Brand NameHEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
Type of DeviceLEFT VENTRICULAR ASSIST SYSTEM
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
MDR Report Key7546927
MDR Text Key109354194
Report Number2916596-2018-02118
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Recall
Type of Report Initial,Followup,Followup
Report Date 11/20/2018
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 Date12/31/2018
Device Model Number106524
Device Catalogue Number106524
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received11/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-1774-2018

Patient Treatment Data
Date Received: 05/25/2018 Patient Sequence Number: 1
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