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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
Catalog Number 106015
Device Problems Partial Blockage (1065); Infusion or Flow Problem (2964)
Patient Problems Anemia (1706); Dyspnea (1816); Pulmonary Edema (2020); Thrombus (2101); Blood Loss (2597)
Event Date 02/26/2018
Event Type  Injury  
Manufacturer Narrative
The initial submission of this event was reported by the manufacturer under mfr. Report # 2916596-2018-01056. This report is being submitted as additional information. Approximate age of device- 1 year and 11 months. Manufacturer's investigation conclusion: the pump remains in use supporting the patient. The reported outflow graft kink and thrombus formations could not be conclusively determined. The reported low flow alarms were confirmed via the submitted system controller log file. The submitted log file captured low flow alarms on (b)(6) 2018 and (b)(6) 2018 when the estimated flow was calculated to be below 2. 5lpm. A specific cause for the change in pump parameters cannot be conclusively determined. The hm ii lvas instructions for use (ifu) lists device thrombus as an adverse event that may be associated with the use of the hm ii lvas and outlines the indications of thrombus, as well as how to respond to such events. The ifu explains how to properly install/orient the sealed outflow graft and provides important warnings regarding the prevention of outflow graft twists/kinks. Information regarding all visual/audio alarms and what action(s) should be performed when they occur is also provided. Pump flow is estimated from the pump power. Pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling. A review of the device history records revealed the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2016. It was reported that the patient was admitted to the hospital overnight for increased low flow alarms when lying on the right side. The patient presented with symptoms of shortness of breath. The patient had been seen in clinic the prior day and was found to be euvolemic and was discharged home. The patient¿s lactate dehydrogenase (ldh) and inr were within normal limits. Technical services reviewed the submitted log file and low flow alarms were confirmed. Ct angiographic examination was performed including 3d reconstruction. The findings showed that there were significant stenosis of the lvad outflow graft, occurring between the outflow graft and the outflow graft bend relief. The stenosis was caused by intraluminal thrombus. Other findings were cardiomegaly, mild pulmonary edema, and mild lung peripheral fibrotic changes. The patient went to the cardiac catheterization lab on (b)(6) 2018 with attempted stenting at the lvad outflow graft. Initial stent was deployed; however, further kinking of the outflow graft occurred. Another attempt resulted in successful percutaneous stenting of the lvad outflow graft. Low flow alarms continued post-procedure, and were initially thought to be secondary to acute blood loss anemia from a right groin hematoma. The patient had lost significant blood due to groin hematomas from the procedure. Ct scan revealed a new alteration of the contour of the outflow graft, with unchanged severe stenosis. The outflow graft kink had migrated further down with residual stenosis. The patient¿s heart failure worsened. The patient received 2 units of packed red blood cells (prbc) and went to the catheterization lab again that night for additional intervention to mitigate the outflow graft stenosis. Ct angiography of the chest on (b)(6) 2018 showed interval stenting with stenosis of 50%. The stenting procedure that night was successful and the patient returned to the intensive care unit (icu) for continued management. The patient continued to do well and was stable for discharge home. No additional information was provided.
 
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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 Key7973988
MDR Text Key123980224
Report Number2916596-2018-04542
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 Other Health Care Professional
Type of Report Initial
Report Date 10/17/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2018
Device Catalogue Number106015
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 Received09/28/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/09/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/17/2018 Patient Sequence Number: 1
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