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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE

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THORATEC CORPORATION HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Catalog Number 107801
Device Problem Partial Blockage (1065)
Patient Problem Thrombus (2101)
Event Date 01/20/2018
Event Type  Injury  
Manufacturer Narrative
Patient¿s weight was not provided. The referenced previous thrombosis was reported under medwatch mfr report #2916596-2016-02274. (b)(4). Approximate age of device ¿ 1 year and 2 months. The device was returned for investigation. The evaluation is not yet completed. 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 was admitted to the hospital on (b)(6) 2018 with complaint of dark, coca cola colored urine and an increase in pump flows and powers. At the time of the event, the patient¿s anticoagulation regimen included aspirin, plavix and coumadin for prior history of thrombosis. On admission, the patient¿s inr was 2. 5, brain natriuretic peptide (bnp) was 4803 pg/ml and lactate dehydrogenase (ldh) was unable to be read by the laboratory because it was so high. The patient was started on heparin with plan to replace the lvad. An echocardiogram performed showed inability to offload the left ventricle. The patient underwent a pump exchange on (b)(6) 2018, due to suspected device thrombosis.
 
Manufacturer Narrative
The report of device thrombus was confirmed based on the evaluation of the returned pump. Upon disassembly, depositions were found surrounding the inlet bearing cup and the head of the rotor. The depositions were tissue-like in nature, denatured, and displayed laminated layering, suggesting that they developed in the pump for an undetermined amount of time while the pump was operating. A white deposition was found situated between the outlet bearing ball and stator blades. The formation was not denatured and was tissue-like in nature. Additionally, the formation lacked laminated layering. Duration of time for which it was present in the pump could not be determined. The depositions found in the pump could have contributed to the reported elevated ldh; however, a correlation to the patient¿s history of infection cannot be conclusively determined. Examination of the remaining pump blood contacting surfaces revealed no adhered depositions or thrombus formations. The rotor, bearings, and other blood contacting surfaces were viewed under a microscope. No anomalies were noted. Examination of the returned portion of the driveline found it to be unremarkable. Electrical continuity testing of the wires found no discontinuities or shorts. The pump was reassembled and operated on a mock circulatory loop and functioned as intended. Thrombus and hemolysis are listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system. A review of the device history records revealed that the device met applicable specifications. No further information was provided. The manufacturer is closing the file on this event.
 
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Brand NameHEARTMATE II LVAS
Type of DeviceLEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer (Section G)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 94588
Manufacturer Contact
bob fryc
6101 stoneridge dr.
pleasanton, CA 94588
7818528390
MDR Report Key7288705
MDR Text Key100693413
Report Number2916596-2018-00647
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number107801
Other Device ID NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/30/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2018
Was Device Evaluated by Manufacturer? Yes
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: 02/22/2018 Patient Sequence Number: 1
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