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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II; LEFT VENTRICULAR ASSIST DEVICE
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THORATEC CORPORATION HEARTMATE II; LEFT VENTRICULAR ASSIST DEVICE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Pulmonary Edema (2020); Thrombus (2101); Test Result (2695)
Event Type  Injury  
Event Description
Pt with 1 subtherapeutic inr (1.9) over the last 6 months.Goal range 2-2.5.Not on asa due to gi bleed.Compliant with coumadin regime.Admitted (b)(6) 2018 for increased ldh of 447 (baseline 100-200) and signs of left ventricular dysfunction and pulmonary edema.T-bill slightly elevated with ast and alt wnl.Lvad running wnl.Heparin started.On (b)(6) 2018 pt with noted nsvt episodes x3.Despite use of heparin ldh continued to increase with emergent exchange occurring on (b)(6) 2018.Visible thrombus noted on the lvad inflow stator.
 
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Brand Name
HEARTMATE II
Type of Device
LEFT VENTRICULAR ASSIST DEVICE
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge dr.
pleasanton CA 94588
MDR Report Key8289255
MDR Text Key134701306
Report Number8289255
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 11/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Returned to Manufacturer11/19/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/22/2018
Device Age31 MO
Event Location Home
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention;
Patient Weight122
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