• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106015
Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Hematoma (1884); Hemothorax (1896); Pleural Effusion (2010); Tachycardia (2095); Ventricular Fibrillation (2130); Syncope/Fainting (4411); Aortic Valve Insufficiency/ Regurgitation (4450); Tricuspid Valve Insufficiency/ Regurgitation (4453); Pulmonary Hypertension (4460)
Event Date 06/02/2022
Event Type  Injury  
Event Description
It was reported that the patient was found unresponsive at home after having large black stool. The patient was given bolus by the first responders and brought to the emergency department (ed) with improved mental status, but then quickly decompensated requiring cpr and then multiple shocks for ventricular fibrillation. The patient was given intravenous (iv) amiodarone, levophed, lidocaine, and was intubated. Gastrointestinal (gi) bleeding was not confirmed and the guaiac was negative. On (b)(6) 2022, an echo showed a mildly enlarged right ventricle (rv) with reduced systolic function, mild tricuspid regurgitation, and mild pulmonary hypertension. The aortic valve did not seem to open with each cardiac cycle, and mild aortic regurgitation was present. At the time, the patient was status post cardiac arrest that they had at the ed. On (b)(6) 2022 an abdominal computerized tomography (ct) scan revealed a heterogenous intrahepatic hematoma measuring up to 13 cm (measured 6 cm on (b)(6) 2022 and involved most of the left lobe as well as demonstrated active extravasation with moderate to large volume hemoperitoneum. Also noted were multiple hypodensities in the spleen some which were peripheral and wedge-shaped concerning for multiple splenic infarcts. That same day, a chest ct revealed interval increase in size of the moderate volume layering bilateral effusions which were thought to be hemothorax due to the fractured ribs resulting from the fall. Mild interstitial edema was also present, as well as evidence of non ischemic cardiomyopathy. The patient reportedly had no history of ventricular tachycardia/fibrillation, and had no history of implanted cardioverter defibrillator use. The log file review captured multiple low flow alarms on the morning of the fall. These events seemed to be due to patient condition and were not device related. The low flows were reportedly due to volume depletion as a result of decreased po intake. The patient was given epinephrine and lidocaine, as well as shocks and fluid expansion. The patient reportedly experienced altered mental status throughout this event.
 
Manufacturer Narrative
No further information was provided. A supplemental report will be submitted once the manufacturer¿s investigation is complete.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Type of DeviceVENTRICULAR (ASSIST) BYPASS
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
6035 stoneridge drive
pleasanton, CA 94588
7818528204
MDR Report Key14754016
MDR Text Key294782651
Report Number2916596-2022-11512
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/31/2017
Device Model Number106015
Device Catalogue Number106015
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/07/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/21/2022 Patient Sequence Number: 1
-
-