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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

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THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pleural Effusion (2010); Tachycardia (2095); Heart Failure/Congestive Heart Failure (4446); Aortic Valve Insufficiency/ Regurgitation (4450)
Event Date 06/15/2022
Event Type  Injury  
Manufacturer Narrative
Specific patient information and device serial number are documented as unknown. Device was implanted at time of event. Author information: masaru hatano, et al. Journal of cardiology 80 (2022) 110¿115. Department of cardiovascular medicine, the university of tokyo hospital, tokyo, japan, department of advanced medical center for heart failure, the university of tokyo hospital, tokyo, japan, department of computational diagnostic radiology and preventive medicine, the university of tokyo, tokyo, japan, department of therapeutic strategy for heart failure, the university of tokyo, tokyo, japan, department of cardiac surgery, the university of tokyo hospital, tokyo, japan. No further information was provided. A supplemental report will be submitted once the manufacturer's investigation is complete.
 
Event Description
The event date is unknown and has been entered as the date the article was reviewed. It was reported through the case study "late-onset right ventricular failure after continuous-flow left ventricular assist device implantation: case presentation and review of the literature" that heartmate ii may be associated with arrhythmia, right heart failure, aortic insufficiency, and multisystem organ failure. This case study involved a patient that experienced frequent ventricular tachycardia (vt) 20 months after receiving a heartmate ii implant. The patient's arrhythmia was suppressed with by taking sotalol and bepridil daily. The patient was later hospitalized after 24 months of left ventricular assist device (lvad) support due to right heart failure (rhf). A chest radiography showed a large right pleural effusion and moderate aortic insufficiency that was not observed pre-implant. A right heart catheterization (rhc) was performed that revealed right arterial and right ventricular pressures were equal, which indicated severe rhf. Milrinone and tolvaptan were administered, sotalol was discontinued and carvedilol administration was reduced. A subsequent rhc revealed an improvement in the patient's rhf, and a subsequent chest radiography showed no pleural effusion. An aortic valve patch closure and a transcatheter aortic valve replacement (tvr) were performed. Although inotropes could not be discontinued following the operation, the patient was able to undergo a heart transplant after 30 months of lvad support.
 
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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 Key14939240
MDR Text Key295398273
Report Number2916596-2022-11848
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P060040
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Literature
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number106015
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/15/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/06/2022 Patient Sequence Number: 1
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