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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Dysphagia/ Odynophagia (1815); Pleural Effusion (2010); Heart Failure/Congestive Heart Failure (4446)
Event Date 05/17/2022
Event Type  Injury  
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(4), and the reported events could not be conclusively determined through this evaluation. Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided. The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time. The heartmate 3 lvas ifu, rev. C, is currently available. The ifu, ¿introduction¿, lists potential adverse events, including cardiac arrhythmia and right heart failure, that may be associated with the use of the heartmate 3 left ventricular assist system. The ifu, ¿patient care and management¿, lists arrhythmia as a potential late postimplant complication. The relevant sections of the device history records for (b)(4) were reviewed and showed no deviations from manufacturing or quality assurance specifications. The implant kit was shipped on 26apr2022. No further information was provided. The manufacturer is closing the file on this event.
 
Event Description
It was reported that the patient fibrillated and was cardioverted during surgery. The arrhythmia occurred after sternotomy but prior to device implant. Cardiopulmonary bypass (cpb) was initiated before further manipulation of the left ventricle due to the patient's history of ventricular tachycardia (vt) and irritable myocardium. Following left ventricular assist device (lvad) implant the patient was cardioverted three times due to vt. Lvad speed was decreased, cardiac resynchronization therapy defibrillator (crtd) was interrogated, and an amiodarone bolus was given. Of note, the patient had a history of ventricular tachycardia, atrial fibrillation and atrial flutter prior to implant. Additional information was received that a chest x-ray on 21may2022 showed bilateral pleural effusions and probable atelectasis. A swallow study showed mild dysphagia due to weakness from debility and intubation. It was noted that the patient had a history of pulmonary hypertension and right side lung cancer. Post radiation the patient was having increased oxygen demands. It was also noted that as of (b)(6) 2022, the patient remained on inotropes since lvad placement, indicating right heart failure.
 
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Brand NameHEARTMATE 3 LVAS IMPLANT KIT
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 Key14688466
MDR Text Key294596920
Report Number2916596-2022-11492
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number8426382
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received05/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/12/2022
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: 06/14/2022 Patient Sequence Number: 1
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