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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 Problem Arrhythmia (1721)
Event Date 07/18/2022
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.The controller event log file contained data from 16jul2022 through 18jul2022.No notable events or alarms were captured, and the pump appeared to function as intended at the set speed.The patient remains ongoing on hm3 lvas, serial number (b)(4), and no further events have been reported at this time.The hm3 lvas ifu, rev.C, is currently available.The ifu, ¿introduction¿, lists cardiac arrhythmia as a potential adverse event 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 01aug2019.No further information was provided.The manufacturer is closing the file on this event.
 
Event Description
It was reported that the patient was admitted on (b)(6) 2022 after arrhythmia.Liable pulsatility index (pi) events were noted.Log file review did not capture any unusual events.The patient was on an antiarrhythmic drip.
 
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Brand Name
HEARTMATE 3 LVAS IMPLANT KIT
Type of Device
VENTRICULAR (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 Key15115211
MDR Text Key296719730
Report Number2916596-2022-12422
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public00813024013297
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 Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/17/2022
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number7077506
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/18/2022
Initial Date FDA Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/08/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
Patient Age56 YR
Patient SexMale
Patient Weight125 KG
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