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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
Event Date 07/01/2022
Event Type  Injury  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
 
Event Description
It was reported that the patient went into post-operative shock on (b)(6) 2022.Right ventricular function was normal pre-implant but was mildly depressed post-implant.The patient was diuresed post op with 80mg of lasix and was later diuresed again with another 80mg.Inotropes and pressors were initiated and the patient's lactate was measured at 4.3mmol/l with blood pressure of 90/69.The patient left the operating room on a ventilator but was extubated the next day.The patient was put on inhaled nitrous oxide and then later moved to nasal cannula with no clinical compromise.It was reported that as of (b)(6) 2022 the patient was off of all therapies.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between the device and the reported events could not be conclusively established through this evaluation.The patient remains ongoing on heartmate 3 lvas.No further events have been reported at this time.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) is currently available.Section 1, "introduction," lists all adverse events which may be associated with the use of heartmate 3 lvas, including right heart failure and respiratory failure.No further information was provided.The manufacturer is closing the file on this event.
 
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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 Key15107713
MDR Text Key296655236
Report Number2916596-2022-12193
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 Study,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/14/2022
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 Health Professional
Device Expiration Date03/05/2024
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number8458962
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/06/2022
Initial Date FDA Received07/26/2022
Supplement Dates Manufacturer Received10/03/2022
Supplement Dates FDA Received10/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2022
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) Life Threatening; Hospitalization;
Patient Age47 YR
Patient SexFemale
Patient Weight97 KG
Patient EthnicityNon Hispanic
Patient RaceBlack Or African American
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