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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 (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106015
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Confusion/ Disorientation (2553)
Event Date 12/21/2021
Event Type  Injury  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient was admitted on (b)(6) 2021 for subdural hematoma confirmed by head cat scan.The cause of the head trauma was unknown.The patient had altered mental status.No alarms were associated with the event.The patient did not have any deficits due to the head trauma.The patient was discharged on (b)(6) 2021.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the submitted computed tomography (ct) image confirmed the reported bleeding, however, a direct correlation between the device and the bleeding could not conclusively be determined through this evaluation.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit shipped on 01aug2016.The heartmate ii lvas ifu lists bleeding as an adverse event that may be associated with the use of the heartmate ii left ventricular assist system.The patient care and management section provides information on anticoagulation, including recommended inr values.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
Type of Device
VENTRICULAR (ASSISST) 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 Key13827516
MDR Text Key287616534
Report Number2916596-2022-01684
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024011224
UDI-Public00813024011224
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 04/18/2022
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 Date06/30/2019
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
Initial Date Manufacturer Received 03/10/2022
Initial Date FDA Received03/19/2022
Supplement Dates Manufacturer Received04/15/2022
Supplement Dates FDA Received04/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/19/2016
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 Age70 YR
Patient SexMale
Patient Weight84 KG
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