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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSIST) BYPASS

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THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Model Number 104911JPN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Intracranial Hemorrhage (1891); Pleural Effusion (2010); Hemorrhagic Stroke (4417)
Event Date 02/03/2020
Event Type  Injury  
Event Description
It was reported that the patient was admitted on (b)(6) 2020 for pleural effusion.On (b)(6) 2020 the patient experienced neurological dysfunction (intracranial bleed in the left hemisphere).
 
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed. .
 
Manufacturer Narrative
Manufacturer's investigation conclusion: a specific cause for the reported events as well as a direct correlation to heartmate ii left ventricular assist system (hmii lvas), serial number (b)(6) could not conclusively be determined through this evaluation.The patient remains ongoing on heartmate ii lvas, serial number (b)(6) , and not further events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 19apr2017.The heartmate ii lvas instructions for use (ifu) lists stroke and bleeding as adverse events 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.
 
Event Description
A hemorrhagic stroke was diagnosed via computed tomography (ct) scan.There were no changes to the patient's condition and anticoagulation status that may have contributed.The patient was under follow-up as an outpatient due to sequelae.
 
Event Description
During admission for pleural effusion, the patient underwent chest drainage and was discharged on (b)(6) 2020.The patient was readmitted on (b)(6) 2020 due to the hemorrhagic stroke.Motor aphasia was noted as a clinical manifestation of the hemorrhagic stroke.The patient underwent an anticoagulation reverse procedure and was treated with chemicals.The patient was on warfarin and aspirin at the time of the event.The patient was discharged on (b)(6) 2020.The cause of the neurological dysfunction was unknown.
 
Manufacturer Narrative
This event was originally reported under mfr#2916596-2022-02063 as part of a historical jmacs patient registry review in japan through mcs abbott japan affiliate.On 26sep2022 the review of files of this event type was completed.No further information was provided.The manufacturer is closing the file on this event.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: the pump remains in use supporting the patient.A correlation between the device and the report of stroke could not be conclusively determined.Stroke is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system.Stroke has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.No further information was provided.The manufacturer is closing the file on this event.
 
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Brand Name
HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
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 Key13384918
MDR Text Key286963188
Report Number2916596-2022-00541
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 Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 10/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date01/31/2020
Device Model Number104911JPN
Device Lot Number5952758
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received10/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/14/2017
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) Required Intervention; Hospitalization;
Patient Age53 YR
Patient SexMale
Patient Weight65 KG
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