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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3¿; VENTRICULAR (ASSIST) BYPASS
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THORATEC CORPORATION HEARTMATE 3¿; VENTRICULAR (ASSIST) BYPASS Back to Search Results
Device Problem Fracture (1260)
Patient Problems Neurological Deficit/Dysfunction (1982); Weakness (2145); Confusion/ Disorientation (2553)
Event Date 10/03/2019
Event Type  Injury  
Event Description
Heartmate 2 left ventricular assist device (lvad) presents with pump stops and confirmed driveline fracture per abbott review of logfile data.Suspicious area were identified on radiographic imaging.Patient underwent heartmate 2 to heartmate 3 lvad exchange.On pod #1 patient required cardioversion for atrial fib with rapid ventricular response.On pod#2 patient was observed with left hemiparesis and gaze preference, left basilar ganglia infarct was confirmed via cat scan.Aspirin and coumadin therapy had been resumed, however heparin bridging had not been started postoperatively.Patients neuro deficits included confusion & weakness which prevented independent living after discharge.
 
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Brand Name
HEARTMATE 3¿
Type of Device
VENTRICULAR (ASSIST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
4550 norris canyon rd
san ramon CA 94583
MDR Report Key9952921
MDR Text Key187396891
Report Number9952921
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/13/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/03/2020
Event Location Home
Date Report to Manufacturer04/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Life Threatening; Required Intervention; Disability;
Patient Age24090 DA
Patient Weight79
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