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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

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THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS Back to Search Results
Model Number 106524US
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Right Ventricular Dysfunction (2054)
Event Date 01/05/2020
Event Type  Injury  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
 
Event Description
It was reported that the patient experienced dizziness and multiple pi (pulsatility index) events.It was suspected that the pi (pulsatility index) events were caused by volume, orthostatic blood pressure changes, right ventricular dysfunction, and small lvidd (left ventricular internal diameter).The patient had mild right ventricular dysfunction prior to being implanted with an lvad (left ventricular assist device), however it was now moderate-severe.It was unclear if the patient's right ventricular dysfunction worsened related to the vad or due to progressive heart failure.The patient was given intravenous fluids and started back on midodrine with symptomatic improvement.The patient was sent home with a planned routine follow-up as an outpatient.No further information was provided.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas and the reported events could not be conclusively determined through this evaluation.The account submitted log files for review.The system controller event log file contains data from (b)(6) 2020 at 8:24:41 through (b)(6) 2020 at 8:00:04.The log file was comprised of routine power cable disconnects and pi events.Transient pi events were observed throughout the log file, resulting in momentary decreases in speed per design.The pump appeared to function as intended.The patient remains ongoing on heartmate 3 lvas.The hm3 lvas ifu lists right heart failure as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.It also states ¿right heart failure can occur following implantation of the pump.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.¿ 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 (ASSISST) BYPASS
Manufacturer (Section D)
THORATEC CORPORATION
6035 stoneridge drive
pleasanton CA 95488
MDR Report Key9648018
MDR Text Key177142584
Report Number2916596-2020-00239
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024013297
UDI-Public00813024013297
Combination Product (y/n)N
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/28/2020
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 Date05/23/2022
Device Model Number106524US
Device Catalogue Number106524US
Device Lot Number7093825
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/13/2020
Initial Date FDA Received01/30/2020
Supplement Dates Manufacturer Received04/23/2020
Supplement Dates FDA Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age55 YR
Patient Weight90
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