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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 106524INT
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturers investigation is completed.
 
Event Description
It was reported that the patient underwent a heartware ventricular assist device (hvad) to heartmate 3 (hm3) pump exchange on 14sep.The bend relief did not look fully engaged with outflow graft during implant surgery.Pictures were taken during this procedure to document the steps- upon reviewing the pictures it was noted that the bend relief did not look fully engaged with outflow graft during implant surgery.At present, the patient was stable, extubated and doing well.
 
Manufacturer Narrative
Manufacturer's investigation conclusion: evaluation of the submitted photos confirmed the reported outflow graft bend relief disconnect.A specific cause for this finding could not conclusively be determined through this evaluation.It was reported that review of the photos taken during the implant of heartmate 3 left ventricular assist system (lvas), serial number (b)(6), on 14sep2021 noted that the outflow graft bend relief did not appear to be fully engaged to the graft attachment hardware.It was recommended that baseline x-rays in the lateral and frontal positions be taken to confirm the bend reliefs current position.Further x-rays would need to be taken to evaluate any gap or detachment.It was also recommended that a subcostal incision could be made to check the bend relief; however, the reoperation will not be performed, and the patient is stable and extubated.The submitted photos showed that the outflow graft bend relief was not fully secured to the outflow graft hardware.A specific cause for this finding could not conclusively be determined through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No product is available for investigation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The lvas kit was shipped on 29jun2021.The heartmate 3 lvas ifu and the heartmate 3 patient handbook are currently available.Section 5 of the ifu, "surgical procedures" (under "preparing the sealed outflow graft"), contains information on how to prepare the sealed outflow graft for implant.Section 5, under ¿de-airing the pump¿, explains that when de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring until it engages into place.This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may lead to serious adverse events such as low left ventricular assist device flow and/or bleeding.This section then instructs the user to visually inspect the bend relief to confirm that it is fully connected and seated to the sealed outflow graft.To confirm, try to unseat the connected bend relief from the metal fitting by gently pulling the bend relief back toward the anastomosis and then towards the pump.The bend relief should remain captured and move approximately 0.5 mm without disengaging from the graft.Section 5 of the ifu, under "securing the pump and connections", cautions that care should be taken to ensure that the sealed outflow graft bend relief remains connected during sternal closure.The ifu instructs that once the flow through the blood pump is satisfactory, ensure that the sealed outflow connections are dry and secure.Obtain hemostasis and close all wounds in the standard fashion.Furthermore, the hm3 patient handbook instructs the user to call their hospital contact if the user thinks, for any reason, any portion of the equipment is not functioning as usual, is broken, or the user is uncomfortable with the operation of the equipment.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 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 Key12567316
MDR Text Key274442230
Report Number2916596-2021-05444
Device Sequence Number1
Product Code DSQ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P160054
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/02/2022
Device Model Number106524INT
Device Lot Number7955149
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/15/2021
Initial Date FDA Received10/04/2021
Supplement Dates Manufacturer Received12/07/2021
Supplement Dates FDA Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/04/2021
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 SexMale
Patient Weight82 KG
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