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

Model Number 106524INT

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Twisted/Bent (2981)

Patient Problems Dyspnea (1816); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 05/28/2022

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient experienced frequent low flow alarms on (b)(6) 2022.The patient was admitted and an echocardiogram (echo), an electrocardiogram (ecg), and computerized tomography angiogram (cta) were performed.Blood labs were also taken.Log file analysis and imaging results revealed the issue was likely due to an outflow graft obstruction.The patient was taken to the or (operating room) and the outflow graft was found to be twisted and have a gelatin-like obstruction.A revision and removal was performed, and the pump parameters stabilized.An outflow graft clip was installed.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the patient¿s submitted images confirmed the reported twisted outflow graft.A specific cause for the observed twist could not be conclusively determined through this evaluation.Additionally, low flow alarms were confirmed through evaluation of the submitted log files and could be correlated to the observed outflow graft twist.The controller event log file contained data on (b)(6).2022 from 05:19:40 to 08:08:21.The pump operated as intended at the set speed for the duration of the log file.The log file consisted almost entirely of low flow alarms and low flow faults.The alarms and faults temporarily resolved between events when the flow temporarily rose above the low flow threshold of 2.5 lpm.The controller periodic log file contained data from (b)(6).2022 to (b)(6).2022.The flow appeared to gradually decrease starting approximately on (b)(6).2022 and continuing through the remaining duration of the log file.The patient remains ongoing on vad (ventricular assist device) support with no further issues reported at this time.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.Heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) (rev.G) is currently available.Section 5 of the ifu, "surgical procedures", contains information on "preparing the sealed outflow graft" and explains that prior to implantation, the bend relief should be disengaged from the graft for the de-airing procedure.Section 5 also contains a sub-section on "attaching the sealed outflow graft to the aorta", which instructs the user to stretch the graft completely and then measure and cut the sealed outflow graft to the appropriate length.Section 5, under "attaching the sealed outflow graft to the pump", instructs the user to verify that the outflow graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.Section 5, under "de-airing the pump", cautions the user: "do not rotate/twist the sealed graft.Check the alignment of the black line on the graft to verify that the sealed graft is not twisted or kinked." this section also explains how to attach the bend relief once the vent needle has been removed from the sealed outflow graft and leaks have been ruled out.The outflow graft clip addendum to the heartmate 3 lvas ifu (rev.B) lists the outflow graft clip as a required component for implant.The document further instructs the user to ¿attach the outflow graft clip to prevent post-operative outflow graft twisting¿ and warns that failure to install the outflow graft clip so that it is flush with the bend relief can allow graft twisting or abrasion which may lead to serious adverse events such as bleeding, graft occlusion, thrombosis, and/or death.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: the patient had progressive dyspnea due to the obstruction.The patient was discharged after their surgery and would be monitored via telephone.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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 Key: 14604882
• MDR Text Key: 293378903
• Report Number: 2916596-2022-11378
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: EZ
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2019
• Device Model Number: 106524INT
• Device Lot Number: 5885215
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 72 YR