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

Model Number 106524US

Device Problem Infusion or Flow Problem (2964)

Patient Problem Anxiety (2328)

Event Date 05/06/2022

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 had a suspected outflow graft obstruction.The patient had started having low flow alarms on (b)(6) 2022, but was asymptomatic other than anxiety from alarms during the night.The patient underwent computerized tomography (ct) angiography which showed an outflow graft obstruction.A review of the log files showed multiple low flow alarms on (b)(6) 2022.The estimated flow appeared to have fluctuated below the alarm threshold of the 2.0lpm.The patient underwent an external outflow graft obstruction (eogo) exploratory surgery on (b)(6) 2022.During surgery, a fibrinous yellow discharge was found in the bend relief and removed, and pump flow immediately increased.After surgery, the patient was stable.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the reported extrinsic outflow graft (ofg) obstruction and (b)(6) could not conclusively be determined through this evaluation as no images of the obstruction were submitted.A specific cause for the reported obstruction could not conclusively be determined through this evaluation.The submitted photograph showed the patient¿s chest cavity with part of the pump visible.The visible part of the pump appeared unremarkable.The controller event log file captured transient low flow fault flags resulting in 15 low flow hazard alarms on 06may2022.No other atypical events were captured.Despite these events, the pump appeared to function as intended and operated at the set speed for the duration of the file.Pump flow immediately increased after the surgery, and no further alarms have been reported.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number: (b)(6).No product is available for investigation.The heartmate 3 lvas ifu, rev.C, and the heartmate 3 lvas patient handbook, rev.D, are 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.Section 1 lists the outflow graft clip as a required component for implant.Section 5, 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.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 06aug2018.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 14462914
• MDR Text Key: 292371331
• Report Number: 2916596-2022-10953
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6531254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q124-HF-1
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 179 KG