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

Model Number 106524US

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

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

Event Date 04/28/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient was admitted to the hospital on (b)(6) 2022 for continuous low flow alarms and further workup.The patient experienced the low flow alarms primarily when lying on their left side or when up walking around.A 4d computed tomography scan was performed on (b)(6) 2022 and obstruction of the outflow graft was noted.It was planned to discuss options for surgical intervention.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of an outflow graft obstruction could not be confirmed as no product was returned for evaluation and no images were provided for review.Additionally, review of the log files provided by the account confirmed low flow alarms; however, a specific cause for these events could not be determined through this evaluation.The controller event log file contained data from 28apr2022 through 29apr2022, per the timestamps.Intermittent low flow alarms were captured throughout the file.No other notable events or alarms were captured, and the pump appeared to function as intended at the set speed.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 (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and no further events have been reported at this time.The heartmate 3 lvas ifu, rev.C, and the heartmate 3 patient handbook, document #10006136, rev.D, are currently available.Section 1 of the ifu, ¿introduction¿, addresses all pump parameters.Section 4 of the ifu, ¿system monitor¿, describes the pump flow display and the hazard alarms.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.Section 4 also explains that changes in patient condition can result in low flow.Section 5 of the patient handbook, ¿alarms and troubleshooting¿, and section 7 of the ifu, ¿alarms and troubleshooting¿, provides information on all system alarm conditions as well as the appropriate actions associated with each condition.A section on ¿handling emergencies¿ is also provided in the patient handbook.Section 5 of the ifu, ¿surgical procedures¿, outlines considerations for pump placement and provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.Section 5, under "attaching the sealed outflow graft to the pump," instructs the user to verify that the 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 of the ifu, "preimplant procedures" and "implant procedures", cautions the user: "the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure" and "stretch the sealed outflow graft completely prior to measuring and cutting the graft to the appropriate length." section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 23jan2019.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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14431157
• MDR Text Key: 291962768
• Report Number: 2916596-2022-10860
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/02/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6818446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2019
• 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): Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 133 KG