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

Model Number 106524US

Device Problems Device Difficult to Setup or Prepare (1487); Pumping Stopped (1503)

Patient Problems Cognitive Changes (2551); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2022

Event Type  malfunction  

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 having pump stops at home.Log file review confirmed pump stops on (b)(6) 2022 and (b)(6) 2022 due to the driveline being disconnected.Healthcare providers believed the disconnect occurred at the modular cable and the patient's significant other attributed it to a loose connection.No equipment was exchanged and the patient was discharged home on (b)(6) 2022.Related manufacturer's report regarding the modular cable: 2916596-2022-11234.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed pump stop events due to the driveline being disconnected.Although a specific cause for these events could not be conclusively determined through this evaluation, they appeared to be consistent with the report of a loose modular cable connection.The system controller event log file contained data from (b)(6) 2022.Driveline disconnects that caused the pump to stop were observed on (b)(6) 2022.These events were associated with power b broken, power a broken, com b fault, com a fault, and low pump current, pump stop, low speed hazard, and low speed advisory fault flags, as well as low flow, driveline disconnect, and lvad off alarms.These events lasted between approximately 12 seconds and 4 minute and 17 seconds each, following which, the pump regained speed without issue.Although a specific cause for these events could not be conclusively determined through this evaluation, they appeared to be consistent with the report of a loose modular cable connection.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 hm3 lvas patient handbook, rev.D, are currently available.Section 2 of the ifu, "system operations" (under "system controller warnings and cautions"), states "check the system controller driveline connector to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump stops.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation." additionally, section 2 of the ifu, under "connecting the driveline to the system controller", provides instructions on connecting/disconnecting the driveline to/from the system controller and making sure that it is fully and properly inserted into the system controller socket.This sections also provides instructions for connecting the modular cable to the pump cable as well as exchanging the modular cable.These instructions state: ¿connect the replacement modular cable to the pump cable by aligning the white triangles and pushing the connectors firmly together.Rotate the locking nut of the modular inline connector until the clicking sound has stopped and the yellow line is hidden by the locking nut.¿ section 5 of the ifu "surgical procedures" also states that the yellow line on the threaded portion of the inline connector should be fully covered to ensure a secure connection.Furthermore, this section warns that a complete back up system must be available on-site and in close proximity for use in an emergency during implant.Section 2 of the patient handbook, ¿how your heart pump works¿, also advises the user to ¿check the system controller driveline connector often to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump will stop.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation¿.The patient handbook also explains that the pump cannot run without power.Furthermore, section 5 of the patient handbook, "alarms and troubleshooting", and section 7 of the ifu, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.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 25may2021.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed pump stop events due to the driveline being disconnected.Although a specific cause for these events could not be conclusively determined through this evaluation, they appeared to be consistent with the report of a loose modular cable connection.Additionally, a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6) , and the reported cognitive issues could not be conclusively established through this evaluation.The controller event log file contained data from 19may2022 through 20may2022, the driveline was disconnected causing the pump to stop.These events were associated with power b broken, power a broken, com b fault, com a fault, and low pump current, pump stop, low speed hazard, and low speed advisory fault flags, as well as low flow, driveline disconnect, and lvad off alarms.These events lasted between approximately 12 seconds and 4 minute and 17 seconds each, following which, the pump regained speed and assumed normal operation.Although a specific cause for these events could not be conclusively determined through this evaluation, they appeared to be consistent with the report of a loose modular cable connection.No other notable events or alarms were captured, and the pump appeared to function as intended at the set speed.The heartmate 3 lvas ifu, rev.C, and the hm3 lvas patient handbook, rev.D, are currently available.Section 1 of this ifu lists psychiatric episode as an adverse event that may be associated with the use of the hm3 lvas.Section 2 of the ifu, "system operations" (under "system controller warnings and cautions"), states "check the system controller driveline connector to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump stops.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation." additionally, section 2 of the ifu, under "connecting the driveline to the system controller", provides instructions on connecting/disconnecting the driveline to/from the system controller and making sure that it is fully and properly inserted into the system controller socket.This sections also provides instructions for connecting the modular cable to the pump cable as well as exchanging the modular cable.These instructions state: ¿connect the replacement modular cable to the pump cable by aligning the white triangles and pushing the connectors firmly together.Rotate the locking nut of the modular inline connector until the clicking sound has stopped and the yellow line is hidden by the locking nut.¿ section 5 of the ifu "surgical procedures" also states that the yellow line on the threaded portion of the inline connector should be fully covered to ensure a secure connection.Furthermore, this section warns that a complete back up system must be available on-site and in close proximity for use in an emergency during implant.Section 2 of the patient handbook, ¿how your heart pump works¿, also advises the user to ¿check the system controller driveline connector often to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump will stop.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation¿.The patient handbook also explains that the pump cannot run without power.Section 6 of the ifu, ¿patient care and management¿, also lists psychosocial issues as a potential late postimplant complication.Furthermore, section 5 of the patient handbook, "alarms and troubleshooting", and section 7 of the ifu, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.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 25may2021.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that the patient had cognitive issues and the driveline disconnect on (b)(6) 2022 was accidental.

• 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: 14626285
• MDR Text Key: 295979709
• Report Number: 2916596-2022-11235
• 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,Followup
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/12/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7943517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• 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 Age: 65 YR
• Patient Sex: Male
• Patient Weight: 69 KG