MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSISST) BYPASS

Model Number 106015

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problems Syncope (1610); Nausea (1970)

Event Date 12/07/2019

Event Type  Injury  

Manufacturer Narrative

This event was also reported against the system controller in mfr.Report #2916596-2019-05817.The patient remains on lvad support with no further issues reported.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 was disconnected from her primary controller following low voltage and no external power alarms.She was then placed on her backup controller.The log confirmed the low voltage and no external power alarms on (b)(6) 2019 due to total depletion of the batteries.The patient may have felt the drop in speed when the controller entered the power saver mode.The patient disconnected the drive line to change the backup controller.The backup controller was connected.The pump did stop for 4 minutes when the patient was trying to connect to the back up controller.There were no unusual events seen within the log file prior to this event.The vad was functioning as intended.The low power alarm, no external power alarms, and pump stops resolved.The patient had syncope, nausea and vomiting.Patient was discharged in stable condition.It is possible the patient had difficulty connecting the controller which resulted in the 4 minute pump stop.Additional information was requested but not provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the submitted log files appeared to show the pump operating as intended while the driveline was connected.A direct correlation between the reported events and heartmate ii lvas, serial number (b)(6) could not be conclusively established through this evaluation.The submitted log files are investigated under (b)(4) for system controller serial number (b)(6).A no external power event occurred on (b)(6) 2019 at 20:03 which appeared to have been caused a disconnection of both power cables.The backup battery operated the system during this time and support to the pump was not interrupted.The patient¿s driveline was disconnected on (b)(6) 2019 at 20:13 in order to conduct the reported controller exchange once the patient had connected to a power module.No other notable events were observed.The pump appeared to be operating as intended while the driveline was connected.The patient remained ongoing on heartmate ii lvas, serial number (b)(6) until ultimately expiring due to an embolic cva with presumed pump thrombosis on (b)(6) 2020 (reported in mfr report #2916596-2020-00607).It should be noted that the center reported that these events were due to the patient disconnecting the driveline on (b)(6) 2019.A direct correlation between these events and (b)(6) could not be conclusively established.The pump was not explanted for evaluation.Although no vad-related issues were observed in the submitted log files, the hm ii lvas ifu explains that if the driveline disconnects from the system controller, the pump stops.Promptly reconnect it to resume pump operation.The ifu outlines all system controller alarms, as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 9532458
• MDR Text Key: 173286028
• Report Number: 2916596-2019-06048
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5855538
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 80