MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

Related mfr # 2916596-2021-04185 captures (b)(6) 2021 pump exchange.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 short to shield events on (b)(6) 2023.The patient underwent a heartmate ii to heartmate ii pump exchange on (b)(6) 2021 due to a damaged driveline causing multiple pump stop events.These short to shield events are the first presentation on the patient's new pump.The patient's driveline was x-rayed.These revealed an internal bend in the driveline by the pump.A review of the log file revealed one pump stop and 14 low speed events on (b)(6) 2023 while the patient was using the power module.

Manufacturer Narrative

Manufacturer's investigation conclusion: pump stop and low speed events were confirmed via the submitted log file.The submitted log file contained events and data captures spanning from 28sep2023 to 17oct2023.A pump stop event associated with low speed alarms, low flow alarms, and elevated pump powers was captured on 17oct2023 while the system was supported by a power module.Additional low speed events associated with low flow alarms and elevated pump powers were also captured on 17oct2023 while the system was grounded by a power module.No other notable events or alarms were captured.Based on heartmate ii complaint history and similarly reported events, the data captured in the log file is consistent with potential wire compromise within the patient¿s driveline; however, a specific cause for the pump stop and low speed events cannot be conclusively determined through this evaluation.Additional information regarding the event was requested from the account; however, nothing further has been communicated at this time.The patient remains ongoing on (b)(6) and no further events have been reported at this time.The heartmate ii left ventricular assist system instructions for use, rev.C, and patient handbook, rev.C, are currently available.These documents discuss damage due to wear and fatigue of the driveline and include driveline care instructions.However, all heartmate ii left ventricular assist device drivelines have the potential for wire/shield breakdown to occur depending upon the length of use and movement/flexing over time.Additionally, several sections of the instructions for use and patient handbook warn to not use batteries to power the system when the patient is sleeping.The patient must always connect to the power module or mobile power unit for sleeping or when there is a chance of sleep.A sleeping patient may not hear the system controller alarms.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d3, g1: updated information.Section d1, brand name: corrected.Section d4, catalog number: corrected.Section d4, primary udi number: corrected.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 18087069
• MDR Text Key: 327715483
• Report Number: 2916596-2023-07553
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 05/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/10/2021
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 7718747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/07/2023
• Supplement Dates Manufacturer Received: 01/16/2024; 05/14/2024
• Supplement Dates FDA Received: 01/18/2024; 05/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2020
• 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: 46 YR
• Patient Sex: Male
• Patient Weight: 183 KG