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

Model Number 107801

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

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

Event Date 10/22/2023

Event Type  malfunction  

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 short-to-shield issue, while in the hospital for a non-pump-related issue.The patient had a low speed advisory alarm while on their bedside power module.The patient reported rarely using the mobile power unit and spending all of their time on batteries.The external portion of the patient's driveline was pristine with no signs or symptoms of damage.The patient was placed on an ungrounded patient cable.A log file review revealed speed drops and/or pump stops on (b)(6) 2023.These occurred intermittently throughout the remained of the log file.A plan was made to discharge the patient on an ungrounded patient cable with monthly follow-up for log file checks.No more alarms were seen since the patient was placed on the ungrounded patient cable.

Manufacturer Narrative

Manufacturer's investigation conclusion: low speed events were confirmed via the submitted log file.The submitted log file contained events spanning from (b)(6) 2023 to (b)(6) 2023.Multiple low speed events with associated low flows and elevated pump powers were captured on (b)(6) 2023 and (b)(6) 2024 while the system was supported 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 low speed events cannot be conclusively determined through this evaluation.The patient was discharged home on an ungrounded patient cable and no further low speed events have been reported at this time.The patient will undergo a monthly log file follow-up and remains ongoing on vad-62591.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.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 vad-62591 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.

• Brand Name: HEARTMATE II 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: 18121922
• MDR Text Key: 327949547
• Report Number: 2916596-2023-07728
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: 00813024011996
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2020
• Device Model Number: 107801
• Device Lot Number: 5922510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2017
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 69 KG