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

Model Number 106524US

Device Problems Mechanical Problem (1384); Contamination /Decontamination Problem (2895)

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

Event Date 02/14/2024

Event Type  malfunction  

Event Description

It was reported that log files and an image of the patient's driveline were sent for analysis after interrogation of the patient's system controller was unremarkable.It was noted on analysis that the driveline had a tear and there was old brown tape on the driveline.A review of the log files revealed nothing remarkable.The modular cable was exchanged due to tears in the outer covering and concern of increased risk of infection.

Manufacturer Narrative

(b)(4) captures the onset of the driveline infection, symptoms, and treatment.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted image confirmed superficial damage to the pump cable; however, a specific cause for the damage could not conclusively be determined.The account submitted a photo for review showing the pump cable and in-line connector bend relief wrapped in a brown tape.The brown tape appeared to be removed or damaged in some areas where a red residue was visible.The quality of the image made it difficult to discern the exact condition of the cable; however, a tear in the outer jacket appeared to be visible, revealing the underlying armor layer.The jacket underlying the armor layer was not visible.The submitted controller event log file contained events from (b)(6) 2024.The pump appeared to operate as intended at the stored patient speed for the duration of the file.It was later reported that there was continued wear and tear to the driveline since the damage was originally reported in 2022 as reported in mfr #: 2916596-2023-00207.No damage to the underlying wires was observed.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number mlp-014210, and no further related events have been reported at this time.The heartmate 3 (hm3) left ventricular assist system (lvas) instructions for use (ifu), rev.C, is currently available.Section 6 entitled ¿patient care and management¿ explains how to clean and care for the driveline.Section 6 also cautions the user to avoid pulling on or moving the driveline.This ifu further emphasizes not to twist, kink, or sharply bend the driveline, system controller power cables, or mobile power unit patient cable, which may cause damage to the wires inside, even if the external damage is not visible.Damage to the driveline or cables could cause the pump to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten.Section 6 (under "caring for the driveline") also instructs the user to check the driveline daily for signs of damage, such as cuts, holes, or tears.Section 7 of this ifu provides additional instruction regarding the driveline in a sub-section entitled "what not to do: driveline and cables." section 8 entitled ¿equipment storage and care¿ explains that as needed, the user can clean exterior surfaces of the driveline cables with a damp, lint-free cloth.If more aggressive cleaning is needed, use warm water and mild dish soap.The heartmate 3 lvas patient handbook, rev.D, is also currently available.Section 4 ¿living with the heartmate 3¿ contains information regarding how to clean and care for the driveline.Wipe off any dirt or grime and if the driveline gets dirty, use a towel with mild dish soap and warm water to gently clean it.Never submerge the driveline or other system components in water or liquid.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.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18838665
• MDR Text Key: 337246804
• Report Number: 2916596-2024-01079
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/10/2021
• Device Model Number: 106524US
• Device Lot Number: 6838376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2019
• 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 Age: 61 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Race: White