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

Model Number 106524US

Device Problem Mechanical Problem (1384)

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

Event Date 03/11/2024

Event Type  malfunction  

Event Description

It was reported that log files were submitted for driveline damage.The guard was unable to be repositioned due to bunching of the outer sheath in the guard.The system had no alarms.Log files noted a few intermittent low flow flags which did not persist long enough to trigger alarms.The log files did not contain any evidence of any type of electrical driveline issues.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted photos confirmed superficial damage of the external pump cable as well as displacement of its bend relief.Although a specific cause for these findings could not be conclusively determined, there were no electrical issues reported or identified in association with the damage.Review of the submitted photos confirmed tears in the jacket of the pump cable at the terminus of the external bend relief and near the driveline exit site.The armor layer was breached and the underlying bionate layer was visible at the tear near the terminus of the bend relief.The bend relief was also noted to be separated from the inline connector by approximately 1¿.The bend relief and jacket of the pump cable were ultimately taped.Review of the submitted log files found that the system appeared to be operating as intended at the stored patient speed, and there were no notable alarms active in the log files.The patient remains ongoing on (b)6) with no further reported issues at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C is currently available.Section 5 ¿surgical procedures¿ cautions the user that sharp bends, twists, or kinks in the driveline may make it more susceptible to wear and fatigue over time.Section 6 ¿patient care and management¿ cautions the user to avoid pulling on or moving the driveline.This section further cautions: "do not twist, kink, or sharply bend the driveline, system controller power cables, the power module patient cable, or the mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible.Damage to the driveline or cables could cause the left ventricular assist device to stop.If the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten.¿ section 6 also instructs the user to check the driveline daily for signs of damage, such as cuts, holes, or tears and to counsel patients to inform their hospital contact immediately if they find signs of driveline damage.Section 7 ¿alarms and troubleshooting¿ provides additional instructions regarding driveline care in a sub-section entitled "what not to do: driveline and cables".Section 8 ¿equipment storage and care¿ states: "as needed, 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." section 3 ¿powering the system¿ and section 6 warn that the patient must always connect to the power module or mpu for sleeping or when there is a chance of sleep.A sleeping patient may not hear system alarms.The heartmate 3 lvas patient handbook, rev.D, is currently available.Section 4 ¿living with the heartmate 3¿ contains information regarding how to clean and care for the driveline.This section instructs the user to check the driveline daily for signs of damage and to call your hospital contact right away if the driveline is damaged.Section 4 also instructs the user to ¿keep your driveline clean.Wipe off any dirt or grime.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.¿ section 5 ¿alarms and troubleshooting¿ cautions the user not to twist, kink, or sharply bend the driveline.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that rescue tape was applied, and the patient was educated on driveline positioning and safety points.

• 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: 19005958
• MDR Text Key: 339004036
• Report Number: 2916596-2024-01595
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2022
• Device Model Number: 106524US
• Device Lot Number: 7757175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American