MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP; VENTRICULAR (ASSIST) BYPASS

Model Number 104911JPN

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

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  Injury  

Event Description

It was reported that the patient was admitted to the hospital due to low speed operations.The pump speed was observed to have dropped to 6600 rotations per minute in the system monitor history.The facility suspects driveline fatigue and planned to admit the patient and connect the system to the power module to confirm reproducibility.The log files showed 2 low speed advisories on (b)(6)2023.These issues only occured when connected to the power module.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was additionally reported that the patient underwent a pump exchange, and an unshielded patient cable was used during surgery.There was a pump driving part failure and possible driveline damage or possible thrombus.The patient remained hospitalized.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: superficial damage to the outer jacket of the driveline evaluation of heartmate ii left ventricular assist system, serial number (b)(6), confirmed driveline wire damage.(b)(6) was returned assembled with the driveline severed approximately 6.5¿ from the pump housing.A portion of the distal end of the driveline was also returned, measuring approximately 20.5¿ in length.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned attached to the pump¿s inlet port; however, the flex section had been cut in half prior to return.The sealed outflow graft was returned attached to the outflow elbow, which was attached to the pump¿s outlet port.The bend relief collar was returned detached from the device.Upon disassembly of the returned device, examination of the blood-contacting surfaces revealed no adhered depositions or thrombus formations.Examination of the pump's bearings, rotor, and blood-contacting surfaces under a microscope revealed no abnormalities.The returned portions of driveline were tested for electrical continuity and all wires were found to be electrically intact.No wire-to-wire or wire-shield shorts were induced during testing.The driveline was carefully disassembled and microscopic inspection of the underlying wires revealed a breach in the insulation of the orange wire, adjacent to the controller connector of the distal end portion of driveline.Although a specific cause could not conclusively be determined through this evaluation, the observed damage appeared to be the result of fatigue failure due to repetitive flexing of the driveline and abrasion against the metal shield.Examination of the remaining wire portions revealed no signs of damage to the wire insulation or the underlying conductors.The returned portions of the driveline were then submerged in a saline bath for high potential testing to verify the integrity of each wire¿s insulation.This test did not reveal any additional areas of current leakage.If the exposed conductors of the orange wire contacted the braided shield while the system was operating on a grounded power source, such as the power module with a grounded patient cable or the mobile power unit, the resulting short-to-ground would have resulted in the low speed events confirmed via the submitted log files.The relevant sections of the device history records for (b)(6) and driveline, serial number (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas ifu, rev.B and the heartmate ii patient handbook, rev.D are currently available.Sections 6 and 8 of the ifu, as well as sections 4 and 6 of the patient handbook, provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.However, all heartmate ii drivelines have the potential for wire/shield breakdown to occur dependent on duration of use and movement/flexing over time.Additionally, these sections outline indications of driveline damage as well as the how to respond to such events.Section 7 of the ifu and section 5 of the patient handbook address hazard and advisory alarms, as well as how to respond to each alarm condition.The patient handbook also contains a section on handling emergencies and further instructs the user to call their hospital contact if the patient thinks that, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, JP
• 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: 18017331
• MDR Text Key: 326928917
• Report Number: 2916596-2023-07636
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2018
• Device Model Number: 104911JPN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 85 KG