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); Pumping Stopped (1503)

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

Event Date 07/04/2022

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 was hospitalized due to a recorded pump stop and low speed operation.The patient had no symptoms when pump stop and low speed operation occurred.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6) confirmed internal wire damage that could have contributed to the reported low speed and pump stop events observed within the submitted log file.The log file contained data from day 371, hour 8, minute 32 through day 372, hour 20, minute 7, per the timestamps.Several low speed events were captured which resulted in one pump stop while the system was connected to the power module.Based on previous complaint history, the abnormal pump operation appeared consistent with potential driveline wire compromise.(b)(6) was returned assembled with the driveline severed approximately 0.75¿ from the pump housing.The distal portion of the dl was returned in one segment measuring approximately 36.5¿.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned detached from the pump¿s inlet port.The outlet elbow was returned attached to the pump¿s outlet port.The sealed outflow graft had been severed at it¿s hardware, which was returned detached from the outlet elbow.No graft material was returned.The sealed outflow graft bend relief had been severed approximately 0.5¿ from its hardware and was returned detached from the sealed outflow graft attachment.The remainder of the bend relief material was not returned.The bend relief collar was returned detached from the bend relief hardware.Upon disassembly of the (b)(6), visual inspection of the blood contacting surfaces within the pump revealed no evidence of developed or adhered depositions or thrombus formations that would have contributed to a functional issue.The returned portions of the driveline were tested for electrical continuity and did not reveal any discontinuities or shorts, despite manipulation of the driveline.Visual inspection of the 0.75¿ driveline segment revealed a breach in the insulation of the brown wire at the pump housing.The observed wire damage appeared to be result of fatigue failure due to repetitive flexing and abrasion against the metal braided shield.Visual inspection of the remaining driveline portions revealed no evidence of damage to the wires or the underlying conductors that would have contributed to the reported events.The returned segments of the driveline were then submerged in a saline solution for hi-pot 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 brown wire contacted the braided shield while the system was operating on a tethered power source such as the power module or mobile power unit, the resulting short to ground could have resulted in the low speed and pump stop events that were confirmed through the submitted log file.The pump was cleaned, and the bearings, rotor and blood contacting surfaces were examined under a microscope; no anomalies were observed that would have contributed to a functional issue.Due to the location of the observed driveline wire damage, the pump was not functionally tested using a mock circulatory loop.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on 07may2018.The heartmate ii lvas instructions for use (ifu) and the heartmate ii patient handbook are currently available.The hmii ifu and patient handbook provide information regarding how to clean and care for the driveline and address damage due to wear and fatigue of the driveline.These documents state that despite care, 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 documents outline indications of driveline damage as well as the how to respond to such events.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).The ifu and patient handbook also address all hazard and advisory alarms, as well as how to respond to each alarm condition.The patient handbook 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.

Event Description

The pump stop and low speed were presumed to be caused by driveline damage.The patient was switched to battery power, but it was unknown if the alarms resolved.On (b)(6) 2022, an alarm sounded when the patient connected to the power module before going to bed.On (b)(6) 2022, the patient went to the hospital and the log file found pump off alarms which indicated the possible driveline damage.The patient underwent a pump exchange on (b)(6) 2022.

• 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: 15066262
• MDR Text Key: 303059264
• Report Number: 2916596-2022-12399
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 104911JPN
• Device Lot Number: 6377543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2018
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 60 KG