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); Infusion or Flow Problem (2964)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that during a regular outpatient visit, there were occasional low speed alarms and low flow alarms recorded.These alarms occurred when the system controller was connected to the power module.The patient had no symptoms, and driveline fatigue was suspected.Log files were submitted for review.The log file captured 1 pump stop and 11 low speed advisories while the patient was connected to the power module.It was noted that these could be related to either something other than blood passing through the pump or to an issue with the driveline.Due to possible driveline damage, the patient was hospitalized.A pump exchange was to be planned and the patient was placed on an unshielded power module patient cable.It was noted that no x-ray images of the driveline damage were available.

Manufacturer Narrative

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

Manufacturer Narrative

Section e1: the customer site was (b)(6) hospital.Manufacturer's investigation conclusion: the evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6), confirmed internal driveline wire damage that could have contributed to the low speed and pump stop events captured in the submitted log file.The submitted log file captured low speed and pump stop events while the system was connected to the power module.Based on previous complaint history, the abnormal pump operation appeared to be consistent with potential driveline wire compromise.The pump was able to regain speed following the last event.No other notable events or alarms were observed.(b)(6) was returned assembled with the driveline severed approximately 2.5¿ from the pump housing.The remainder of the driveline (including the controller connector) was returned in one segment measuring approximately 35.5¿.The inflow conduit (inlet tube, inflow conduit flex section, and inlet elbow) was returned attached to the pump¿s inlet port.The apical sewing ring was not returned.The outlet elbow was returned attached to the pump¿s outlet port.The outflow graft was returned attached to the outlet elbow.The outflow graft bend relief and bend relief collar were not returned.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 all wires were found to be intact.Visual and microscopic inspection of the underlying wires revealed a breach in the insulation of the orange wire of the 35.5¿ driveline segment, approximately 35¿ from the controller connector.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 wire portions revealed no evidence of damage to the wire insulations or the underlying conductors.The driveline was 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 metal braided shield while the system was operating on a tethered power source such as the mobile power unit or power module with grounded patient cable, 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.(b)(6) was reassembled and functionally tested under normal operating conditions using a test distal end driveline segment and a mock circulatory loop.The data retrieved from that testing revealed normal pump power consumption and pressure values that met manufacturing specification and the device functioned as intended.Superficial damage to the outer jacket of the external driveline was found.The relevant sections of the device history records for (b)(6) and the driveline, serial number (b)(6) , were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) and the heartmate ii patient handbook are currently available.The hmii ifu and hmii patient handbook, provide information regarding how to care for 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.These documents address damage due to wear and fatigue of the driveline and outline indications of driveline damage as well as the how to respond to such events.The ifu and patient handbook instruct the user to check their driveline daily for signs of damage (cuts, hole, tears, etc.).The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).The patient handbook and ifu provide information on system alarm conditions as well as the appropriate actions associated with each 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.

Event Description

The patient underwent a pump exchange surgery on (b)(6) 2023.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18354494
• MDR Text Key: 330871090
• Report Number: 2916596-2023-08409
• 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
• Report Date: 05/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Model Number: 104911JPN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2023
• Initial Date FDA Received: 12/19/2023
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• 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: 50 YR
• Patient Sex: Male
• Patient Weight: 79 KG