MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

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

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

Event Date 10/02/2023

Event Type  malfunction  

Event Description

It was reported that the patient had low speed advisory alarms on (b)(6) 2023.X-rays of the modular cable were performed, and they were put on an ungrounded cable.The customer reported that the patient was asymptomatic and experienced no further episodes after using an ungrounded.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log file confirmed low speed operation events while the patient was operating on the power module.Based on past experience with the heartmate ii left ventricular assist system (lvas) and similar reported events, this finding could be indicative of an issue with the driveline; however, a specific cause for this event could not be conclusively determined through this evaluation.The submitted log file contained events and data from (b)(6) 2023 through (b)(6) 2023, per the timestamps.Multiple low speed operation events were captured between (b)(6) 2023 and (b)(6) 2023 while the patient was operating on the power module.One of these events was associated with a low-speed hazard and low flow hazard alarm.The remainder of the file captured the pump operating at or above the low-speed limit.No other notable events or alarms were captured.The account indicated that the patient was asymptomatic and experienced no further episodes since using an ungrounded patient cable as of (b)(6) 2023.It was noted that the patient would be monitored.The account declined to provide any additional information.The patient remains ongoing on heartmate ii lvas, serial number (b)(6), with no further issues reported at this time.The relevant sections of the device history records for vad-19267, and driveline, serial number (b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate ii lvas instructions for use (ifu), is currently available.Section 6, ¿patient care and management¿, covers wear and tear to the driveline.Section 7, ¿alarms and troubleshooting¿, addresses system controller alarms (including low speed advisory and hazard alarms) and how to respond to such events.The heartmate ii lvas patient handbook, is also currently available.The patient handbook contains a section on ¿caring for the driveline¿; however, all heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.Additionally, the patient handbook address hazard and advisory alarms, as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information reported that the patient underwent a pump exchange on (b)(6) 2023.

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6), confirmed damage to all wires that would have contributed to the reported low speed operation events and associated alarms captured in the submitted log file.(b)(6) was returned assembled with the driveline severed approximately 4" from the pump housing.The remaining distal portion of the driveline was also returned.Rescue tape was present approximately 19.5-21.5" from the controller connector.Removal of this tape revealed damage to the underlying outer jacket approximately 20" from the controller connector.The pins of the controller connector appeared unremarkable.The apical sewing ring was not returned.The inflow conduit (inlet tube, inflow conduit flex section, and inlet elbow) was not returned.The outflow graft and outflow graft bend relief were also not returned.The outlet elbow was returned attached to the pump.No developed depositions or thrombus formations were identified upon disassembly of the device.The driveline was tested for electrical continuity in the condition that it was received and failed due to an electrical connection between all wires and the metal braided shield.Following careful removal of all layers, visual and microscopic inspection revealed breaches in all wires within an area approximately 5-6" from the pump housing.Although a specific cause could not conclusively be determined, the wire insulation breaches appeared to be the result of abrasion from the metal braided shield as a result of repetitive flexing of the driveline.The remaining areas of all wires appeared to be free of damage and were submerged in a saline bath solution for high potential (hi-pot) testing to further verify the integrity of each wire's insulation.This test did not reveal any additional areas of current leakage.If any of the exposed conductors of any wire made contact with the metal braided shield while operating on a grounded power source, a short-to-shield would have resulted, potentially contributing to the low-speed operation events and associated alarms observed within the submitted log file while the patient was operating on the power module.Furthermore, if any of the exposed conductors from wires of different motor phases made contact with each other, or simultaneous contact with the metal braided shield, a phase-to-phase short would have resulted, which would contribute to low-speed operation events on any power source.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 specification.The heartmate ii lvas instructions for use (ifu), is currently available.Section 6, ¿patient care and management¿, addresses how to care for the driveline and notes that the driveline should be inspected daily for signs of damage, such as cuts, holes, or tears.This section states that the driveline should never be severely bent or kinked.Section 7 of the ifu, "alarms and troubleshooting", outlines system controller alarms (including low speed alarms) and the appropriate actions associated with them.The heartmate ii lvas patient handbook, is also currently available.The patient handbook contains a section on ¿caring for the driveline¿; however, heartmate ii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and patient handling.Additionally, the patient handbook address hazard and advisory alarms, as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: 17961749
• MDR Text Key: 326137520
• Report Number: 2916596-2023-07263
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: SN
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/02/2024

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: 11/30/2019
• Device Model Number: 106015
• Device Lot Number: 5855538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 11/16/2023; 01/11/2024
• Supplement Dates FDA Received: 12/08/2023; 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• 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: 66 YR
• Patient Sex: Male
• Patient Weight: 57 KG