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

Model Number 107801

Device Problems Mechanical Problem (1384); Communication or Transmission Problem (2896)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  Injury  

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 a pump was explanted due to a driveline fault.An exchange was required.The driveline faults resolved with the exchange.There were no additional alarms.

Manufacturer Narrative

Manufacturer's investigation conclusion: the evaluation of the replaced external portion of the driveline confirmed external wire damage that could have contributed to the reported driveline faults, low speed alarms, and pump stop events captured in the first submitted log file.Additionally, the low speed events captured within the second submitted log file following the driveline repair appeared to be consistent with driveline wire compromise; however, no internal wire damage was observed during the evaluation of heartmate ii lvas, serial number (b)(6) , that would have contributed to the low speed events.(b)(6) was returned assembled with the driveline (dl) severed approximately 1.5¿ from the pump nipple housing.The distal portion of the dl was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was not returned.The outlet elbow was returned attached to the pump¿s outlet port.The sealed outflow graft, sealed 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.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.A distal-end driveline replacement was performed on (b)(6) 2020 and approximately 17¿ of the external portion/distal-end of the driveline was returned for evaluation.Electrical continuity testing of the replaced driveline was conducted and found that the red wire produced an open circuit.All remaining wires passed continuity testing.Visual inspection of the wires revealed a complete fracture in the red wire approximately 2.5¿ from the metal connector.The observed wire damage appeared to be the result of fatigue failure due to repetitive flexing of the driveline in this area.Examination of the remaining wire portions revealed no obvious signs of damage to the wire insulation 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.The test did not reveal any additional areas of current leakage in the insulation of any of the driveline wires.The hmii lvas operates on a three-phase motor, where each phase is powered by two redundant wires.The system controller monitors the current in each redundant wire pair to detect open circuit conditions.When the system controller compared the current in the fractured red wire to its redundant motor phase wire, the fractured inner conductors of the red wire would have resulted in the driveline fault alarms captured in the first submitted log file.Furthermore, if the exposed conductors of the red wire contacted the braided shield while operating on a tethered power source such as the power module or mobile power unit, the resulting short to ground would have resulted in the low speed and pump stop events from (b)(6) 2020 that were confirmed through the first submitted log file.The portion of the driveline returned with (b)(6) was tested for electrical continuity and all wires were found to be electrically intact.Visual inspection of driveline wires revealed no obvious signs of breaches or damage to the wire insulation or underlying conductors.The returned portion of the driveline was then submerged in a saline bath for high potential testing to verify the integrity of each wire¿s insulation.The test did not reveal any areas of current leakage in the insulation of any of the driveline wires.No internal wire damage was observed that would have contributed to the reported low speed events captured in the second submitted log file following the driveline repair.The pump was reassembled and functionally tested under normal operating conditions using 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.The heartmate ii lvas ifu, and the heartmate ii patient handbook are currently available.Sections 6 and 8 of the hmii ifu, as well as sections 4 and 6 of the hmii patient handbook, provide information regarding how to care for the driveline and address damage due to wear and fatigue of the driveline.These sections 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 sections outline indications of driveline damage as well as the how to respond to such events.Furthermore, section 7 of the hmii ifu and section 5 of the hmii patient handbook address all hazard and advisory alarms, as well as how to respond to each alarm condition.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 26may2017 via customer order (b)(4).No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11084009
• MDR Text Key: 224754676
• Report Number: 2916596-2020-06168
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: 00813024011996
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 6536306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 111