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

Model Number 106015

Device Problem Obstruction of Flow (2423)

Patient Problems Thrombosis (2100); Obstruction/Occlusion (2422)

Event Date 12/01/2020

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 the patient underwent a pump exchange on (b)(6) 2020 due to device thrombosis.The device did not operate as expected.The patient was discharged home after the device exchange.

Manufacturer Narrative

This event was determined to be a duplicate to mfr.#2916596-2020-06068.Manufacturer's investigation conclusions from 2916596-2020-06068: the evaluation of heartmate ii left ventricular assist system (lvas), serial number: (b)(6), identified a compromised driveline that could have contributed to the pump stop and low speed events.(b)(6) was returned with the driveline severed approximately 3.5¿ from the pump housing, and a distal portion, measuring approximately 13.5¿ in length, was also returned.The sealed inflow conduit (inlet elbow, flex section, and inlet extension) was returned.The sealed outflow graft, bend relief, and bend relief collar were returned attached to the outlet elbow.The outlet elbow was returned attached to the outlet port.Examination of the blood-contacting surfaces revealed no evidence of depositions or thrombus formations.The driveline was severed approximately 3.5¿ from the pump housing, and a distal portion, measuring approximately 13.5¿ in length, was also returned.Upon removal of the outer silicone sleeve, visual examination of the bionate layer was unremarkable.An electrical continuity test of the returned pump end and distal portion of driveline was conducted, and variation in the resistance of the black, brown, red, orange and green wires was found upon manipulation of the distal portion of returned driveline.The pump end driveline was found to be electrically intact, event with manipulation of the driveline.No wire-to-wire or wire-to-shield shorts were induced for the pump end driveline.The bionate was removed and revealed a large area of shield breakdown approximately 2¿-4¿ and 6¿ from the pump side of the returned distal portion of driveline.The shielding was removed, and visual and microscopic inspection of the underlying wires revealed wear/damage to the insulation of the black, brown, red, orange and green wires exposing the internal conductors.Visual and microscopic inspection of the remaining underlying wires of the distal returned driveline and 3.5¿ of pump end returned driveline revealed no damage/breaches to the insulation.The wires were submerged in a saline solution for high potential testing to further verify each wire¿s insulation.The test did not identify any additional breaches.The observed breaches to the black, brown, red, orange and green wires had the potential to result in a pump stoppage if the exposed conductors contacted the braided shield and electrically shorted to ground while the patient was supported by a tethered power source, such as a power module or mobile power unit.The insulation breaches also had the potential to result in a pump stoppage if the exposed conductors from the two wires made direct contact with each other or simultaneous contact with the braided shield while the patient was supported by 14 volt lithium-ion batteries or an ungrounded 14 volt power module patient cable.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump was shipped on 08oct2014.The heartmate ii left ventricular assist system (hmii lvas) instructions for use (ifu) is currently available.The section entitled ¿pump performance monitoring¿ under patient care and management covers wear and tear to the percutaneous lead.Section 7, titled ¿alarms and troubleshooting¿, addresses all system controller alarms (including driveline fault, low speed advisory, low flow hazard, and pump off alarms) and how to respond to such events.Additionally, this ifu lists hemolysis as an adverse event that may be associated with the use of heartmate ii left ventricular assist system.This ifu also outlines the recommended anticoagulation therapy and international normalized ratio range.The hmii 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.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11095452
• MDR Text Key: 224403508
• Report Number: 2916596-2020-06509
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR
• Patient Weight: 139