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

Model Number 106015

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503); Obstruction of Flow (2423); Low Readings (2460)

Patient Problems Thrombus (2101); Thrombosis/Thrombus (4440)

Event Date 08/27/2020

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 pump stoppages were observed.Technical services reviewed the submitted log files, and pump stoppages and pump decelerations were confirmed.A pump exchange was performed.

Event Description

It was reported that the patient received a pump exchange on (b)(6) 2020.It was reported that the patient was recovering well.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the evaluation of the returned portion of the driveline confirmed wire damage that would have contributed to the reported pump stop event that was captured in the submitted log file.(b)(6) was returned assembled with the driveline cut approximately 0.5 inches from the pump housing and approximately 37 inches of the distal portion of the dl was also returned.All parts of the sealed inflow conduit (the inlet tube, inflow conduit flex section, and inlet elbow) were returned.The inlet elbow was attached to the pump.The sealed outflow conduit was returned attached to the pump outlet housing.The bend relief and bend relief collar was returned detached from the pump.Visual examination of the pump¿s blood-contacting surfaces upon disassembly of (b)(6)revealed no evidence of developed depositions or developed thrombus formations.The disassembled pumps bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies were observed.Electrical continuity testing of the driveline did not reveal any discontinuities or shorts.However, examination of the dl (37 inches) revealed breaches to the insulation of the black, brown, red, orange, yellow, and green wires was found approximately 8 inches through 8.5 inches from distal end driveline repair confirmed through hipot testing (figure 4).An additional breach to the insulation of the yellow wire was found approximately 7 inches from the distal end driveline repair.The observed wire damage appeared to be the result of wear and tear due to repetitive flexing.The yellow and green wires redundantly support motor phase 1, black and brown wires redundantly support motor phase 2, and the red and orange wire redundantly supports motor phase 3.The remainder of the dl was submerged in a saline solution for hi-pot testing to further verify the integrity of each wire's insulation.This test did not reveal any additional areas of current leakage.The yellow and green wires redundantly support motor phase 1, black and brown wires redundantly support motor phase 2, and the red and orange wire redundantly supports motor phase 3.If the exposed conductors of the black, brown, red, orange, yellow, and green wires contacted the braided shield and electrically shorted to ground while the patient was supported by a tethered power source, such as the power module or the mobile power unit.The wire damage could have also resulted in a pump stoppage if the exposed conductors from two or more of the wires, from different phases, 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 submitted log files contained data from (b)(6) 2020 to (b)(6) 2020.A momentary pump stop event, and associated alarms, were captured on (b)(6) 2020 at 15:26:21.The event occurred while the system was operating on battery power.Based on previous complaint experience, the captured events appear consistent with a potential driveline wire compromise.41 pi events were also recorded throughout the log file.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 shipped on (b)(6) 2013.The most recent revision of the heartmate ii instructions for use (ifu) is rev.C.Section 1 of this ifu contains information regarding definitions and usage of pump speed, power, flow, and pulsatility index (pi).Additionally, section 6 of this document explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.The section "system operations" describes the "driveline" and outlines indications of driveline damage as well as how to respond to such events.The section "equipment storage and care" describes "care of the driveline." the section "alarms and troubleshooting" outlines alarms and how to respond to them, including pump stops and low speed events.The heartmate ii left ventricular assist system (lvas) patient handbook, rev.C is currently available.Section 4 of this handbook contains a section on ¿caring for the driveline;" however, all heartmate ii left ventricular assist device (lvad) drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and movement/flexing over time.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: 10528831
• MDR Text Key: 206791506
• Report Number: 2916596-2020-04370
• 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,Followup
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2016
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 93