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

Model Number 107801

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503); Electrical Shorting (2926)

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

Event Date 03/24/2021

Event Type  Injury  

Manufacturer Narrative

Pre-existing ¿short to shield¿ driveline issue reported on (b)(6) 2020 has been reported in mfr# 2916596-2021-01886.

Event Description

It was reported that patient came went to the emergency department (ed) for pump stops.Log file analysis showed 39 pump stops and 17 low speed advisories intermittent on (b)(6) 2021 through (b)(6) 2021.Speed drops were as low as 0 rpm.It was also noted that patient has a pre-existing ¿short to shield¿ driveline issue reported on (b)(6) 2020 which appeared to have progressed to a "phase to phase" driveline issue.The patient was issued an unshielded patient cable on (b)(6) 2020.Additional information stated that patient has been transferred by air to primary lvad (left ventricular assist device) center where patient is listed for transplant.Fortunately, patient didn¿t have any pump stops while in the ed.Patient was sent off on heparin drip and on battery power.Dobutamine was available on aircraft, if needed.Driveline was also taped with tongue depressors.

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent heart transplant on (b)(6) 2021.

Manufacturer Narrative

Manufacturer's investigation conclusion: although the reported pump stop events, as well as associated alarms, were confirmed via the submitted log file, the report of a suspected driveline (dl) issue could not be confirmed during the evaluation of (b)(6).The submitted log files contained data from (b)(6) 2021 to (b)(6) 2021.Momentary pump stop events, and associated alarms, were captured on (b)(6) 2021 at 16:26:46, (b)(6) 2021 between 09:11:26 and 10:59:18, (b)(6) 2021 between 11:32:27 and 11:48:19, (b)(6) 2021 between 13:29:16 and 13:29:21, (b)(6) 2021 between 17:31:10 and 17:32:22, (b)(6) 2021 at 18:44:50, (b)(6) 2021 at 01:54:45, (b)(6) 2021 between 03:11:53 and 04:26:54.Each of the events occurred while the system was operating on both batteries and power module.Based on previous complaint experience, the captured events appear consistent with a potential driveline wire compromise.(b)(6) was returned assembled with the driveline (dl) cut approximately 11.5¿ from the pump housing and the distal portion of the dl was not returned (figure 1).All parts of the sealed inflow conduit (the inlet tube, inflow conduit flex section, and inlet elbow) were returned.The inlet elbow was detached from the pump.The sealed outflow conduit was returned attached to the pump outlet housing.The bend relief collar was also present.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.Visual inspection of the driveline did not reveal any damage to the insulation of the wires.The driveline was submerged in a saline bath for hipot testing to check for current leakage through each wire's insulation.The test did not reveal any insulation breaches that could have contributed to an electrical short.The pump was cleaned, 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 specifications and the device functioned as intended.Heartmate ii lvas patient handbook is currently available.Section 4 of this 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 movement/flexing over time.Additionally, the heartmate ii lvas ifu is also available.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.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) 2018.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: 11710004
• MDR Text Key: 246805157
• Report Number: 2916596-2021-01814
• 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: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2020
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 6323658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 131