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 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

Section e: this event occurred at (b)(6) hospital in (b)(6).No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that there were multiple low speed operations recorded.The patient was asymptomatic.The log file review captured a lone low speed operation while using the mobile power unit (mpu) which was noted to be as low as 5520 rotations per minute.The patient visited the hospital and log files were obtained for concern of possible driveline damage.No driveline damage was confirmed.A pump replacement would be considered if the alarms returned.

Manufacturer Narrative

Section d4 (catalog number): corrected.Manufacturer's investigation conclusion: evaluation of heartmate ii left ventricular assist system (lvas), serial number (b)(6), confirmed driveline wire fatigue.The pump was returned assembled with the driveline cut approximately 8¿ from the pump housing, and the distal portion of the driveline was returned measuring approximately 30¿.The outflow elbow was returned attached to the pump outlet port.The sealed inflow conduit, apical sewing ring, sealed outflow graft, and sealed outflow graft bend relief were not returned.Upon disassembly of the pump body, visual inspection of the pump¿s blood-contacting surfaces revealed no evidence of adhered depositions or thrombus formations.Electrical continuity testing of the returned portion of the driveline did not reveal any discontinuities or shorts.The layers of the driveline were removed for evaluation.Breakdown of the metal braided shield was intermittently noted in the approximately 30¿ distal portion of driveline.Wire insulation damage was discovered in the black, red, and orange wires approximately 10¿ from the pump body.The insulation damage appeared consistent with fatigue due to repetitive flexing of the driveline and abrasion of the wires with the metal braided shield layer.The wire insulation damage could have caused the low speed events while the device was connected to the mpu.The pump underwent cleaning, reassembly, and functional testing under load conditions using a mock circulatory loop and a test driveline as the distal section of driveline had wire damage.The retrieved data revealed pump power consumption and pressure values that met manufacturing specification.The pump operated as intended during the functional testing on a mock loop.The relevant sections of the device history records for (b)(6) and the driveline, serial #(b)(6), were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) rev.B is currently available.Section 6 ¿patient care and management¿ discusses damage due to wear and fatigue of the driveline.This section also contains information on ¿caring for the driveline¿ (under ¿ongoing system assessment and care¿) and provides possible indications of driveline damage as well as how to respond to such events.Section 7 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.Section 8 ¿equipment storage and care¿ also contains information on ¿care of the driveline,¿ and provides possible indications of driveline damage.The heartmate ii lvas patient handbook, rev.D, is also currently available.Section 4 ¿living with the heartmate ii¿ contains information on caring for the driveline.Section 5 "alarms and troubleshooting" outlines all system controller 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

An additional set of log files was sent for review after multiple low speed operations were recorded again on 31dec2023 during the morning and night while the patient was at home and at rest, they were still asymptomatic.The patient visited the hospital on (b)(6) 2024 and log files captured 13 low speed advisories with speed drops as low as 5520 rpm.The cause was not clear but driveline damage was suspected and the patient was under outpatient management.There was an alarm with a slowdown suggesting a break in the wire.The patient underwent a heartmate ii pump exchange on (b)(6) 2024 due to low speed advisory alarms and driveline damage.The patient remained in the hospital, and it was noted that the patient did not suffer hemodynamic compromise.The patient was discharged on (b)(6) 2024.

• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18407164
• MDR Text Key: 331862129
• Report Number: 2916596-2023-08747
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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: 11/09/2021
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 7034592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2019
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 65 KG