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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Tachycardia (2095); Hernia (2240); Presyncope (4410); Gastrointestinal Hemorrhage (4476); Stomach Ulceration (4488)

Event Date 09/22/2023

Event Type  Injury  

Event Description

It was reported that the patient was admitted for gastrointestinal bleeding as well as arrhythmias.A review of the log files revealed the pump fixed speed was reduced from 9600rpm to 9400 rpm on (b)(6) 2023.There was low speed advisory alarms on (b)(6) 2023 from 1530 through to 1753 while using the power module.The patient had a known intermittent short-to-shield condition.

Manufacturer Narrative

Short to shield captured under mfr #2916596-2017-02639.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 was admitted for gastrointestinal bleeding as well as arrhythmias on (b)(6) 2023.The source of the bleeding was confirmed with an upper gastrointestinal endoscopy.White nummular lesions in esophageal mucosa, a 4cm hiatal hernia, and several patchy erosions in the patient's stomach were found.The bleeding spontaneously resolved.The patient experienced palpitations and pre-syncopal episodes associated with non-sustained ventricular tachycardia.The patient had a history of arrhythmia prior to left ventricular assist device (lvad) implantation, they had an atrioventricular implantable cardioverter-defibrillator placed in 2006.Although the arrhythmia resolved, plans were made for ventricular tachycardia ablation.An interrogation of the controller on (b)(6) 2023 revealed more frequent pump power and flow spikes.There were no alarms noted.A review of the log files revealed the pump fixed speed was reduced from 9600 rpm to 9400 rpm on 2(b)(6) 2023.Additionally, an upward trend in pump power and flows starting on (b)(6) 2023 was found.These elevations were thought to be due to packed red blood cells and/or iron infusions.The patient had a transthoracic echocardiogram, a chest computed tomography angiography, an electrocardiogram, and an lvad ramp study performed to determine the cause of the upward trend.However, the patient's lactate dehydrogenase and plasma hemoglobin levels were negative for hemolysis and there was no evidence of thrombus in the imaging.Pump powers were elevated as high as 14 w.Additional log files captured low speed advisory alarms on (b)(6) 2023 from 15:30 through to 17:53 while using the power module.The patient had an intermittent short-to-shield condition.A percutaneous lead repair was scheduled for (b)(6) 2023 but was ultimately not performed due to the patient not wanting the repair, due to the distance from the exit site to the repair area.The patient was placed on an ungrounded cable and a power module.The patient was later readmitted on (b)(6) 2024.The patient had two pump stops and a low speed advisory alarm on (b)(6) 2024 at 11:33 while on battery power, indicating a phase to phase short.The pump was exchanged on (b)(6) 2024.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed the reported low speed and pump stop events.Although a specific cause for these events could not be conclusively determined through the evaluation of (b)(6), based on previous complaint history, the abnormal pump operation appeared to be consistent with potential driveline wire compromise.Review of the submitted log files also confirmed elevations in pump power and flow; however, a specific cause for these elevations could not be conclusively determined through this evaluation.Additionally, a direct correlation between the evaluation of heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6), and the reported bleeding and arrhythmia could not be conclusively determined through this evaluation.(b)(6) was returned assembled with the driveline severed approximately 1.5¿ from the pump housing.The severed distal end portion was not returned.The sealed inflow conduit (inlet tube, flex section, and inlet elbow) was returned attached to the pump¿s inlet port.The sealed outflow graft and bend relief were not returned.The outflow elbow was attached to the pump¿s outlet port.Upon disassembly of the returned pump, examination of the pump blood-contacting surfaces revealed no adhered depositions or thrombus formations.The returned portion of driveline was tested for electrical continuity and all wires were found to be electrically intact.No wire-to-wire or wire-shield shorts were induced during testing.The bionate layer and metal shielding of the pump end portion appeared unremarkable.Microscopic inspection of the underlying wires of the returned portions of the driveline portion revealed that they were free from any insulation breaches or damage.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.The returned pump bearings, rotor, and blood-contacting surfaces were examined under a microscope and no anomalies related to wear or damage were observed.The pump was cleaned, reassembled, and functionally tested under load conditions.The device was connected to a mock circulatory loop, and the retrieved data showed normal pump power consumption and pressure measurements that were within the manufacturing specification.The pump operated as intended.The heartmate ii lvas ifu, rev.C, and the heartmate ii patient handbook, rev.C, are currently available.Section 1 of the ifu lists bleeding and cardiac arrythmia as adverse events that may be associated with the use of the heartmate ii lvas.Section 1 of the ifu also addresses pump parameters including pump power and pulsatility index (pi).This section explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.In addition, device flow and power generally retain a linear relationship at a given speed.This section also notes that any increase in power not related to increased flow causes erroneously high flow readings.Section 4 of the ifu states that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events may be initiated for reasons other than true pi events, including sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.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.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).Section 6 of the ifu, under ¿pump performance monitoring¿, further explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.This section also lists arrhythmia as a potential late postimplant complication.Section 6 of the ifu, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation therapy and inr range, as well as suggested anticoagulation modifications.Section 7 of the ifu and section 5 of the patient handbook address 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) and the driveline, serial numbers (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d1 brand name: corrected section d4 lot number: corrected section d4 catalog number: corrected section d4 primary udi number: corrected.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17908728
• MDR Text Key: 325338408
• Report Number: 2916596-2023-07093
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 80 KG