It was reported that the patient was implanted with a heartmate 3 on (b)(6) 2020.The case was uneventful and the patient was extubated the next morning.The patient was transferred from the intensive care unit (icu) to a step down unit shortly after.The patient had a stroke prior to the pump implantation.The patient developed signs of an ischemic stroke again.On (b)(6) 2020, the nurses noted a flow drop from around 4 liters per minute (lpm) to 0 lpm, then back to 4 lpm.The patient had pain in his left leg at the time of the flow drop.The patient had a computed tomography (ct) scan.A review of the ct scan noted that the outflow graft did not show contrast, the left leg artery was occluded, and the patient had a small lung embolism.The patient had acute pump thrombosis 11 days after initial implantation with peripheral leg embolism and segmental pulmonary embolism despite anticoagulation.The account decided to exchange the pump.The patient was heparin-induced thrombocytopenia (hit) positive so the procedure was done with flolan and heparin.The thrombus from the left leg artery was removed and the pump was replaced without issues.The anesthetist noticed that the patient had a coagulation disorder while checking the thromboelastography (teg).The patient had hypercoagulopathy.The device was occluded in the inflow and the outflow.Pictures of the pump and outflow graft and ct scan images were provided.The pump will be returned.
|
Manufacturer's investigation conclusion: the reported event of suspected thrombus was confirmed through the evaluation of the returned device and submitted photographs.However, the account reported that the patient had a coagulation disorder.Furthermore, a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reports of a stroke and embolisms could not conclusively be established through this evaluation.(b)(6) was returned assembled with the pump cable severed approximately 7¿ from the pump header.The remaining distal end of the pump cable and the modular cable were not returned.The sealed outflow graft conduit (outflow graft, outflow graft bend relief) was returned detached from the pump cover outlet port.The outflow graft clip was also returned detached from the device.The apical cuff was not returned.Upon disassembly of the returned device, a soft, loose, dark red deposition of coagulated blood was observed within the distal end of the inflow cannula which appeared to extend into the rotor prior to disassembly.The deposition was not strongly adhered and did not reveal evidence of laminated layering.Additionally, similar soft, dark red depositions of coagulated blood were observed within the pump cover above the rotor, with a slightly more tissue-like deposition within the eye of the rotor and extending into the rotor vanes.The lack of structure of these depositions suggests that they developed acutely, with the loosely coagulated depositions likely forming due to poor surface washing as a result of the decrease in flow confirmed through the evaluation of the retrieved left ventricular assist device (vad) log files.Furthermore, the account submitted several photographs for review, which showed a deposition of coagulated blood within the outflow graft during surgery.This deposition appears to be similar to the observed depositions within the inflow cannula/rotor well and pump cover.The retrieved lvad event log file contained data on (b)(6) 2020 from 10:08:59 through 20:58:18.Starting at 15:22:44, the flow began to quickly decrease down to 0 lpm.The lvad temperature, as well as the rotor noise were noted to increase during the low flow events.(b)(6) was cleaned, reassembled, and functionally tested on a mock circulatory loop.The device functioned as intended and in accordance with manufacturing specifications.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 was shipped on 27nov2020.The heartmate 3 left ventricular assist system (lvas) instruction for use (ifu) is currently available.Section 1 of this document lists stroke, pump thrombosis, and arterial non-central nervous system (cns) thromboembolism as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 entitled ¿patient care and management¿ also lists thromboembolism as a potential late postimplant complication.Section 1 provides an explanation of all pump parameters, including flow.Section 4 provides information for the system monitor describing the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm).The ifu explains that changes in patient conditions can result in low flow.Section 5, "surgical procedures" (under ¿preparing the ventricular apex site¿), instructs to inspect the ventricular chamber for mural thrombi and crossing trabeculae following removal of the core and to address one or both, as needed.Furthermore, section 5, under ¿implant procedures¿, warns to inspect the ventricle and remove any previously formed clots that may cause embolism or any trabeculae that may impede flow.Section 6 entitled ¿patient care and management¿ provides information regarding anticoagulation, including recommended international normalized ratio (inr) values.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.The heartmate 3 lvas patient handbook is also currently available.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 this event.
|