It was reported that the patient had an arterial peripheral thromboembolism (apt) on (b)(6) 2022.A transesophageal echocardiogram (tee) revealed a small mobile thrombus on the ventricular side of the aortic valve.Thrombus density was.8cm.Aortic valve density was not observed.On (b)(6) 2022, deep vein thromboses in the right internal jugular, subclavian, and brachial veins were seen on an ultrasound.On (b)(6) 2022 the patient had 30 cc's of clear fluid aspirated from their right knee.Additional information revealed the implantable cardioverter-defibrillator gave the patient an inappropriate shock after the patient went into atrial fibrillation with rapid ventricular rate (af rvr).
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Manufacturer's investigation conclusion a direct correlation between the device and the reported peripheral thromboembolism and cardiac arrhythmia could not be conclusively determined through this evaluation.Privacy laws prohibit the customer from providing further information regarding the case.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), (b)(6).No product is available for investigation.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.C lists venous thromboembolism, arterial non-central nervous system (cns) thromboembolism, and cardiac arrhythmia as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.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.This section also states that pump function will be compromised in the presence of inlet obstruction.Section 5 (under ¿implant procedures¿) additionally warns to inspect the ventricle and remove any previously formed clots that may cause embolism or any trabeculae that may impede flow.Section 6 "patient care and management" (under "anticoagulation") contains information regarding the recommended anticoagulation therapy for patients using the device.The relevant sections of the device history records for (b)(6) was reviewed and showed no deviations from manufacturing or quality assurance specifications.The mod cable shipped on 23feb2022.No further information was provided.The manufacturer is closing the file on this event.
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