The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacture record evaluation cannot be conducted because no lot number was provided by the customer.Manufacturer's ref.# (b)(4).
|
It was reported that a female patient ((b)(6) lb) underwent an idiopathic ventricular tachycardia (idvt) ablation procedure under general anesthesia using stereotaxis and a navi-star¿ rmt electrophysiology catheter and suffered cardiac arrest, heart failure and death.Patient was noted to have a rapid heart rate thought to be related to atrial arrhythmia.Plan was for an av node ablation and placement of a bi-ventricular pacemaker.Prior to planned procedure, it was discovered that the patient had in fact a slow ventricular tachycardia with more ventricular electrograms than atrial electrograms.After undergoing anesthesia, the patient converted to sinus rhythm.Decision was made to perform a bipolar map of the lv to look for regions of scar.There were no noted low voltage regions.Areas of double potentials were targeted.A small number of lesions were placed (approximately 10-15) and there was no evidence of impedance rise or product malfunction.Temperature was set at 45 degrees celsius.Procedure was completed, and patient was awakening from anesthesia.About one hour after the case was completed, the patient coded, and the blood pressure dropped.Bedside echocardiogram did not reveal any pericardial effusion.Multiple rounds of cardiopulmonary resuscitation (cpr) were administered, an unspecified medication was also administered, and the patient¿s blood pressure recovered.About 30-45 minutes later, the patient coded again.Echocardiogram was called back and again revealed no effusion though right ventricle was not moving properly.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition-related, the patient had been through a lot in the last 8 days of being in a slow vt storm and shocked 4 different occasions with multiple shocks in those settings.Patient passed away later that evening.Physician believed that patient may have suffered a myocardial infarction; however, the autopsy report revealed the death was due to right ventricle failure, most likely after being in vt for 8 days when anesthesia put her under for the procedure she went into normal sinus rhythm and her heart was finally able to rest and with the weakened right ventricle (rv) she went into flash pulmonary edema.
|