It was reported that the patient presented with severe multivessel coronary artery disease and the procedure was performed to treat a heavily calcified, stenosed lesion at the bifurcation of the left main artery into the ramus intermedius and circumflex artery.A 3.0x38 mm xience sierra stent was deployed successfully at 18 atmospheres at the left main to ramus intermedius artery.Post dilatation was then performed at the bifurcation using the kissing balloon (dilatation) technique with a non-compliant unspecified balloon dilatation catheter (bdc) and a 3.5 x12 mm trek bdc at 8 atmospheres.During inflation, the balloon of the trek bdc ruptured causing a dissection.The patient developed hypotension, bradycardia, and ultimately pulseless electrical activity.Medication was administered and cardiopulmonary resuscitation (cpr) was performed.Angiogram showed timi grade 0 flow.Air emboli was suspected and an air bubble was aspirated.Timi flow was restored back to grade 3 and the patient stabilized quickly.The patient was transferred to the intensive care unit.No additional information was provided.
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Exemption number e2019001.The device was returned for analysis.The reported balloon rupture was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents/complaints from this lot.The reported patient effects of intimal dissection, embolism and hypotension are listed in the coronary dilatation catheters (cdc), trek rx and mini trek rx, global instructions for use, as known patient effects.There is no indication of a product quality issue with respects to the design, manufacture, or labeling of the device.The investigation determined the reported balloon rupture appears to be related to operational context as it is likely that the balloon interacted with the previously implanted stent such that the balloon became damaged and ruptured during inflation.A conclusive cause for the reported patient effects of intimal dissection, air embolism, bradycardia, cardiac arrest ekg/ecg changes and hypotension and the relationship to the product, if any, cannot be determined.
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