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Manufacturing site: manufacturing site could not be determined because the product lot number information was not available.Device investigation could not be performed because the device was not returned.Investigation of production records could not be performed because lot information was unavailable.Although lot history record review could not be performed, all the shipped products were inspected in the production process for meeting the product specifications and release criteria; therefore, it was concluded there was no indication of product deficiency.How the microcatheter had contributed was unable to identify as it was not specified in this case report.Considering the event description, it was presumed that patient anatomical conditions and operator's techniques had most likely contributed to the reported dissection.It was concluded that this event was not attributed to product quality.Instructions for use (ifu) states: [warnings] do not use this microcatheter in advanced calcified lesion; [warnings] if any resistance or something abnormal is felt when operating this product, do not continue the operation while the causes are unclear.If it is suspected that the product is not operating correctly, avoid excessive manipulations, and carefully remove the entire catheter system while paying full attention to avoid complications.(continuing the operation while the cause of the problem is not identified may cause damage to or separation of the catheter, and damage the blood vessel.Life-threatening adverse events may occur.); [warnings] the microcatheter must always be operated under high-resolution fluoroscopic guidance.Particular attention should be paid when inserting or withdrawing the microcatheter into stenotic areas and narrower vessels than the product.(abrasion may result in damage or separation of the microcatheter.This may cause vascular injury and perforation, possibly leading to a life-threatening adverse event.); [malfunction and adverse effects] vessel dissection.
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According to literature titled "combined use of excimer laser and high-speed rotational atherectomy to overcome a severely calcified lesion in endovascular therapy" in case reports in vascular medicine (volume 2019, article id 1719035), an asahi corsair pv microcatheter and a caravel microcatheter were used in an evt where severe vessel dissection occurred; which device had contributed to the dissection was unspecified.Breakage of the corsair pv microcatheter was also mentioned.The case was presented as follows: since echography also indicated moderate stenosis of the bilateral iliac arteries, we initiated evt in the right sfa-cto using the contralateral approach.The first angiogram revealed the severely calcified sfa-cto (figure 1; video clip s1).The antegrade approach with the stiff cto wire resulted in the subintimal wiring.Therefore, we used the bidirectional approach with direct distal-sfa puncture.Finally, the retrograde-antegrade rendezvous technique led to wire externalization (figure 2; video clip s2).Regardless of the strong back-up force by wire externalization and child catheter support, no devices were able to pass the lesion by the antegrade and retrograde approaches and the thin balloon catheter was bent, corsair microcatheter (asahi intecc, (b)(4)) was fractured, crosser system (c.R.Bard, (b)(4) usa) could not pass the lesion, and needle cracking technique [6] from outside and inside of the vessel could not modify the lesion fully.Despite using all these techniques, a minimal balloon could not pass the lesion (figure 3).We consider abandonment and elective surgical conversion; however, bleeding from the retrograde puncture point and needle cracking techniques was uncontrollable.Therefore, we had to cross the lesion to perform balloon-assisted hemostasis.Hence, we applied the ela using the turbo elite 0.9 mm (spectranetics, co., usa).This device also could not pass the lesion; however, it modified the cto entry-morphology (figure 4(a)).After ela ablation, the caravel microcatheter (asahi intecc) finally crossed the lesion using an antegrade approach with the balloon deployment using forcible manner (badform) technique [7] (figure 4(b)), which enabled change of the wire from conventional the 0.014- inch wire to 0.009-inch rotawire floppy (boston scientific) and rotalink plus 1.5mm burr ablation (boston scientific) (figure 4(c)).Thereafter, we dilated the entire sfa lesion with conventional balloons and simultaneously achieved hemostasis of the distal-sfa puncture point.A bare nitinol stent was deployed due to severe dissection of the partial sfa.The final angiography revealed acceptable result without delay in blood-flow or bleeding complications (figure 5; video clips s3 and s4).Thereafter we treated the bilateral iliac arteries using the bare nitinol stents.The right abi of the patient improved from being unmeasurable to 0.79, and his intermittent claudication disappeared.His abi and symptom has remained satisfactory eight months after current evt.
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