The device will not be returned for investigation.Response letter is required.Event term: balloon damaged (remained in the body) treated lesion: sfa, 100% stenosed, h calcified, s tortuous.The physician performed pre-dilation of the lesion with the product, placed two eluvia 6.0x120 mm, and then performed post-dilation using the product again.Then the balloon was ruptured and got stuck in the stent placed.The physician was able to solve the stack and remove it from the stent by anterogradely inserting a guiding sheath and then crossing a small-diameter balloon beside the damaged product and expanding it.However, the physician was unable to retrieve the product which was removed from the stent into the guiding sheath, so that having the balloon pulled to the eia, he had no choice but placed the e-luminexx with sandwiching the product, therefore a part of the product remained in the body.Since then, the patient's condition has been stable.The physician commented about this event, "i'm not sure if the cause was a product defect.I want to know omkk's view on the causes regarding the balloon rupture and the stacking.".
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