Date of event: estimated.Date of implant: estimated.The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed because the product was not returned for evaluation and the lot number was not reported.The reported patient effects of dissection, perforation and pain are listed in the rx herculink elite instructions for use as known patient effects associated with the use of the device.Based on the case information, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.Article title: covered stents in renal artery interventions.
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It was reported through a research article that a herculink stent was implanted in the calcified right renal artery without issue; however, a dissection was noted.No treatment was provided.While observing the patient post procedure, the patient complained of abdominal pain and angiography noted free flow of contrast.A 5.5x15mm balloon was inflated to tamponade the bleed.There was no reported adverse patient sequela.Details are listed in the article, titled ¿covered stents in renal artery interventions¿.
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