(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).A partial udi is reported because the lot number was not provided.It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation concluded that a definitive cause for the reported inaccurate delivery and subsequent patient effects could not be determined.It should be noted that the reported patient effects of perforation and hypotension are addressed as known observed and potential patient effect as listed in the absolute pro instruction for use (ifu).Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The 8x80mm absolute pro device referenced is filed under a separate manufacturing report number.
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It was reported that an 8x100 absolute pro stent jumped 4-5 cm during stent deployment at the iliac artery lesion into the descending aorta.Reportedly, there were no issues noted during deployment and part of the stent remained partially at the lesion site.An 8x80mm absolute pro stent was successfully implanted, overlapping the 8x100mm at the external iliac artery lesion without issue.Post procedure, the patient became hypotensive.Angiography was performed and a perforation occurred in the common iliac.Per physician, either stent could have caused the perforation.A non-abbott covered stent treated the perforation successfully.The patient is in stable condition.There was no additional information provided.
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