(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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 similar incidents from this lot.The investigation determined the reported resistance during advancement and patient effect appears to be related to circumstances of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.
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It was reported that the patient presented with unstable angina.The procedure on (b)(6) 2017 was to treat a lesion located in the distal left anterior descending (lad) artery with soft calcification, long stenosis, ectatic vessel and 85% stenosis.Vessel sizing was performed with angiography and determined to be 3 mm in diameter.Predilatation was performed with two semi-compliant balloons (2.0x30 and 2.5x30) with residual stenosis reduced to less than 40%.After vessel preparation, a 3.0x23mm absorb was advanced to the distal part of the lesion with some difficulty in deliverability causing a plaque shift; however, there were no adverse patient effects.The procedure was successfully completed with 2 absorb overlapped to treat the plaque shift and more proximal area of the lesion.There was a good final patient outcome.There were no reported adverse patient effects or clinically significant delay in procedure.No additional information was provided.
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