(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The udi# is unknown because the part number and lot number were not provided.The three additional absorb scaffolds referenced, are being filed under separate manufacturer report numbers.The absorb device is currently not commercially available in the u.S; however, it is similar to a device sold in the us.The device was not returned for evaluation.A review of the lot history record and complaint history could not be conducted because the part and lot numbers were not provided.The reported patient effects of angina and restenosis, as listed in the absorb instructions for use (ifu), are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.
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It was reported that index procedure on (b)(6) 2015 was performed at (b)(6) on a patient with coronary artery disease.Four absorb scaffolds were implanted in the left anterior descending (lad) and left circumflex (lcx) vessels.On (b)(6) 2016, the patient experienced chest pain and had a re-intervention at the (b)(6).Intravascular ultrasound (ivus) showed the lad scaffold(s) undersized with heavy plaque.The lcx scaffolds were, was totally occluded with restenosis and the lad scaffolds had 80% restenosis.Three drug eluting stents were implanted for treatment with a good final patient outcome.No additional information was provided.
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