(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The absorb 3.0 x 23 mm scaffold referenced is being filed under a separate manufacturer report number.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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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 the procedure was to treat a lesion located in the proximal, mid and distal left anterior descending (lad) artery with heavy calcification.Predilatation was performed and a 2.5x28mm absorb was placed in the distal lad.The placement was successful and uneventful.Then a 3.0x23mm absorb was placed in the mid lad.The placement was successful and uneventful.A 3.5x28mm absorb was advanced to the proximal lad and was placed overlapping the 3.0x23mm absorb with 9 atmospheres, one inflation for 30 seconds.While overlapping there was a hematoma that was seen in the overlapping area.A 3.0x28 xience alpine was then placed in the overlapping area successfully.There was no clinically significant delay in the procedure.The patient was doing fine and was later discharged.No additional information was provided.
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