Event date: estimated dates.Unique device identifier (udi#): in the absence of a reported part number, the udi cannot be calculated.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 intimal dissection, angina and occlusion, are listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use, as known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the information reviewed, a conclusive cause for the patient effects could not be determined.The treatment appears to be related to the circumstances of the procedure.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 u.S.Attached article: "routine use of optical coherence tomography in bioresorbable vascular scaffold implantation: insights on technique optimization and long-term outcomes".
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It was reported in a research article that absorb bioresorbable vascular scaffold (bvs) can be related to angina, dissection, jailing of a side branch and intervention.Additional details can be found in the attached article "routine use of optical coherence tomography in bioresorbable vascular scaffold implantation: insights on technique optimization and long-term outcomes".
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