(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Date of implant: (b)(6) 2013: electrocardiogram=no myocardial infarction; (b)(6) 2013: troponin i=0.48 ng/ml, upper reference limit 0.09.Though the device is not approved for sale in the u.S., it uses a delivery system which is similar to a device sold in the u.S.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.The reported patient effects of angina and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use (ifu), are known adverse events associated with the use of a coronary scaffold in native coronary arteries.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 and 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.
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It was reported that on (b)(6) 2013, a 3.5x28mm absorb bioresorbable vascular scaffold (bvs) was successfully implanted in the proximal left anterior descending (lad) coronary artery lesion.On (b)(6) 2016, the patient started experiencing chest pain.Imaging was performed and on (b)(6) 2016, the patient was admitted to the hospital for another percutaneous intervention.Balloon angioplasty was performed in the proximal lad, restenosed lesion and medication was provided.On (b)(6) 2016, the patient was discharged from the hospital.There was no additional information provided.
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