Age or date of birth: mean age.Sex: majority sex.Date of event, implant date: estimated date.The scaffold was implanted and will not return for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The absorb device was not commercially available in the u.S; however, it was similar to a device sold in the u.S.The patient death referenced filed under a separate medwatch report number.
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It was reported through a research article that the absorb scaffold may be related to myocardial infarction, thrombosis, target lesion and vessel failure, target lesion revascularization, and stroke.Specific patient information is documented as unknown.Details provided in the attached article titled: " three-year clinical outcomes with the absorb bioresorbable vascular scaffold in real life: insights from the france absorb registry¿.
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A2: mean age.A3: majority sex.B3, c4, d6: estimated.D4: the udi# is unknown because the part and lot numbers were not provided.The absorb device was not commercially available in the us; however, it was similar to a device sold in the u.S.The device was not returned for analysis.A review of the lot history record and complaint history of the reported lot could not be conducted because the lot and part number were not provided.A conclusive cause for the difficulties listed cannot be determined based on the limited information available.The reported patient effects of thrombus, cerebrovascular accident, and myocardial infarction are consistent with the product risk profile and are therefore expected.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.Na.
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