Device is a combination product.(b)(4).Device evaluated by mfr: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
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Same case as mdr id: 2134265-2018-05879, 2134265-2018-05881, and 2134265-2018-05882.It was reported that stent fracture occurred.In (b)(6) 2015, the patient had pre-existing lesion in a coronary artery.The patient already had conventional stents implanted; additionally, a 4.00x20mm, a 4.00x28mm, a 4.00x38mm promus element¿ plus drug-eluting stents, and a 32 x 3.00 promus premier¿ drug-eluting stent were successfully implanted.In (b)(6) 2018, the patient underwent medical examination and stent fracture was noted.A need for new emergency angioplasty was scheduled a week after.
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