Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
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It was reported that stent migration, inadequate stent apposition and stent damage occurred.The target lesion was an 8mm lesion.A 4.00 x 8 synergy⠄rug eluting stent was selected for use and advanced to treat the lesion.However, during the procedure, the restenosed lesion was missed.The stent was incorrectly placed proximal to the lesion and the stent was deployed in the 8-10mm segment of the vessel.The stent was not well apposed to the graft, shortened and could move freely throughout the vessel.The stent was then crushed into the graft and the procedure was completed with a large bare metal stent.No patient complications were reported and patient's status was stable.This product is only ous approved but is similar to an approved us device.
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