(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 med watch will be filed.(b)(4).
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It was reported that balloon pinhole and partial deployment of stent occurred.A 3.00 x 16 synergy ii drug-eluting stent was advanced to treat the lesion.Deployment was attempted, however, it was noted that the stent would not fully deploy as the stent delivery balloon had a hole.A balloon catheter was advanced and deployed the stent.The procedure was completed using a new stent.No patient complications were reported and the patient's status was stable.
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