Device is a combination product.Age at time of event: 18 years or older.(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 inadequate stent apposition and migration occurred.The target lesion was located in a 2.75mm diameter saphenous vein graft (svg).After a drug-eluting stent was deployed in the distal svg, a 3.00 x 20 synergy¿ drug-eluting stent was advanced to the proximal svg with a 10mm distance from the distal and mid stent.Deployment was then performed at 9 atmospheres; however, instantly upon deflation of the stent delivery balloon, the stent migrated, touching the proximal end of the distal stent.As the stent was still covering the lesion, the physician decided to post-dilate the stent where it migrated to.No patient complications were reported and the patient's status was stable.It was discussed with the physician that the stent appeared to have migrated the moment the stent delivery balloon was deflated, indicating the stent was most likely deployed undersized.
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