Model Number H7493926008350 |
Device Problems
Migration or Expulsion of Device (1395); Device Or Device Fragments Location Unknown (2590); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/18/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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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Event Description
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It was reported that stent inadequate apposition and migration occurred.While the physician was working on the left circumflex artery, the left main coronary artery (lmca) dissected.A 3.50mmx8mm synergy ii everolimus-eluting platinum chromium coronary stent system was deployed in the lmca.However, the stent did not adhere to the vessel wall and migrated.The location of the migrated stent is not known.Fluoro of the patient's body was performed, however the stent was not located.The procedure was completed with another synergy stent.No patient further complications were reported and the patient's status was well.
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Search Alerts/Recalls
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