Four months following a successful coil embolization procedure using penumbra coil 400 coils, the patient was admitted to the hospital for a transient ischemic attack.The event was an uncertain relationship to the penumbra coil 400 devices, it was definitely not related to angiography or the aneurysm disease state itself.The event was resolved the following day.
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Conclusion: the product was implanted in the patient and was not returned for evaluation.Without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.This mdr is associated with mdr 3005168196-2014-00922, 00923, and 00925.Devices were implanted in the patient.
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