The product was not returned for evaluation.From the information provided, there is no indication that there was any device malfunction, nonconformance, or misuse that contributed to the reported event.Ischemia and neurological deficits including stroke are known and anticipated complications with these types of procedures and are noted in the device labeling.Therefore, it was determined that these reported adverse events were anticipated procedural complications.The product lot number was not provided, therefore, the manufacturing records could not be reviewed.This report is associated with mfr report numbers: 3005168196-2018-01423, 3005168196-2018-01424, 3005168196-2018-01425, 3005168196-2018-01426.
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On (b)(6) 2018, the patient underwent a coil embolization procedure to treat a rupture aneurysm using penumbra coils 400 (pc400s) with no issues.The next day, the patient health status declined.A computerized tomography/computerized tomography angiogram (ct/cta) then magnetic resonance imaging (mri) were ordered.The patient remains weak on right side and somnolent.According to the physician, the mri with left side infract that appeared more watershed.The cta was clear beyond the coil mass.The magnetic resonance angiography (mra) showed some narrowing near the coil mass which is partially artifact but overall looks patent.The patient is already on acetylsalicylic acid (asa) and had heparin during case.The patient was discharged to a rehabilitation center on (b)(6) 2018.As of 03-jul-2018, the event was still considered unresolved.The left cerebral watershed stroke was reported to be a serious adverse event with a probable relationship to the pc400 system and the procedure.
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