Same journal article as mdr id: 2134265-2014-04844, 2134265-2014-04847, 2134265-2014-04848, 2134265-2014-04849, 2134265-2014-04850 and 2134265-2014-04846.Reported via journal article.It was reported that post a transcatheter arterial embolization procedure, re-embolization and hysterectomy were performed.After the patient had a normal spontaneous vaginal delivery (nsvd), the patient experienced uterine atony.Unilateral femoral artery catheterization was performed and pelvic angiography revealed extravasation.The patient received contour polyvinyl alcohol particles in both uterine arteries.An unspecified amount of time later, the patient underwent re-embolization and a hysterectomy.
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Hwang, s.M., jeon, g.S., kim, s.H., lee, j.T., kim, m.D., choi, m.J.(2013).Transcatheter arterial embolization for the management of obstetric haemorrhage associated with placental abnormality in 40 cases.European society of radiology, 23:766-773.Device evaluated by manufacturer: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.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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