Catalog Number INS4500 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fistula (1862)
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Event Type
Injury
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Manufacturer Narrative
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The reported device was not returned for evaluation.Based on the absence of lot and catalog number used in the retrospective study published on 2013, it is not possible to perform the dhr review and neither to identify the manufacturing time frame for the histories review.The reported condition is unconfirmed.The evaluation of the complaint unit is required to determine a potential root cause of the reported condition.The root cause is undetermined.Doi: 10.1227/neu.0b013e318279e783.Linked to mfg report numbers: 2648988-2018-00083, 2648988-2018-00085, 2648988-2018-00086, 2648988-2018-00087, 2648988-2018-00088, 2648988-2018-00089, 2648988-2018-00090.
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Event Description
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This is 1 out of 8 reports.Operative neurosurgery (2013) published "iatrogenic vascular complications associated with external ventricular drain placement: a report of 8 cases and review of the literature" in which described 9 cases of evd-related vascular trauma: arteriovenous fistulas and 2 traumatic aneurysms.This study includes patients who were treated in the neuro critical care unit at a university affiliated level i trauma center and children¿s hospital during a 3-year period.Patients included in this study had placement of an evd and an angiographically confirmed vascular lesion associated with the evd.During a 3 year period, 299 evds were placed.An integra large-style ventricular catheter (3mm outer diameter) was passed through the craniostomy into the frontal horn of the lateral ventricle.The trajectory of the catheter in the coronal plane was the medial canthus of the ipsilateral eye and the external auditory canal in the sagittal plane.Catheters were not inserted deeper than 7 cm at the bone edge.Once clear cerebrospinal fluid was visualized, the metal stylet was removed and the catheters were tunneled subcutaneously approximately 2 to 3 cm away form the incision.The incision was closed with nylon suture and the ventricular catheter was connected to the drainage system in a sterile manner ad secured to the patient.A head ct was performed after the procedure to verify catheter position.Eight patients (2.75%), 3 male and 5 female (mean age, 48 +/- 20 years), developed vascular lesions associated with evds.Six patients developed arteriovenous fistulas and 2 patients developed a traumatic aneurysm.Result: patient 1: a (b)(6) woman presented with a severe headache after rupture of a 3-mm wide neck anterior communicating artery aneurysm.She underwent surgical clipping of the aneurysm though a right pterional approach.A left-sided evd was placed while she was in the operating room to treat the symptomatic hydrocephalus.The evd was placed through a standard incision and burr hole anterior to the coronal suture.The catheter tip was placed just central to the foramen of monro.A left common carotid catheter angiogram obtained 2 days later demonstrated interval development of a small superior left frontal dural avf where the evd entered the brain.It was fed by a branch from the mma with early venous drainage into an inferolateral meningeal vein.The evd was removed on postoperative day 3.A repeat angiogram on postoperative day 14 showed persistence of the fistula.The tortuosity and caliber of the mma prevented distal navigation; therefore, the proximal mma was embolized with contour 150- to 250 um polyvinyl alcohol particles (boston scientific, natick, massachusetts).Postembolization digital subtraction angiography showed occlusion of the avf.The patient suffered no adverse consequences.Conclusion: the data suggest that iatrogenic vascular trauma associated with evd insertions (2.75%) may be more common than is currently appreciated.Endovascular treatment is effective and may be necessary when these lesions do not resolve spontaneously.
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Search Alerts/Recalls
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