H10: manufacturing review: the device history records have been reviewed with special attention to the raw materials, subassemblies, manufacturing process, and quality control testing.This lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately five years and three months later, computed tomography (ct) revealed that the inferior vena cava contains two closely adjacent umbrella type inferior vena cava filters.One of them was well centered in and parallel to the central axis of the inferior vena cava but extends slightly superior to both the right and left main renal veins.Five of the 11 tines appear to perforate the inferior vena cava wall but without significant sign of hemorrhage.One of the perforating tines at 11 o'clock contacts the medial margin of the descending duodenum.Another extends into the right renal vein and perforates its inferior margin.There are two others at 9 o'clock and 6:30 which extend into the retroperitoneal fat.There was one at 1 o'clock that shows borderline perforation into the third portion of the duodenum.The second inferior vena cava filter was centered along the posteromedial wall of the inferior vena cava.It also has 11 tines and substantially overlaps the central filter with its upper tip being about 9mm below the central one.Its upper tip also contacts the posterior wall of the inferior vena cava apparently stretching it outward slightly.All but three or four of its upper tine segments appear to extend briefly posterior to the inferior vena cava into adjacent retroperitoneal fat but without significant sign of hemorrhage.They all re-enter inferior vena cava inferiorly and none of the tips of the tines appears to be outside of the vena cava with certainty.A few are at the margin.Therefore, the investigation is confirmed for alleged perforation of the inferior vena cava (ivc).Based on the available information, the definitive root cause is unknown.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, and unit label) showed that the product labeling is adequate.H10: d4 (expiry date: 06/2014).H3 other text : device not returned.
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