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The coils were well imbedded in the ileum [device dislocation into abdominal cavity] intra-abdominal breakage of a tubal occlusion device [device breakage] right essure coil was found to be perforated through the uterus [uterine perforation] ([device dislocation]).Case description: serious, related, listed, incident.This case report from united states was derived from medical literature on 05/01/2014, article entitled "essure perforation with intra-abdominal breakage".It refers to a (b)(6) -year-old female pt who had essure (fallopian tube occlusion insert) inserted for permanent sterilization and experienced right essure coil was found to be perforated through the uterus, the coils were well imbedded in the ileum, and intra-abdominal breakage of the tubal occlusion device.Pt had been previously on medroxyprogesterone acetate for 12 years, but due to dexa scans that revealed osteopenia (lumbar spine t-score -1.1) she was encouraged to seek an alternative method.She was counseled for an essure permanent sterilization procedure and was subsequently set-up for an office procedure.A normal intrauterine cavity was noted and bilateral ostia were visualized.Both fallopian tubes were occluded with essure device.No complications were noted and the pt tolerated the procedure well.A confirmatory hysterosalpingogram (hsg) showed the left essure coils was found to be in an anatomically correct position with subsequent blockage of fluoroscopic dye of the left fallopian tube.The right essure coil, however, appeared to be malpositioned and in two locations.A portion of the right coil was imbedded in the right cornual aspect of the uterus with a second portion in an unspecified area in the pelvic cavity.A laparoscopic tubal fulguration protruding through the right uterine cornua.The second part of the right essure coil was found to be perforated through the uterus and attached in a parallel fashion to the serosa of the bowel.The coils were well imbedded in the ileum without evidence of perforation, erythema, bowel dilatation, or strangulation.There was no blood in the abdominal or pelvic cavity and the remainder of the bowel was grossly normal.The specimen was retained in the pelvis with no further surgery.The authors concluded that his case study shows the possibility of hysteroscopic perforation and intra-abdominal breakage of a tubal occlusion device and show the importance of post operative hsg after essure tubal occlusion device.This medical literature case report refers to a (b)(6)-year-old pt, who had essure (fallopian tube occlusion insert) inserted and experienced right essure coil was found to be perforated through the uterus, the coils were well imbedded in the ileum, and intra-abdominal breakage of a tubal occlusion device.The first two events were considered serious, as medically significant and are listed according to the reference safety info for essure.The event intra-abdominal breakage of a tubal occlusion device was regarded as non-serious and is unlisted.Uterine perforation may happen with any trans-cervical intrauterine procedure including essure therapy; in which it occurs most often during insertion.Owing to the anatomical relationship between bowel and uterus, the bowel may be perforated due to essure device migration or during the placement procedure.Also, in cases of difficult removals, single cases have been reported of essure breakage.In this particular case it was reported that at hysterosalpingography, the right essure coil was malpositioned; a laparoscopy was performed and confirmed that one portion of essure was perforating the uterus and a second portion was in the pelvic cavity (embedded in ileum, however, without bowel perforation), the author concluded on an intra-abdominal breakage of essure.Considering the above mention info and the events characteristics, they were considered as related to essure therapy and due to the required intervention regarded as incidents.
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Ptc investigation result was received on 22-aug-2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc global number (b)(4).Final assessment: when a term like "break", "breakage", "broke", "broken", "falling apart", "fractured", or "split" is used when describing a device event, it is difficult to determine the true nature of the event from the complaint description alone.Unless additional detail is provided in the event description, it is difficult to determine if the reporter is describing an event where the micro-insert actually broke into individual pieces, if the micro-insert bent or stretched into an unintended shape, and hence was considered by the reporter to be "broken", or if a different portion of the delivery catheter was broken off inside the patient.Failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The insert's outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If the outer coils of the micro-insert partially deploy during user attempts to repositioning the device and the coil catheter is not fully retracted, the outer coils of the micro-insert could become entangled within the distal portion of the coil catheter.If the outer coils are partially deployed, the insert will begin to anchor itself to the fallopian tube.If the inner coil is still affixed to the delivery wire because all ifu steps have not yet been completed, subsequent attempts by the user to remove the catheter assembly may lead to either a stretching of the microinsert, stretching of the inner catheter large tight pitch coil, or breakage of the large tight pitch coil.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the microinsert.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, the outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all are within manufacturing specifications.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.Since neither product was returned for inspection nor do we have a photograph of the actual device, we cannot determine exactly what the failure is.Based on our experience with device complaints of a similar nature, it is likely the reporter is referring to an event in which the micro-insert was bent or stretched into a shape which rendered the device to be unusable, and hence, "broken." since no product was returned for investigation, we are unable to confirm any quality defect or device malfunction at this time.Conclusions: the possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment: the reported adverse events are known, possible, undesirable events and not indicative of a quality defect per se.In this particular case additionally a technical defect (breakage) was reported.The reported technical defect could not be evaluated in more detail due to lack of sample return.No batch number was reported.Without this information neither a technical batch evaluation nor a batch signal cluster review in the (b)(4) database for a more detailed statistical medical evaluation is possible.Due to lack of sample return and any valid batch information the rqu was unable to confirm any quality defect and therefore concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit.Company causality comment: this medical literature case report refers to a (b)(6) years-old female patient, who had essure (fallopian tube occlusion insert) inserted and experienced right essure coil was found to be perforated through the uterus, the coils were well imbedded in the ileum, and intra-abdominal breakage of a tubal occlusion device.The first two events were considered serious, as medically significant and are listed according to the reference safety information for essure.The non-serious event intra-abdominal breakage of a tubal occlusion device interpreted as a device breakage and previously considered unlisted according to reference safety information for essure, was, upon receipt of product technical investigation (ptc) updated to listed (anticipated).Uterine perforation may happen with any trans-cervical intrauterine procedure including essure therapy; in which it occurs most often during insertion.Owing to the anatomical relationship between bowel and uterus, the bowel may be perforated due to essure device migration or during the placement procedure.Also, in cases of difficult removals, single cases have been reported of essure breakage.In this particular case it was reported that at hysterosalpingography, the right essure coil was malpositioned; a laparoscopy was performed and confirmed that one portion of essure was perforating the uterus and a second portion was in the pelvic cavity (embedded in ileum, however without bowel perforation), the author concluded on a intraabdominal breakage of essure.Considering the above mention information and the events's characteristics, they were considered as related to essure therapy and due to the required intervention regarded as incidents.Product technical complaint (ptc) analysis was performed and concluded to an unconfirmed quality defect.Medical assessment considered that, based on the available information, there is no reason to suspect quality defect of the product.
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