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This is a spontaneous case report received from a gynecologist/obstetrician in netherlands on (b)(6) 2015 which refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014 for definitive contraception.Patient's medical history included para1 (vaginal delivery).She had a transvaginal echo which showed normal uterus and annexae.On (b)(6) 2014, essure was easily inserted bilaterally in 3 minutes and 50 seconds.Two windings were visible on both sides.On (b)(6) 2014, an extra control was performed because of pain after pill stop.Gynecological examination was normal (i.E.Lab, echo.No particulars; devices bilateral in situ).Differential diagnosis was ovulation.On (b)(6) 2014, patient did not have complaints anymore.Follow-up echo showed right essure device in situ and there was a suspicion of left curled device.Negative pregnancy test was also reported.On (b)(6) 2014, hsg (hysterosalpingogram) and rx list: tubal bilaterally closed right device in situ (extravasation), left curled device.Some suspicions were reported: first echo ((b)(6) 2014) presumably left device not properly interpreted, relationship with 1x pain (?); tubal closed on hysterosalpingogram (hsg); trustworthy (?); what with abnormal position left device, laparoscopy necessary (?).On (b)(6) 2015, the reporting physician wanted to have the ultrasound and hsg reviewed due to patient's cyclical abdominal pain and as in ultrasound image it seemed that the essure was not situated well.The images were reviewed and the conclusion was that a thing was not good.On (b)(6) 2015, echo and hsg were conducted again.On the echo, it seemed indeed a kind of curl in the left coil.After a dynamic hsg was made, by use of the bullet forceps to move the uterus back and forth, which in the first instance was not done, it was clear that the coil had perforated the fallopian tube halfway.Incidentally, the tube seemed to be closed at the beginning (of the tube).Because of the perforation, thus a reason to not assume the reliability of the essure.After this consultation it was decided that patient should come back for a laparoscopy to remove the coil, and immediately perform a tubectomy.Ptc investigation result was received on (b)(6) 2015.This adverse event report is related to a product technical complaint (ptc).(b)(4).Final assessment: 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 to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.No new failure mode has been identified.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The ae case refers also to a product issue.The reported adverse event considered related is a known possible undesirable event and not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.Neither batch number nor complaint sample was available for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Company causality comment: this medically confirmed, spontaneous case report; refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and hsg (hysterosalpingogram) showed left coil had perforated the fallopian tube halfway.Physician will perform a laparoscopy in order to remove the coil and fallopian tube.The reported event was considered serious due to medical importance and is listed according to essure's reference safety information.Uterine/fallopian tube perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).In this particular case, essure insertion was reported as easy.At 3 months control, physician suspected left essure was curled; later a fallopian tube perforation was diagnosed with dynamic hsg.Although the exact mechanism of this perforation was unknown, given its nature causality with the suspect insert cannot be excluded.This case was considered an incident, since an intervention (laparoscopy) will be required for essure removal.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow-up information is being sought.
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Follow-up received on 29-jul-2015: reporter informed that she will wait for the laparoscopy result (planned to the end of (b)(6) 2015) to complete the perforation questionnaire.In addition, essure expert assessment of the essure images and cd-rom was provided.According to essure expert, the photos are not sharp, and there's no zooming, which makes assessment difficult.There is no dynamic hysterosalpingogram made according to protocol such as is actually needed to tell if the devices may or may not sit well.Finally, there is excessive force used resulting in intravasation but therefore also seems to be passage on the right.Case is in follow-up.Follow-up information received on 13-aug-2015 from reporter via account manager: reporter just finished the laparoscopy in the patient with the essure perforation at the height of tuba left.This went smoothly.Proximal the device went in a curl through the left tuba.This was already encapsulated and could not cause damage to surrounding tissue.The device was quickly removed and a partial tubectomy left was performed.At the request of patient, the reporter performed the same procedure on the right side (where the essure device was good).Follow up (perforation questionnaire) information received on 18-aug-2015 from physician: (b)(4).The patient was gravida 1 and has normal body mass index.She had none previous gynecological intervention.She was not breastfeeding at time of the procedure.The insertion was performed during patient's oral contraception.Prior to the insertion no uterine abnormal findings were observed.The procedure was considered easy with easy visualization of both tubal os.The fluid loss during hysteroscopy was not more than 1500cc.The patient had no complaints after the insertion.On (b)(6) 2014, the hsg and ultrasound were done and did not showed occlusion.The patient was advised to not rely on essure based on test's result.A second confirmation test was performed due to suspicion of perforation of the left tube.The physician stated the perforation occurred after the coil deployment.She experienced abdominal along with the perforation.The coil on right side was in correct position.On (b)(6) 2015, the devices were bilaterally removed laparoscopic under patient request.The physician reported the removal was not medically necessary.No pathology results or signs of infection/inflammation were reported.Physician reported the patient recovered.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 19-aug-2015 for the following meddra preferred term: fallopian tube perforation.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to these meddra pts.Company causality comment: this medically confirmed, spontaneous case report; refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and hsg (hysterosalpingogram) showed left coil had perforated the fallopian tube halfway.A laparoscopy was performed and the device was quickly removed and a partial tubectomy left and right side were performed.It was reported that there was excessive force used resulting in intravasation but therefore also seems to be passage on the right.Patient has recovered.The reported event was considered serious due to medical importance and is listed according to essure's reference safety information.Uterine/fallopian tube perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).In this particular case, essure insertion was reported as easy.At 3 months control, physician suspected left essure was curled; later a fallopian tube perforation was diagnosed with dynamic hsg.Although the exact mechanism of this perforation was unknown, given its nature causality with the suspect insert cannot be excluded.This case was considered an incident due to performed surgical intervention.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.
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