| Model Number ESS305 |
| Device Problems
Break (1069); Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017); Separation Failure (2547); Biocompatibility (2886)
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| Patient Problems
Hemorrhage/Bleeding (1888); Cramp(s) (2193); Device Embedded In Tissue or Plaque (3165)
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| Event Date 08/13/2013 |
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Event Type
malfunction
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Event Description
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This is a spontaneous case report received from a consumer in united states on 20-jun-2014 which refers to herself.She is a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and experienced the adverse events as described below.Consumer reported that she essure failed during insertion on the left side.When the doctor was inserting it and released it from the probe, it did not completely release because the coils broke off.She tried to remove it then, the rest of it, and all the coils kept coming off; every loop was coming off.They were going to send the consumer to surgery but they decided not to do it, so they left it.Consumer did not put another one on that side.The doctor had to open another pack for the probe or the instrument itself to help get it out, but consumer's insurance company only covered one.Three months later, in (b)(6) 2013, the right side, the good side that they had no issues with, fell out.Consumer went to the bathroom and there it was.She went in to the doctor after the essure on the right side came out and they did x-rays and the x-ray showed that the only part was the broken piece seen on the left side.They never did the hsg (hysterosalpingogram).Her doctor required four-five months to do the hsg instead of the recommended three.Consumer experienced a lot of bleeding and cramping ever since the essure was put in and she called the doctor a couple of times after that.The doctor said it was because it was probably still irritated because of the complications with the insertion but she thought it was normal.Eventually it did subside when the other side came out.Consumer bled almost the whole three months until the other side came out; not a lot, not heavy and not every day, but ever since the essure was put in.After the essure on the right side came out consumer had tons and tons and tons of severe cramping and bleeding for three to four days and then it stopped.
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Manufacturer Narrative
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Follow up information from 30-jun-2014: ptc result received.(b)(4).Assessment: when a term like "broke" 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 m 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 aiiifu 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, breakage of the large tight pitch coil, or breakage of a portion of the delivery catheter.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 micro-insert.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, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for and inspect the device 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 at this time.Conclusions: the report did not state a patient injury occurred.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 medical events are not necessarily indicative of a quality defect.Additionally, this case reported complication of insertion due to deployment issue because of coil breakage and difficult to use due to breakage during removal.These events are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the gpv database for a more detailed statistical medical evaluation is possible without a batch number.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect" and noted that the breakage event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.Follow-up from 03-jul-2014: the required number of follow-up attempts has been made, with no response to date.Company causality comment: this non-medically confirmed, spontaneous case report, refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and experienced it did not completely release; the coils broke off/ x-ray showed the broken piece on the left side (complication of device insertion); the physician tried to remove it then,the rest of it, and all the coils kept coming off; 3 months later the right side fell out and she never did the hsg.The consumer also reported that she had a lot of bleeding and cramping since the essure was put in/after the essure on the right side came out she had severe bleeding and cramping.The reported bleeding was considered serious;due to medical importance while the other events are non serious.Upon receipt of technical investigation, event the coils broke off/ x-ray showed the broken piece on the left side, interpreted as a device breakage and previously considered unlisted according to reference safety information for essure, was updated to listed (anticipated).Case was regarded as near-incident,as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.The remaining events are listed and non incidents.Abnormal bleeding,menses pattern changes and cramping may occur with essure therapy.Given this information causality between consumer's genital bleeding and cramping and the suspect insert cannot be excluded.Regarding the remaining events single cases of essure breakage have been reported.In this particular case, an essure deployment issue followed by device breakage and failed removal were reported on the left side.On the right side the consumer stated that the device came out (it was found in the bathroom)., considering their nature a causal relationship with essure cannot be excluded.Ptc final assessment ,at the time of this medical assessment the technical investigation concluded "unconfirmed quality defect" and noted that the breakage event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.
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Manufacturer Narrative
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F/u info was received on 7/11/2014.Consumers weight was provided.On (b)(6) 2013 essure lot number a73751 was implanted.Coil did not deploy correctly resulting in coil falling out.The physician experienced trouble getting the coil to deploy properly.When device removed on (b)(6) 2013, inner coil came out but outer coil remained.No further info was provided.Ptc investigation result was received on 7/22/2014.This adverse event report is related to a product technical complaint (ptc).The bayer ref number for the ptc report is: ptc local number "(b)(4)" and ptc global number (b)(4).Final assessment: the child case was opened since the lot number was provided as add'l info.When a term like "broke" is used when describing a device event, it is difficult to determine the true nature of the event from the complaint description alone.Unless add'l 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 pt.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 micro- insert, 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, outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Conclusions: the report did not state a patient injury occurred.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 medical events are not necessarily indicative of a quality defect.Additionally, this case reported complication of insertion due to deployment issue because of coil breakage and difficult to use due to breakage during removal.These events are not necessarily indicative of a quality defect.Five (5) additional ae case reports have been received to date in relation to batch number a73751.Two (2) of these cases refer to a difficult to use event but not in the same context as reported in this case and one (1) of these cases refers to a deployment issue.No batch signal could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.No complaint sample was provided for technical investigation.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect" and noted that the breakage event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report, refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and experienced it did not completely release; the coils broke off / x-ray showed the broken piece on the left side (complication of device insertion); the physician tried to remove it then, the rest of it, and all the coils kept coming off; 3 months later the right side fell out and she never did the hsg.The consumer also reported that she had a lot of bleeding and cramping since the essure was put in/after the essure on the right side came out she had severe bleeding and cramping.The reported bleeding was considered serious; due to medical importance while the other events are nonserious.Upon receipt of technical investigation, event the coils broke off / x-ray showed the broken piece on the left side, interpreted as a device breakage and previously considered unlisted according to reference safety information for essure, was updated to listed (anticipated).Case was regarded as near-incident, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.The remaining events are listed and nonincidents.Abnormal bleeding, menses pattern changes and cramping may occur with essure therapy.Given this information causality between consumer's genital bleeding and cramping and the suspect insert cannot be excluded.Regarding the remaining events single cases of essure breakage have been reported.In this particular case, an essure deployment issue followed by device breakage and failed removal were reported on the left side.On the right side the consumer stated that the device came out (it was found in the bathroom)., considering their nature a causal relationship with essure cannot be excluded.Ptc final assessment, at the time of this medical assessment the technical investigation concluded "unconfirmed quality defect" and noted that the breakage event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.
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Manufacturer Narrative
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Data correction for us reporting: the code knh was replaced with hhs.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("the coils broke off / x-ray showed the broken piece on the left side/leave the broken coil inside of her/ part of it broke off in her tube and part of it came out when doctor pulled wand out (as per social media)/tiny piece left inside her") and genital haemorrhage ("had a lot of bleeding since the essure was put in/after the essure on the right side came out i had severe bleeding/had terrible bleeding for weeks/ has been bleeding every two weeks since had it done (as per social media)/ she had been having clots") in a (b)(6) female patient who had essure (batch no.A73751) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "she tried to remove it then, the rest of it, and all the coils kept coming off" on (b)(6) 2013 and device monitoring procedure not performed "never did the hsg".The patient's past medical history included parity 4 (date of births: (b)(6) 1996, (b)(6) 1999, (b)(6) 2001, (b)(6) 2012), psychological disorder nos, headache, multigravida and miscarriage in 1994.Concurrent conditions included body mass index increased and heavy periods.Concomitant products included norlestrin fe (ethinylestrad w/ferrous fum/norethister acet) in 2010 for contraception, bupropion (wellbutrin) in 1999 for depression, sumatriptan (imitrex) for headache and lansoprazole for heartburn.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), complication of device insertion ("complication of device insertion"), device deployment issue ("it did not completely release / coil/spring did not completely release into her tube (as per social media)/major issue on her left side (as per social media)") and the first episode of abdominal pain lower ("had a lot of cramping ever since the essure was put in/after the essure on the right side came out i had severe cramping/ had terrible cramping/ severe cramping after coil fell/ cramping so bad (as per social media)").In (b)(6) 2013, the patient experienced device expulsion ("3 months later the right side fell out/ the coil from her right side fell out/ right side fell out a morning (as per social media)").In (b)(6) 2014, the patient experienced the second episode of abdominal pain lower ("severe cramping after coil fell").On (b)(6) 2014, the patient experienced vaginal discharge ("seen for vaginal discharge") with vulvovaginal discomfort.On (b)(6) 2014, the patient experienced pelvic pain ("seen for pelvic pain/pelvis pain").On (b)(6) 2015, the patient experienced vulvovaginal discomfort ("seen for vaginal irritation (this was being experienced for months prior to seeing a doctor.)/ vaginal discomfort (burning sensation, very irritated)").On an unknown date, the patient experienced abdominal distension ("bloating"), allergy to metals ("not able to wear earrings made of nickel but have never been officially tested"), back pain ("backaches"), urine analysis abnormal ("urine labs came back high and abnormal (as per social media)"), memory impairment ("memory problems (as per social media)"), emotional disorder ("freaked out (as per social media)"), mental disorder ("aggravated any psychiatric and/or psychological condition(s)"), migraine ("migraines") with headache and malaise ("just not feeling well (as per social media)/ sick all the time (as per social media)").The patient was treated with ibuprofen and ibuprofen (advil).Essure treatment was not changed.In 2013, the genital haemorrhage had resolved.At the time of the report, the device breakage, complication of device insertion, device deployment issue, vulvovaginal discomfort, device expulsion, vaginal discharge, allergy to metals, pelvic pain, urine analysis abnormal, memory impairment, emotional disorder, mental disorder and malaise outcome was unknown and the last episode of abdominal pain lower, abdominal distension, back pain and migraine was resolving.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue, device expulsion, genital haemorrhage and the first episode of abdominal pain lower with essure.The reporter considered abdominal distension, allergy to metals, back pain, emotional disorder, malaise, memory impairment, mental disorder, migraine, pelvic pain, urine analysis abnormal, vaginal discharge, vulvovaginal discomfort and the second episode of abdominal pain lower to be related to essure.The reporter commented: she did not claim hypersensitivity reaction to nickel or any other component of essure.Her husband underwent vasectomy in 2014 due to the essure placement failing.For vaginal irritation she underwent treatment as bacterial vaginal infection & for vaginal discharge and irritation underwent treatment yeast infection.On the right side 5 coils were then seen.Her physician tat anytime she wanted, she could have a laser hysterectomy to remove the broken coil.She was concerned that it would cause problems later on.At that time, she chose to let it be and leave the broken coil inside of her.At the time of x-ray, it was still in the correct area of tube.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.2 kg/sqm.X-ray - on an unknown date: only the broken piece on the left side was seen between (b)(6) 2013 and (b)(6) 2014: sterilization dye with x-ray.Concerning the injuries reported in this case, the following events were reported via social media urine labs came back high and abnormal, memory problems,freaked out,have constant burning.Quality-safety evaluation of ptc: final assessment:the child case was opened since the lot number was provided as additional information.Since no product was returned to us for investigation,we were unable to perform an investigation of the actual device involved in this complaint.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Conclusions: the report did not state a patient injury occurred.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 medical events are not necessarily indicative of a quality defect.Additionally, this case reported complication of insertion due to deployment issue because of coil breakage and difficult to use due to breakage during removal.These events are not necessarily indicative of a quality defect.Five (5) additional ae case reports have been received to date in relation to batch number a73751.Two (2) of these cases refer to a difficult to use event but not in the same context as reported in this case and one (1) of these cases refers to a deployment issue.No batch signal could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.No complaint sample was provided for technical investigation.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿ and noted that the breakage event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on 27-nov-2017: follow up received from pfs+mr-events ¿severe cramping after coil fell out, seen for pelvic pain, vaginal irritation, vaginal discharge, vaginal discomfort, not able to wear earrings made of nickel but have never been officially tested, aggravated any psychiatric and/or psychological conditions, headache, urine labs came back high and abnormal, memory problems, freaked out, have constant burning¿ are added.Lab data updated.Historical condition& drug added.Concomitant condition & drug updated.Patient, product & reporter information updated.Essure legal manufacture has changed from (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only¿.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("the coils broke off / x-ray showed the broken piece on the left side/leave the broken coil inside of her/ part of it broke off in her tube and part of it came out when doctor pulled wand out (as per social media)/tiny piece left inside her") and genital haemorrhage ("had a lot of bleeding since the essure was put in/after the essure on the right side came out i had severe bleeding/had terrible bleeding for weeks/ has been bleeding every two weeks since had it done (as per social media)/ she had been having clots") in a (b)(6) female patient who had essure (batch no.A73751) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "she tried to remove it then, the rest of it, and all the coils kept coming off" on (b)(6) 2013 and device monitoring procedure not performed "never did the hsg".The patient's past medical history included parity 4 (date of births: (b)(6) 1996, (b)(6) 1999, (b)(6) 2001, (b)(6) 2012), psychological disorder nos, headache, multigravida and miscarriage in 1994.Concurrent conditions included body mass index increased and heavy periods.Concomitant products included norlestrin fe (ethinylestrad w/ferrous fum/norethister acet) from 2010 to 2013 for contraception, bupropion (wellbutrin) since 1999 for depression, sumatriptan (imitrex) for headache and lansoprazole for heartburn.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), complication of device insertion ("complication of device insertion"), device deployment issue ("it did not completely release / coil/spring did not completely release into her tube (as per social media)/major issue on her left side (as per social media)") and the first episode of abdominal pain lower ("had a lot of cramping ever since the essure was put in/after the essure on the right side came out i had severe cramping/ had terrible cramping/severe cramping after coil fell/ cramping so bad (as per social media)").In (b)(6) 2013, the patient experienced device expulsion ("3 months later the right side fell out/ the coil from her right side fell out/ right side fell out a morning (as per social media)").In (b)(6) 2014, the patient experienced the second episode of abdominal pain lower ("severe cramping after coil fell").On (b)(6) 2014, the patient experienced pelvic pain ("seen for pelvic pain/pelvis pain").On (b)(6) 2015, the patient experienced the first episode of vulvovaginal discomfort ("seen for vaginal irritation (this was being experienced for months prior to seeing a doctor.)/ vaginal discomfort (burning sensation, very irritated)") and the second episode of vulvovaginal discomfort ("have constant burning down there (as per social media)/vaginal discomfort/ vaginal irritation").On (b)(6) 2015, the patient experienced vaginal discharge ("seen for vaginal discharge").On an unknown date, the patient experienced abdominal distension ("bloating"), allergy to metals ("not able to wear earrings made of nickel but have never been officially tested"), headache ("her headache got more severe after she had essure placement"), back pain ("backaches"), urine analysis abnormal ("urine labs came back high and abnormal (as per social media)"), memory impairment ("memory problems (as per social media)"), emotional disorder ("freaked out (as per social media)"), mental disorder ("aggravated any psychiatric and/or psychological condition(s)"), migraine ("migraines"), malaise ("just not feeling well (as per social media)/ sick all the time (as per social media)") and procedural pain ("me being in a lot of pain").The patient was treated with ibuprofen and ibuprofen (advil).Essure treatment was not changed.In 2013, the genital haemorrhage was resolving.At the time of the report, the device breakage, complication of device insertion, device deployment issue, device expulsion, vaginal discharge, allergy to metals, pelvic pain, urine analysis abnormal, memory impairment, emotional disorder, the last episode of vulvovaginal discomfort, mental disorder, malaise and procedural pain outcome was unknown and the last episode of abdominal pain lower, abdominal distension, headache, back pain and migraine was resolving.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue, device expulsion, genital haemorrhage and the first episode of abdominal pain lower with essure.The reporter considered abdominal distension, allergy to metals, back pain, emotional disorder, malaise, memory impairment, mental disorder, migraine, pelvic pain, procedural pain, urine analysis abnormal, vaginal discharge, the first episode of vulvovaginal discomfort and the second episode of abdominal pain lower to be related to essure.No further causality assessment were provided for the product.The reporter commented: she did not claim hypersensitivity reaction to nickel or any other component of essure.Her husband underwent vasectomy in 2014 due to the essure placement failing.For vaginal irritation she underwent treatment as bacterial vaginal infection & for vaginal discharge and irritation underwent treatment yeast infection.On the right side 5 coils were then seen.Her physician tat anytime she wanted, she could have a laser hysterectomy to remove the broken coil.She was concerned that it would cause problems later on.At that time, she chose to let it be and leave the broken coil inside of her.At the time of x-ray, it was still in the correct area of tube.Patient received treatment for severe cramping, pelvic pain, vaginal irritation,vaginal discharge.Complication during insertion.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.2 kg/sqm.X-ray - on an unknown date: only the broken piece on the left side was seen.Between (b)(6) 2013 and (b)(6) 2014: sterilization dye with x-ray between (b)(6) 2013 and (b)(6) 2014, sterilization dye test with - ray.Provider communicated that essure was not in correct location in both fallopian tubes.Concerning the injuries reported in this case, the following events were reported via social media urine labs came back high and abnormal, memory problems,freaked out,have constant burning, quality-safety evaluation of ptc: final assessment:the child case was opened since the lot number was provided as additional information.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.In this case, we conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Conclusions: the report did not state a patient injury occurred.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 medical events are not necessarily indicative of a quality defect.Additionally, this case reported complication of insertion due to deployment issue because of coil breakage and difficult to use due to breakage during removal.These events are not necessarily indicative of a quality defect.Five (5) additional ae case reports have been received to date in relation to batch number a73751.Two (2) of these cases refer to a difficult to use event but not in the same context as reported in this case and one (1) of these cases refers to a deployment issue.No batch signal could be identified at this time.The review of the lot history records confirmed that the product met product release specifications.No complaint sample was provided for technical investigation.At the time of this medical assessment the technical investigation concluded ¿unconfirmed quality defect¿ and noted that the breakage event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.Most recent follow-up information incorporated above includes: on (b)(6) 2018: events : ¿bloating ,me being in a lot of pain" reporter added from pfs.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("the coils broke off / x-ray showed the broken piece on the left side/leave the broken coil inside of her/ part of it broke off in her tube and part of it came out when doctor pulled wand out (as per social media)/tiny piece left inside her") and genital haemorrhage ("had a lot of bleeding since the essure was put in/after the essure on the right side came out i had severe bleeding/had terrible bleeding for weeks/ has been bleeding every two weeks since had it done (as per social media)/ she had been having clots") in a (b)(6) female patient who had essure (batch no.A73751) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "she tried to remove it then, the rest of it, and all the coils kept coming off" on (b)(6) 2013 and device monitoring procedure not performed "never did the hsg".The patient's past medical history included parity 4 (date of births: (b)(6) 1996, (b)(6) 1999, (b)(6) 2001, (b)(6) 2012), psychological disorder nos, headache, multigravida and miscarriage in 1994.Concurrent conditions included body mass index increased and heavy periods.Concomitant products included norlestrin fe (ethinylestrad w/ferrous fum/norethister acet) from 2010 to 2013 for contraception, bupropion (wellbutrin) since 1999 for depression, sumatriptan (imitrex) for headache and lansoprazole for heartburn.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), complication of device insertion ("complication of device insertion"), device deployment issue ("it did not completely release / coil/spring did not completely release into her tube (as per social media)/major issue on her left side (as per social media)") and the first episode of abdominal pain lower ("had a lot of cramping ever since the essure was put in/after the essure on the right side came out i had severe cramping/ had terrible cramping/ severe cramping after coil fell/ cramping so bad (as per social media)").In (b)(6) 2013, the patient experienced device expulsion ("3 months later the right side fell out/ the coil from her right side fell out/ right side fell out a morning (as per social media)").In (b)(6) 2014, the patient experienced the second episode of abdominal pain lower ("severe cramping after coil fell").On (b)(6) 2014, the patient experienced pelvic pain ("seen for pelvic pain/pelvis pain").On (b)(6) 2015, the patient experienced the first episode of vulvovaginal discomfort ("seen for vaginal irritation (this was being experienced for months prior to seeing a doctor.)/ vaginal discomfort (burning sensation, very irritated)") and the second episode of vulvovaginal discomfort ("have constant burning down there (as per social media)/vaginal discomfort/ vaginal irritation").On (b)(6) 2015, the patient experienced vaginal discharge ("seen for vaginal discharge").On an unknown date, the patient experienced abdominal distension ("bloating"), allergy to metals ("not able to wear earrings made of nickel but have never been officially tested"), headache ("her headache got more severe after she had essure placement"), back pain ("backaches"), urine analysis abnormal ("urine labs came back high and abnormal (as per social media)"), memory impairment ("memory problems (as per social media)"), emotional disorder ("freaked out (as per social media)"), mental disorder ("aggravated any psychiatric and/or psychological condition(s)"), migraine ("migraines"), malaise ("just not feeling well (as per social media)/ sick all the time (as per social media)") and procedural pain ("me being in a lot of pain").The patient was treated with ibuprofen and ibuprofen (advil).Essure treatment was not changed.In 2013, the genital haemorrhage was resolving.At the time of the report, the device breakage, complication of device insertion, device deployment issue, device expulsion, vaginal discharge, allergy to metals, pelvic pain, urine analysis abnormal, memory impairment, emotional disorder, the last episode of vulvovaginal discomfort, mental disorder, malaise and procedural pain outcome was unknown and the last episode of abdominal pain lower, abdominal distension, headache, back pain and migraine was resolving.The reporter provided no causality assessment for complication of device insertion, device breakage, device deployment issue, device expulsion, genital haemorrhage and the first episode of abdominal pain lower with essure.The reporter considered abdominal distension, allergy to metals, back pain, emotional disorder, headache, malaise, memory impairment, mental disorder, migraine, pelvic pain, procedural pain, urine analysis abnormal, vaginal discharge, the first episode of vulvovaginal discomfort, the second episode of abdominal pain lower and the second episode of vulvovaginal discomfort to be related to essure.The reporter commented: she did not claim hypersensitivity reaction to nickel or any other component of essure.Her husband underwent vasectomy in 2014 due to the essure placement failing.For vaginal irritation she underwent treatment as bacterial vaginal infection & for vaginal discharge and irritation underwent treatment yeast infection.On the right side 5 coils were then seen.Her physician tat anytime she wanted, she could have a laser hysterectomy to remove the broken coil.She was concerned that it would cause problems later on.At that time, she chose to let it be and leave the broken coil inside of her.At the time of x-ray, it was still in the correct area of tube.Patient received treatment for severe cramping, pelvic pain, vaginal irritation,vaginal discharge.Complication during insertion - diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.2 kg/sqm.X-ray - on an unknown date: only the broken piece on the left side was seen.Between (b)(6) 2013 and (b)(6) 2014: sterilization dye with x-ray between (b)(6) 2013 and (b)(6) 2014, sterilization dye test with - ray.Provider communicated that essure was not in correct location in both fallopian tubes.Concerning the injuries reported in this case, the following events were reported via social media urine labs came back high and abnormal, memory problems, freaked out, have constant burning, quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-jun-2018: quality-safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a lawyer and describes the occurrence of device breakage ("the coils broke off / x-ray showed the broken piece on the left side/leave the broken coil inside of her/ part of it broke off in her tube and part of it came out when doctor pulled wand out (as per social media)/tiny piece left inside her") and genital haemorrhage ("had a lot of bleeding since the essure was put in/after the essure on the right side came out i had severe bleeding/had terrible bleeding for weeks/ has been bleeding every two weeks since had it done (as per social media)/ she had been having clots") in a (b)(6) female patient who had essure (batch no.A73751) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "she tried to remove it then, the rest of it, and all the coils kept coming off" on (b)(6) 2013, device deployment issue "it did not completely release / coil/spring did not completely release into her tube (as per social media)/major issue on her left side (as per social media)" on (b)(6) 2013 and device monitoring procedure not performed "never did the hsg".The patient's past medical history included parity 4 (date of births: (b)(6) 1996, (b)(6) 1999, (b)(6) 2001, (b)(6) 2012), psychological disorder nos, headache, multigravida and miscarriage in 1994.Concurrent conditions included body mass index increased and heavy periods.Concomitant products included norlestrin fe (ethinylestrad w/ferrous fum/norethister acet) from 2010 to 2013 for contraception, bupropion (wellbutrin) since 1999 for depression, sumatriptan (imitrex) for headache and lansoprazole for heartburn.On (b)(6) 2013, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), complication of device insertion ("complication of device insertion") and the first episode of abdominal pain lower ("had a lot of cramping ever since the essure was put in/after the essure on the right side came out i had severe cramping/ had terrible cramping/ severe cramping after coil fell/ cramping so bad (as per social media)").In (b)(6) 2013, the patient experienced device expulsion ("3 months later the right side fell out/ the coil from her right side fell out/ right side fell out a morning (as per social media)").In (b)(6) 2014, the patient experienced the second episode of abdominal pain lower ("severe cramping after coil fell").On (b)(6) 2014, the patient experienced pelvic pain ("seen for pelvic pain/pelvis pain").On (b)(6) 2015, the patient experienced the first episode of vulvovaginal discomfort ("seen for vaginal irritation (this was being experienced for months prior to seeing a doctor.)/ vaginal discomfort (burning sensation, very irritated)") and the second episode of vulvovaginal discomfort ("have constant burning down there (as per social media)/vaginal discomfort/ vaginal irritation").On (b)(6) 2015, the patient experienced vaginal discharge ("seen for vaginal discharge").On an unknown date, the patient experienced abdominal distension ("bloating"), allergy to metals ("not able to wear earrings made of nickel but have never been officially tested"), headache ("her headache got more severe after she had essure placement"), back pain ("backaches"), urine analysis abnormal ("urine labs came back high and abnormal (as per social media)"), memory impairment ("memory problems (as per social media)"), emotional disorder ("freaked out (as per social media)"), mental disorder ("aggravated any psychiatric and/or psychological condition(s)"), migraine ("migraines"), malaise ("just not feeling well (as per social media)/ sick all the time (as per social media)") and procedural pain ("me being in a lot of pain").The patient was treated with ibuprofen and ibuprofen (advil).Essure treatment was not changed.In 2013, the genital haemorrhage was resolving.At the time of the report, the device breakage, complication of device insertion, device expulsion, vaginal discharge, allergy to metals, pelvic pain, urine analysis abnormal, memory impairment, emotional disorder, the last episode of vulvovaginal discomfort, mental disorder, malaise and procedural pain outcome was unknown and the last episode of abdominal pain lower, abdominal distension, headache, back pain and migraine was resolving.The reporter provided no causality assessment for complication of device insertion, device breakage, device expulsion, genital haemorrhage and the first episode of abdominal pain lower with essure.The reporter considered abdominal distension, allergy to metals, back pain, emotional disorder, headache, malaise, memory impairment, mental disorder, migraine, pelvic pain, procedural pain, urine analysis abnormal, vaginal discharge, the first episode of vulvovaginal discomfort, the second episode of abdominal pain lower and the second episode of vulvovaginal discomfort to be related to essure.The reporter commented: she did not claim hypersensitivity reaction to nickel or any other component of essure.Her husband underwent vasectomy in 2014 due to the essure placement failing.For vaginal irritation she underwent treatment as bacterial vaginal infection & for vaginal discharge and irritation underwent treatment yeast infection.On the right side 5 coils were then seen.Her physician tat anytime she wanted, she could have a laser hysterectomy to remove the broken coil.She was concerned that it would cause problems later on.At that time, she chose to let it be and leave the broken coil inside of her.At the time of x-ray, it was still in the correct area of tube.Patient received treatment for severe cramping, pelvic pain, vaginal irritation,vaginal discharge.Complication during insertion - diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 26.2 kg/sqm.X-ray - on an unknown date: only the broken piece on the left side was seen between (b)(6) 2013 and (b)(6) 2014: sterilization dye with x-ray between (b)(6) 2013 and (b)(6) 2014, sterilization dye test with - ray.Provider communicated that essure was not in correct location in both fallopian tubes.Concerning the injuries reported in this case, the following events were reported via social media urine labs came back high and abnormal, memory problems,freaked out,have constant burning, quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 10-jul-2018: quality-safety evaluation of ptc.Incident: at the time of reporting, there is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Search Alerts/Recalls
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