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| Model Number ESS305 |
| Device Problems
Material Fragmentation (1261); Difficult to Insert (1316)
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| Patient Problem
Foreign Body In Patient (2687)
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Event Type
Injury
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Event Description
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This is a spontaneous case report received from a gynecologist/obstetrician on (b)(6) 2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.During uncoupling and rotating the essure at placement procedure, it seemed as if the essure did not uncouple enough or not at all.During retraction of the inserter a whole trail (probably the un-winded coil) came out, subsequently a piece of the (green) sleeve remained in the uterus and was removed this with a forceps.Next checked with the hysteroscope and another part (possible from the end part or from a piece that broke off) was seen left in the tuba, the physician was able to remove this as well with forceps with a lot of effort.The pieces appeared to be broken off and left in the uterus and tuba.After the procedure, the patient had a consult with anesthesist and subsequently performed lapster (understood as laparoscopic sterilization).The patients outcome was still unknown.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and essure breakage during insertion occurred.This event is non-serious and unlisted in the reference safety information for essure.During difficult insertions, single cases have been reported of essure breakage.In the present case, during uncoupling and rotating the essure at placement procedure, it seemed as if the essure did not uncouple enough or not at all, and during retraction of the inserter a whole trail (probably the un-winded coil) came out (interpreted as device deployment issue).Another part (possible from the end part or from a piece that broke off) was seen left in the tuba.As the device breakage in this case, occurred during essure insertion procedure, a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.The patient underwent a laparoscopic sterilization afterwards, however this procedure was not performed to prevent permanent damage; it was performed as second line contraception method.A product technical analysis and further information are expected.
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Manufacturer Narrative
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Follow-up received on 28-dec-2015: product technical complaint investigation results were provided.Ptc global number: (b)(4).Final assessment: failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The inserts 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 all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the 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.For cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned as of 11-dec-2015.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We were unable to confirm any quality defect or device malfunction at this time.The possibility of the catheter breaking and detachment difficulty is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: based on the available information no product quality defect was confirmed.Moreover, no medical events were reported at this time, therefore the assessment of a relationship with a quality defect is not applicable.Since no medical events and no batch number are reported, a batch investigation with respect to similar ae cases is not applicable.Follow-up information received on 06-jan-2016 from account manager: the essure was inserted on (b)(6) 2015 (lot number was unknown).The pieces that broke off were all removed (hysteroscopically).Laparoscopic sterilization was performed successfully, no further complaints.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and essure breakage during insertion occurred.This event is non-serious and was considered anticipated according to product technical analysis.During difficult insertions, single cases have been reported of essure breakage.In the present case, during uncoupling and rotating the essure at placement procedure, it seemed as if the essure did not uncouple enough or not at all, and during retraction of the inserter a whole trail (probably the un-winded coil) came out (interpreted as device deployment issue).Another part (possible from the end part or from a piece that broke off) was seen left in the tuba.The pieces that broke off were all removed (hysteroscopically) (date was not provided).As the device breakage in this case, occurred during essure insertion procedure, a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.The patient underwent a laparoscopic sterilization afterwards, however this procedure was not performed to prevent permanent damage; it was performed as second line contraception method.Based on the available information no product quality defect was confirmed.Further information is expected.
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Manufacturer Narrative
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Follow-up received on 12-feb-2016: no response to follow-up attempts was received.No further information was obtained.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 12-feb-2016 for the following meddra preferred term: device breakage.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 this meddra pt.Company causality comment: this spontaneous medically confirmed case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and essure breakage during insertion occurred.This event is non-serious and was considered anticipated according to product technical analysis.During difficult insertions, single cases have been reported of essure breakage.In the present case, during uncoupling and rotating the essure at placement procedure, it seemed as if the essure did not uncouple enough or not at all, and during retraction of the inserter a whole trail (probably the un-winded coil) came out (interpreted as device deployment issue).Another part (possible from the end part or from a piece that broke off) was seen left in the tuba.The pieces that broke off were all removed (hysteroscopically) (date was not provided).As the device breakage in this case, occurred during essure insertion procedure, a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.The patient underwent a laparoscopic sterilization afterwards, however this procedure was not performed to prevent permanent damage; it was performed as second line contraception method.Based on the available information no product quality defect was confirmed.Further information could not be obtained, despite follow-up attempts.
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Manufacturer Narrative
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Follow-up from 05-apr-2016: no response to follow-up attempts was received.No further information was obtained.Follow-up information received on 12-apr-2016 from gynecologist - device breakage questionnaire provided: the patient was (b)(6) years old.Her bmi was (b)(6).Essure was inserted on (b)(6)-2015 (lot number c12710).The implant broke during placement.There was no release when pushing the black button when the device was in the right position.The instructions in the ifu (instructions for use) were followed.Essure was removed by hysteroscopy.The broken pieces were retrieved from uterus and fallopian tubes (it was medically necessary to remove essure).Patient injury included discomfort.Laparoscopy was performed right away with tubal ligation; there was no further damage.The outcome was reported as recovered.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6)-year-old female patient who had essure (fallopian tube occlusion insert) inserted.During the procedure, an implant breakage occurred (the pieces appeared to be broken off).The broken pieces were removed by hysteroscopy and the patient outcome was reported as recovered.Device breakage is an anticipated event according to product technical analysis.During difficult insertions, single cases have been reported of essure breakage.In the present case, physician experienced a device deployment issue and the implant broke.Considering the event occurred in association with essure procedure, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.The patient underwent a laparoscopic sterilization afterwards.However, this procedure was regarded as a second line contraception method.An updated product technical analysis is expected.
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Manufacturer Narrative
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Quality-safety evaluation of product technical complaint (ptc): received on 31-may-2016: lot number: c12710; production date: 15-jan-2014; expiration date: 31-jan-2017.Detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: rollback to initial hard stop.Depress button.Perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the inserts grip on the delivery wire, and potential manufacturing deficiencies.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint, visual inspection was performed and it was confirmed that all components are present.Ifu steps were completed; micro-insert was found damaged (stretched).Delivery catheter was found broken and stretched.As per device condition, dimensional inspection was not able to be performed.We also 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.The possibility of a detachment difficulty event is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Based on the provided information the defect type corresponds to the following meddra llt: device deployment issue.As a product quality defect could not be confirmed but is considered plausible, a relationship with the reported medical event cannot be totally excluded.However, the medical event is a known, possible, undesirable event and not indicative of a quality deficit per se.No similar ae case reports have been received to date in relation to the reported batch.Device similar case listing 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 03-jun-2016 for the following meddra preferred terms: device breakage: 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 pt.Company causality comment: this medically confirmed, spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted.During the procedure, an implant breakage occurred (the pieces appeared to be broken off).The broken pieces were removed by hysteroscopy and the patient outcome was reported as recovered.Device breakage is an anticipated event according to product technical analysis.During difficult insertions, single cases have been reported of essure breakage.In the present case, physician experienced a device deployment issue and the implant broke.In this case, the device deployment issue might have contributed to device breakage.Considering the event occurred in association with essure procedure, causality with the suspect insert cannot be excluded.This case was regarded as other reportable incident as although the device breakage did not lead to death or serious deterioration in health, this might have occurred under less fortunate circumstances.The patient underwent a laparoscopic sterilization afterwards.However, this procedure was regarded as a second line contraception method.Since product was returned for investigation, visual inspection was performed and it was confirmed that all components were present.Instruction for use steps were completed.Micro-insert was found damaged (stretched).Delivery catheter was found broken and stretched.As per device condition, dimensional inspection was not able to be performed.We also 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.
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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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Search Alerts/Recalls
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