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| Model Number ESS305 |
| Device Problems
Break (1069); Difficult to Insert (1316)
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| Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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Ptc investigation result was received on 22-sep-2014.This adverse event report is related to a product technical complaint (ptc).(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.As of (b)(4) 2014, 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 events are not indicative of a quality defect per se.In this particular case a technical defect (breakage) was reported in the context of a complicated insertion.The reported technical defect could not be evaluated in more detail due to lack of sample return.Three further ae case reports have been received to date in relation to batch no.50750351 (expiration date 31-aug-2016 and production date 27-aug-2013), of which 3 cases refer also to a similar type of adverse events.No unusual pattern could be identified.The review of the manufacturing- and release documentation of the concerned batch revealed no reason to suspect a quality deficit (see technical statement).The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit.Company causality comment: this medically confirmed, spontaneous case report, refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and device broke during placement in left fallopian tube.Reporter causality was not provided.The reported event, regarded as a device breakage (complication of device insertion) is non-serious, and was initially considered as unlisted according to essure reference safety information; however, upon receipt of product technical investigation (ptc) it was amended to listed, since ptc analysis concluded that the breakage is an anticipated event.Single cases of essure breakage have been reported.In this particular case, as the event was reported in association with essure placement procedure a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to device breakage.The ptc technical analysis concluded to an unconfirmed quality defect.Ptc medical evaluation considered that there is no reason to suspect a causal relationship to a potential quality deficit.Follow-up information is being sought.
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Manufacturer Narrative
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Follow-up information received on 10-dec-2014.No further information was provided.Case closed.The list of similar cases contains reports with similar events coded in meddra.It includes recent cases received by bayer pharma and older cases received from the previous owner of the essure product (conceptus).These legacy reports have been re-coded according to bayer pharma standards.In this particular case a search in the database was performed on 12-dec-2014 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.This includes consideration of the legacy cases in safety analyses.The cumulative review of the reports has not yielded any new safety signal.Company causality comment: this medically confirmed, spontaneous case report, refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and device broke during placement in left fallopian tube.Reporter causality was not provided.The reported event, regarded as a device breakage (complication of device insertion) is non-serious, and was initially considered as unlisted according to essure reference safety information; however upon receipt of product technical investigation (ptc) it was amended to listed, since ptc analysis concluded that the breakage is an anticipated event.Single cases of essure breakage have been reported.In this particular case, as the event was reported in association with essure placement procedure a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to device breakage.The ptc technical analysis concluded to an unconfirmed quality defect.Ptc medical evaluation considered that there is no reason to suspect a causal relationship to a potential quality deficit.No further information is expected.
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Event Description
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This is a spontaneous case report received from a physician in (b)(6) on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) implanted and experienced device broke during placement in left fallopian tube.On (b)(6) 2014 the patient had essure (fallopian tube occlusion insert), lot number 50750351, implanted.The device broke during placement in left fallopian tube.Bilateral placement was performed.France bhp local drug safety department assessed the causal relationship with essure as not applicable according to the french method of causality.
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Manufacturer Narrative
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Company causality comment: this medically confirmed, spontaneous case report, refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and device broke during placement in left fallopian tube.Reporter causality was not provided.The reported event, regarded as a device breakage (complication of device insertion) is non-serious, unlisted according to the reference safety information for essure, and was considered a near-incident, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Single cases of essure breakage have been reported.In this particular case, it was reported that a device breakage occurred during essure placement procedure; therefore a causal relationship with the suspect insert cannot be excluded.Follow-up information and product technical analysis are being sought.
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Manufacturer Narrative
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Follow up information received on 12-jan-2015 from the gynecologist.Patient´s demographic information was provided.Patient with no medical history.Intervention performed on (b)(6) 2014.Clinical reminder: patient currently with lud which had been to be kept for the 3 next months.Intervention: rachianesthesia.Uterine cavity exploration showed: uterine cavity showed lud with endocavitary thread ascent; tubal ostia were found without any difficulty; lud was withdrawn and gave for bacteriological examination.Essure implants were placed in each of both ostia of each fallopian tube.Batch number: on right side: batch number (b)(4), expiration date on feb-2017.On left side: batch number (b)(4), expiration date on feb-2017, there was placement failure.On left side: batch number (b)(4), expiration date on feb-2017, was placed.No further information will be provided.Case closed.Ptc investigation result updated received on 30-jan-2015.(b)(4).Final assessment: lot number: 50750351 - production date: 27-aug-2013 and expiration date: 31-aug-2016.Lot number: c26937 - production date: 19-feb-2014 and expiration date: 28-feb-2017.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 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.Since product was returned to us for this complaint, we were able to conduct an investigation of the returned product.We typically inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.As received, micro-insert found to be bent.The initial rollback was not performed.We were unable to confirm any quality defect or device malfunction at this time.We also conducted a review of the manufacturing batch record and confirmed that final product testing for these lots were performed per requirements and the product met all release requirements.The possibility of micro-insert breaking during the procedure is an anticipated event.The risk to the patient for these types of breakage events were assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk as documented in the design fmea.Medical assessment: this ptc was initiated due to a product quality issue (breakage).In addition, the ae case refers to a usability issue.No adverse events were reported at this point in time.The batch documentation of the reported batches was reviewed.The provided complaint sample was investigated with no failure detected.The technical assessment concluded unconfirmed quality defect.Since no related adverse events have been reported, a batch investigation with respect to similar ae cases is not applicable.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report as neither a quality defect was confirmed nor an adverse event was reported at this point in time.The list of similar cases contains reports with similar events coded in meddra.It includes recent cases received by bayer pharma and older cases received from the previous owner of the essure product (conceptus).These legacy reports have been re-coded according to bayer pharma standards.In this particular case a search in the database was performed on 03-feb-2015 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.This includes consideration of the legacy cases in safety analyses.The cumulative review of the reports has not yielded any new safety signal.Company causality comment: this medically confirmed, spontaneous case report, refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and device broke during placement in left fallopian tube.Reporter causality was not provided.The reported event, regarded as a device breakage (complication of device insertion) is non-serious, and was initially considered as unlisted according to essure reference safety information; however upon receipt of product technical investigation (ptc) it was amended to listed, since ptc analysis concluded that the breakage is an anticipated event.Single cases of essure breakage have been reported.In this particular case, as the event was reported in association with essure placement procedure a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.The ptc technical analysis (lot number provided 50750351) concluded to an unconfirmed quality defect.Ptc medical evaluation considered that there is no reason to suspect a causal relationship to a potential quality deficit.According to new product technical analysis for the lot number c26937, micro-insert found to be bent (interpreted as device use error).The initial rollback was not performed (interpreted as device deployment issue).Medical ptc assessment concluded that the provided complaint sample was investigated with no failure detected.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report as neither a quality defect was confirmed nor an adverse event was reported at this point in time.
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Manufacturer Narrative
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Follow-up received on 09-apr-2015: information received from ptc team states that device was received at quality unit on 30-mar-2015.The other device was received on 15-jan-2015 (previously reported).Ptc investigation and final assessment was updated.Final assessment: since product was returned to us for this complaint, we were able to conduct an investigation of the returned product.We typically inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.As received, micro-insert found to be bent and still intact to delivery catheter.The final rollback was not completed.We were unable to confirm any device breakage.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 micro-insert breaking during the procedure is an anticipated event.Medical assessment: the reported events are not indicative of a quality defect per se.In this particular case a technical defect (breakage) was reported in the context of a complicated insertion.The ae case refers also to a usability issue.However, no adverse events were reported at this point in time.The batch documentation of the reported batch (50750351) was reviewed.The provided complaint sample was inspected.The technical assessment concluded unconfirmed quality defect.At this point in time no adverse events have been reported therefore a batch investigation with respect to similar ae cases is not applicable.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report as no quality defect was confirmed neither an adverse event was reported at this point in time.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and micro-insert found to be bent.The reported event, regarded as a device use error is non-serious, and listed in the reference safety information for essure.During difficult insertions, the micro-insert may bend per use error.In this particular case, as the event was reported in association with essure placement procedure a causal relationship with the suspect insert cannot be excluded.This case was initially regarded as other reportable incident due to the reported device breakage, however upon receipt of two complaint samples, the technical analysis was updated.The devices were found to be bent and not broken.Therefore, the event was amended and this case was downgraded to non-incident.According to updated technical analysis, the provided complaint samples were investigated with no failure detected.There is no reason to suspect a causal relationship to a potential quality deficit based on this report as neither a quality defect was confirmed nor an adverse event was reported at this point in time.
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Search Alerts/Recalls
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