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| Model Number ESS305 |
| Device Problems
Break (1069); Difficult to Insert (1316); Difficult to Remove (1528); Separation Failure (2547)
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| Patient Problem
Device Embedded In Tissue or Plaque (3165)
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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 gynecologist/obstetrician in (b)(6) on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.On (b)(6) 2014 essure (fallopian tube occlusion insert) was inserted with lot number c26941.It was reported that failure of implant placement in left horn occurred; the implant deployed and hung in tubal area.Broken implant remained in place despite appropriate manipulation.No further information was provided.Follow-up information received from the gynecologist on (b)(6) 2014.Number of defective unit was reported as 1.Event occurred in operating room during insertion.Bilateral insertion was done with concerned implant.Despite a good manipulation with delivery handle (release button and thumbwheel), implant did not deliver correctly.A coil clung to the delivery catheter and while trying to remove it, the coil broke, leaving the green release catheter and the rest of the coil into the fallopian tube.The gynecologist tried to remove it with grasping forceps without success and so leaving the rest in place.It occurred on left side following a very correct insertion and with no problem on right side.On x-ray, it seemed that both implants were anyway correctly placed.The gynecologist waited for confirmation by hysterosalpingography which was planned in 3 months.The gynecologist was worried about the piece of plastic in the fallopian tube.No other new medical information was provided.Follow-up information received from the gynecologist on (b)(6) 2014.Patient's initials and date of birth were provided.This report refers to a (b)(6) female patient.Historical condition included acaridae allergy, asthma under seretide (fluticasone propionate, salmeterol xinafoate), hypercholesterolaemia treated by homeopathy treatment, depression under cymbalta (duloxetin), oral contraception intolerance (facial odema, headaches), appendicectomy, cholecystectomy, hysteroscopy and curettage for cervical polyp, migraines, and 2 normal deliveries.At the beginning, insertion was planned without anaesthesia but passage of the cervix was painful and so, general anaesthesia was made.She was in gynaecological position, disinfection with betadine (povidone-iodine) was done, tried to insert hysteroscope without speculum, passage of the cervix disorder even with speculum.The patient did not bear hysteroscope insertion.General anaesthesia, col dilatation, passage of the hysteroscope, cavity was well visualized and implant insertion on right with no incident.On the left, when implant was deployed, it broke in the middle.So, there were some spirals which remained in the fallopian tube with a piece of inserter covered by a green plastic.No further information was provided.Company causality comment: this medically confirmed, spontaneous case report refers to a 42 year old female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure there was a failure of implant placement in left horn; implant deployed and hung in tubal area , broken implant, remained in place despite appropriate manipulation, passage of cervix was painful and cervix disorder.Reporter causality was not provided.All the reported events are non-serious.Device breakage during insertion is unlisted on the reference safety information for essure and was considered a other reportable event, 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.Single cases of essure breakage have been reported.In this particular case, the physician had difficulties during the insert deployment and stated that the implant had broken.A product technical analysis will be requested for further evaluation of the reported events, however considering that they occurred in association with essure placement procedure, their a causal relationship with the suspect insert cannot be excluded.
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Manufacturer Narrative
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Ptc investigation result was received on (b)(4) 2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: (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) and a usability issue were reported.At the point in time of this medical statement the reported technical defect could not be evaluated in more detail due to lack of sample return.One further ae case report has been received to date in relation to batch no.C26941 (production date 21-feb-2014 and expiration date 28-feb-2017), which also refers to similar product issue and usability issue type of 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.The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit.The reported usability issue will be subject to post marketing surveillance monitoring.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 (b)(4) 2014 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 853 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 (b)(6) female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure there was a failure of implant placement in left horn; implant deployed and hung in tubal area, broken implant, remained in place despite appropriate manipulation, passage of cervix was painful and cervix disorder.Reporter causality was not provided.All the reported events are non-serious.Device breakage during insertion was initially considered as unlisted according to reference safety information for essure; however upon receipt of product technical investigation (ptc) it was amended to listed, since ptc analysis concluded that the breakage is an anticipated event.The remaining events are listed.Single cases of essure breakage have been reported.In this particular case, the physician had difficulties during the insert deployment and stated that the implant had broken.Considering that the reported events occurred in association with essure placement procedure, their a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to device breakage.The ptc analysis concluded that there is no reason to suspect a causal relationship to a potential quality deficit.No further information is expected.
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Manufacturer Narrative
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Ptc investigation result updated received on 23-jan-2015.(b)(4).Final assessment: 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, large tight pitch coil found to be stretched and broken.No micro-insert was returned.All ifu steps were completed.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 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.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 and a usability issue.The batch documentation of the reported batch was reviewed.The returned complaint sample was investigated.The technical assessment concluded unconfirmed quality defect.One further ae case report has been received to date in relation to the reported batch, which refers also to a similar type of adverse events.No unusual pattern could be identified.The reported adverse events are not indicative of a quality deficit per se.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.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 27-jan-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 (b)(6) female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure there was a failure of implant placement in left horn; implant deployed and hung in tubal area, broken implant, remained in place despite appropriate manipulation, passage of cervix was painful and cervix disorder.Later, after receipt of device sample, large tight pitch coil found to be stretched and broken, interpreted also as device breakage and device use error.Reporter causality was not provided.All the reported events are non-serious.Device breakage during insertion was initially considered as unlisted according to reference safety information for essure; however upon receipt of product technical investigation (ptc) it was amended to listed, since ptc analysis concluded that the breakage is an anticipated event.The remaining events are listed.Single cases of essure breakage have been reported.In this particular case, the physician had difficulties during the insert deployment and stated that the implant had broken.Considering that the reported events occurred 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 updated ptc analysis (sample was later received) concluded that there is no reason to suspect a causal relationship to a potential quality deficit.No further information is expected.
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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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