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| Model Number ESS305 |
| Device Problems
Difficult to Remove (1528); Separation Failure (2547)
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| Patient Problems
Tissue Damage (2104); Disability (2371)
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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 pharmacist in france on (b)(6) 2014 which refers to a female patient of unspecified age who had an attempt to insert essure (fallopian tube occlusion insert) lot number c38211.The problem happened in the gynecological operating room.At the placement of essure system, it was not possible to release it in the fallopian tube.Indeed, the coil was attached to the sheath that surrounded it.The sheath and the insert had to be removed by removing the delivery catheter.One part of the coil was removed and a portion of the insert remained in intratubular area.Ligating of the uterine tubes was performed via celioscopy due to failure of the method with essure system.Seriousness was not reported by the reporter.Follow up information received on 26-nov-2014: the patient had no particular past medical history.The patient had a twin pregnancy which delivery was a c-section in 2010; she also had an elective abortion in 2012.On (b)(6) 2014, the patient had her uterine tubes tied via celioscopy due to failure of the method with essure.When the first essure was placed in the left fallopian tube, it was impossible to release the insert which led to partial removal of essure system.No further information will be available.Case closed.The product technical complaint investigation and final assessment were received on 28-nov-2014.The bayer reference number for the ptc report is: (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 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 (instructions for use) 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.As of 20-nov-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.The possibility of pieces of the delivery system or micro-insert breaking off and detachment difficulty events during the procedure are anticipated events.The risk to the patient for this failure mode was 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 in the context of a difficult device 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 was reviewed.No complaint sample was provided for a technical investigation.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, as no adverse events were reported at this point in time a causal relationship to a potential quality defect cannot be assessed.Sample is expected.Company causality comment: this medically confirmed spontaneous report refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure essure system was unable to be released in the fallopian tube/the coil was attached to the sheath that surrounded it.The delivery catheter was removed and one part of the coil was removed and a portion of the insert remained in intratubular area.These events, interpreted as a device deployment issue, breakage and removal failure were considered non-serious.According to essure's reference safety information, the events are listed.Product technical analysis (ptc) corroborates this by stating that there is a possibility of pieces of the delivery system or micro-insert breaking off and detachment difficulty events during the procedure and therefore they are anticipated events.During essure removal, essure micro-insert may break.In this case, the physician had difficulties in the deployment of the device; he tried to remove it unsuccessfully and a breakage occurred.It was also reported that the patient was submitted to a tubal ligation due to failure of the method with essure system.Considering that the reported events occurred during essure insertion procedure, a causal relationship with the suspect insert cannot be excluded.This case was considered other reportable incident due to device breakage.So far, neither batch number nor sample was provided, thus the technical assessment concluded an unconfirmed quality defect.A review of the manufacturing batch record was conducted and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.As no adverse events were reported at this point in time, a causal relationship to a potential quality defect cannot be assessed.Further information is expected after the receipt of essure sample.
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Manufacturer Narrative
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Follow-up received on 09-apr-2015.Product technical complaint investigation and final assessment were updated: the bayer reference number for the ptc report is (b)(4).Final assessment: lot number: c38211; production date: 20-mar-2014; expiration date: 31-mar-2017.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 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.The device was received without micro-insert.The large tight pitch coil found to be broken.The distal end portion of broken large tight pitch coil was missing (see attached pictures).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.Medical assessment: this ptc was initiated due to a product quality issue in the context of a difficult device 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 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 neither a quality defect was confirmed nor an adverse event was reported at this point in time.The list of similar cases contains essure reports received by bayer with similar events coded in meddra.In this particular case a search in the database was performed on 13-apr-2015 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 this meddra pt.Company causality comment: this medically confirmed spontaneous report refers to a female patient who had an attempt to insert essure (fallopian tube occlusion insert) and during the procedure essure system was unable to be released in the fallopian tube/the coil was attached to the sheath that surrounded it.The delivery catheter was removed and one part of the coil was removed and a portion of the insert remained in intratubular area.These events, interpreted as a device deployment issue, breakage and removal failure were considered non-serious.According to essure's reference safety information, the events are listed.Product technical analysis (ptc) corroborates this by stating that there is a possibility of pieces of the delivery system or micro-insert breaking off and detachment difficulty events during the procedure and therefore they are anticipated events.During essure removal, essure micro-insert may break.In this case, the physician had difficulties in the deployment of the device; he tried to remove it unsuccessfully and a breakage occurred.It was also reported that the patient was submitted to a tubal ligation due to failure of the method with essure system.Considering that the reported events occurred during essure insertion 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.According to updated technical analysis (sample was investigated), 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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Data correction for us reporting: the code knh was replaced with hhs.
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Search Alerts/Recalls
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