| Model Number ESS305 |
| Device Problems
Break (1069); Material Fragmentation (1261); Insufficient Information (3190)
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| Patient Problems
Pain (1994); Injury (2348); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
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| Event Date 03/01/2009 |
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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 consumer of unspecified age via regulatory authority (case# mw5044412) in united states on 12-oct-2015 who had essure (fallopian tube occlusion insert) inserted.The consumer reported the insertion of the device took twice as long as it should have and the physician had to use three coils as one failed before it was in place.The essure device fell out of fallopian tube and broke into tiny pieces that the physician said he didn't think he got them all.The consumer stated that this caused her great pain.Serious injury was mentioned as report type, and required intervention was mentioned as event outcome, but not specified and/or assigned to one of the events.Follow up received on 26-oct-2015: ptc investigational result.(b)(4).Final assessment: 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.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.No capa investigation is required at this time because the possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.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: no product quality defect was confirmed therefore a relationship to the reported medical event(s) is excluded.The reported medical event is a known, possible, undesirable event and not indicative of a quality defect per se.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and during the procedure the essure device fell out of her fallopian tube and broke into tiny pieces.This event, interpreted as device breakage, is non-serious and anticipated according to product technical analysis.During difficult insertions, single cases of device breakage have been reported.In the present case, according to the consumer, the insertion procedure took twice as long as it should have, and one of the coils failed before it was in place; the device fell out of fallopian tube and broke into pieces.Since the device breakage 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 reported device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Required intervention was mentioned as event outcome but there was no performed intervention referring to an event described.Based on the available information, there is no relationship between the reported medical event(s) and a quality defect.Further information are expected.
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Manufacturer Narrative
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Follow-up information received on 27-jan-2016.Follow-up attempts have been completed with no response to date.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and during the procedure the essure device fell out of her fallopian tube and broke into tiny pieces.This event, interpreted as device breakage, is non-serious and anticipated according to product technical analysis.During difficult insertions, single cases of device breakage have been reported.In the present case, according to the consumer, the insertion procedure took twice as long as it should have, and one of the coils failed before it was in place; the device fell out of fallopian tube and broke into pieces.Since the device breakage 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 reported device breakage did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Required intervention was mentioned as event outcome but there was no performed intervention referring to an event described.Based on the available information, there is no relationship between the reported medical events and a quality defect.No further information is expected.
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Manufacturer Narrative
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Follow-up information received on 19-oct-2016 from legal claim: the case is in litigation.In (b)(6) 2009 the patient had two essure coils implanted into her body.In (b)(6) 2009 the patient underwent hsg (hysterosalpingogram) procedure and it was discovered that one of the coils was malpositioned.After the implant procedure, the patient began to experience pelvic pains and increased bleeding during menstruation.These symptoms started out minor and gradually increased in intensity.On or about (b)(6) 2009, the patient underwent a removal procedure for the faulty left coil as a definitive solution to the problems that she had been experiencing.Currently, the right coil remains in place and continues to cause issues in her life.The pain and bleeding experienced is a direct and proximate result of the defendant failure to disseminate accurate information regarding their product.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and during the procedure the essure device fell out of her fallopian tube and broke into tiny pieces.Upon receipt of follow-up information, it was reported that one of the coils was malpositioned (left coil) (seen as device dislocation).Left coil was removed and right coil remained in place.This case became legal.The events device breakage and device dislocation are anticipated according to product technical analysis.During difficult insertions, single cases of device breakage have been reported.In the present case, according to the consumer, the insertion procedure took twice as long as it should have, and one of the coils failed before it was in place; the device fell out of fallopian tube and broke into pieces.The device dislocation was diagnosed about two months after essure insertion, however the exact date and mechanism were not known.Considering the device breakage occurred during essure insertion procedure and the nature of device dislocation, a causal relationship with the suspect insert cannot be excluded.This case was regarded as incident because a device removal was required.Based on the available information, there is no relationship between the reported medical events and a quality defect.Further information will be obtained through the litigation process.
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Manufacturer Narrative
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Quality-safety evaluation of ptc: sample not available.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 were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of micro-insert breaking 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 breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are known, possible, undesirable events and not indicative of a quality deficit per se.A review of similar cases for this batch resulted in no unusual pattern identified.Most recent follow-up information incorporated above includes: on 2-mar-2017: updated quality safety evaluation of ptc for lot no: 627757.Company causality comment: this spontaneous non-medically confirmed case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and during the procedure the essure device fell out of her fallopian tube and broke into tiny pieces.Upon receipt of follow-up information, it was reported that one of the coils was malpositioned (left coil) (seen as device dislocation).Left coil was removed and right coil remained in place.This case became legal.The events device breakage and device dislocation are anticipated according to product technical analysis.During difficult insertions, single cases of device breakage have been reported.In the present case, according to the consumer, the insertion procedure took twice as long as it should have, and one of the coils failed before it was in place; the device fell out of fallopian tube and broke into pieces.The device dislocation was diagnosed about two months after essure insertion, however the exact date and mechanism were not known.Considering the device breakage occurred during essure insertion procedure and the nature of device dislocation, a causal relationship with the suspect insert cannot be excluded.This case was regarded as incident because a device removal was required.According to the product technical analysis, product quality defect could not be confirmed but is considered plausible.Further information will be obtained through the litigation process.
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Manufacturer Narrative
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This case was initially received via regulatory authority (fda, reference number: mw5044412) on 12-oct-2015.The most recent information was received on 08-jan-2019.This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("left coil was malpositioned"), menorrhagia ("increased bleeding during menstruation/abnormal bleeding (menorrhagia)"), device breakage ("the essure device fell out of my fallopian tube and broke into tiny pieces") and device expulsion ("migration of essure device (uterus)") in a 24-year-old female patient who had essure (batch no: 627757) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included eye operation on (b)(6) 2009.Concurrent conditions included arthritis since on (b)(6) 2009.Concomitant products included ibuprofen.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2009, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and vaginal discharge ("vaginal discharge").On (b)(6) 2009, the patient was found to have hormone level abnormal ("hormonal changes").On (b)(6) 2009, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6) 2009, the patient experienced fatigue ("fatigue").On (b)(6) 2009, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On (b)(6) 2009, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).In 2009, the patient experienced pelvic pain ("pelvic pains").On (b)(6) 2009, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced complication of device removal ("the doctor said he didn't think he got them all"), procedural pain ("this caused me great pain"), complication of device insertion ("he had to use three coils as one failed before it was in place"), abdominal pain lower ("lower abdomen") and back pain ("lower back").The patient was treated with surgery (on (b)(6) 2009, the patient underwent a removal procedure for the faulty left coil, ablation, tubal ligation on (b)(6) 2009 and on (b)(6) 2009, the patient underwent a removal procedure for the faulty left coil).Essure was removed on (b)(6) 2009.At the time of the report, the device dislocation, menorrhagia, complication of device removal, procedural pain and complication of device insertion outcome was unknown and the device breakage, device expulsion, pelvic pain, dysmenorrhoea, dyspareunia, vaginal haemorrhage, vaginal discharge, fatigue, hormone level abnormal, abdominal pain lower and back pain had not resolved.The reporter considered abdominal pain lower, back pain, complication of device insertion, complication of device removal, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, fatigue, hormone level abnormal, menorrhagia, pelvic pain, procedural pain, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: the consumer reported the insertion of the device took twice as long as it should have and the physician had to use three coils as one failed before it was in place.The essure device fell out of fallopian tube and broke into tiny pieces that the physician said he didn't think he got them all.The consumer stated that this caused her great pain.On or about on (b)(6) 2009, the patient underwent a removal procedure for the faulty left coil as a definitive solution to the problems that she had been experiencing.Currently, the right coil remains in place and continues to cause issues in her life.The pain and bleeding experienced is a direct and proximate result of the defendant failure to disseminate accurate information regarding their product.Once the tubal ostium was clear the essure device was properly deployed in the left tubal ostium.At the completion there were three coils seen coming from the tubal ostium.This was again taken away with grasping forceps.The essure device was then again passed through the tubal o5tium into the proximal tube.It was deployed without difficulty.Two coils were seen from the tubal ostium.The patient tolerated the procedure well, (on (b)(6) 2009: one coil would not activate so they had to place another.) essure implant taken out in pieces, not sent to pathology.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram: on (b)(6) 2009: results: one of coils was malpositioned (as per pfs) :migration of essure device, breakage of essure device.As per mr: 1.Occluded right fallopian tube.2.Free flow of contrast throughout the left fallopian tube.Pregnancy test urine: on (b)(6) 2009: negative.¿concerning the injuries reported in this case, the following one was described in patients medical record: cramping.Quality-safety evaluation of ptc: sample not available.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 were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of micro-insert breaking 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 breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are known, possible, undesirable events and not indicative of a quality deficit per se.A review of similar cases for this batch resulted in no unusual pattern identified.Most recent follow-up information incorporated above includes: on 8-jan-2019: pfs received: event menorrhagia, abdominal pain lower, device expulsion, vaginal discharge, hormonal level abnormal, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse) were added.Historical & concomitant conditions drugs, patient demographic details updated.Incident: we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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Manufacturer Narrative
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This case was initially received via regulatory authority (fda, reference number: mw5044412) on (b)(6)2015.The most recent information was received on (b)(6)2019.Quality-safety evaluation of ptc: sample not available.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 were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of micro-insert breaking 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 breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are known, possible, undesirable events and not indicative of a quality deficit per se.A review of similar cases for this batch resulted in no unusual pattern identified.This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("left coil was malpositioned"), menorrhagia ("increased bleeding during menstruation/abnormal bleeding (menorrhagia)"), device breakage ("the essure device fell out of my fallopian tube and broke into tiny pieces/device breakage") and device expulsion ("migration of essure device (uterus)/physician stated that it looked like one had fallen out") in a 24-year-old female patient who had essure (batch no.627757) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included eye operation on (b)(6)2009.Concurrent conditions included arthritis since (b)(6)2009.Concomitant products included hydrocodone bitartrate;paracetamol (vicodin) and ibuprofen.On (b)(6)2009, the patient had essure inserted.On (b)(6)2009, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("abnormal bleeding (vaginal)") and vaginal discharge ("vaginal discharge").On (b)(6)2009, the patient was found to have hormone level abnormal ("hormonal changes").On (b)(6)2009, the patient experienced dyspareunia ("dyspareunia (painful sexual intercourse)").On (b)(6)2009, the patient experienced fatigue ("fatigue").In may 2009, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On (b)(6)2009, the patient experienced device expulsion (seriousness criteria medically significant and intervention required).In 2009, the patient experienced pelvic pain ("pelvic pains").On (b)(6)2009, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced complication of device removal ("the doctor said he didn't think he got them all"), procedural pain ("this caused me great pain"), complication of device insertion ("he had to use three coils as one failed before it was in place"), abdominal pain lower ("lower abdomen"), back pain ("lower back") and mood swings ("hormonal changes: extreme mood swings").The patient was treated with surgery (in (b)(6)2009, the patient underwent a removal procedure for the faulty left coil, ablation, tubal ligation on (b)(6)2009 and n (b)(6)2009, the patient underwent a removal procedure for the faulty left coil).Essure was removed on (b)(6)2009.At the time of the report, the device dislocation, menorrhagia, complication of device removal, procedural pain, complication of device insertion and mood swings outcome was unknown and the device breakage, device expulsion, pelvic pain, dysmenorrhoea, dyspareunia, vaginal haemorrhage, vaginal discharge, fatigue, hormone level abnormal, abdominal pain lower and back pain had not resolved.The reporter considered abdominal pain lower, back pain, complication of device insertion, complication of device removal, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, fatigue, hormone level abnormal, menorrhagia, mood swings, pelvic pain, procedural pain, vaginal discharge and vaginal haemorrhage to be related to essure.The reporter commented: the consumer reported the insertion of the device took twice as long as it should have and the physician had to use three coils as one failed before it was in place.The essure device fell out of fallopian tube and broke into tiny pieces that the physician said he didn't think he got them all.The consumer stated that this caused her great pain.On or about (b)(6)2009, the patient underwent a removal procedure for the faulty left coil as a definitive solution to the problems that she had been experiencing.Currently, the right coil remains in place and continues to cause issues in her life.The pain and bleeding experienced is a direct and proximate result of the defendant failure to disseminate accurate information regarding their product.Once the tubal ostium was clear the essure device was properly deployed in the left tubal ostium.At the completion there were three coils seen coming from the tubal ostium.This was again taken away with grasping forceps.The essure device was then again passed through the tubal o5tium into the proximal tube.It was deployed without difficulty.Two coils were seen from the tubal ostium.The patient tolerated the procedure well, ((b)(6)2009: one coil would not activate so they had to place another.) essure implant taken out in pieces, not sent to pathology diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6)2009: results: one of coils was malpositioned (as per pfs) :migration of essure device, breakage of essure device.As per mr: 1.Occluded right fallopian tube.2.Free flow of contrast throughout the left fallopian tube.Pregnancy test urine - on (b)(6)2009: negative.¿concerning the injuries reported in this case, the following one was described in patients medical record: cramping quality-safety evaluation of ptc: sample not available.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 were unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.The possibility of micro-insert breaking 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 breakage.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.The reported medical events are known, possible, undesirable events and not indicative of a quality deficit per se.A review of similar cases for this batch resulted in no unusual pattern identified.Most recent follow-up information incorporated above includes: on (b)(6)2019: pfs received : following event was added : hormonal changes describe: extreme mood swings.Concomitant products added.Incident we received a lot number in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, this will be provided in a supplementary report.
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