| Model Number ESS305 |
| Device Problems
Device Or Device Fragments Location Unknown (2590); Insufficient Information (3190)
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| Patient Problems
Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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| Event Date 07/31/2008 |
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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 female consumer of unspecified age in united states on (b)(6) 2013 via internet who had essure (fallopian tube occlusion insert) inserted and experienced that essure was lost inside her body and she reported "woman sick and dying".This case was not medically confirmed at the time of the report.No information was given on consumer's history, past drugs, concomitant drugs and concurrent conditions.On an unspecified date the consumer had essure inserted.It was not reported whether essure was used previously.The consumer reported that essure was lost in her body and "woman sick and dying".The consumer's outcome was unknown at the time of the report.Reporter causality: no causality comment was given.Follow-up received on 25-oct-2013: case category was changed from incident to non-incident.No ptc will be created.Follow-up received on 25-oct-2013: reporter did not provide any response.Case considered to be closed.Follow-up received on 29-oct-2014: information received from consumer states that essure made her feel like she was dying for 6 years.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: ptc global number (b)(4).Final assessment: 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 to confirm that all parts are accounted for and inspect the device to look for any manufacturing deficiencies.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Medical assessment: this ptc was initiated due to a request for confirmation of quality.The reported adverse events are not indicative of a quality deficit per se.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for a technical investigation.The technical assessment concluded "unconfirmed quality defect".In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Follow up 10.Dec.2014: follow up information received from the consumer via social media.Case upgraded to incident.Essure for birth control was added.Consumer reported that had essure coil removed and still sick and had hysto still fighting.No additional information was provided.Company causality comment: this non-medically confirmed, spontaneous case report was received via internet and refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and essure was lost inside her body.This event, interpreted as device dislocation, was considered serious due to medical importance and is listed according to essure's reference safety information.During essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) or dislocation (distal fallopian tube or peritoneal cavity).In this particular case, based on the available information and due to lack of alternative explanation, causality between the reported event and essure use cannot be excluded.Additionally non-serious event was reported.This case was upgraded from non-incident to incident since essure device were removed.The product technical analysis was unable to perform an investigation of the actual device involved since no product was returned for investigation.No valid lot number was provided, thus no review of the manufacturing batch was possible.The product technical analysis concluded "unconfirmed quality defect" and that there is no reason to suspect a causal relationship to a potential quality deficit based on this report.No further information is expected.
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Manufacturer Narrative
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Follow up 17-aug-2016: follow-up information was received from consumer via social media where she posted questions about if she still has essure fragments inside her and where other 2cm was.She was also questioning if her bones were deteriorating.No additional information was provided.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and essure was lost inside her body (seen as a device dislocation).She was submitted to a hysterectomy and the devices were removed.This reported event was considered serious, as medically significant and is listed according to essure's reference safety information.She was also suspecting about essure fragments inside her (seen as a device breakage - nonserious and unlisted).During essure micro-insert therapy there is a risk that the device could move in/out of fallopian tubes, this movement could be an expulsion or dislocation (into distal fallopian tube or to abdominal cavity).In this case, limited information was provided.Nevertheless considering its nature, causality with the suspect insert cannot be excluded.This case was regarded as incident since device removal was required.During difficult insertions, single cases of essure breakage have been reported.In this particular case, consumer was only suspecting about a device breakage and no other information about this event was reported.However, given its nature, causality cannot be totally excluded.The technical assessment concluded unconfirmed quality defect.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Update in this technical assessment is expected after follow-up information containing a suspicion of device breakage was received.No further information from reporter 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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Manufacturer Narrative
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Quality-safety evaluation of ptc: updated assessment: the essure is made upon 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.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.We cannot exclude the possibility of having a technical issue involved in the complaint.The possibility micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.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.However, the medical events are known, possible, undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 2-feb-2017: updated quality safety evaluation of ptc.Company causality comment: this spontaneous consumer report refers to a female of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced essure lost inside body (seen as a device dislocation).She underwent hysterectomy and device removal.She was also suspecting that essure fragments inside her.Device dislocation, serious due to medical significance, is anticipated according to the reference safety information of essure.During the use of essure micro-insert, there is a risk that the device may move along or outside of the fallopian tubes, resulting in dislocation or expulsion of the coils (for example into the distal portion of the tube or in the abdominal cavity).In this particular case, the clinical information was very limited, however, considering the nature of the event, a causal relationship between the dislocation and the inserts cannot be excluded (related).Concerning the suspected device breakage, single cases of coil breakage have been observed during difficult insertion procedures.Although no diagnostic tests were mentioned in support of the breakage and medically-confirmed information was lacking altogether, given the nature of the event a causality cannot be totally excluded (related).Other events, non-serious, were additionally reported.This case was classified as incident since device removal was required.An updated technical assessment resulted in an unconfirmed quality defect, as no batch number or complaint sample were available.No further information is expected.
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Manufacturer Narrative
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This spontaneous case was reported by a consumer and describes the occurrence of device dislocation ("essure is lost inside body") and device breakage ("essure broke inside her/ essure fragments inside her (questioning where the other 2cm was)") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.The patient's past medical history included multigravida and multiparous.In 2008, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), malaise ("woman sick and dying / made me feel like i was dying for 6 years"), bone loss ("suspicion of bones deterioration"), complication of device removal ("doctors recovered 1.5 cm of the device") and adverse event ("she now suffers with fragments inside of her").The patient was treated with surgery (hysterectomy and device removal).Essure was removed.At the time of the report, the device dislocation outcome was unknown and the device breakage, malaise, bone loss, complication of device removal and adverse event had not resolved.The reporter considered adverse event, bone loss, complication of device removal, device breakage, device dislocation and malaise to be related to essure.The reporter commented: she had essure coil removed and was still sick and had hysto still fighting.She posted questions about if she still has essure fragments inside her and where the other 2cm was.She was also questioning if her bones were deteriorating.Most recent follow-up information incorporated above includes: on (b)(6) 2018: information received from social media.Consumer mentioned that she is a mother of four and she had essure inserted in 2008.Consumer stated that essure broke inside of her and doctors recovered 1.5 cm of the device and that she now suffers with fragments inside of her.Patient ultimately had to have a hysterectomy.Incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Ntaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of uterine perforation ("essure coil was noted protruding out of uterine serosa on right cornual site"), device dislocation ("essure is lost inside body") and device breakage ("essure broke inside her/ essure fragments inside her (questioning where the other 2cm was)") in an adult female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 4 and multiparous.Concurrent conditions included menstruation abnormal, dysmenorrhea, ovarian cyst, uterine enlargement, pelvic pain, hypermenorrhea and menometrorrhagia.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), malaise ("woman sick and dying / made me feel like i was dying for 6 years"), bone loss ("suspicion of bones deterioration"), complication of device removal ("doctors recovered 1.5 cm of the device") and adverse event ("she now suffers with fragments inside of her").The patient was treated with surgery (dilatation and curettage,laparoscopic essure removal) and surgery (hysterectomy and device removal).Essure was removed.At the time of the report, the uterine perforation and device dislocation outcome was unknown and the device breakage, malaise, bone loss, complication of device removal and adverse event had not resolved.The reporter considered adverse event, bone loss, complication of device removal, device breakage, device dislocation, malaise and uterine perforation to be related to essure.The reporter commented: she had essure coil removed and was still sick and had hysto still fighting.She posted questions about if she still has essure fragments inside her and where the other 2cm was.She was also questioning if her bones were deteriorating.The essure was then placed through the operative channel.This was placed in the right tubal ostia without difficulty.Attempt at left tubal ostial placement was unsuccessful as there was resistance noted.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: uterine perforation" most recent follow-up information incorporated above includes: on (b)(6) 2018: event "essure coil was noted protruding out of uterine serosa on right cornual site ", reporter, hostorical and concomittant condition added from medical record.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, berlin, and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Manufacturer Narrative
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Cutaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("essure coil was noted protruding out of uterine serosa on right cornual site / fallopian tubes perforated"), fallopian tube perforation ("fallopian tube perforation occurred duing insertion procedure"), the first episode of device dislocation ("essure is lost inside body"), device breakage ("essure broke inside her/ essure fragments inside her (questioning where the other 2cm was) / she now suffers with fragments inside of her / device fragmentation"), the second episode of device dislocation ("3cm of device migrated to hips and ribs / essure migrated in my body"), genital haemorrhage ("profuse bleeding"), uterine haemorrhage ("abnormal uterine bleeding (heavy bleeding)"), uterine cancer ("uterine cancer") and cholecystectomy ("gallbladder removal") in a 38-year-old female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.The patient's past medical history included parity 4, multiparous and uterine prolapse.Concurrent conditions included menstruation abnormal, dysmenorrhea, ovarian cyst, uterine enlargement, pelvic pain, hypermenorrhea and menometrorrhagia.On (b)(6) 2008, the patient had essure inserted.On the same day, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain, fallopian tube perforation (seriousness criteria medically significant and intervention required) with malaise and abdominal pain, pain ("feel like having a knife stabbing on the left side / body pain"), musculoskeletal chest pain ("severe and persistent pain in center ribs") and complication of device insertion ("perforation occurred during insertion procedure").On an unknown date, the patient experienced the first episode of device dislocation (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), the second episode of device dislocation (seriousness criterion medically significant), genital haemorrhage (seriousness criterion medically significant), uterine haemorrhage (seriousness criterion medically significant), uterine cancer (seriousness criterion medically significant), cholecystectomy (seriousness criterion medically significant), bone loss ("suspicion of bones deterioration"), alopecia ("hair loss"), amnesia ("memory loss"), nausea ("nausea"), vomiting ("vomiting"), myalgia ("muscle pain"), abdominal distension ("bloating"), confusional state ("confusion"), hypertension ("high blood pressure"), visual impairment ("vision problems"), gingival disorder ("gum problems"), tooth disorder ("teeth problems"), lethargy ("lethargy"), burning sensation ("burning sensation"), headache ("bad headaches that last for days at a time"), menstrual disorder ("periods are worse than ever"), back pain ("lower back pain is unbearable"), asthenia ("weakness"), dizziness ("dizziness"), allergy to metals ("hypersensitivity reaction to nickel"), mental disorder ("caused or aggravated psychiatric - psychological conditions"), rotator cuff syndrome ("torn rotor cuff"), musculoskeletal pain ("shoulder pain") and complication of device removal ("doctors recovered 1.5 cm of the device").The patient was treated with surgery (dilatation and curettage,laparoscopic essure removal), surgery (laparoscopic essure removal), surgery (hysterectomy and device removal), surgery (laparoscopic essure removal) and surgery (hysterectomy with portion of essure removed).Essure was removed.At the time of the report, the uterine perforation, fallopian tube perforation, the last episode of device dislocation, genital haemorrhage, uterine haemorrhage, uterine cancer, cholecystectomy, alopecia, amnesia, nausea, vomiting, myalgia, abdominal distension, confusional state, hypertension, visual impairment, gingival disorder, tooth disorder, lethargy, burning sensation, headache, asthenia, dizziness, allergy to metals, mental disorder, rotator cuff syndrome and complication of device insertion outcome was unknown and the device breakage, bone loss, pain, menstrual disorder, back pain, musculoskeletal chest pain, musculoskeletal pain and complication of device removal had not resolved.The reporter considered abdominal distension, allergy to metals, alopecia, amnesia, asthenia, back pain, bone loss, burning sensation, cholecystectomy, complication of device insertion, complication of device removal, confusional state, device breakage, dizziness, fallopian tube perforation, genital haemorrhage, gingival disorder, headache, hypertension, lethargy, menstrual disorder, mental disorder, musculoskeletal chest pain, musculoskeletal pain, myalgia, nausea, pain, rotator cuff syndrome, tooth disorder, uterine cancer, uterine haemorrhage, uterine perforation, visual impairment, vomiting, the first episode of device dislocation and the second episode of device dislocation to be related to essure.The reporter commented: she had essure coil removed and was still sick and had hysto still fighting.She posted questions about if she still has essure fragments inside her and where the other 2cm was.She was also questioning if her bones were deteriorating.The essure was then placed through the operative channel.This was placed in the right tubal ostia without difficulty.Attempt at left tubal ostial placement was unsuccessful as there was resistance noted.She experienced stabbing pain and burning sensation but subsided a little after 1cm of essure was explanted.During the explant, physician was only able to get 1cm out of the 4cm implanted and this was due to device fragmentation.A 3cm of device has migrated to consumer´s ribs and hips.Explanting physician also realized the implanting physician performed a tubal as well and her fallopian tubes were perforated as a result of the procedure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 56.1 kg/sqm.¿concerning the injuries reported in this case, the following one/ones were described in patient¿s medical record: uterine perforation" further company follow-up with the lawyer or lawyer is not possible.Most recent follow-up information incorporated above includes: on (b)(6) 2018: (b)(4) (mfr number 2951250-2014-00349) and (b)(4) (mfr number 2951250-2018-00046) were identified as a duplicate of this case and will be deleted from bayer database.All information was transferred to this remaining case - reporters and events stabbing pain,3cm of deice migrated to hips and ribs, fallopian tubes perforated during insertion procedure, profuse bleeding,felt sick immediately after implant of essure, hair loss, memory loss, nausea, vomiting, muscle pain, severe abdominal pain,bloating, confusion, high blood pressure, vision problems, gum problems, teeth problems, lethargy, burning sensation, uterine cancer, gallbladder removal, abnormal uterine bleeding (heavy bleeding), severe and persistent pelvic pain, bad headaches that last for days a time, feels like having a knife stabbing on left side / body pain, periods are worse than ever, lower back pain is unbearable, severe and persistent pain in center ribs, weakness, dizziness added incident no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.
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Search Alerts/Recalls
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