MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Break (1069); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Uterine Perforation (2121); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('left coil was embedded in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), procedural pain ("procedural pain"), fibromyalgia ("fibromyalgia"), incision site pruritus ("itchy incision"), incision site erythema ("red or hot incision site"), polyp ("polyp"), arthralgia ("hip pain"), plantar fasciitis ("plantar fascitis"), gait inability ("couldnt walk for days") and rash macular ("red dots on arms").At the time of the report, the embedded device, procedural pain, fibromyalgia, incision site pruritus, incision site erythema, polyp, arthralgia, plantar fasciitis, gait inability and rash macular outcome was unknown.The reporter considered arthralgia, embedded device, fibromyalgia, gait inability, incision site erythema, incision site pruritus, plantar fasciitis, polyp, procedural pain and rash macular to be related to essure.Concerning the injuries reported in this case, the following one was reported via social media: fibromyalgia, incision site pruritus and redness"., gait inability, plantar fasciitis, rash macular.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: fu 7 and 8 were processed together.Social media received.Reporter information added.Event : plantar fasciitis, couldnt walk for days, red dots on arms added.On 23-mar-2020: fu 7 and 8 were processed together.Social media received.Reporter information added.Event : red dots on arms added.On 23-mar-2020: based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('broke in me') and embedded device ('left coil was embdded in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "physician struggled to get the left coil in".The patient's medical history included uterine fibroid (removed during essure insertion procedure).On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), rash macular ("red dots on arms"), procedural pain ("unbearable pain during insertion"), fibromyalgia ("fibromyalgia"), incision site pruritus ("itchy incision"), incision site erythema ("red or hot incision site"), polyp ("polyp"), arthralgia ("hip pain") and plantar fasciitis ("plantar fascitis").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the device breakage, embedded device, rash macular, procedural pain, fibromyalgia, incision site pruritus, incision site erythema, polyp, arthralgia and plantar fasciitis outcome was unknown.The reporter considered arthralgia, device breakage, embedded device, fibromyalgia, incision site erythema, incision site pruritus, plantar fasciitis, polyp, procedural pain and rash macular to be related to essure.The reporter commented: she could not walk for days.Concerning the injuries reported in this case, the following one was reported via social media: fibromyalgia, incision site pruritus and redness", plantar fasciitis, rash macular quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 13-may-2020: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of embedded device ('left coil was embdded in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "physician struggled to get the left coil in".The patient's medical history included uterine fibroid (removed during essure insertion procedure).On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criterion medically significant), rash macular ("red dots on arms"), procedural pain ("unbearable pain during insertion"), fibromyalgia ("fibromyalgia"), incision site pruritus ("itchy incision"), incision site erythema ("red or hot incision site"), polyp ("polyp"), arthralgia ("hip pain") and plantar fasciitis ("plantar fascitis").At the time of the report, the embedded device, rash macular, procedural pain, fibromyalgia, incision site pruritus, incision site erythema, polyp, arthralgia and plantar fasciitis outcome was unknown.The reporter considered arthralgia, embedded device, fibromyalgia, incision site erythema, incision site pruritus, plantar fasciitis, polyp, procedural pain and rash macular to be related to essure.The reporter commented: she could not walk for days.Concerning the injuries reported in this case, the following one was reported via social media: fibromyalgia, incision site pruritus and redness", plantar fasciitis, rash macular.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: fu 7 and 8 were processed together.Social media received.Reporter information added.Event : plantar fasciitis, couldnt walk for days, red dots on arms added.On 23-mar-2020: fu 7 and 8 were processed together.Social media received.Reporter information added.Event : red dots on arms added.On 23-mar-2020: fu9 processed together with fu 7 and 8.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('broke in me') and embedded device ('left coil was embdded in my uterus') in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "physician struggled to get the left coil in".The patient's medical history included uterine fibroid (removed during essure insertion procedure).On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required), rash macular ("red dots on arms"), procedural pain ("unbearable pain during insertion"), fibromyalgia ("fibromyalgia"), incision site pruritus ("itchy incision"), incision site erythema ("red or hot incision site"), polyp ("polyp"), arthralgia ("hip pain") and plantar fasciitis ("plantar fascitis").The patient was treated with surgery (essure removal).Essure was removed.At the time of the report, the device breakage, embedded device, rash macular, procedural pain, fibromyalgia, incision site pruritus, incision site erythema, polyp, arthralgia and plantar fasciitis outcome was unknown.The reporter considered arthralgia, device breakage, embedded device, fibromyalgia, incision site erythema, incision site pruritus, plantar fasciitis, polyp, procedural pain and rash macular to be related to essure.The reporter commented: she could not walk for days.Concerning the injuries reported in this case, the following one was reported via social media: fibromyalgia, incision site pruritus and redness", plantar fasciitis, rash macular.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 23-mar-2020: new reporter and event device broke were added.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of device breakage ("broke in me") and embedded device ("left coil was embdded in my uterus") in an adult female patient who had essure inserted for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: device insertion difficult ("physician struggled to get the left coil in").The patient had a medical history of uterine fibroid (removed during essure insertion procedure).On (b)(6) 2014, the patient had essure inserted.Essure was removed on (b)(6) 2018.An unknown time later she experienced device breakage (seriousness criteria medically important and intervention required), embedded device (seriousness criteria medically important and intervention required), rash macular ("red dots on arms"), procedural pain ("unbearable pain during insertion"), fibromyalgia ("fibromyalgia"), incision site pruritus ("itchy incision"), incision site erythema ("red or hot incision site"), polyp ("polyp"), arthralgia ("hip pain") and plantar fasciitis ("plantar fascitis").The patient was treated with surgery (essure removal).At the time of the report, the outcomes for these events were unknown.The reporter considered arthralgia, device breakage, embedded device, fibromyalgia, incision site erythema, incision site pruritus, plantar fasciitis, polyp, procedural pain and rash macular to be related to essure administration.The reporter commented: she could not walk for days.Concerning the injuries reported in this case, the following one was reported via social media: fibromyalgia, incision site pruritus and redness", plantar fasciitis, rash macular.Quality-safety evaluation of ptc: for essure: unable to confirm complaint the most recent follow-up information incorporated above includes data received on: (b)(6) 2023: pif received.Reporter information, patient date of birth, product indication, start and stop date added.Annex f updated.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device breakage ("broke in me") and embedded device ("left coil was embdded in my uterus") in a 48 year-old female patient who had essure inserted (lot no.863660-invalid) for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: device insertion difficult ("physician struggled to get the left coil in").The patient had a medical history of ovarian cyst, chronic pain, pelvic pain, irregular periods, right lower quadrant pain, pain ankle, hypothyroidism, hypokalemia, hyperlipidemia, obesity, gravida, parity, low back pain, vaginal pain, vaginal bleeding and uterine fibroid (removed during essure insertion procedure).On 06-jun-2014, the patient had essure inserted.Essure was removed on 01-jan-2018.An unknown time later she experienced device breakage (seriousness criteria medically important and intervention required), embedded device (seriousness criteria medically important and intervention required), rash macular ("red dots on arms"), procedural pain ("unbearable pain during insertion"), fibromyalgia ("fibromyalgia"), incision site pruritus ("itchy incision"), incision site erythema ("red or hot incision site"), polyp ("polyp"), arthralgia ("hip pain") and plantar fasciitis ("plantar fascitis").The patient was treated with surgery (bilateral salpingectomy,hysteroscopy diagnostic,ovarian cystectomy laparoscopic (bilateral) and essure removal).At the time of the report, the outcomes for these events were unknown.The reporter considered arthralgia, device breakage, embedded device, fibromyalgia, incision site erythema, incision site pruritus, plantar fasciitis, polyp, procedural pain and rash macular to be related to essure administration.The reporter commented: she could not walk for days.Coils: right 4 left 5.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 45.179 kg/sqm.[hysterosalpingogram] on 12-sep-2014: procedure: xr hysterosalpingography.History : post essure.Findings : fluoroscopy time 18 seconds.A 5 french balloon tipped catheter was positioned in the endometrial cavity and 8 cc of omnipaque 300 injected.The uterus projects to the left of the midline and is slightly anteflexed.The coils are in good position with complete occlusion of both oviducts.Impression: complete occlusion of both oviducts by the essure coils.[pathology test] on 04-oct-2017: final pathologic diagnosis: a: fallopian tube and coil, left, laparoscopic salpingectomy: -fallopian tube with no significant pathologic abnormality.- coil present.B: fallopian tube and coil, right, laparoscopic salpingectomy: - fallopian tube with no significant pathologic abnormality.- coil present.C: cyst, right ovary, laparoscopic cystectomy: - compatible with benign corpus hemorrhagicum.D: cyst, left ovary, laparoscopic cystectomy: - compatible with benign corpus hemorrhagicum.Clinical history: pelvic pain / ovarian cyst.Bilateral laparoscopic salpingectomy/hysteroscopy.A.Left fallopian tube and coil b.Right fallopian tube and coil c.Right ovarian cyst d.Left ovarian cyst.Gross description: the cut surfaces show soft tissue with a patent pinpoint lumen and coil involving the proximal 1/3 of tube.The coil (14.6 cm in length) is separate in the container.[x-ray] (dates unknown): shows both fallopian tubes are blocked.And narrative: single view of abdomen.History: prior essure removal.Findings: there are punctate metallic radiopaque foreign bodies in the area of the left pelvis suspicious for retained essure device.Concerning the injuries reported in this case, the following one was reported via social media: fibromyalgia, incision site pruritus and redness", plantar fasciitis, rash macular 863660-invalid.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 08-dec-2023: quality safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer (subsequently medically confirmed) and describes the occurrence of device breakage ("broke in me") and embedded device ("left coil was embedded in my uterus") in a 48 year-old female patient who had essure inserted (lot no.863660) for female sterilisation.Additional non-serious events are detailed below.Product or product use issues identified: device insertion difficult ("physician struggled to get the left coil in").The patient had a medical history of ovarian cyst, chronic pain, pelvic pain, irregular periods, right lower quadrant pain, pain ankle, hypothyroidism, hypokalemia, hyperlipidemia, obesity, gravida, parity, low back pain, vaginal pain, vaginal bleeding and uterine fibroid (removed during essure insertion procedure).On (b)(6) 2014, the patient had essure inserted.Essure was removed on (b)(6) 2018.An unknown time later she experienced device breakage (seriousness criteria medically important and intervention required), embedded device (seriousness criteria medically important and intervention required), rash macular ("red dots on arms"), procedural pain ("unbearable pain during insertion"), fibromyalgia ("fibromyalgia"), incision site pruritus ("itchy incision"), incision site erythema ("red or hot incision site"), polyp ("polyp"), arthralgia ("hip pain") and plantar fasciitis ("plantar fascitis").The patient was treated with surgery (bilateral salpingectomy,hysteroscopy diagnostic,ovarian cystectomy laparoscopic (bilateral) and essure removal).At the time of the report, the outcomes for these events were unknown.The reporter considered arthralgia, device breakage, embedded device, fibromyalgia, incision site erythema, incision site pruritus, plantar fasciitis, polyp, procedural pain and rash macular to be related to essure administration.The reporter commented: she could not walk for days.Coils: right 4 left 5.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 45.179 kg/sqm.[hysterosalpingogram] on (b)(6) 2014: procedure: xr hysterosalpingography.History: post essure.Findings: fluoroscopy time 18 seconds.A 5 french balloon tipped catheter was positioned in the endometrial cavity and 8 cc of omnipaque 300 injected.The uterus projects to the left of the midline and is slightly anteflexed.The coils are in good position with complete occlusion of both oviducts.Impression: complete occlusion of both oviducts by the essure coils.[pathology test] on (b)(6) 2017: final pathologic diagnosis: fallopian tube and coil, left, laparoscopic salpingectomy: fallopian tube with no significant pathologic abnormality.Coil present.Fallopian tube and coil, right, laparoscopic salpingectomy: fallopian tube with no significant pathologic abnormality.Coil present.Cyst, right ovary, laparoscopic cystectomy: compatible with benign corpus hemorrhagicum.Cyst, left ovary, laparoscopic cystectomy: compatible with benign corpus hemorrhagicum.Clinical history: pelvic pain/ovarian cyst.Bilateral laparoscopic salpingectomy/hysteroscopy.Left fallopian tube and coil; right fallopian tube and coil; right ovarian cyst; left ovarian cyst.Gross description: the cut surfaces show soft tissue with a patent pinpoint lumen and coil involving the proximal 1/3 of tube.The coil (14.6 cm in length) is separate in the container.[x-ray] (dates unknown): shows both fallopian tubes are blocked.And narrative: single view of abdomen.History: prior essure removal.Findings: there are punctate metallic radiopaque foreign bodies in the area of the left pelvis suspicious for retained essure device.Concerning the injuries reported in this case, the following one was reported via social media: fibromyalgia, incision site pruritus and redness", plantar fasciitis, and rash macular.The most recent follow-up information incorporated above includes data received on: 02-nov-2023: reporters, patient information, medical history, lab data, lot no., and non drug treatment added.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 relevant data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 9976533
• MDR Text Key: 188208342
• Report Number: 2951250-2020-04617
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 863660-INVALID
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 48 YR
• Patient Sex: Female
• Patient Weight: 123 KG