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

Model Number ESS305

Device Problems Break (1069); Fracture (1260); Migration (4003)

Patient Problems Pain (1994); Uterine Perforation (2121); Device Embedded In Tissue or Plaque (3165)

Event Date 10/17/2016

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant") in a female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.In (b)(6) 2016, the patient had essure inserted.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage and pelvic pain outcome was unknown.The reporter considered device breakage and pelvic pain to be related to essure.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.

Manufacturer Narrative

Spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant"), uterine perforation ("migration of essure device location of device: punctured my uterine wall/ expelled essure,") and embedded device ("essure device was noted to be partly embedded into the right pelvic sidewall") in a female patient who had essure (batch no.A78080) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's past medical history included idiopathic thrombocytopenia, postpartum depression, human papilloma virus exposure, anemia and vitamin b12 deficiency.Concurrent conditions included nausea.On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced migraine ("migraines / headaches"), headache ("migraines / headaches") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain ("abdominal pain").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (to remove the essure implant), surgery ((hysterectomy with bilateral salpingectomy) and surgery ((hysterectomy with bilateral salpingectomy)).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, uterine perforation, embedded device, migraine and headache outcome was unknown and the pelvic pain, dysmenorrhoea, dyspareunia, fatigue and abdominal pain had resolved.The reporter considered abdominal pain, device breakage, dysmenorrhoea, dyspareunia, embedded device, fatigue, headache, migraine, pelvic pain and uterine perforation to be related to essure.The reporter commented: discrepancy noted in essure insertion date: (b)(6) 2013 & (b)(6) 2016.Diagnostic results: (b)(6) 2016:surgical pathology report: clinical history: pelvic pain, fractured essure device.The essure device in b part was found during operation in pelvis which appears to be the device previously lodged in the right fallopian tube.The device removed from left fallopian tube at the time of gross examination is reviewed with two pathologists.It appears that the parts appear to be and intact essure device broken off during grossing procedure to remove from the left fallopian tube rather than fractured device.Left fallopian tube: grossly identified coiled gray metal wire with microscopic finding of intraluminal fibrosis containing refractile material and metallosis consistent with essure device lodged within left fallopian tube.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 14-aug-2018: quality-safety evaluation of product technical problem update.Incident: at the time of reporting, 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("fracturing of the implant"), uterine perforation ("migration of essure device location of device: punctured my uterine wall/ expelled essure,") and embedded device ("essure device was noted to be partly embedded into the right pelvic sidewall") in a female patient who had essure (batch no.A78080) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's past medical history included idiopathic thrombocytopenia, postpartum depression, human papilloma virus exposure, anemia and vitamin b12 deficiency.Concurrent conditions included nausea.On (b)(6) 2013, the patient had essure inserted.In april 2013, the patient experienced fatigue ("fatigue").In may 2013, the patient experienced migraine ("migraines / headaches"), headache ("migraines / headaches") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2013, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain ("abdominal pain").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), uterine perforation (seriousness criteria medically significant and intervention required), embedded device (seriousness criteria medically significant and intervention required) and pelvic pain ("pain").The patient was treated with surgery (to remove the essure implant), surgery ((hysterectomy with bilateral salpingectomy) and surgery ((hysterectomy with bilateral salpingectomy) ).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, uterine perforation, embedded device, migraine and headache outcome was unknown and the pelvic pain, dysmenorrhoea, dyspareunia, fatigue and abdominal pain had resolved.The reporter considered abdominal pain, device breakage, dysmenorrhoea, dyspareunia, embedded device, fatigue, headache, migraine, pelvic pain and uterine perforation to be related to essure.The reporter commented: discrepancy noted in essure insertion date: (b)(6) 2013 & may-2016 diagnostic results: (b)(6) 2016:surgical pathology report: clinical history: pelvic pain, fractured essure device.The essure device in b part was found during operation in pelvis which appears to be the device previously lodged in the right fallopian tube.The device removed from left fallopian tube at the time of gross examination is reviewed with two pathologists.It appears that the parts appear to be and intact essure device broken off during grossing procedure to remove from the left fallopian tube rather than fractured device.Left fallopian tube: grossly identified coiled gray metal wire with microscopic finding of intraluminal fibrosis containing refractile material and metallosis consistent with essure device lodged within left fallopian tube.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff fact sheet & medical record received.Events migraines / headaches, uterine perforation, dysmenorrhea,fatigue, abdominal pain, embedded device, are added.Lab data updated.Concomitant conditions were added.Product, patient & reporter information updated.Incident at the time of reporting, 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('fracturing of the implant/ device breakage'), uterine perforation ('migration of essure device location of device: punctured my uterine wall/ expelled essure,') and embedded device ('essure device was noted to be partly embedded into the right pelvic sidewall') in a 39-year-old female patient who had essure (batch no.A78080) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "patient did not undergo an essure confirmation test".The patient's medical history included idiopathic thrombocytopenia, postpartum depression, human papilloma virus exposure, anemia and vitamin b12 deficiency.Concurrent conditions included nausea.Concomitant products included medroxyprogesterone acetate (depo-provera).On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced fatigue ("fatigue").In (b)(6) 2013, the patient experienced migraine ("migraines / headaches"), headache ("migraines / headaches") and dyspareunia ("dyspareunia (painful sexual intercourse)").In 2013, the patient experienced pelvic pain ("pain"), dysmenorrhoea ("dysmenorrhea (cramping)") and abdominal pain ("abdominal pain/right side abdominal pain").On (b)(6) 2016, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) and embedded device (seriousness criteria medically significant and intervention required).The patient was treated with surgery ((hysterectomy with bilateral salpingectomy, (hysterectomy with bilateral salpingectomy) and to remove the essure implant).Essure was removed on (b)(6) 2016.At the time of the report, the device breakage, uterine perforation, embedded device, migraine and headache outcome was unknown and the pelvic pain, dysmenorrhoea, dyspareunia, fatigue and abdominal pain had resolved.The reporter considered abdominal pain, device breakage, dysmenorrhoea, dyspareunia, embedded device, fatigue, headache, migraine, pelvic pain and uterine perforation to be related to essure.The reporter commented: discrepancy noted in essure insertion date: (b)(6) 2013 & (b)(6) 2016 diagnostic results: (b)(6) 2013 final diagnosis: squamous epithelial-lined mucosa with chronic inflammation and squamous metaplasia.Negative for dysplasia or malignancy.Endo cervix, curettage: low-grade squamous intra epithelial lesion (cin 1/mild dysplasia).Strips of benign endo cervical mucosa.Micro description: microscopic examination performed.Gross description: tissue submitted: 1.3 o'clock.Wedge of pale pink tissue 4 x 2 x 2 mm, submitted whole te-a1.2.Ecc.Collected from a straight brush and accompanying blood tinged fluid are portions of bloody mucus and possible tissue that aggregate to 15 x 12 x 1 rum.Te-bi.On (b)(6) 2016, ct scan - ct abdomen/pelvis w/v contrast.Impression: retro verted uterus with presence of a fractured right fallopian tube micro insert without acute inflammatory process or free fluid.1.5 cm right ovarian cyst.7 mm right hepatic cyst.Left nephrolithiasis without obstruction.On (b)(6) 2016:surgical pathology report: clinical history: pelvic pain, fractured essure device.The essure device in b part was found during operation in pelvis which appears to be the device previously lodged in the right fallopian tube.The device removed from left fallopian tube at the time of gross examination is reviewed with two pathologists.It appears that the parts appear to be and intact essure device broken off during grossing procedure to remove from the left fallopian tube rather than fractured device.Left fallopian tube: grossly identified coiled gray metal wire with microscopic finding of intraluminal fibrosis containing refractile material and metallosis consistent with essure device lodged within left fallopian tube.On (b)(6) 2016 tissue sent: uterus &, cervix, bilateral fallopian tubes essure device.Final pathological diagnosis: a.Uterus, cervix and bilateral fallopian tubes, hysterectomy and bilateral.Salpingectomy: cervix: no dysplasia is seen.Endometrium: benign secretory endometrium.No atypia or mauonancy is seen.Myometrium and serosa: unremarkable.Uterine weight: 122 grams.Clinical history of pelvic path.B.Medical device.Removal: medical device: gray metal wire identified.Gross description: a received in formalin labeled "uterus, cervix, bilateral fallopian tubes" is a hysterectomy specimen composed of uterus with attached cervix and attached bilateral fimbriated fallopian tubes no ovaries are present.Weight dimensions: the uterus with attached cervix weighs 122 gm and measures 9 om from ecto cervix to fundus, 5.2 cm from cornu to cornu, and 4.6 cm from anterior to posterior.Serosa: the serosa is smooth, tan pink and without fibrous adhesions cervix: the cervix is 4.2 cm in length and 3.5 cm in diameter.The cervix is tan-pink, smooth to roughened, measures 4 cm in diameter and contains a 1 cm in diameter probe-pmentos.The endo cervical canel is tan-white, measures 3.7 cm in length.And contains multi simple cysts containing gelatinous material measuring up to 0.4 cm in greatest dimension.Uterine cavity: the triangular uterine cavity measures 25 cm from cornu 10 cornu and 4 5cm in length endometrium: the uterine cavity is lined by shaggy irregular red-purple endometrium measuring up to 0.5 cm in thickness.Myometrium: the myometrium is tan-pink.Measures up to 1,9 cm in thickness and contains no or lesions.Fallopian tubes: the light fimbriated fallopian tube is 7.2 cm in length and 0.6 cm in diameter with a smooth tan-pink serosa.Sections reveal tan-pink mucosa and a pinpoint lumen.No masses or lesions are identified.The left fimbriated fallopian tube is 7 cm in length and 0.7 cm in diameter with a smooth tan-pink serosa.Sections reveal tan-pink mucosa and a pinpoint lumen microscopic description: a: sections of uterine cervix show multiple endo cervical tunnel dusters.No dysplasia is seen.Endometrium is benign composed of colloid glands mostly lined by a single layer of non-vacuolated columnar cells where pseudodecidual changes are seen stroma appears mostly edematous.Underlying myometrium appears unremarkable.Serosa shows no significant adhesion bilateral fallopian tubes appear unremarkable b: (gross only).Addendum final pathological diagnosis: left fallopian tube: grossly identified coiled gray metal wire with microscopic finding of intraluminal fibrosis containing retractile maternal and metalloids consistent with fractured essure device lodged within left fallopian tube.Microscopic description: entire remaining tissue from both fallopian tubes is unremarkable except for a section from left fallopian tube where the coiled 9fay metal wire was found, this section shows lumen plugged by fibrous tissue containing multiple retractile materials and macrophages containing gray granular material consistent with metalloids.This foreign material appears to be consistent with a part of fractured essure device.Quality-safety evaluation of ptc: unable to confirm complaint.Amendment: the report was amended for the following reason: upon internal review it was found that this case is duplicate of case (b)(4).Therefore this case marked for deletion from argus database.All source document , event reporter , information has been transferred to retention case (b)(4).No new follow-up information was received from the reporter.Incident: at the time of reporting, 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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• MDR Report Key: 7056307
• MDR Text Key: 92857544
• Report Number: 2951250-2017-08081
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2015
• Device Model Number: ESS305
• Device Lot Number: A78080
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 06/07/2018; 08/14/2018; 08/14/2018
• Supplement Dates FDA Received: 06/21/2018; 08/17/2018; 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO-PROVERA
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR