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

Model Number ESS305

Device Problems Biocompatibility (2886); Device Dislodged or Dislocated (2923)

Patient Problems Abortion (1688); Autoimmune Disorder (1732); Bronchitis (1752); Edema (1820); Hair Loss (1877); Headache (1880); Hemorrhage/Bleeding (1888); Inflammation (1932); Menstrual Irregularities (1959); Nausea (1970); Pain (1994); Pneumonia (2011); Rash (2033); Swelling (2091); Thyroid Problems (2102); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Cramp(s) (2193); Anxiety (2328); Toxicity (2333); Depression (2361); Weight Changes (2607); Foreign Body In Patient (2687); Pregnancy (3193)

Event Type  Injury  

Event Description

Retrospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: unknown ¿ coils not seen"), genital haemorrhage ("heavy and irregular bleeding/haemorrhaging"), pregnancy with contraceptive device ("pregnancy (stillbirth or miscarriage)") and abortion spontaneous ("pregnancy (stillbirth or miscarriage)") in an adult female patient (gravida 6, para 5) who had essure (batch no.B82474) 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 essure confirmation test" and device ineffective "pregnancy (stillbirth or miscarriage)".The patient's past medical history included multiparous ((b)(6) 2002, (b)(6) 2003, (b)(6) 2006, (b)(6) 2013 and (b)(6) 2014) and cholecystectomy in 2003.Concurrent conditions included back pain, swelling nos, headache, hemorrhage (nos), hypothyroidism since (b)(6) 2014, pneumonia and chronic bronchitis.Concomitant products included clonazepam (klonopin), duloxetine hydrochloride (cymbalta), escitalopram oxalate (lexapro), levothyroxine sodium (synthroid), loratadine (claritin), montelukast (singulair) and ziprasidone hydrochloride (geodon).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced hypothyroidism ("autoimmune disorder type of disorder: hypothyroid").In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), pelvic pain ("chronic pelvic pain/pelvic pain/pain/pelvic pain"), alopecia ("hair loss/hair loss"), depression ("psychological or psychiatric problems condition: severe depression, ptst and anxiety") and vaginal discharge ("vaginal discharge").In (b)(6) 2017, the patient experienced weight increased ("weight gain / loss specify which one: weight gain").In 2017, the patient experienced blood oestrogen abnormal ("hormonal changes describe: low/high estrogen").In 2018, the patient experienced anxiety ("psychological or psychiatric problems condition: severe depression, ptst and anxiety") and post-traumatic stress disorder ("psychological or psychiatric problems condition: severe depression, ptst and anxiety").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant), abortion spontaneous (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding(vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding(vaginal, menorrhagia)"), inflammation ("allergic or hypersensitivity reaction type: inflammation throughout my body"), vaginal infection ("infection (bladder/ urinary tract/vaginal)type: constant vaginal infections"), flushing ("rashes or skin conditions type: extremely dry skin (flushing at times)"), dry skin ("rashes or skin conditions type: extremely dry skin (flushing at times)"), migraine ("migraines / headaches"), headache ("migraines / headaches/headaches"), nausea ("nausea"), tooth disorder ("dental problems"), allergy to metals ("nickel allergy"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), back pain ("back pain"), oedema ("swelling/holding water weight"), adnexa uteri pain ("fallopian tube pain"), haemorrhage in pregnancy ("haemorrhage in pregnancy") and swelling ("swelling").Last menstrual period and estimated date of delivery were not provided.At the time of the report, the device dislocation, genital haemorrhage, pelvic pain, pregnancy with contraceptive device, abortion spontaneous, alopecia, blood oestrogen abnormal, vaginal haemorrhage, menorrhagia, inflammation, vaginal infection, depression, anxiety, post-traumatic stress disorder, hypothyroidism, flushing, dry skin, migraine, headache, nausea, tooth disorder, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, back pain, oedema, adnexa uteri pain and haemorrhage in pregnancy outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, adnexa uteri pain, allergy to metals, alopecia, anxiety, back pain, blood oestrogen abnormal, depression, device dislocation, dry skin, dysmenorrhoea, dyspareunia, fatigue, flushing, genital haemorrhage, haemorrhage in pregnancy, headache, hypothyroidism, inflammation, menorrhagia, migraine, nausea, oedema, pelvic pain, post-traumatic stress disorder, pregnancy with contraceptive device, swelling, tooth disorder, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Concerning the injuries reported in this case, the following ones were confirmed in patient's medical record: anxiety, depression, post traumatic stress disorder, most recent follow-up information incorporated above includes: on 20-jun-2018: plaintiff fact sheet- all relevant medical history condition, concurrent condition, concomitant medication and events migration of essure device location of device: unknown ¿ coils not seen and swelling were added.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

Rospective pregnancy case was reported by a lawyer and describes the occurrence of device dislocation ("migration of essure device location of device: unknown ¿ coils not seen"), genital haemorrhage ("heavy and irregular bleeding/haemorrhaging"), pregnancy with contraceptive device ("pregnancy (stillbirth or miscarriage)") and abortion spontaneous ("pregnancy (stillbirth or miscarriage)") in an adult female patient (gravida 6, para 5) who had essure (batch no.B82474) 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 essure confirmation test" and device ineffective "pregnancy (stillbirth or miscarriage)".The patient's past medical history included multiparous ((b)(6) 2002, (b)(6) 2003, (b)(6) 2006, (b)(6) 2013 and (b)(6) 2014) and cholecystectomy in 2003.Concurrent conditions included back pain, swelling nos, headache, hemorrhage (nos), hypothyroidism since (b)(6) 2014, pneumonia and chronic bronchitis.Concomitant products included clonazepam (klonopin), duloxetine hydrochloride (cymbalta), escitalopram oxalate (lexapro), levothyroxine sodium (synthroid), loratadine (claritin), montelukast (singulair) and ziprasidone hydrochloride (geodon).On (b)(6) 2014, the patient had essure inserted.In (b)(6) 2014, the patient experienced hypothyroidism ("autoimmune disorder type of disorder: hypothyroid").In 2014, the patient experienced genital haemorrhage (seriousness criterion medically significant), pelvic pain ("chronic pelvic pain/pelvic pain/pain/pelvic pain"), alopecia ("hair loss/hair loss"), depression ("psychological or psychiatric problems condition: severe depression, ptst and anxiety") and vaginal discharge ("vaginal discharge").In (b)(6) 2017, the patient experienced weight increased ("weight gain / loss specify which one: weight gain").In 2017, the patient experienced blood oestrogen abnormal ("hormonal changes describe: low/high estrogen").In 2018, the patient experienced anxiety ("psychological or psychiatric problems condition: severe depression, ptst and anxiety") and post-traumatic stress disorder ("psychological or psychiatric problems condition: severe depression, ptst and anxiety").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), pregnancy with contraceptive device (seriousness criterion medically significant), abortion spontaneous (seriousness criterion medically significant), vaginal haemorrhage ("abnormal bleeding(vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding(vaginal, menorrhagia)"), inflammation ("allergic or hypersensitivity reaction type: inflammation throughout my body"), vaginal infection ("infection (bladder/ urinary tract/vaginal)type: constant vaginal infections"), flushing ("rashes or skin conditions type: extremely dry skin (flushing at times)"), dry skin ("rashes or skin conditions type: extremely dry skin (flushing at times)"), migraine ("migraines / headaches"), headache ("migraines / headaches/headaches"), nausea ("nausea"), tooth disorder ("dental problems"), allergy to metals ("nickel allergy"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), back pain ("back pain"), oedema ("swelling/holding water weight"), adnexa uteri pain ("fallopian tube pain"), haemorrhage in pregnancy ("haemorrhage in pregnancy") and swelling ("swelling").Last menstrual period and estimated date of delivery were not provided.At the time of the report, the device dislocation, genital haemorrhage, pelvic pain, pregnancy with contraceptive device, abortion spontaneous, alopecia, blood oestrogen abnormal, vaginal haemorrhage, menorrhagia, inflammation, vaginal infection, depression, anxiety, post-traumatic stress disorder, hypothyroidism, flushing, dry skin, migraine, headache, nausea, tooth disorder, allergy to metals, dysmenorrhoea, dyspareunia, vaginal discharge, weight increased, back pain, oedema, adnexa uteri pain and haemorrhage in pregnancy outcome was unknown.The pregnancy outcome was reported as spontaneous abortion.The reporter considered abortion spontaneous, adnexa uteri pain, allergy to metals, alopecia, anxiety, back pain, blood oestrogen abnormal, depression, device dislocation, dry skin, dysmenorrhoea, dyspareunia, fatigue, flushing, genital haemorrhage, haemorrhage in pregnancy, headache, hypothyroidism, inflammation, menorrhagia, migraine, nausea, oedema, pelvic pain, post-traumatic stress disorder, pregnancy with contraceptive device, swelling, tooth disorder, vaginal discharge, vaginal haemorrhage, vaginal infection and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 36.6 kg/sqm.Concerning the injuries reported in this case, the following ones were confirmed in patient's medical record: anxiety, depression, post traumatic stress disorder, quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jul-2018: quality-safety evaluation of ptc.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: 7689170
• MDR Text Key: 114008978
• Report Number: 2951250-2018-03087
• Device Sequence Number: 1
• Product Code: HHS
• UDI-Device Identifier: 10888853003051
• UDI-Public: (01)10888853003051
• 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,other
• Type of Report: Initial,Followup
• Report Date: 08/02/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Model Number: ESS305
• Device Lot Number: B82474
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 07/25/2018
• Supplement Dates FDA Received: 08/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CLARITIN; CLARITIN; CYMBALTA; CYMBALTA; GEODON; GEODON; KLONOPIN; KLONOPIN; LEXAPRO; LEXAPRO; SINGULAIR; SINGULAIR; SYNTHROID; SYNTHROID; CLARITIN; CYMBALTA; GEODON; KLONOPIN; LEXAPRO; SINGULAIR; SYNTHROID
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 91