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

Model Number ESS305

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Autoimmune Disorder (1732); Fall (1848); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Depression (2361); Ambulation Difficulties (2544); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain/right and left sides of pelvis") and multiple sclerosis ("multiple sclerosis") in an adult female patient who had essure (batch no.A78087) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included overweight, endometriosis, polymenorrhoea, menses irregular, pap smear abnormal, squamous cell carcinoma, endometrial ablation and factor viii antibodies in blood.Previously administered products included for an unreported indication: nuvaring.Concomitant products included bupropion hydrochloride (wellbutrin), levothyroxine, medroxyprogesterone acetate (depo provera), rizatriptan and sertraline hydrochloride (zoloft).In 2013, the patient experienced fatigue ("fatigue") and gait disturbance ("legs would stop working and i would fall down").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced amnesia ("memory loss").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2014, the patient experienced depression ("depression") and feeling abnormal ("brain fog").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines"), headache ("headaches"), anaemia ("chronic anemia"), dysmenorrhoea ("dysmenorrhea (cramping)") and multiple sclerosis (seriousness criterion medically significant).The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, female sexual dysfunction, amnesia, depression, feeling abnormal, anaemia, dysmenorrhoea, fatigue, multiple sclerosis and gait disturbance had resolved and the migraine and headache was resolving.The reporter considered amnesia, anaemia, depression, dysmenorrhoea, fatigue, feeling abnormal, female sexual dysfunction, gait disturbance, headache, menorrhagia, migraine, multiple sclerosis, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: current weight (b)(6) lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones was/were reported from patient¿s medical record: confirming - pelvic pain, dysmenorrhea, menorrhagia.Most recent follow-up information incorporated above includes: on 10-may-2019: pfs and mr received- previously reported event "injuries" updated to "), pain / right and left sides of pelvis", events- "abnormal bleeding (vaginal), abnormal bleeding (menorrhagia), apareunia (inability to have sexual intercourse), memory loss, depression, brain fog, migraines, headaches, chronic anemia, dysmenorrhea (cramping, fatigue, multiple sclerosis, legs would stop working and i would fall down", reporter, lab data, lot number, medical history added.Incident: we received a lot number/returned sample 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ('pain / right and left sides of pelvis') and multiple sclerosis ('multiple sclerosis') in an adult female patient who had essure (batch no.A78087) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included overweight, endometriosis, polymenorrhoea, menses irregular, pap smear abnormal, squamous cell carcinoma, endometrial ablation and factor viii antibodies in blood.Previously administered products included for an unreported indication: nuvaring.Concomitant products included bupropion hydrochloride (wellbutrin), levothyroxine, medroxyprogesterone acetate (depo provera), rizatriptan and sertraline hydrochloride (zoloft).In 2013, the patient experienced fatigue ("fatigue") and gait disturbance ("legs would stop working and i would fall down").On (b)(6) 2013, the patient had essure inserted.In (b)(6) 2013, the patient experienced amnesia ("memory loss").In (b)(6) 2013, the patient experienced female sexual dysfunction ("apareunia (inability to have sexual intercourse)").In 2014, the patient experienced depression ("depression") and feeling abnormal ("brain fog").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("abnormal bleeding (menorrhagia)"), migraine ("migraines"), headache ("headaches"), anaemia ("chronic anemia"), dysmenorrhoea ("dysmenorrhea (cramping)") and multiple sclerosis (seriousness criterion medically significant).The patient was treated with surgery (hysterectomy with bilateral salpingectomy).Essure was removed on (b)(6) 2014.At the time of the report, the pelvic pain, vaginal haemorrhage, menorrhagia, female sexual dysfunction, amnesia, depression, feeling abnormal, anaemia, dysmenorrhoea, fatigue, multiple sclerosis and gait disturbance had resolved and the migraine and headache was resolving.The reporter considered amnesia, anaemia, depression, dysmenorrhoea, fatigue, feeling abnormal, female sexual dysfunction, gait disturbance, headache, menorrhagia, migraine, multiple sclerosis, pelvic pain and vaginal haemorrhage to be related to essure.The reporter commented: current weight 170 lbs.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 28 kg/sqm.Hysterosalpingogram - on (b)(6) 2013: total bilateral occlusion.Concerning the injuries reported in this case, the following one/ones was/were reported from patient¿s medical record : confirming - pelvic pain, dysmenorrhea,menorrhagia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 21-may-2019: quality safety evaluation of ptc.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.

• 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: 8611602
• MDR Text Key: 145151797
• Report Number: 2951250-2019-01920
• 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: 05/30/2019

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: 12/01/2015
• Device Model Number: ESS305
• Device Lot Number: A78087
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 05/15/2019
• Supplement Dates Manufacturer Received: 05/21/2019
• Supplement Dates FDA Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO PROVERA; DEPO PROVERA; LEVOTHYROXINE; LEVOTHYROXINE; RIZATRIPTAN; RIZATRIPTAN; WELLBUTRIN; WELLBUTRIN; ZOLOFT; ZOLOFT; DEPO PROVERA; LEVOTHYROXINE; RIZATRIPTAN; WELLBUTRIN; ZOLOFT
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 70