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

Model Number ESS305

Device Problems Break (1069); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problems Adhesion(s) (1695); Fatigue (1849); Headache (1880); Hemorrhage/Bleeding (1888); Incontinence (1928); Unspecified Infection (1930); Nausea (1970); Cramp(s) (2193); Confusion/ Disorientation (2553); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 07/19/2013

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), device dislocation ("migration of essure device location of device: left coil migrated") and abdominal adhesions ("adhesions") in a (b)(6) female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude fallopian tube".On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, 3 months 5 days after insertion of essure, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).On (b)(6) 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)") and fatigue ("fatigue").On (b)(6) 2013, the patient experienced pelvic pain ("pelvic pain") and back pain ("back pain").On (b)(6) 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced wound infection ("wound infection").On an unknown date, the patient experienced abdominal adhesions (seriousness criterion medically significant), mental disorder ("psychological/ psychiatric problems"), bladder disorder ("bladder problems"), urinary tract disorder ("urinary problems"), migraine ("migraines"), headache ("headaches"), reproductive tract disorder ("reproductive system disorder "), nausea ("nausea"), dyspareunia ("dyspareunia (painful sexual intercourse)"), device expulsion ("expulsion of essure device"), hormone level abnormal ("hormonal changes") and pelvic floor muscle weakness ("pelvic floor dysfunction").The patient was treated with surgery (hysterectomy (full)/bilateral salpingectomy) and surgery (diagnostic lap/lysis).Essure was removed on (b)(6) 2014.At the time of the report, the device breakage, device dislocation, abdominal adhesions, wound infection, mental disorder, bladder disorder, urinary tract disorder, migraine, headache, reproductive tract disorder, nausea, dysmenorrhoea, dyspareunia, device expulsion, pelvic pain, hormone level abnormal, pelvic floor muscle weakness and back pain outcome was unknown and the vaginal haemorrhage, menorrhagia and fatigue had resolved.The reporter considered abdominal adhesions, back pain, bladder disorder, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, fatigue, headache, hormone level abnormal, menorrhagia, mental disorder, migraine, nausea, pelvic floor muscle weakness, pelvic pain, reproductive tract disorder, urinary tract disorder, vaginal haemorrhage and wound infection to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: unilateral occlusion (right tube occluded); on (b)(6) 2013: migration of essure device most recent follow-up information incorporated above includes: on 28-feb-2018: case upgraded to incident.Reporter, demographic detail, lab data, essure insertion/removal dates and indication added.Event: physical injuries was updated to hormonal changes, abnormal bleeding (vaginal, menorrhagia), wound infection, psychological/psychiatric problems, bladder/urinary problems, migraines/headaches, reproductive system disorder, left coil migrated, nausea, device breakage, dysmenorrhea, adhesions, dyspareunia, expulsion of essure device, back pain/pelvic pain, failure to occlude fallopian tube, fatigue and pelvic floor dysfunction.She had recovered form events: abnormal bleeding, migraines and fatigue.Essure legal manufacturer 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.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), device dislocation ("migration of essure device location of device: left coil migrated/ failure to occlide (close) fallopian tube(s)"), pelvic floor muscle weakness ("pelvic floor dysfunction") and abdominal adhesions ("adhesions") in a 40-year-old female patient who had essure (batch no.968711) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude fallopian tube".The patient's concurrent conditions included acid reflux (oesophageal), precancerous skin lesion, irregular menstrual cycle, endometritis, uterine bleeding, adenomyosis, cervicitis and metaplasia.Concomitant products included evra (ortho evra), ondansetron (zofran), pantoprazole (protonix) and prenatal.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced migraine ("migraines"), headache ("headaches") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2012, the patient experienced marital problem ("marital problems") and depression ("depression").On (b)(6) 2012, 3 months 27 days after insertion of essure, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)") and fatigue ("fatigue").On (b)(6) 2013, the patient experienced pelvic pain ("pelvic pain/ pain") and back pain ("back pain").On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In 2014, the patient experienced bladder disorder ("bladder problems") and urinary tract disorder ("urinary problems").On (b)(6) 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced wound infection ("wound infection") and infection ("infection").On an unknown date, the patient experienced pelvic floor muscle weakness (seriousness criterion medically significant) with urinary incontinence, abdominal adhesions (seriousness criterion medically significant), mental disorder ("psychological/ psychiatric problems"), reproductive tract disorder ("reproductive system disorder"), nausea ("nausea"), device expulsion ("expulsion of essure device"), hormone level abnormal ("hormonal changes"), libido decreased ("decreased libido") and stress ("stress").The patient was treated with surgery (hysterectomy (full)/bilateral salpingectomy) and surgery (diagnostic laparoscopy/ lysis of pelvic adhesions on (b)(6) 2015).Essure was removed on (b)(6) 2014.At the time of the report, the device breakage, device dislocation, pelvic floor muscle weakness, abdominal adhesions, wound infection, mental disorder, bladder disorder, urinary tract disorder, migraine, headache, reproductive tract disorder, nausea, dysmenorrhoea, dyspareunia, device expulsion, pelvic pain, hormone level abnormal, back pain, libido decreased, stress, marital problem, depression and infection outcome was unknown and the vaginal haemorrhage, menorrhagia and fatigue had resolved.The reporter considered abdominal adhesions, back pain, bladder disorder, depression, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, fatigue, headache, hormone level abnormal, infection, libido decreased, marital problem, menorrhagia, mental disorder, migraine, nausea, pelvic floor muscle weakness, pelvic pain, reproductive tract disorder, stress, urinary tract disorder, vaginal haemorrhage and wound infection to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: unilateral occlusion (right tube occluded); on (b)(6) 2013: migration of essure device.Concerning the injuries reported in this case, the following one was confirmed in patient's medical records: device expulsion.Most recent follow-up information incorporated above includes: on 5-jun-2018: information from pfs and mr.New reporter added.Case medically confirmed.Ethnicity added.Lot number added.Concomitant conditions and drugs added.New events added: decreased libido, stress, maritalpoblems, depression, incontinence, infection.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

Cutaneous case was reported by a lawyer and describes the occurrence of device breakage ("device breakage"), device dislocation ("migration of essure device location of device: left coil migrated/ failure to occlude (close) fallopian tube(s)"), pelvic floor muscle weakness ("pelvic floor dysfunction") and abdominal adhesions ("adhesions") in a 40-year-old female patient who had essure (batch no.968711-invalid) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "failure to occlude fallopian tube".The patient's concurrent conditions included acid reflux (oesophageal), precancerous skin lesion, irregular menstrual cycle, endometritis, uterine bleeding, adenomyosis, cervicitis, endocervical squamous metaplasia and menstrual disorder.Concomitant products included evra (ortho evra), ondansetron (zofran), pantoprazole (protonix) and prenatal.On (b)(6) 2012, the patient had essure inserted.In 2012, the patient experienced migraine ("migraines"), headache ("headaches") and dyspareunia ("dyspareunia (painful sexual intercourse)").In (b)(6) 2012, the patient experienced marital problem ("marital problems") and depression ("depression").On (b)(6) 2012, 3 months 27 days after insertion of essure, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia)"), dysmenorrhoea ("dysmenorrhea (cramping)") and fatigue ("fatigue").On (b)(6) 2013, the patient experienced pelvic pain ("pelvic pain/ pain") and back pain ("back pain").On (b)(6) 2013, the patient experienced device dislocation (seriousness criteria medically significant and intervention required).In 2014, the patient experienced bladder disorder ("bladder problems") and urinary tract disorder ("urinary problems").On (b)(6) 2014, the patient experienced device breakage (seriousness criteria medically significant and intervention required).On (b)(6) 2014, the patient experienced wound infection ("wound infection") and infection ("infection").On an unknown date, the patient experienced pelvic floor muscle weakness (seriousness criterion medically significant) with urinary incontinence, abdominal adhesions (seriousness criterion medically significant), mental disorder ("psychological/ psychiatric problems"), reproductive tract disorder ("reproductive system disorder"), nausea ("nausea"), device expulsion ("expulsion of essure device"), hormone level abnormal ("hormonal changes"), libido decreased ("decreased libido") and stress ("stress").The patient was treated with surgery (hysterectomy (full)/bilateral salpingectomy), surgery (hysterectomy (full)/bilateral salpingectomy), surgery (diagnostic laparoscopy/ lysis of pelvic adhesions on (b)(6) 2015) and surgery (diagnostic lap/lysis on (b)(6) 2015).Essure was removed on (b)(6) 2014.At the time of the report, the device breakage, device dislocation, pelvic floor muscle weakness, abdominal adhesions, wound infection, mental disorder, bladder disorder, urinary tract disorder, migraine, headache, reproductive tract disorder, nausea, dysmenorrhoea, dyspareunia, device expulsion, pelvic pain, hormone level abnormal, back pain, libido decreased, stress, marital problem, depression and infection outcome was unknown and the vaginal haemorrhage, menorrhagia and fatigue had resolved.The reporter considered abdominal adhesions, back pain, bladder disorder, depression, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, fatigue, headache, hormone level abnormal, infection, libido decreased, marital problem, menorrhagia, mental disorder, migraine, nausea, pelvic floor muscle weakness, pelvic pain, reproductive tract disorder, stress, urinary tract disorder, vaginal haemorrhage and wound infection to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2012: unilateral occlusion (right tube occluded); on (b)(6) 2013: migration of essure device concerning the injuries reported in this case, the following one was confirmed in patient's medical records: device expulsion.Lot number 968711 is invalid.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality safety evaluation of ptc.Incident: no valid 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.

• 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: 7452163
• MDR Text Key: 106253769
• Report Number: 2951250-2018-01935
• 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
• Report Date: 09/04/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 968711-INVALID
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 06/05/2018; 09/04/2018
• Supplement Dates FDA Received: 06/20/2018; 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ORTHO EVRA; ORTHO EVRA; PRENATAL; PRENATAL; PROTONIX; PROTONIX; ZOFRAN; ZOFRAN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR