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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Material Perforation (2205); Migration (4003)

Patient Problems Abdominal Pain (1685); Hemorrhage/Bleeding (1888); Menstrual Irregularities (1959); Pain (1994); Uterine Perforation (2121); Cramp(s) (2193)

Event Date 01/01/2009

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migration/perforation of the essure device") and genital haemorrhage ("heavy and irregular bleeding") in a female patient who had essure inserted for birth control.The occurrence of additional non-serious events is detailed below.On (b)(6) 2009, the patient had essure inserted.In 2009, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), pelvic pain ("chronic pain"), abdominal pain ("abdominal pain") and abdominal pain lower ("severe cramping").The patient was treated with surgery (pelvic surgery in 2014).At the time of the report, the uterine perforation, genital haemorrhage, pelvic pain, abdominal pain and abdominal pain lower outcome was unknown.The reporter considered abdominal pain, abdominal pain lower, genital haemorrhage, pelvic pain and uterine perforation 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

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migration/perforation of the essure device") and genital haemorrhage ("heavy and irregular bleeding") in an adult female patient who had essure (batch no.674117) 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".The patient's past medical history included spinal fusion surgery in 2004.Previously administered products included for an unreported indication: aspirin.Past adverse reactions to the above products included hypersensitivity with aspirin.Concurrent conditions included headache, migraine, backache, acute pharyngitis, anxiety, depression, dysmenorrhea, menometrorrhagia, ovarian cyst, uterine leiomyoma and nabothian cyst.Concomitant products included alprazolam (xanax) since 2009, oxycocet (percocet) since 2012 and vicodin (lortab) since 2012.In 2009, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain ("abdominal pain/abdomen pain") and abdominal pain lower ("severe cramping").On (b)(6)2009, the patient had essure inserted.In 2012, the patient experienced pelvic pain ("chronic pain/pain") and vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)").On an unknown date, the patient experienced menorrhagia ("abnormal bleeding (vaginal, menorrhagia)") and weight increased ("weight gain/ loss specify which one: weight gain").The patient was treated with surgery (hysterectomy (full), salpingectomy (one sided removal of fallopian tube), oophorectomy (bilateral)).Essure was removed on (b)(6) 2014.At the time of the report, the uterine perforation, abdominal pain lower, menorrhagia and weight increased outcome was unknown and the genital haemorrhage, pelvic pain, abdominal pain and vaginal haemorrhage had resolved.The reporter considered abdominal pain, abdominal pain lower, genital haemorrhage, menorrhagia, pelvic pain, uterine perforation, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: patient tolerated the procedure well.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.8 kg/sqm.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: abdominal pain.Most recent follow-up information incorporated above includes: on (b)(6) 2018: plaintiff's fact sheet and medical records received.Events per pfs: abnormal bleeding (vaginal, menorrhagia), pain, weight gain/ loss specify which one: weight gain, patient did not undergo essure confirmation test 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

Ntaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migration/perforation of the essure device") and genital haemorrhage ("heavy and irregular bleeding") in a 40-year-old female patient who had essure (batch no.674117) 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".The patient's past medical history included spinal fusion surgery in 2004.Previously administered products included for an unreported indication: aspirin.Past adverse reactions to the above products included hypersensitivity with aspirin.Concurrent conditions included headache, migraine, backache, acute pharyngitis, anxiety, depression, dysmenorrhea, menometrorrhagia, ovarian cyst, uterine leiomyoma and nabothian cyst.Concomitant products included alprazolam (xanax) since 2009, oxycocet (percocet) since 2012 and vicodin (lortab) since 2012.On (b)(6).2009, the patient had essure inserted.In 2009, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required) with pelvic pain and abdominal pain, genital haemorrhage (seriousness criterion medically significant) and abdominal pain lower ("severe cramping").In 2012, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia)") and menorrhagia ("abnormal bleeding (vaginal, menorrhagia)").In january 2013, the patient experienced weight increased ("weight gain/ loss specify which one: weight gain").The patient was treated with surgery (hysterectomy (full), salpingectomy (one sided removal of fallopian tube), oophorectomy (bilateral)).Essure was removed on (b)(6).2014.At the time of the report, the uterine perforation, abdominal pain lower, menorrhagia and weight increased outcome was unknown and the genital haemorrhage and vaginal haemorrhage had resolved.The reporter considered abdominal pain lower, genital haemorrhage, menorrhagia, uterine perforation, vaginal haemorrhage and weight increased to be related to essure.The reporter commented: patient tolerated the procedure well.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 24.8 kg/sqm.Concerning the injuries reported in this case, the following ones were confirmed in patient¿s medical records: abdominal pain.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 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: 6947405
• MDR Text Key: 89350317
• Report Number: 2951250-2017-04678
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2012
• Device Model Number: ESS305
• Device Lot Number: 674117
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LORTAB.; LORTAB.; PERCOCET.; PERCOCET.; XANAX.; XANAX.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 64