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

Model Number ESS205

Device Problems Break (1069); Fracture (1260); Insufficient Information (3190)

Patient Problems Ectopic Pregnancy (1819); Hypersensitivity/Allergic reaction (1907); Perforation (2001); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This retrospective pregnancy case was reported by a lawyer and describes the occurrence of perforation ("perforation"), ectopic pregnancy with contraceptive device ("ectopic pregnancy"), device breakage ("fracturing") and device dislocation ("migration") in a female patient (gravida 1) who had essure (ess205) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".In (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required) with pelvic pain, ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), bladder injury ("bladder damage") and hypersensitivity ("allergic reactions").Last menstrual period was not provided.The patient was treated with surgery (she had surgery to remove the essure implant).Essure (ess205) was removed in 2009.At the time of the report, the perforation, ectopic pregnancy with contraceptive device, device breakage, device dislocation, bladder injury and hypersensitivity outcome was unknown.The reporter considered bladder injury, device breakage, device dislocation, ectopic pregnancy with contraceptive device, hypersensitivity and perforation to be related to essure (ess205).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

Retrospective pregnancy case was reported by a lawyer and describes the occurrence of perforation ("perforation"), ectopic pregnancy with contraceptive device ("ectopic pregnancy"), device breakage ("fracturing") and device dislocation ("migration") in a 28-year-old female patient (gravida 1) who had essure (ess205) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device ineffective "device ineffective".The patient's concurrent conditions included cystitis interstitial, dysfunctional uterine bleeding, chronic cervicitis, adenomyosis and bowel adhesions (lysis of adhesions).In (b)(6) 2006, the patient had essure (ess205) inserted.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required) with pelvic pain, ectopic pregnancy with contraceptive device (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required), bladder injury ("bladder damage"), hypersensitivity ("allergic reactions"), dyspareunia ("dyspareunia (painful sexual intercourse),"), vaginal haemorrhage ("abnormal bleeding (vaginal, menorrhagia),"), menorrhagia ("abnormal bleeding (vaginal, menorrhagia),"), dysmenorrhoea ("dysmenorrhea (cramping),"), headache ("migraines / headaches") and migraine ("migraines / headaches").Last menstrual period and estimated date of delivery were not provided.The patient had essure (ess205) in place during the first trimester of pregnancy.The patient was treated with surgery (laparoscopic-assisted total vaginal hysterectomy).Essure (ess205) was removed on (b)(6) 2012.At the time of the report, the perforation, ectopic pregnancy with contraceptive device, device breakage, device dislocation, bladder injury, hypersensitivity, dyspareunia, vaginal haemorrhage, menorrhagia, dysmenorrhoea, headache and migraine outcome was unknown.The reporter considered bladder injury, device breakage, device dislocation, dysmenorrhoea, dyspareunia, ectopic pregnancy with contraceptive device, headache, hypersensitivity, menorrhagia, migraine, perforation and vaginal haemorrhage to be related to essure (ess205).The reporter commented: discrepancy in device insertion and removal date.Previously reported as insertion date (b)(6) 2006 and removal date 2009.Diagnostic results (normal ranges are provided in parenthesis if available): pregnancy test - on an unknown date: negative.On (b)(6) 2012, final surgical pathology report.Pre-op clinical findings: pre-op: chronic pelvic pain, menorrhagia.Post-op: chronic pelvic, pain, menorrhagia.Specimens: uterus, cervix.Gross description: the cervix shows petechial hemorrhages at the ectocervix.The endometrium is hemorrhagic.Final diagnosis: endometrium secretory endometrium.Myometrium superficial adenomyosis.Cervix; erosions, acute and chronic inflammation.Concerning injuries reported in this case the following one/ones were described in patient medical records: it confirms events as perforation.Most recent follow-up information incorporated above includes: on 20-jun-2018: plaintiff fact sheet and medical records received.New reporters added and reporter information updated.Case medically confirmed.Patient¿s demographic added.Event added as abnormal bleeding (vaginal, menorrhagia), dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), migraines / headaches.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.

• 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: 7056298
• MDR Text Key: 92870355
• Report Number: 2951250-2017-07996
• 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
• Report Date: 07/16/2018

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: ESS205
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2017
• Initial Date FDA Received: 11/23/2017
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 28 YR