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

Model Number ESS305

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Autoimmune Disorder (1732); Headache (1880); Hypersensitivity/Allergic reaction (1907); Pain (1994); Perforation (2001); Arthralgia (2355); Depression (2361); Numbness (2415); Tooth Fracture (2428); Abdominal Distention (2601)

Event Date 07/29/2018

Event Type  Injury  

Event Description

This case was initially received via regulatory authority (food and drug administration, reference number: mw5078731) on 10-aug-2018.The most recent information was received on 25-feb-2019.This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("pain"), autoimmune disorder ("auto immune disorder"), abdominal pain ("i have constant abdominal pain") and back pain ("back pain, left side back pain") in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included endometrial ablation.Concomitant products included levothyroxine sodium (synthroid), lisinopril and venlafaxine.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2018, the patient experienced autoimmune disorder (seriousness criterion medically significant), abdominal pain (seriousness criterion medically significant), back pain (seriousness criterion disability), arthralgia ("joint pain, left side hip pain"), headache ("headaches"), tooth fracture ("teeth breaking and cracking"), depression ("depression") and abdominal distension ("bloating") and was found to have smear cervix abnormal ("abnormal pap smear"), 9 years after insertion of essure.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), allergy to metals ("nickel sensitivity"), groin pain ("groin pain"), pain in extremity ("pain in left leg"), hypertension ("high blood pressure") and hypoaesthesia ("extremity numbness,finger tips").The patient was treated with surgery ((b)(6) 2018, total hysterectomy with bilateral salpingo-oophorectomy).Essure was removed on (b)(6) 2018.At the time of the report, the pelvic pain, autoimmune disorder, abdominal pain, back pain, arthralgia, headache, tooth fracture, depression, abdominal distension, smear cervix abnormal, allergy to metals, pain in extremity, hypertension and hypoaesthesia outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, arthralgia, autoimmune disorder, back pain, depression, headache, smear cervix abnormal and tooth fracture with essure.The reporter considered allergy to metals, groin pain, hypertension, hypoaesthesia, pain in extremity and pelvic pain to be related to essure.The reporter commented: disability/ permanent damage was mentioned but not specified and/or assigned to one of the events diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2018: uterus, cervix, bilateral tubes and ovaries: no significant pathologic alteration, cervix.Disordered proliferative endometrium.Extensive adenomyosis physiologic ovaries.Unremarkable fallopian tubes.Paratubal cyst.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-feb-2019: pfs received- events pelvic pain, nickel sensitivity, groin pain, pain in left leg, high blood pressure, extremity numbness, finger tips" were added.Reporter information, lab data and product information were added.Incident: no lot number or device sample was received in this case.At this time, we have no information suggesting that the device failed to meet its specifications.We will conduct a review of our complaint records and other non-conformances data; should any new and reportable information become available from our investigation, this will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was reported by a lawyer and describes the occurrence of perforation ('perforation') and back pain ('back pain, left side back pain') in a 44-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included endometrial ablation.Concomitant products included levothyroxine sodium (synthroid), lisinopril and venlafaxine.On (b)(6) 2009, the patient had essure inserted.On (b)(6) 2018, the patient experienced back pain (seriousness criterion disability), autoimmune disorder ("auto immune disorder"), abdominal pain ("i have constant abdominal pain"), arthralgia ("joint pain, left side hip pain"), headache ("headaches"), tooth fracture ("teeth breaking and cracking"), depression ("depression") and abdominal distension ("bloating") and was found to have smear cervix abnormal ("abnormal pap smear"), 9 years after insertion of essure.On an unknown date, the patient experienced perforation (seriousness criteria medically significant and intervention required), pelvic pain ("pain"), allergy to metals ("nickel sensitivity"), groin pain ("groin pain"), pain in extremity ("pain in left leg"), hypertension ("high blood pressure") and hypoaesthesia ("extremity numbness,finger tips").The patient was treated with surgery (24sep2018, total hysterectomy with bilateral salpingo-oophorectomy, ablation.).Essure was removed on (b)(6) 2019.At the time of the report, the perforation, back pain, pelvic pain, autoimmune disorder, abdominal pain, arthralgia, headache, tooth fracture, depression, abdominal distension, smear cervix abnormal, allergy to metals, pain in extremity, hypertension and hypoaesthesia outcome was unknown.The reporter provided no causality assessment for abdominal distension, abdominal pain, arthralgia, autoimmune disorder, back pain, depression, headache, smear cervix abnormal and tooth fracture with essure.The reporter considered allergy to metals, groin pain, hypertension, hypoaesthesia, pain in extremity, pelvic pain and perforation to be related to essure.The reporter commented: disability/ permanent damage was mentioned but not specified and/or assigned to one of the events discrepancy noted in date of essure removal date:- (b)(6) 2018 and (b)(6) 2019.Diagnostic results (normal ranges are provided in parenthesis if available): pathology test - on (b)(6) 2018: uterus, cervix, bilateral tubes and ovaries: no significant pathologic alteration, cervix.Disordered proliferative endometrium.Extensive adenomyosis physiologic ovaries.Unremarkable fallopian tubes.Paratubal cyst.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 28-jan-2020: pif received: new event were added: perforation, reporter information were updated.Based on the available information, a review of our complaint records and other relevant data will be conducted; any new and reportable information that becomes available from our investigation 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: 8383414
• MDR Text Key: 137593604
• Report Number: 2951250-2019-00917
• 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: 06/18/2020

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 Model Number: ESS305
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/01/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 06/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LISINOPRIL; LISINOPRIL; SYNTHROID; SYNTHROID; VENLAFAXINE; VENLAFAXINE; LISINOPRIL; SYNTHROID; VENLAFAXINE
• Patient Outcome(s): Other; Required Intervention; Disability
• Patient Age: 44 YR