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

Model Number ESS305

Device Problems Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Rash (2033); Blurred Vision (2137); Cramp(s) (2193); Discomfort (2330); Weight Changes (2607); Foreign Body In Patient (2687)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("left essure device asymmetrically protruding into uterus"), pelvic pain ("pelvic pain") and genital haemorrhage ("abnormal heavy bleeding") in a female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's past medical history included uti and anemia.Concomitant products included hydrocodone, ibuprofen and paracetamol (tylenol).In (b)(6) 2010, the patient had essure inserted.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criterion medically significant), abdominal pain lower ("severe abnormal lower abdominal pain"), abdominal pain ("severe abnormal abdominal cramping"), back pain ("back pain/lower back pain"), dyspareunia ("dyspareunia"), abdominal distension ("bloating") and weight increased ("weight gain").In 2015, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), fatigue ("fatigue") and vulvovaginal rash ("rashes or skin conditions (vagina area)").In 2016, the patient experienced vision blurred ("vision/eye problems (blurry vision)"), limb discomfort ("heaviness in legs") and breast tenderness ("breast tenderness").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), migraine ("migraines"), headache ("headaches") and menstrual disorder ("passing blood clots during menstrual cycle").The patient was treated with surgery (essure removal procedure) and surgery (essure removal procedure).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, vaginal haemorrhage, menorrhagia, dysmenorrhoea, fatigue, migraine, headache, vulvovaginal rash, vision blurred and menstrual disorder outcome was unknown, the pelvic pain and limb discomfort had resolved, the genital haemorrhage, abdominal pain lower, abdominal pain, back pain, dyspareunia, abdominal distension and weight increased had not resolved and the breast tenderness was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, back pain, breast tenderness, device dislocation, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, limb discomfort, menorrhagia, menstrual disorder, migraine, pelvic pain, vaginal haemorrhage, vision blurred, vulvovaginal rash and weight increased to be related to essure.The reporter commented: plaintiff had not yet undergone surgery to remove the essure devices.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - on (b)(6) 2011: total bilateral occlusion; in (b)(6) 2011: full occlusion of her fallopian tubes.Quality-safety evaluation of ptc: sample not available.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is a known possible undesirable event and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 5-mar-2018: pfs and medical record received, reporter information, patient details, lab data, product information, concomitant drugs and events- left essure device asymmetrically protruding into uterus, abnormal bleeding (vaginal), menorrhagia, dysmenorrhea, fatigue, migraines, headaches, rashes or skin conditions (vagina area), vision/eye problems (blurry vision), heaviness in legs, breast tenderness, passing blood clots during menstrual cycle were added.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 dislocation ('left essure device asymmetrically protruding into uterus') and pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.694962) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included recurrent uti, anemia and female sterilization.Concomitant products included hydrocodone, ibuprofen, medroxyprogesterone acetate (depo-provera) from 2007 to 2010 and paracetamol (tylenol).On (b)(6) 2010, the patient had essure inserted.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal heavy bleeding"), abdominal pain lower ("severe abnormal lower abdominal pain"), abdominal pain ("severe abnormal abdominal cramping"), back pain ("back pain/lower back pain"), dyspareunia ("dyspareunia") and abdominal distension ("bloating") and was found to have weight increased ("weight gain").In 2015, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), fatigue ("fatigue") and vulvovaginal rash ("rashes or skin conditions (vagina area)").In 2016, the patient experienced vision blurred ("vision/eye problems (blurry vision)"), limb discomfort ("heaviness in legs") and breast tenderness ("breast tenderness").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), migraine ("migraines"), headache ("headaches") and menstrual disorder ("passing blood clots during menstrual cycle").The patient was treated with surgery (essure removal procedure).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, vaginal haemorrhage, menorrhagia, dysmenorrhoea, fatigue, migraine, headache, vulvovaginal rash, vision blurred and menstrual disorder outcome was unknown, the pelvic pain and limb discomfort had resolved, the genital haemorrhage, abdominal pain lower, abdominal pain, back pain, dyspareunia, abdominal distension and weight increased had not resolved and the breast tenderness was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, back pain, breast tenderness, device dislocation, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, limb discomfort, menorrhagia, menstrual disorder, migraine, pelvic pain, vaginal haemorrhage, vision blurred, vulvovaginal rash and weight increased to be related to essure.The reporter commented: plaintiff had not yet undergone surgery to remove the essure devices.5 coils noted on the left and 4 on the right.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: results: full occlusion of her fallopian tubes; on (b)(6) 2011: results: total bilateral occlusion.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 24-dec-2020: quality-safety evaluation of ptc.We received a lot number in this case.A technical investigation was conducted, including a batch review, and a review of complaint records and other relevant 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 device dislocation ('left essure device asymmetrically protruding into uterus') and pelvic pain ('pelvic pain') in an adult female patient who had essure (batch no.694962) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.The patient's medical history included recurrent uti, anemia and sterilization.Concomitant products included hydrocodone, ibuprofen, medroxyprogesterone acetate (depo-provera) from 2007 to 2010 and paracetamol (tylenol).On (b)(6) 2010, the patient had essure inserted.In 2014, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage ("abnormal heavy bleeding"), abdominal pain lower ("severe abnormal lower abdominal pain"), abdominal pain ("severe abnormal abdominal cramping"), back pain ("back pain/lower back pain"), dyspareunia ("dyspareunia") and abdominal distension ("bloating") and was found to have weight increased ("weight gain").In 2015, the patient experienced vaginal haemorrhage ("abnormal bleeding (vaginal)"), menorrhagia ("menorrhagia"), dysmenorrhoea ("dysmenorrhea"), fatigue ("fatigue") and vulvovaginal rash ("rashes or skin conditions (vagina area)").In 2016, the patient experienced vision blurred ("vision/eye problems (blurry vision)"), limb discomfort ("heaviness in legs") and breast tenderness ("breast tenderness").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required), migraine ("migraines"), headache ("headaches") and menstrual disorder ("passing blood clots during menstrual cycle").The patient was treated with surgery (essure removal procedure).Essure was removed on (b)(6) 2017.At the time of the report, the device dislocation, vaginal haemorrhage, menorrhagia, dysmenorrhoea, fatigue, migraine, headache, vulvovaginal rash, vision blurred and menstrual disorder outcome was unknown, the pelvic pain and limb discomfort had resolved, the genital haemorrhage, abdominal pain lower, abdominal pain, back pain, dyspareunia, abdominal distension and weight increased had not resolved and the breast tenderness was resolving.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, back pain, breast tenderness, device dislocation, dysmenorrhoea, dyspareunia, fatigue, genital haemorrhage, headache, limb discomfort, menorrhagia, menstrual disorder, migraine, pelvic pain, vaginal haemorrhage, vision blurred, vulvovaginal rash and weight increased to be related to essure.The reporter commented: plaintiff had not yet undergone surgery to remove the essure devices.5 coils noted on the left and 4 on the right.Diagnostic results (normal ranges are provided in parenthesis if available): hysterosalpingogram - in (b)(6) 2011: results: full occlusion of her fallopian tubes; on (b)(6) 2011: results: total bilateral occlusion.Most recent follow-up information incorporated above includes: on 15-dec-2020: mr received: lot number, medical history, reporter information were added.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 relevant data; should any new and reportable information become available from our investigation, 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: 7512417
• MDR Text Key: 108230146
• Report Number: 2951250-2018-02161
• 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: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Model Number: ESS305
• Device Lot Number: 694962
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DEPO-PROVERA; DEPO-PROVERA; HYDROCODONE; HYDROCODONE; HYDROCODONE; IBUPROFEN; IBUPROFEN; IBUPROFEN; TYLENOL; TYLENOL; TYLENOL [PARACETAMOL]
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 34 YR