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

Model Number ESS305

Device Problems Break (1069); Positioning Failure (1158); Separation Failure (2547); Insufficient Information (3190)

Patient Problems Pain (1994); Pelvic Inflammatory Disease (2000); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device breakage ('essure device broke during insertion in left fallopian tube'), salpingitis ('left fallopian tube segment: intraluminal foreign body (contraceptive device) with mild acute and chronic salpingitis'), pelvic pain ('pain'), astrocytoma ('stage iii/iv brainstem astrocytoma') and menorrhagia ('abnormal bleeding') in a (b)(6) female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "device insertion to insert" and device deployment issue "failure of device to seperate".The patient's medical history included headache, chills, uti, post coital bleeding, skin tags, yeast infection, dyspareunia, loose bowels, cesarean section, abdominoplasty and umbilical hernia repair.On (b)(6) 2012-pathology report: specimen(s) received: left fallopian segment.Final diagnosis: left fallopian tube segment: intraluminal foreign body (contraceptive device) with mild acute and chronic salpingitis.Previously administered products included for an unreported indication: advil and tylenol 8.Concurrent conditions included genital bleeding, stress, hemorrhoids, weight gain, heavy periods, chronic salpingitis, bell's palsy, diplopia and uterine cramps.Concomitant products included alprazolam, ascorbic acid (chemo c), atorvastatin, bimatoprost (latisse), bupivacaine, buspirone hydrochloride (buspar), dexamethasone (dexamethasone), diazepam (valium), gemfibrozil, hydrocodone bitartrate;paracetamol (norco), hydrocortisone, hydromorphone, isotretinoin (accutane), ketorolac, levonorgestrel (mirena), lidocaine, lisinopril, metoprolol, morphine, ondansetron, sertraline hydrochloride (zoloft) and steroid antibacterials.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, the patient experienced vision blurred ("blurred vision").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), salpingitis (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criterion medically significant), fatigue ("fatigue,"), rash ("rash"), vertigo ("vertigo"), abdominal pain ("abdominal pain"), abdominal distension ("bloating"), abdominal pain lower ("lower abdominal pain") and muscle spasms ("tubal spasm") and was found to have astrocytoma (seriousness criterion medically significant).The patient was treated with surgery (unilateral salpingectomy - left).Essure was removed on (b)(6) 2012.At the time of the report, the device breakage, pelvic pain, astrocytoma, menorrhagia, fatigue, rash, dysmenorrhoea, vertigo, vision blurred, abdominal pain, abdominal distension, abdominal pain lower and muscle spasms outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, astrocytoma, device breakage, dysmenorrhoea, fatigue, menorrhagia, muscle spasms, pelvic pain, rash, salpingitis, vertigo and vision blurred to be related to essure.The reporter commented: essure procedure: (as reported) uterus: hysteroscope placed with good visualization of bilateral tubal ostia.Mirena in place.Left fallopian tube cannulated with essure device.Unilateral essure insertion - left fallopian tube diagnostic results (normal ranges are provided in parenthesis if available): abdominal x-ray - on (b)(6) 2012: unilateral occlusion (left tube occluded), other (please describe) essure device in left fallopian tube / hsg if clinically concerned with placement / iud left intact; on (b)(6) 2012: impression: moderate feces.Concerning the injuries reported in this case, the following one/ones was/were described/confirmed in patient¿s medical records: pelvic pain, abdominal pain lower, dysmenorrhea, abdominal distension, vertigo, fatigue, blurred vision, device breakage, astrocytoma, muscle spasms most recent follow-up information incorporated above includes: on 28-jun-2019: pfs+mr received- event injury updated with new events rash, fatigue, rash, dysmenorrhea (cramping), vertigo, stage iii/iv brainstem astrocytoma, blurred vision, essure device broke during insertion in left fallopian tube, abdominal pain, device insertion to insert, lower abdominal pain, tubal spasm, failure of device to separate, bloating were added.Event injury were updated to pelvic pain.New reporter, patient information, medical history, lab data, historical and concomitant drug were added.Incident: no lot number or device sample was received in this case.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 device breakage ('essure device broke during insertion in left fallopian tube'), salpingitis ('left fallopian tube segment: intraluminal foreign body (contraceptive device) with mild acute and chronic salpingitis'), pelvic pain ('pain'), astrocytoma malignant ('stage iii/iv brainstem astrocytoma') and menorrhagia ('abnormal bleeding') in a 38-year-old female patient who had essure inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device difficult to use "device insertion to insert" and device deployment issue "failure of device to seperate".The patient's medical history included headache, chills, uti, post coital bleeding, skin tags, yeast infection, dyspareunia, loose bowels, cesarean section, abdominoplasty and umbilical hernia repair.(b)(6) 2012 pathology report specimen(s) received: left fallopian segment final diagnosis left fallopian tube segment: intraluminal foreign body (contraceptive device) with mild acute and chronic salpingitis.Previously administered products included for an unreported indication: advil and tylenol 8.Concurrent conditions included genital bleeding, stress, hemorrhoids, weight gain, heavy periods, chronic salpingitis, bell's palsy, diplopia and uterine cramps.Concomitant products included alprazolam, ascorbic acid (chemo c), atorvastatin, bimatoprost (latisse), bupivacaine, buspirone hydrochloride (buspar), dexamethasone (dexamethazone), diazepam (valium), gemfibrozil, hydrocodone bitartrate;paracetamol (norco), hydrocortisone, hydromorphone, isotretinoin (accutane), ketorolac, levonorgestrel (mirena), lidocaine, lisinopril, metoprolol, morphine, ondansetron, sertraline hydrochloride (zoloft) and steroid antibacterials.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2012, the patient experienced dysmenorrhoea ("dysmenorrhea (cramping)").On (b)(6) 2013, the patient experienced vision blurred ("blurred vision").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), salpingitis (seriousness criteria medically significant and intervention required), pelvic pain (seriousness criteria medically significant and intervention required), menorrhagia (seriousness criterion medically significant), fatigue ("fatigue,"), rash ("rash"), vertigo ("vertigo"), abdominal pain ("abdominal pain"), abdominal distension ("bloating"), abdominal pain lower ("lower abdominal pain") and fallopian tube spasm ("tubal spasm") and was found to have astrocytoma malignant (seriousness criterion medically significant).The patient was treated with surgery (unilateral salpingectomy - left).Essure was removed on (b)(6) 2012.At the time of the report, the device breakage, pelvic pain, astrocytoma malignant, menorrhagia, fatigue, rash, dysmenorrhoea, vertigo, vision blurred, abdominal pain, abdominal distension, abdominal pain lower and fallopian tube spasm outcome was unknown.The reporter considered abdominal distension, abdominal pain, abdominal pain lower, astrocytoma malignant, device breakage, dysmenorrhoea, fallopian tube spasm, fatigue, menorrhagia, pelvic pain, rash, salpingitis, vertigo and vision blurred to be related to essure.The reporter commented: essure procedure: (as reported) uterus: hysteroscope placed with good visualization of bilateral tubal ostia.Mirena in place.Left fallopian tube cannulated with essure device.Unilateral essure insertion - left fallopian tube.Diagnostic results (normal ranges are provided in parenthesis if available): abdominal x-ray - on (b)(6) 2012: unilateral occlusion (left tube occluded), other (please describe) essure device in left fallopian tube / hsg if clinically concerned with placement / iud left intact; on (b)(6) 2012: impression: moderate feces.Concerning the injuries reported in this case, the following one/ones was/were described/confirmed in patient¿s medical records: pelvic pain, abdominal pain lower, dysmenorrhea, abdominal distension, vertigo, fatigue, blurred vision, device breakage, astrocytoma, muscle spasms quality-safety evaluation of ptc: unable to confirm complaint , most recent follow-up information incorporated above includes: on 12-jul-2019: quality safety evaluation of ptc.No lot number or device sample was received in this case.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.

• 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: 8772017
• MDR Text Key: 150541174
• Report Number: 2951250-2019-03530
• 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: health professional,other
• Type of Report: Initial,Followup
• Report Date: 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACCUTANE; ACCUTANE; ALPRAZOLAM; ALPRAZOLAM; ATORVASTATIN; ATORVASTATIN; BUPIVACAINE; BUPIVACAINE; BUSPAR; BUSPAR; CHEMO C; CHEMO C; DEXAMETHAZONE; DEXAMETHAZONE; GEMFIBROZIL; GEMFIBROZIL; HYDROCORTISONE; HYDROCORTISONE; HYDROMORPHONE; HYDROMORPHONE; KETOROLAC; KETOROLAC; LATISSE; LATISSE; LIDOCAINE; LIDOCAINE; LISINOPRIL; LISINOPRIL; METOPROLOL; METOPROLOL; MIRENA; MIRENA; MORPHINE; MORPHINE; NORCO; NORCO; ONDANSETRON; ONDANSETRON; STEROID ANTIBACTERIALS; STEROID ANTIBACTERIALS; VALIUM; VALIUM; ZOLOFT; ZOLOFT
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 38 YR