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

Model Number ESS305

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Flatus (1865); Headache (1880); Hemorrhage/Bleeding (1888); Pain (1994); Inadequate Pain Relief (2388); Abdominal Distention (2601)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain"), genital haemorrhage ("constant bleeding for 6 months"), back pain ("constant severe back pains/ache") and abdominal pain ("severe and persistent abdominal pain") in a female patient who had essure (batch no.898932) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's past medical history included loop electrosurgical excision procedure (for hpv/ abnormal pap) in 2011, multigravida, parity 3 ((b)(6) 2000, (b)(6) 2004, and (b)(6) 2012) and pneumonia in 2008.Concurrent conditions included obesity.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced genital haemorrhage (seriousness criteria medically significant and intervention required), back pain (seriousness criteria medically significant and intervention required), migraine ("severe headaches/ constant headaches/ migraines"), diarrhoea ("constant diarrhea") and abdominal distension ("bloating").On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), arthralgia ("persistent and constant joint pain"), mental disorder ("essure caused or aggravated her psychiatric and /or psychological conditions") and treatment noncompliance ("following essure placement procedure, she did not use any form of contraception").The patient was treated with surgery (hysterectomy with essure removal).Essure was removed in (b)(6) 2013.In (b)(6) 2013, the back pain, migraine, diarrhoea and abdominal distension had resolved.In (b)(6) 2013, the genital haemorrhage had resolved.At the time of the report, the pelvic pain, abdominal pain, arthralgia and mental disorder was resolving and the treatment noncompliance outcome was unknown.The reporter considered abdominal distension, abdominal pain, arthralgia, back pain, diarrhoea, genital haemorrhage, mental disorder, migraine, pelvic pain and treatment noncompliance to be related to essure.The reporter commented: on plaintiff fact sheet (pfs) that she did not experienced hypersensitivity reaction to nickel or any other component of essure.She denied to be allergic to nickel or any other component of essure.She did not experience claimed injury before the date of her essure placement.She did not claim that essure worsened a previously existing injury/condition.Her alleged symptoms or injuries resolve or decrease after essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 45 kg/sqm.Most recent follow-up information incorporated above includes: on 22-nov-2017: plaintiff fact sheet (pfs) - new reporter (lawyer); demographic data; medical history; indication; stop date (feb-2013); lot number (898932); event severe and permanent injuries deletion; new adverse events (severe headaches/ constant headaches/ migraines, constant bleeding for 6 months, constant diarrhea, constant severe back pains/ache, severe and persistent pelvic pain, severe and persistent abdominal pain, persistent and constant joint pain, bloating, essure caused or aggravated her psychiatric and /or psychological conditions, she did not undergo essure confirmation test, and following essure placement procedure, she did not use any form of contraception).Essure legal manufacture has changed from bayer healthcare, llc, (b)(4) to bayer pharma (b)(4), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type ¿initial¿ indicates here initial submission by the new legal manufacturer only.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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain"), genital haemorrhage ("constant bleeding for 6 months"), back pain ("constant severe back pains/ache") and abdominal pain ("severe and persistent abdominal pain") in an adult female patient who had essure (batch no.898932) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's past medical history included loop electrosurgical excision procedure (for hpv/ abnormal pap) in 2011, multigravida, parity 3 (b)(6) 2000, (b)(6) 2004, and (b)(6) 2012) and pneumonia in 2008.Concurrent conditions included obesity, dysfunctional uterine bleeding and menometrorrhagia.In (b)(6) 2012, the patient had essure inserted.In (b)(6) 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), back pain (seriousness criteria medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), migraine ("severe headaches/ constant headaches/ migraines"), diarrhoea ("constant diarrhea"), abdominal distension ("bloating"), headache ("headaches") and the first episode of arthralgia ("constant joint pain").On an unknown date, the patient experienced the second episode of arthralgia ("persistent and constant joint pain"), mental disorder ("essure caused or aggravated her psychiatric and /or psychological conditions") and treatment noncompliance ("following essure placement procedure, she did not use any form of contraception").The patient was treated with surgery (hysterectomy with essure removal).Essure was removed in (b)(6) 2013.In (b)(6) 2013, the back pain, migraine, diarrhoea and abdominal distension had resolved.In (b)(6) 2013, the genital haemorrhage had resolved.At the time of the report, the pelvic pain, abdominal pain, the last episode of arthralgia and mental disorder was resolving and the treatment noncompliance and headache outcome was unknown.The reporter considered abdominal distension, abdominal pain, back pain, diarrhoea, genital haemorrhage, headache, mental disorder, migraine, pelvic pain, treatment noncompliance, the first episode of arthralgia and the second episode of arthralgia to be related to essure.The reporter commented: on plaintiff fact sheet (pfs) that she did not experienced hypersensitivity reaction to nickel or any other component of essure.She denied to be allergic to nickel or any other component of essure.She did not experience claimed injury before the date of her essure placement.She did not claim that essure worsened a previously existing injury/condition.Her alleged symptoms or injuries resolve or decrease after essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 45 kg/sqm.Most recent follow-up information incorporated above includes: on (b)(6) 2018: pfs received - new event "joint pain, headaches" were added.Historical and concomitant conditions were added.New reporter 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

This spontaneous case was reported by a lawyer and describes the occurrence of pelvic pain ("severe and persistent pelvic pain"), genital haemorrhage ("constant bleeding for 6 months"), back pain ("constant severe back pains/ache") and abdominal pain ("severe and persistent abdominal pain") in an adult female patient who had essure (batch no.898932) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device monitoring procedure not performed "she did not undergo essure confirmation test".The patient's past medical history included loop electrosurgical excision procedure (for hpv/ abnormal pap) in 2011, multigravida, parity 3 (b)(6) 2000, (b)(6) 2004, and (b)(6) 2012 and pneumonia in 2008.Concurrent conditions included obesity, dysfunctional uterine bleeding and menometrorrhagia.In september 2012, the patient had essure inserted.In september 2012, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), genital haemorrhage (seriousness criteria medically significant and intervention required), back pain (seriousness criteria medically significant and intervention required), abdominal pain (seriousness criteria medically significant and intervention required), migraine ("severe headaches/ constant headaches/ migraines"), diarrhoea ("constant diarrhea"), abdominal distension ("bloating"), headache ("headaches") and the first episode of arthralgia ("constant joint pain").On an unknown date, the patient experienced the second episode of arthralgia ("persistent and constant joint pain"), mental disorder ("essure caused or aggravated her psychiatric and /or psychological conditions") and treatment noncompliance ("following essure placement procedure, she did not use any form of contraception").The patient was treated with surgery (hysterectomy with essure removal).Essure was removed in february 2013.In february 2013, the back pain, migraine, diarrhoea and abdominal distension had resolved.In march 2013, the genital haemorrhage had resolved.At the time of the report, the pelvic pain, abdominal pain, the last episode of arthralgia and mental disorder was resolving and the treatment noncompliance and headache outcome was unknown.The reporter considered abdominal distension, abdominal pain, back pain, diarrhoea, genital haemorrhage, headache, mental disorder, migraine, pelvic pain, treatment noncompliance, the first episode of arthralgia and the second episode of arthralgia to be related to essure.The reporter commented: on plaintiff fact sheet (pfs) that she did not experienced hypersensitivity reaction to nickel or any other component of essure.She denied to be allergic to nickel or any other component of essure.She did not experience claimed injury before the date of her essure placement.She did not claim that essure worsened a previously existing injury/condition.Her alleged symptoms or injuries resolve or decrease after essure removal.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 45 kg/sqm.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 25-jun-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: 7128562
• MDR Text Key: 95239820
• Report Number: 2951250-2017-10916
• 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: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2014
• Device Model Number: ESS305
• Device Lot Number: 898932
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 82