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

Model Number ESS305

Device Problems Device Or Device Fragments Location Unknown (2590); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994); Heavier Menses (2666); Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 10/01/2010

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of device dislocation ("could not find the essure device within the fallopian tubes/ hysterectomy which also did not reveal the essure device") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2010, the patient had essure inserted.On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, dyspareunia ("pain during intercourse"), headache ("headaches") and menorrhagia ("heavy menstrual bleeding").The patient was treated with surgery (underwent a bilateral salpingectomy and hysterectomy).At the time of the report, the device dislocation, dyspareunia, headache and menorrhagia outcome was unknown.The reporter considered device dislocation, dyspareunia, headache and menorrhagia to be related to essure.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 ("could not find the essure device within the fallopian tubes/ hysterectomy which also did not reveal the essure device"), menorrhagia ("heavy menstrual bleeding/ abnormal bleeding(menorrhagia)") and genital haemorrhage ("abnormal bleeding") in a 30-year-old female patient who had essure (batch no.699883) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included breast cancer.Concurrent conditions included type 1 diabetes mellitus, lymphadenopathy, perineal pain, dysplasia, ovarian cyst, abdominal pain lower, brain neoplasm benign, muscle strain, afebrile seizure, hepatitis, anxiety, bipolar disorder, hematoma, haemorrhagic anaemia, intra-abdominal bleeding, hepatitis c and thrombocytopenia.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), dysmenorrhoea ("dysmenorrhea (cramping)") and vaginal haemorrhage ("vaginal haemorrhage").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), device expulsion ("expulsion of essure device"), dyspareunia ("pain during intercourse"), headache ("headaches"), abdominal pain ("left side abdominal pain") and back pain ("lower back pain").The patient was treated with surgery (underwent a bilateral salpingectomy and hysterectomy on (b)(6) 2015) and surgery (ablation).At the time of the report, the device dislocation, genital haemorrhage, dyspareunia, headache, female sexual dysfunction, dysmenorrhoea, vaginal haemorrhage, abdominal pain and back pain had resolved and the menorrhagia and device expulsion outcome was unknown.The reporter considered abdominal pain, back pain, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, female sexual dysfunction, genital haemorrhage, headache, menorrhagia and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in insertion date.Previously reported as: (b)(6) 2010.In current follow up reported as: (b)(6) 2010.Plaintiff claimed that hysterectomy which also did not reveal left essure device.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2015: small amount of free fluid in the pelvis.Ultrasound scan vagina - in (b)(6) 2012: malposition of essure device, unilateral occlusion.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records: pelvic pain, dyspareunia, menorrhagia.Most recent follow-up information incorporated above includes: on 2-nov-2018: plaintiff fact sheet received.Reporter information updated.Patient demographic information updated.Other relevant history and lab data updated.Essure lot number added.Essure start date and stop date updated.Event: abnormal bleeding, apareunia (inability to have sexual intercourse), dysmenorrhea (cramping), vaginal haemorrhage, left side abdominal pain, lower back pain and device expulsion were newly added.Event outcome updated.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 device dislocation ("could not find the essure device within the fallopian tubes/ hysterectomy which also did not reveal the essure device"), menorrhagia ("heavy menstrual bleeding/ abnormal bleeding(menorrhagia)") and genital haemorrhage ("abnormal bleeding") in a 30-year-old female patient who had essure (batch no.699883) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included breast cancer.Left coil was out of place and right coil was successful.Concurrent conditions included type 1 diabetes mellitus, lymphadenopathy, perineal pain, dysplasia, ovarian cyst, abdominal pain lower, brain neoplasm benign, muscle strain, afebrile seizure, hepatitis, anxiety, bipolar disorder, hematoma, haemorrhagic anaemia, intra-abdominal bleeding, hepatitis c and thrombocytopenia.On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), dysmenorrhoea ("dysmenorrhea (cramping)") and vaginal haemorrhage ("vaginal haemorrhage").On an unknown date, the patient experienced device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), device expulsion ("expulsion of essure device"), dyspareunia ("pain during intercourse"), headache ("headaches"), abdominal pain ("left side abdominal pain") and back pain ("lower back pain").The patient was treated with surgery (ablation and underwent a bilateral salpingectomy and hysterectomy on (b)(6) 2015).At the time of the report, the device dislocation, genital haemorrhage, dyspareunia, headache, female sexual dysfunction, dysmenorrhoea, vaginal haemorrhage, abdominal pain and back pain had resolved and the menorrhagia and device expulsion outcome was unknown.The reporter considered abdominal pain, back pain, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, female sexual dysfunction, genital haemorrhage, headache, menorrhagia and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in insertion date.Previously reported as: (b)(6) 2010.In current follow up reported as: (b)(6) 2010.Plaintiff claimed that hysterectomy which also did not reveal left essure device.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2015: results: small amount of free fluid in the pelvis.Ultrasound scan vagina - in (b)(6) 2012: results: malposition of essure device, unilateral occlusion.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records:: pelvic pain, dyspareunia, menorrhagia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 29-nov-2018: quality safety evaluation of ptc.Incident: we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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 ("pain in pelvis returned- pieces of coil remains in left side"), device dislocation ("could not find the essure device within the fallopian tubes/ hysterectomy which also did not reveal the essure device"), menorrhagia ("heavy menstrual bleeding/ abnormal bleeding(menorrhagia)") and genital haemorrhage ("abnormal bleeding") in a 30-year-old female patient who had essure (batch no.699883) inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's medical history included breast cancer.Left coil was out of place and right coil was successful.On an unknown date patient underwent essure confirmation test.Concurrent conditions included type 1 diabetes mellitus, lymphadenopathy, perineal pain, dysplasia, ovarian cyst, abdominal pain lower, brain neoplasm benign, muscle strain, afebrile seizure, hepatitis, anxiety, bipolar disorder, hematoma, haemorrhagic anaemia, intra-abdominal bleeding, hepatitis c, thrombocytopenia, depression and deficiency vitamin (vitamin c, b, omega, a,d.).Concomitant products included ascorbic acid, buspirone, folic acid, lurasidone hydrochloride (latuda), retinol, trazodone, vitamin b complex (vitamin b) and vitamin d nos (vitamin d).On (b)(6) 2010, the patient had essure inserted.In (b)(6) 2010, the patient experienced menorrhagia (seriousness criteria medically significant and intervention required), female sexual dysfunction ("apareunia (inability to have sexual intercourse),"), dysmenorrhoea ("dysmenorrhea (cramping)"), vaginal haemorrhage ("vaginal haemorrhage/abnormal bleeding (vaginal)"), abdominal pain ("left side abdominal pain") and back pain ("lower back pain").On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device dislocation (seriousness criteria medically significant and intervention required) with pelvic pain, genital haemorrhage (seriousness criterion medically significant), device expulsion ("expulsion of essure device"), dyspareunia ("pain during intercourse") and headache ("headaches").The patient was treated with surgery (ablation on (b)(6) 2015, hysterectomy with bilateral salpingo-oopherectomy and bilateral salpingectomy and underwent a bilateral salpingectomy and hysterectomy on (b)(6) 2015,oophorectomy (bilateral removal).Essure was removed on (b)(6) 2015.At the time of the report, the device breakage, menorrhagia and device expulsion outcome was unknown and the device dislocation, genital haemorrhage, dyspareunia, headache, female sexual dysfunction, dysmenorrhoea, vaginal haemorrhage, abdominal pain and back pain had resolved.The reporter considered abdominal pain, back pain, device breakage, device dislocation, device expulsion, dysmenorrhoea, dyspareunia, female sexual dysfunction, genital haemorrhage, headache, menorrhagia and vaginal haemorrhage to be related to essure.The reporter commented: discrepancy noted in insertion date.Previously reported as: (b)(6) 2010 in current follow up reported as: (b)(6) 2010 plaintiff claimed that hysterectomy which also did not reveal left essure device.Discrepancy noted as per pfs: removal date od essure device: (b)(6) 2015.Diagnostic results (normal ranges are provided in parenthesis if available): ultrasound pelvis - on (b)(6) 2015: results: small amount of free fluid in the pelvis.Ultrasound scan vagina - in (b)(6) 2012: results: malposition of essure device, unilateral occlusion.Concerning the injuries reported in this case, the following ones were described in patient¿s medical records:: pelvic pain, dyspareunia, menorrhagia.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 1-feb-2019: plaintiff fact sheet received.Event pain in pelvis returned-piece of coil remains in left side was added.Concomitant drugs and conditions were added.Reporter information was updated.Incident we received a lot number/returned sample in this case.A technical investigation will be conducted, including a batch review, and a review of complaint records and other non-conformances data; should any new and reportable information become available as a result, 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: 6964234
• MDR Text Key: 89800687
• Report Number: 2951250-2017-05221
• 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,Followup,Followup,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2012
• Device Model Number: ESS305
• Device Lot Number: 699883
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASCORBIC ACID; BUSPIRONE; FOLIC ACID; LATUDA; RETINOL; TRAZODONE; VITAMIN B; VITAMIN D [VITAMIN D NOS]
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR