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

Model Number ESS305

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Device Embedded In Tissue or Plaque (3165); Insufficient Information (4580)

Event Date 01/01/2021

Event Type  Injury  

Event Description

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("medical device removal") in a 39 year-old female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2021, 3075 days after essure insertion, she underwent medical device removal (seriousness criterion intervention required) hysterectomy - uterus).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed, and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.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.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of medical device removal ("medical device removal") in a 39 year-old female patient who had essure inserted.There was no information on the patient's medical history or concurrent conditions.On (b)(6) 2012, the patient had essure inserted.On (b)(6) 2021, 3075 days after essure insertion, she underwent medical device removal (seriousness criterion intervention required).Essure was removed the same day.The patient was treated with surgery (hysterectomy - uterus).At the time of the report, the outcome of the event was unknown.The reporter considered medical device removal to be related to essure administration.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 15-jun-2023: quality safety evaluation of ptc.Based on the available information, a review of our complaint records and other relevant data was conducted; any new and reportable information that becomes available from our investigation will be provided in a supplementary report.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of embedded device ("displays an embedded coiled silver metal wire") in an adult female patient who had essure inserted (lot no.916888) for female sterilization.The patient had a medical history of obesity, menorrhagia, pelvic pain, bleeding menstrual heavy, parity 2 and multi gravida.On (b)(6) 2012, the patient had essure inserted.Essure was removed on (b)(6) 2021.An unknown time later she experienced embedded device (seriousness criterion intervention required).The patient was treated with surgery (laparoscopic robotic total hysterectomy, bilateral salpingectomy, cystoscopy).At the time of the report, the outcome of the event was unknown.The reporter considered embedded device to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 42.295 kg/sqm.[hysterosalpingogram] on 2012: clinical history: evaluate essure devices procedure.Preliminary spot image reveals essure microinserts projecting over the expected location of the fallopian tubes.Endometrial cavity is normal in size, shape and contour.Based upon the manufacturers specifications, the essure microinserts are in satisfactory position.Based upon the manufacturer s specifications (see classification below), grade one tubal occlusion is demonstrated on the right and grade one tubal occlusion is demonstrated on the left.Manufacturer's classification of tubal occlusion: grade 1: tube is occluded at the cornua.Grade 2: contrast seen within the tube but not past the distal end of the outer coil.Grade 3: contrast seen past the microinserts or in the peritoneal cavity.Impression: 1.Satisfactory location of essure microinserts bilaterally.2.Satisfactory tubal occlusion as discussed above.[pathology test] on (b)(6) 2021: final diagnosis: result: uterus, cervix, bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: cervix-no significant histopathologic abnormality.Endometrium- secretory endometrium.Myometrium-no significant histopathologic abnormality.Right and left fallopian tubes-no significant histopathologic abnormality; right fallopian tube with paratubal cyst.Essure coils identified in fallopian tubes.Gross description: the attached purple gray fimbriated right fallopian tube- displays an embedded coiled silver metal wire the attached purple gray fimbriated left fallopian tube is 7.4 x 0.7 x 0.6 cm and displays embedded coiled silver metal wire.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records:embedded device.The most recent follow-up information incorporated above includes data received on: 17-nov-2023: medical devic removal was updated to embedded device.Reporters,medical history,lab data,patient information,indication,lot no.,removal date,non drug treatment 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.

Manufacturer Narrative

This spontaneous case was originally reported by a lawyer on behalf of a consumer and describes the occurrence of embedded device ("displays an embedded coiled silver metal wire") in an adult female patient who had essure inserted (lot no.916888) for permanent contraceptive tubal implant.The patient had a medical history of obesity, menorrhagia, pelvic pain, bleeding menstrual heavy, parity 2 and multi gravida.On (b)(6) 2012, the patient had essure inserted.Essure was removed on (b)(6) 2021.An unknown time later she experienced embedded device (seriousness criterion intervention required).The patient was treated with surgery (laparoscopic robotic total hysterectomy, bilateral salpingectomy, cystoscopy).At the time of the report, the outcome of the event was unknown.The reporter considered embedded device to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 42.295 kg/sqm.[hysterosalpingogram] on (b)(6) 2012: clinical history: evaluate essure devices procedure.Preliminary spot image reveals essure microinserts projecting over the expected location of the fallopian tubes.Endometrial cavity is normal in size, shape and contour.Based upon the manufacturers specifications, the essure microinserts are in satisfactory position.Based upon the manufacturer s specifications (see classification below), grade one tubal occlusion is demonstrated on the right and grade one tubal occlusion is demonstrated on the left.Manufacturer's classification of tubal occlusion: grade 1: tube is occluded at the cornua.Grade 2: contrast seen within the tube but not past the distal end of the outer coil.Grade 3: contrast seen past the microinserts or in the peritoneal cavity.Impression: 1.Satisfactory location of essure microinserts bilaterally.2.Satisfactory tubal occlusion as discussed above.[pathology test] on (b)(6) 2021: final diagnosis result: uterus, cervix, bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: ¿ cervix-no significant histopathologic abnormality.¿ endometrium- secretory endometrium.¿ myometrium-no significant histopathologic abnormality.¿ right and left fallopian tubes-no significant histopathologic abnormality; right fallopian tube with paratubal cyst.¿ essure coils identified in fallopian tubes.Gross description: ¿ the attached purple gray fimbriated right fallopian tube- displays an embedded coiled silver metal wire ¿ the attached purple gray fimbriated left fallopian tube is 7.4 x 0.7 x 0.6 cm and displays embedded coiled silver metal wire.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records:embedded device lot number:916888 is not valid.Quality-safety evaluation of ptc: for essure: unable to confirm complaint the most recent follow-up information incorporated above includes data received on: 12-jan-2024: 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 originally reported by a lawyer on behalf of a consumer and describes the occurrence of embedded device ("displays an embedded coiled silver metal wire") in an adult female patient who had essure inserted for permanent contraceptive tubal implant.The patient had a medical history of obesity, menorrhagia, pelvic pain, bleeding menstrual heavy, parity 2 and multi gravida.On (b)(6) 2012, the patient had essure inserted.Essure was removed on (b)(6) 2021.On unknown date she experienced embedded device (seriousness criterion intervention required).The patient was treated with surgery (laparoscopic robotic total hysterectomy, bilateral salpingectomy, cystoscopy).At the time of the report, the outcome of the event was unknown.The reporter considered embedded device to be related to essure administration.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index: 42.295 kg/sqm.[hysterosalpingogram] on (b)(6) 2012: clinical history: evaluate essure devices procedure.Preliminary spot image reveals essure micro inserts projecting over the expected location of the fallopian tubes.Endometrial cavity is normal in size, shape and contour.Based upon the manufacturers specifications, the essure micro inserts are in satisfactory position.Based upon the manufacturer s specifications (see classification below), grade one tubal occlusion is demonstrated on the right and grade one tubal occlusion is demonstrated on the left.Manufacturer's classification of tubal occlusion: grade 1: tube is occluded at the cornua.Grade 2: contrast seen within the tube but not past the distal end of the outer coil.Grade 3: contrast seen past the micro inserts or in the peritoneal cavity.Impression: 1.Satisfactory location of essure micro inserts bilaterally.2.Satisfactory tubal occlusion as discussed above.[pathology test] on (b)(6) 2021: final diagnosis.Result: uterus, cervix, bilateral fallopian tubes, hysterectomy with bilateral salpingectomy: cervix-no significant histopathologic abnormality.Endometrium- secretory endometrium.Myometrium-no significant histopathologic abnormality.Right and left fallopian tubes-no significant histopathologic abnormality; right fallopian tube with paratubal cyst.Essure coils identified in fallopian tubes.Gross description: the attached purple gray fimbriated right fallopian tube- displays an embedded coiled silver metal wire.The attached purple gray fimbriated left fallopian tube is 7.4 x 0.7 x 0.6 cm and displays embedded coiled silver metal wire.Concerning the injuries reported in this case, the following one/ones were described in patient¿s medical records:embedded device.Lot number: 916888 is not valid.Quality-safety evaluation of ptc: for essure: no defect could be confirmed by the manufacturer.All product batches have met the specifications regarding labeling, material, and process controls at time of release.Trend analyses of complaints are reviewed regularly, no signal was observed with regard to the reported complaint reason.The risk management file was reviewed and an update was not deemed required.A technical investigation of the complaint sample and batch record review could not be conducted, as no sample or batch number were available.The most recent follow-up information incorporated above includes data received on: 08-feb-2024: 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.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: janice miller ; 100 bayer blvd.; p.o. box 915; whippany, NJ 07981
• MDR Report Key: 16985064
• MDR Text Key: 315794254
• Report Number: 2951250-2023-02271
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Device Lot Number: 916888
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 111 KG