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

Model Number ESS305

Device Problems Break (1069); Sticking (1597)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

This case was initially received via (b)(6) ((b)(4)) on 26-oct-2017.The most recent information was received on 15-nov-2017.This spontaneous case was reported by a pharmacist and describes the occurrence of embedded device ("on left: possible breaking-in of the essure") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii and parity 2.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), pelvic pain ("piercing pain on left side"), back pain ("lumbar pain") and device deployment issue ("2 trailing coils on left side").The patient was treated with surgery (bilateral salpingectomy by laparoscopy).Essure was removed on (b)(6) 2017.At the time of the report, the embedded device, pelvic pain, back pain and device deployment issue outcome was unknown.The reporter provided no causality assessment for back pain, device deployment issue, embedded device and pelvic pain with essure.The reporter commented: integer tube on the right side.Intervention report for essure insertion: uterine cavity was normal with visible ostia.Insertion performed and checked with 3 trailing coils on right and 2 trailing coils on left.Essure batch number not mentioned.Essure removal after request from the patient.There was no infection, inflammation or pathologic results after removal.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 27-oct-2017 for the following meddra preferred term: embedded device.The analysis in the global safety database revealed 399 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Most recent follow-up information incorporated above includes: on 15-nov-2017: removal questionnaire was received.Intervention report for essure insertion: uterine cavity was normal with visible ostia.Insertion performed and checked with 3 trailing coils on right and 2 trailing coils on left.There was no infection, inflammation or pathologic results after removal.Batch number not mentioned.Essure removal method: total bilateral salpingectomy with laparoscopy performed on (b)(6) 2017.Essure removal after request from the patient.The list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 27-oct-2017 for the following meddra preferred term: embedded device.The analysis in the global safety database revealed 399 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment.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 case was initially received via regulatory authority (b)(6) (reference number: (b)(4)) on 26-oct-2017.The most recent information was received on 15-nov-2017.This spontaneous case was reported by a pharmacist and describes the occurrence of embedded device ("on left: possible breaking-in of the essure") in an adult female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii and parity 2.On (b)(6) 2009, the patient had essure inserted.On an unknown date, the patient experienced embedded device (seriousness criteria medically significant and intervention required), pelvic pain ("piercing pain on left side"), back pain ("lumbar pain") and device deployment issue ("2 trailing coils on left side").The patient was treated with surgery (bilateral salpingectomy by laparoscopy).Essure was removed on (b)(6) 2017.At the time of the report, the embedded device, pelvic pain, back pain and device deployment issue outcome was unknown.The reporter provided no causality assessment for back pain, device deployment issue, embedded device and pelvic pain with essure.The reporter commented: integer tube on the right side.Intervention report for essure insertion: uterine cavity was normal with visible ostia.Insertion performed and checked with 3 trailing coils on right and 2 trailing coils on left.Essure batch number not mentioned.Essure removal after request from the patient.There was no infection, inflammation or pathologic results after removal.The updated list of similar cases contains essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 20-nov-2017 for the following meddra preferred term: embedded device.The analysis in the global safety database revealed 409 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Most recent follow-up information incorporated above includes: on 15-nov-2017: removal questionnaire was received.Intervention report for essure insertion: uterine cavity was normal with visible ostia.Insertion performed and checked with 3 trailing coils on right and 2 trailing coils on left.There was no infection, inflammation or pathologic results after removal.Batch number not mentioned.Essure removal method: total bilateral salpingectomy with laparoscopy performed on (b)(6) 2017.Essure removal after request from the patient.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.

• 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: k shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 7043714
• MDR Text Key: 92466940
• Report Number: 2951250-2017-06800
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/15/2017
• 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): Other; Required Intervention