MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; INSERT, TUBAL OCCLUSION

Catalog Number ESS305

Device Problems Structural Problem (2506); Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 02/06/2017

Event Type  Injury  

Event Description

This (b)(6) female patient was involved in a reimbursement or compensation activity.The patient received essure for female sterilisation.The report describes a case of pelvic pain ("pain on right iliac fossa, pelvic pain on right zone").The occurrence of additional non-serious events is detailed below.On (b)(6) 2017, the patient started essure at an unspecified dose and frequency.On (b)(6) 2017, 11 days after starting essure, the patient experienced pelvic pain (seriousness criteria medically significant and clinically significant/intervention required).On an unknown date, the patient experienced device physical property issue ("essure device got compacted in a "ball shape"").The patient was treated with surgery (essure was removed from right fallopian tube on (b)(6) 2017 without complications).Essure was withdrawn.On (b)(6) 2017, the pelvic pain had resolved.At the time of the report, the device physical property issue outcome was unknown.The reporter considered pelvic pain and device physical property issue to be related to essure.The reporter commented: bilateral insertion of essure was successfully performed.After insertion, patient presented pain on right iliac fossa.After diagnostic tests it was observed a correct insertion of device but with pain persistence.Essure was removed from right fallopian tube on (b)(6) 2017 without complications.After essure removal from right fallopian tube, the pain disappeared.After removal, it was observed that essure device was compacted in a "ball shape" when it was removed, so it occurred while it was still.The coil was not available.Diagnostic results: on unspecified date (s): diagnostic tests: correct insertion of device observed.Most recent follow-up information incorporated above includes: on 27-feb-2017: physician provided correct lot number: he011h7.He clarified regarding shape change ( "essure device got compacted in a "ball shape") that it was already compacted when it was removed, so it occurred while it was still in patient.Company causality comment: this medically confirmed spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and experienced pelvic pain ("pain on right iliac fossa, pelvic pain on right zone").She presented with the pain eleven days after essure insertion and another two days later the insert was removed surgically from the right fallopian tube without complications.After removal it was noticed that essure got compacted in a "ball shape".The pain resolved after removal of the insert.Pelvic pain is assessed as serious due to its medical significance and it is anticipated according to essure's reference safety information.After essure insertion, abdominal, pelvic and uncharacterized pain may occur.Considering the compatible temporal relationship and the event's nature, causality of pelvic pain with essure cannot be excluded (related).This case was regarded as incident since device removal was required (intervention required).A product technical analysis is being sought.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of pelvic pain ("pain on right iliac fossa, pelvic pain on right zone") in a (b)(6) female patient who had essure (batch no.He011h7) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2017, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device physical property issue ("essure device got compacted in a "ball shape"").The patient was treated with surgery (essure removed through a hysteroscopy from right fallopian tube on (b)(6) 2017 without complications).Essure was removed on (b)(6) 2017.On (b)(6) 2017, the pelvic pain had resolved.At the time of the report, the device physical property issue outcome was unknown.The reporter considered device physical property issue and pelvic pain to be related to essure.The reporter commented: bilateral insertion of essure was successfully performed.After insertion, patient presented pain on right iliac fossa.After diagnostic tests it was observed a correct insertion of device but with pain persistence.Essure was removed from right fallopian tube on (b)(6) 2017 without complications.After essure removal from right fallopian tube, the pain disappeared.After removal , it was observed that essure device was compacted in a "ball shape" when it was removed, so it occurred while it was still.The coil was not available.Diagnostic results: on unspecified date (s): diagnostic tests: correct insertion of device observed.Most recent follow-up information incorporated above includes: on 12-apr-2017: it was confirmed that case is spontaneous.Report type was changed from study to spontaneous.Company causality comment: this medically confirmed spontaneous case report refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and experienced pelvic pain ("pain on right iliac fossa, pelvic pain on right zone").She presented with the pain eleven days after essure insertion and another two days later the insert was removed surgically from the right fallopian tube without complications.After removal it was noticed that essure got compacted in a "ball shape".The pain resolved after removal of the insert.Pelvic pain is assessed as serious due to its medical significance and it is anticipated according to essure's reference safety information.After essure insertion, abdominal, pelvic and uncharacterized pain may occur.Considering the compatible temporal relationship and the event's nature, causality of pelvic pain with essure cannot be excluded (related).This case was regarded as incident since device removal was required (intervention required).A product technical analysis is being sought.

Manufacturer Narrative

This spontaneous case was reported by a gynecologist/obstetrician and describes the occurrence of pelvic pain ("pain on right iliac fossa, pelvic pain on right zone") in a (b)(6) female patient who had essure (batch no.He011h7) inserted for female sterilisation.The occurrence of additional non-serious events is detailed below.On (b)(6) 2017, the patient had essure inserted.On (b)(6) 2017, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced device physical property issue ("essure device got compacted in a "ball shape"").The patient was treated with surgery (essure removed through a hysteroscopy from right fallopian tube on (b)(6) 2017 without complications).Essure was removed on (b)(6) 2017.On (b)(6) 2017, the pelvic pain had resolved.At the time of the report, the device physical property issue outcome was unknown.The reporter considered device physical property issue and pelvic pain to be related to essure.The reporter commented: bilateral insertion of essure was successfully performed.After insertion, patient presented pain on right iliac fossa.After diagnostic tests it was observed a correct insertion of device but with pain persistence.Essure was removed from right fallopian tube on (b)(6) 2017 without complications.After essure removal from right fallopian tube, the pain disappeared.After removal , it was observed that essure device was compacted in a "ball shape" when it was removed, so it occurred while it was still.The coil was not available.Diagnostic results: on unspecified date (s): diagnostic tests: correct insertion of device observed.The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same medra preferred term.In this particular case a search in the database was performed on 09-jun-2017 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 2.918 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.Quality-safety evaluation of ptc: since the sample was not returned for investigation, we cant confirm a "ball shape" on the device.Sample not available.We conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.We are unable to confirm any quality defect or device malfunction at this time.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.No capa investigation is required at this time because there was no event reported which indicates a new technical failure mode for the device.No specific quality issue was defined, therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical event cannot be totally excluded.However, the reported medical event is a known possible undesirable event and not indicative of a quality deficit per se.No further ae case reports have been received to date in relation to the reported batch.Most recent follow-up information incorporated above includes: on 6-jun-2017: quality safety evaluation of ptc.Company causality comment: 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: INSERT, TUBAL OCCLUSION
• 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: 6417716
• MDR Text Key: 70355456
• Report Number: 2951250-2017-00931
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2018
• Device Catalogue Number: ESS305
• Device Lot Number: HE011H7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/05/2017; 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2015
• 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
• Patient Age: 39 YR