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

Model Number ESS305

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Fatigue (1849); Pain (1994); Tinnitus (2103); Constipation (3274)

Event Date 05/29/2017

Event Type  Injury  

Manufacturer Narrative

This case was initially received via regulatory authority (b)(6) (reference number: (b)(4)) on 30-jun-2017.The most recent information was received on 17-aug-2017.This spontaneous case was reported by a consumer and describes the occurrence of pelvic pain ("pelvic pains") in a (b)(6) year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included ankle fracture in 2009.Concomitant products included anesthetics and general (general anesthesia) on (b)(6) 2017 for anaesthesia.In (b)(6) 2008, the patient had essure inserted.On (b)(6) 2009, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), hormone level abnormal ("hormonal disorders"), depression, back pain ("back pain"), vertigo ("vertigo"), migraine, myalgia ("muscular pain"), palpitations ("cardiac palpitation"), endometrial thickening ("very thick endometrium"), allergy to metals ("nickel allergy/cobalt allergy"), insomnia and hyperhidrosis ("sweatiness").On an unknown date, the patient experienced ear pruritus ("itching inside ear"), tinnitus, constipation ("constipation"), fatigue ("overwhelming fatigue (only fatigue related to recent anaesthesia)") and arthralgia ("joint pain especailly on fractured ankle").The patient was treated with surgery (essure removal via bilateral salpingectomy).Essure was removed on (b)(6) 2017.In 2017, the ear pruritus, tinnitus, constipation and arthralgia had resolved.At the time of the report, the pelvic pain, hormone level abnormal, depression, back pain, vertigo, migraine, myalgia, palpitations, endometrial thickening, allergy to metals, insomnia and hyperhidrosis outcome was unknown and the fatigue had resolved.The reporter provided no causality assessment for allergy to metals, arthralgia, back pain, constipation, depression, ear pruritus, endometrial thickening, fatigue, hormone level abnormal, hyperhidrosis, insomnia, migraine, myalgia, palpitations, pelvic pain, tinnitus and vertigo with essure.The reporter commented: since removal, no more constipation, transit returned to normal.No more itching inside ear and no more tinnitus.No more overwhelming fatigue (only fatigue related to recent anaesthesia), no more joint pain (especially in fractured ankle in 2009).The list of device similar incidents contains essure reports received by bayer and older cases received by conceptus coded with the same meddra preferred terms.In this particular case a search in the database was performed on 18-aug-2017 for the following meddra preferred term: pelvic pain: the analysis in the global safety database revealed 3518 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.Further company follow-up with the unknown is not possible.Most recent follow-up information incorporated above includes: on 17-aug-2017: new events were reported: hormone level abnormal, depression, back pain, vertigo, migraine, myalgia, pelvic pains, palpitations, endometrial thickening, allergy to metals, insomnia and hyperhidrosis were reported.Event essure removal via bilateral salpingectomy was deleted, as it was considered that pelvic pains is the indication for procedure.Insertion date of essure was also provided.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.

Event Description

This case was initially received via regulatory authority ansm (reference number: (b)(4)) on (b)(6) 2017.This spontaneous case was reported by a consumer and describes the occurrence of salpingectomy ("essure removal via bilateral salpingectomy") in a (b)(6) female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.The patient's past medical history included ankle fracture in (b)(6) 2009.Concomitant products included anesthetics and general (general anesthesia) on (b)(6) 2017 for anaesthesia.On an unknown date, the patient had essure inserted.On (b)(6) 2017, the patient underwent salpingectomy (seriousness criteria medically significant and intervention required).On an unknown date, the patient experienced ear pruritus ("itching inside ear"), tinnitus ("tinnitus"), constipation ("constipation"), fatigue ("overwhelming fatigue (only fatigue related to recent anaesthesia)") and arthralgia ("joint pain especailly on fractured ankle").The patient was treated with surgery.In 2017, the ear pruritus, tinnitus, constipation and arthralgia had resolved.At the time of the report, the salpingectomy outcome was unknown and the fatigue had resolved.The reporter provided no causality assessment for arthralgia, constipation, ear pruritus, fatigue, salpingectomy and tinnitus with essure.The reporter commented: since removal, no more constipation, transit returned to normal.No more itching inside ear and no more tinnitus.No more overwhelming fatigue (only fatigue related to recent anaesthesia), no more joint pain (especially in fractured ankle in (b)(6) 2009) the list of device similar events 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 (b)(6) 2017 for the following meddra preferred term: salpingectomy.The analysis in the global safety database revealed (b)(4) 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.Further company follow-up with the unknown is not possible.Company causality comment: 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: 6689779
• MDR Text Key: 133128197
• Report Number: 2951250-2017-02434
• 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: consumer,foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/05/2017

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2017
• Initial Date FDA Received: 07/06/2017
• Supplement Dates Manufacturer Received: 08/17/2017
• Supplement Dates FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 44 YR