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

Model Number ESS305

Device Problem Material Deformation (2976)

Patient Problems Emotional Changes (1831); Hypersensitivity/Allergic reaction (1907); Failure of Implant (1924); Unspecified Infection (1930); Itching Sensation (1943); Memory Loss/Impairment (1958); Menstrual Irregularities (1959); Pain (1994); Sweating (2444)

Event Type  Injury  

Event Description

This is a spontaneous case report received via regulatory authority in (b)(6) on 16-mar-2016 from a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2014 and forwarded to bayer on 04-aug-2016.The consumer's concurrent condition included nickel allergy.At insertion on (b)(6) 2014, it was reported: placement painful, device insertion complication, first placement failed, first coil curled up immediately into the oviduct.After that, an unspecified date the consumer experienced pelvis / hips pain, eczema, itching skin, allergic complaints in eye, irregular bleeding or breakthrough bleeding, bladder infection, muscle pain, memory loss or concentration problems, and excessive sweating.Consumer also reported: social activities and happiness disorder, disempowerment, big consequences and trust in doctors lost.Essure and the fallopian tubes were removed on (b)(6) 2015.Consumer's outcome was reported as not recovered.Company causality comment: this spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and experienced pelvis pain.This event is listed in the reference safety information for essure and this case was regarded as incident since essure removal was required (intervention required).Pelvic pain may occur within consumers under essure use.Thus, based on a positive temporal relationship, essure safety profile and lack of alternative explanation, the causality between the event pelvis pain and essure use was assessed as related.Other nonserious events were reported.Technical analysis has been requested.No further information is expected from consumer.

Manufacturer Narrative

Follow up 09-sep-2016: quality-safety evaluation of ptc.Ptc global number: (b)(4).No sample available for this investigation.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.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.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.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 12-sep-2016 for the following meddra preferred term: pelvic pain.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.Company causality comment: this spontaneous case report refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and experienced pelvis pain.This event is listed in the reference safety information for essure and this case was regarded as incident since essure removal was required (intervention required).Pelvic pain may occur within consumers under essure use.Thus, based on a positive temporal relationship, essure safety profile and lack of alternative explanation, the causality between the event pelvis pain and essure use was assessed as related.Other nonserious events were reported.According to technical analysis, a product quality defect could not be confirmed but is considered plausible.No further information is expected from consumer.

Manufacturer Narrative

This spontaneous case was reported by a consumer via regulatory authority (ha_nl_igz) on 16-mar-2016 and forwarded to bayer on 04-aug-2016 and describes the occurrence of pelvic pain ("pelvis pain") in a (b)(6) year-old female patient who had essure inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "first coil curled up immediately into the oviduct" in (b)(6) 2014.The patient's concurrent conditions included nickel sensitivity.In (b)(6) 2014, the patient had essure inserted.On the same day, the patient experienced procedural pain ("placement painful"), the first episode of complication of device insertion ("device insertion complication") and the second episode of complication of device insertion ("first placement failed").On an unknown date, the patient experienced pelvic pain (seriousness criteria disability and intervention required), arthralgia ("hips pain"), eczema, pruritus ("itching skin"), eye allergy ("allergic complaints in eye"), metrorrhagia ("irregular bleeding or breakthrough bleeding"), cystitis ("bladder infection"), myalgia ("muscle pain"), amnesia ("memory loss or concentration problems"), disturbance in attention ("memory loss or concentration problems") and hyperhidrosis ("excessive sweating").The patient was treated with surgery (3 surgeries to remove the xenobiotic material).Essure was removed on (b)(6) 2015.At the time of the report, the pelvic pain, arthralgia, eczema, pruritus, eye allergy, metrorrhagia, cystitis, myalgia, amnesia, disturbance in attention and hyperhidrosis had not resolved and the procedural pain and the last episode of complication of device insertion outcome was unknown.The reporter considered amnesia, arthralgia, cystitis, disturbance in attention, eczema, eye allergy, hyperhidrosis, metrorrhagia, myalgia, pelvic pain, procedural pain, pruritus, the first episode of complication of device insertion and the second episode of complication of device insertion to be related to essure.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 26-jul-2017 for the following meddra preferred term: pelvic pain.The analysis in the global safety database revealed 3210 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: no sample available for this investigation.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.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.There was no event reported which indicates a new technical failure mode for the device.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on (b)(6) 2017: follow-up received from the patient via letter in which she holds the company liable for the damage caused (legal case).Patient's initials provided.Essure start date updated.She underwent 3 surgeries to remove the xenobiotic material.Essure legal manufacture has changed from bayer healthcare, llc, milpitas to bayer pharma ag, (b)(6), and this report is being submitted as a follow up to a previous report submitted under the former legal manufacturer.Report type 'initial' indicates here initial submission by the new legal manufacturer only.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: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, CA 13353 ; GM 13353
• Manufacturer Contact: k shaw lamberson ; 100 bayer blvd.; whippany, NJ 07981-0915
• MDR Report Key: 5900672
• MDR Text Key: 52904443
• Report Number: 2951250-2016-01582
• 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,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2016
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• 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): Required Intervention; Disability
• Patient Age: 42 YR