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

Model Number ESS305

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Memory Loss/Impairment (1958); Pain (1994); Weight Changes (2607); Heavier Menses (2666)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a female consumer of unspecified age via regulatory authority (case# mw5064460) in united states on 26-sep-2016 who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2011.Consumer reported within weeks of implanting she started presenting abdominal pain, severe fatigue, memory loss, brain fogginess, weight gain, heavy bleeding, abnormal periods, lack of sex drive and pain during sex (when it happened).After 3 years of pain and trying to find a doctor to believe her, her only option was a total laparoscopic hysterectomy (tlh).Surgery was performed on (b)(6) 2015 after which, only one coil was found.Consumer informed after recovery from tlh, her health, energy and memory returned and she has no pain.Additionally, the seriousness criteria hospitalization, disability/permanent damage and required intervention were reported.However, it was not specified for which event.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced abdominal pain and heavy bleeding (seen as genital bleeding).A total laparoscopic hysterectomy was performed and it was found only one coil.The events are anticipated in the reference safety information for essure.In this case, she experienced abdominal pain and heavy bleeding within weeks of essure insertion.The exact location of the essure coil which was not found after surgery was not provided.Based on the nature of the events, a causal relationship with suspect insert cannot be excluded.The hospitalization, disability/permanent damage and required intervention was only mentioned as event outcome and the reporter did not specify it.This case was regarded as incident since surgical intervention was performed.Additionally, non-serious events were reported.Further information and product technical analysis are being sought.

Manufacturer Narrative

Quality safety evaluation of ptc received on 24-oct-2016: ptc global number is (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.The reported medical events are not necessarily indicative of a quality defect.As no batch number was reported a technical batch investigation and a review of similar ae case reports is not possible.No complaint sample was provided for further investigation therefore the complaint could not be evaluated in greater detail.The technical assessment concluded a quality defect was not confirmed but considered plausible.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 events cannot be totally excluded.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced abdominal pain and heavy bleeding (seen as genital bleeding).A total laparoscopic hysterectomy was performed and it was found only one coil.The events are anticipated in the reference safety information for essure.In this case, she experienced abdominal pain and heavy bleeding within weeks of essure insertion.The exact location of the essure coil which was not found after surgery was not provided.Based on the nature of the events, a causal relationship with suspect insert cannot be excluded.The hospitalization, disability/permanent damage and required intervention was only mentioned as event outcome and the reporter did not specify it.This case was regarded as incident since surgical intervention was performed.Additionally, non-serious events were reported.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Further information is being sought.

Manufacturer Narrative

Most recent follow-up information incorporated above includes: on 13-feb-2017: follow-up was pursued and completed.Company causality comment: this non-medically confirmed, spontaneous case report refers to a female consumer who had essure (fallopian tube occlusion insert) inserted and experienced abdominal pain and heavy bleeding (seen as genital bleeding).A total laparoscopic hysterectomy was performed and it was found only one coil.The events are anticipated in the reference safety information for essure.In this case, she experienced abdominal pain and heavy bleeding within weeks of essure insertion.The exact location of the essure coil which was not found after surgery was not provided.Based on the nature of the events, a causal relationship with suspect insert cannot be excluded.The hospitalization, disability/permanent damage and required intervention was only mentioned as event outcome and the reporter did not specify it.This case was regarded as incident since surgical intervention was performed.Additionally, non-serious events were reported.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Despite follow-up attempts no further information could be obtained.

• 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, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6050375
• MDR Text Key: 58154755
• Report Number: 2951250-2016-02289
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2017

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
• Initial Date Manufacturer Received: 09/26/2016
• Initial Date FDA Received: 10/24/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/16/2016; 03/08/2017
• 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): Hospitalization; Other; Required Intervention; Disability