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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problems Abdominal Pain (1685); Cyst(s) (1800); Pain (1994); Therapeutic Response, Decreased (2271); Depression (2361); No Code Available (3191)

Event Type  Injury  

Event Description

This case has been identified during monitoring of postings on an fda hosted docket website, which has been established in preparation of a public fda advisory committee meeting, which took place in september 2015 (fda-2014-n-0736-1195, awareness date 04-oct-2015).It refers to a female consumer of unspecified age in united states who had essure (fallopian tube occlusion insert) inserted in (b)(6) 2014.On insertion, the consumer was on multiple pain and relaxing drugs and had multiple local injections to numb more pain.Despite all of this, the pain of the procedure shot her blood pressure up to near stroke levels - she had to lie in bed for almost an hour before they would let her leave because her blood pressure would not drop (it had never been high before).After the occasional stabbing pains and weird bouts of depression, she had the confirmation test done which failed: the left tube was not blocked and she needed surgery to be sterilized.Both coils were turned in on themselves like they had hit a brick wall and just started coming back down her tubes the way they were inserted.She was scheduled for a tubal ligation in (b)(6) 2015.The operating doctor took pictures of her tubes where the coils were so bound up that they had her tubes stretched thin and it could clearly be seen the coils through the tissue of her fallopian tubes.She stated that her doctor was very unhappy at how narrowly she escaped of having them ruptured.She was still struggling with depression, her teeth were turning into chalk and she constantly had pains that feel like ovarian cysts.The events were considered related to essure.Company causality comment: this non-medically confirmed, spontaneous case report; refers to a female consumer whose blood pressure up to near stroke levels due to pain during essure (fallopian tube occlusion insert) procedure.Later, her confirmation test showed left tube was not blocked.She was submitted to a surgery which revealed the coils through the tissue of her fallopian tubes (regarded as fallopian tube perforation).Only fallopian tube perforation is listed according to essure's reference safety information.Fallopian tube perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).This event can be suspected if excessive pain or discomfort occurs during the insertion procedure.In this particular case, consumer reported excessive pain which lead to an increase in her blood pressure during essure procedure.This suggests an association between the fallopian tube perforation and devices insertion.Therefore, causality with the suspect insert cannot be excluded.Additionally, non-serious events were reported.This case was considered an incident, as although it is unclear the exact treatment for the reported fallopian tube perforation; a surgical intervention was required.A product technical analysis is expected.No active follow-up will be pursued, as this case was identified during health authority website monitoring.

Manufacturer Narrative

Result and assessment of the product technical complaint investigation received on 02-nov-2015: this adverse event report is related to a product technical complaint (ptc).(b)(4).Final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.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.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: no product quality defect was confirmed therefore a relationship to the reported medical events is excluded.The reported medical events are not indicative of a quality deficit per se.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical events, the lack of efficacy and a quality defect.Company causality comment: this non-medically confirmed, spontaneous case report; refers to a female consumer whose blood pressure up to near stroke levels due to pain during essure (fallopian tube occlusion insert) procedure.Later, her confirmation test showed left tube was not blocked.She was submitted to a surgery which revealed the coils through the tissue of her fallopian tubes (regarded as fallopian tube perforation).Only fallopian tube perforation is listed according to essure's reference safety information.Fallopian tube perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).This event can be suspected if excessive pain or discomfort occurs during the insertion procedure.In this particular case, consumer reported excessive pain which lead to an increase in her blood pressure during essure procedure.This suggests an association between the fallopian tube perforation and devices insertion.Therefore, causality with the suspect insert cannot be excluded.Additionally, non-serious events were reported.This case was considered an incident, as although it is unclear the exact treatment for the reported fallopian tube perforation; a surgical intervention was required.The product technical analysis concluded that based on the available information, there is no relationship between the reported medical events, the lack of efficacy and a quality defect.No active follow-up will be pursued, as this case was identified during (b)(6) website monitoring.

Manufacturer Narrative

Data correction for us reporting: the code knh was replaced with hhs.

• 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: 5188465
• MDR Text Key: 29875827
• Report Number: 2951250-2015-01275
• 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: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2015
• 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