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

Model Number ESS305

Device Problems Break (1069); Component Falling (1105); Device Dislodged or Dislocated (2923)

Patient Problems Abdominal Pain (1685); Incontinence (1928); Itching Sensation (1943); Memory Loss/Impairment (1958); Arthralgia (2355)

Event Type  malfunction  

Event Description

This spontaneous case report was received by regulatory authority in (b)(6) on (b)(6) 2016 from a (b)(6)-year-old female consumer and forwarded to bayer on 04-aug-2016.On (b)(6) 2009 essure (fallopian tube occlusion insert) was implanted.Complication during insertion was reported.One fallopian tube succeeded; other not, afterwards sterilized with clips.In an unspecified date the consumer experienced itching skin, incontinence, pain during ovulation, arthralgia, tiredness, memory loss, concentration problems, and pimples.She reported that one coil was lost during shower, captured.Gynecologist indicates to have the other coil removed by half.In an unspecified date she contacted her physician.She also had bowel examination; however, the results were not provided.She was treated with pill, bowel drug, 3 to 4 times surgery.Unspecified treatment was planned.Company causality comment: this spontaneous case report received via regulatory authority refers to a (b)(6)-year-old female consumer who had essure (fallopian tube occlusion insert) inserted and one coil was lost during shower and the other coil removed by half (seen as device breakage).Device breakage is unlisted in the reference safety information for essure.Single cases of device breakage have been reported, mainly during difficult insertions.In this case, the insertion was complicated.Despite of the lack of details, considering events nature per se, causality with essure use cannot be excluded.This case is assessed as other reportable incident since the breakage in this report did not lead to serious injury, however, it might have led under less fortunate circumstances.Other non-serious events were informed.Technical analysis is being sought.Further information cannot be obtained.

Manufacturer Narrative

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

Manufacturer Narrative

Quality-safety evaluation of ptc: (b)(4).Unconfirmed quality defect.Sample not available.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.The possibility of micro-insert breaking is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.The current dfmea was reviewed for this failure mode to confirm that adequate risk mitigation actions were taken to minimize the residual risk.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.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 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.Most recent follow-up information incorporated above includes: on 20-jan-2017: quality safety evaluation of ptc.Company causality comment: this spontaneous case report received via regulatory authority refers to a (b)(6) female consumer who had essure (fallopian tube occlusion insert) inserted and one coil was lost during shower and the other coil removed by half (seen as device breakage) device breakage was previously regarded as unanticipated in the reference safety information for essure, however upon receipt of the product technical analysis (ptc), which stated that micro-insert breaking is an anticipated event; it was amended to anticipated.Single cases of device breakage have been reported, mainly during difficult insertions.In this case, the insertion was complicated.Despite of the lack of details, considering events nature per se, causality with essure use cannot be excluded.This case is assessed as other reportable incident since the breakage in this report did not lead to serious injury, however, it might have led under less fortunate circumstances.Other non-serious events were informed.According to the product technical complaint, a product quality defect could not be confirmed but is considered plausible.Further information cannot 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; p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 5914396
• MDR Text Key: 54291228
• Report Number: 2951250-2016-01786
• 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: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2017
• 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 Age: 31 YR