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

Model Number ESS305

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Sticking (1597); Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a physician in (b)(6) on 30-sep-2014 (with additional information received from medical records on (b)(6)-2014) and refers to a (b)(6) female patient who had essure (fallopian tube occlusion insert) implanted, lot number c6960.The patient's medical history included 2 vaginal deliveries and 1 cesarean delivery.Antigone (desogestrel) was used as contraception at time of insertion procedure.Patient had the essure implanted with no anesthesia.As premedication, nsaid (non-steroidal anti-inflammatory drug) and doliprane were used.The introduction of rigid diagnosis hysteroscope was with no difficulty and made according to the betocchi technique.The cavity was slightly enlarged and widened bottom; however, was easy to well individualize left ostium.It was noticed a problem while making the trackwheel roll.The trackwheel seemed to turn blank, with no blocking.After a certain time it was decided to try to release the implant by pressing the appropriate button.However, the implant did not get released and the stent seemed to be wound on the rod of the device essure.It was then tried to remove step by step the device but the stent broke up and stayed for the 3/4 intracavitary and for 1/4 intra tubal.The procedure was stopped.According to the reporting physician, the event was a serious incident and a new surgery (unspecified) had to be done to remove essure.Company causality comment: this medically confirmed and spontaneous case report refers to a (b)(6) female patient who had an attempt to have essure (fallopian tube occlusion insert) implanted and, during the insertion procedure, the implant (essure) did not get released and the stent broke up.The event implant (essure) did not get released and the stent broke up was seen as a device breakage and was considered serious due to medical significance by the reporting physician.It is unlisted in the reference safety information for essure.During difficult insertions, single cases of essure breakage have been reported.In this present case, reporting physician stated that the device did not get released from the delivery catheter and then broke up.Considering the nature of reported event and also it has occurred in connection with insertion procedure, company assesses device breakage as related to essure.This case was regarded as incident as, according to reporting physician, a new surgery to removed essure had to be done.No further information from reporter is will be available.Product technical analysis is expected.

Manufacturer Narrative

Follow-up received on 02-feb-2015.Product technical complaint investigation and final assessment were received: this adverse event report is related to a product technical complaint and was initiated due to a reported product quality issue and also to a usability issue.The bayer reference number for the ptc report is (b)(4).Final assessment: lot number was corrected: c26960; expiration date: 28-feb-2017; production date: 25-feb-2014.Failure mode/mechanism: the essure insert is made up of a flexible outer coil that is deployed into the fallopian tube.The insert's outer coils expand to conform to the fallopian tube, acutely anchoring itself until the insert elicits tissue ingrowth.After the first roll back is completed and the button is pressed, user attempts to reposition the device could lead to detachment difficulty, premature deployment, or improper device function.If all ifu steps have not been completed, user attempts to reposition or remove the catheter assembly could lead to either a stretching or breakage of the micro-insert or a part of the catheter.If the physician attempts to remove a deployed micro-insert that is located within the fallopian tube by pulling on the outer coil of the micro-insert with a grasper, this action could also lead to breakage of the outer coil of the micro-insert.Since product was returned to us for this complaint, we were able to conduct an investigation of the returned product.We typically inspect the micro-insert, outer catheter, the inner catheter, and all parts within the handle assembly.As received, micro-insert found to be stretched and tangled.All ifu steps were completed as evidenced by the location of the delivery wire holder within the handle assembly.We were unable to confirm any quality defect or device malfunction at this time.We also conducted a review of the manufacturing batch record and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.The possibility of micro-insert breaking during the procedure and premature deployment are anticipated events.Medical assessment: this ptc was initiated due to a reported product quality issue.In addition, the adverse event (ae) case refers to a usability issue.However, no adverse events have been reported.The returned complaint sample was investigated.The batch documentation of the batch c26960 was reviewed.The ae case refers to the lot number c6960, which is not correct according to the responsible quality unit (rqu).The technical assessment concluded unconfirmed quality defect.Since no adverse events have been reported, a batch investigation with respect to similar ae cases is not applicable.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.The list of similar cases contains reports with similar events coded in (b)(4).It includes recent cases received by bayer pharma and older cases received from the previous owner of the essure product (conceptus).These legacy reports have been re-coded according to bayer pharma standards.In this particular case a search in the database was performed on 03-feb-2015 for the following (b)(4) preferred term: device breakage.The analysis in the global safety database revealed (b)(4) cases.Bayer is closely monitoring the benefit-risk profile of essure.This includes consideration of the legacy cases in safety analyses.The cumulative review of the reports has not yielded any new safety signal.Company causality comment: this medically confirmed and spontaneous case report refers to a (b)(6) female patient who had an attempt to have essure (fallopian tube occlusion insert) implanted and, during the insertion procedure, the implant (essure) did not get released and the stent broke up.The event implant (essure) did not get released and the stent broke up was seen as a device breakage and was considered serious due to medical significance by the reporting physician.It is listed according to technical analysis.During difficult insertions, single cases of essure breakage have been reported.In this present case, reporting physician stated that the device did not get released from the delivery catheter and then broke up.Considering the nature of reported event and also it has occurred in connection with insertion procedure, company assesses device breakage as related to essure.This case was regarded as incident as, according to reporting physician, a new surgery to remove essure had to be done.No further information from reporter is will be available.After investigation of returned product (micro-insert found to be stretched and tangled), the technical assessment concluded unconfirmed quality deficit.There is no reason to suspect a causal relationship to a potential quality deficit.

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: 4356631
• MDR Text Key: 5116587
• Report Number: 2951250-2014-00550
• 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: Other,Foreign,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: ESS305
• Device Lot Number: C26960
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DOLIPRANE (PARACETAMOL); DESOGESTREL (DESOGESTREL)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 46 YR