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

Model Number ESS305

Device Problems Separation Failure (2547); Mechanics Altered (2984)

Patient Problem Exposure to Body Fluids (1745)

Event Type  Injury  

Manufacturer Narrative

Follow-up information was received from the gynecologist on (b)(6)-2014.Initials, date of birth, weight and height concerned the patient who had essure easily inserted was provided.Ultrasound showed that essure was in place.Plain abdomen x-ray was requested.No immediate consequences.This case refers to gynecologist's assistant and new follow-up attempt was to be done to obtained sex and age of the gynecologist's assistant.Follow-up information received from the gynecologist on 29-sep-2014: the physician reported that a control abdomen x-ray was performed in the patient who had essure inserted and the implants were visible at true pelvis region in place.Follow-up information received on 30-sep-2014: the patient´s initial and date of birth were updated (she was (b)(6)).No medical history was provided.On (b)(6)-2014, the gynecologist hurt herself when she took the material apart during surgery.She experienced small cut due to metallic thread and got two stitches (the previous reported event stitches for the operator following the check of the material (during essure insertion) was updated to small cut due to metallic thread/stitches for the operator following the check of the material (during essure insertion).The event was resolved at the time of this report, there was no problem (the outcome of the events blood exposure accident for the operator following the check of the material (during essure insertion) and small cut due to metallic thread/stitches for the operator following the check of the material (during essure insertion) were considered recovered/resolved.No further information will be provided.Case closed.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 (b)(6)-2014 for the following meddra preferred term: injury.The analysis in the global safety database revealed 2 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, spontaneous case report refers to a gynecologist's assistant who had blood exposure accident for the operator following the check of the material during essure (fallopian tube occlusion insert) insertion in a (b)(6) female patient and received small cut due to metallic thread/stitches for the operator following the check of the material (during essure insertion) (previously reported as stitches for the operator following the check of the material (during essure insertion)).Also at the procedure there was a material defect: thumbwheel ran idle, no click sound at release.All the reported events are non-serious.The event small cut due to metallic thread/stitches for the operator following the check of the material (during essure insertion); interpreted as an occupational injury to the assistant, was initially considered listed in the reference safety information for essure and further amended to unlisted after a company internal review.The remaining events are listed.Considering that the injury and reported material defect occurred at essure insertion procedure a causal relationship with the suspect insert cannot be excluded.Regarding the event blood exposure accident for the operator following the check of the material (during essure insertion), given its nature it was considered as unrelated to essure.This case was regarded as other reportable incident since it could have led to serious injury.A product technical investigation concluded unconfirmed quality defect, stated that medical event reported was due to handling error and that a detachment difficulty event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.No further information is expected.

Event Description

This is a spontaneous case report received from a pharmacist in (b)(6) on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and experienced the adverse events as described below.Pharmacist reported that essure was inserted in an operating room on (b)(6) 2014.Essure material defect: thumbwheel ran idle, no clic sound at release.Essure was placed and delivery catheter removed without usual protocol, material was checked after surgery.Thumbwheel which ran idle finally unlocked.Essure system was not available.Blood exposure accident and stitches for the operator following the check of the material.No further information available at the time of this report.Correction performed on (b)(6) 2014 regarding the initial report from (b)(4) 2014: this case refers to a gynecologist's assistant (gender not reported) who was exposed to essure during insertion procedure in a patient and experienced the adverse events as previously described in the narrative.Also the event stitches for the operator following the check of the material (during essure insertion) was amended to unlisted.Ptc investigation result was received on (b)(4) 2014.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc global number (b)(4).Final assessment: detachment difficulty is defined as a failure of the micro-insert to detach (separate) from the delivery system.Per the instructions for use (ifu), the physician must perform the following steps in order to achieve proper detachment: 1) rollback to initial hard stop.2) depress button.3) perform final rollback.Under normal circumstances, when the physician completes all deployment steps as outlined in the ifu, the micro-insert assembly will detach from the delivery wire and remain in the fallopian tube.Several factors can contribute to a detachment difficulty event.The most likely root causes are tubal spasms which can clamp down on the distal end of the catheter and prevent the micro-insert from releasing from the delivery wire, stretching of micro-insert during placement attempts which tightens the inserts grip on the delivery wire, repositioning of the catheter after the first rollback and button press are completed which can also tighten the insert's grip on the delivery wire, and potential manufacturing deficiencies.Since no product was returned to us for investigation, we were unable to perform an investigation of the actual device involved in this complaint.Typically, we would inspect the micro-insert, the outer catheter, the inner catheter, and all parts within the handle assembly to confirm that all are within manufacturing specifications.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.Conclusions: the report did not state a patient injury occurred; however, the operator was injured due to the handling error.The possibility of a detachment difficulty event during the procedure is an anticipated event.According to the dfmea, the main consequence is a physician inconvenience because the procedure could need to be aborted or rescheduled.Medical assessment: the medical events reported as well as the reported technical issue are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No batch number was reported.Neither a technical batch investigation nor a batch cluster review in the (b)(4) database for a more detailed statistical medical evaluation is possible without a batch number.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect", stated that medical event reported was due to handling error and that a detachment difficulty event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.Company causality comment: this medically confirmed, spontaneous case report refers to a gynecologist's assistant who had blood exposure accident for the operator following the check of the material during essure (fallopian tube occlusion insert) insertion in a patient and received stitches for the operator following the check of the material (during essure insertion).Also at the procedure there was a material defect: thumbwheel ran idle, no clic sound at release.All the reported events are non-serious.The event stitches for the operator following the check of the material (during essure insertion); interpreted as an occupational injury to the assistant, was initially considered listed in the reference safety information for essure and further amended to unlisted after a company internal review.This event was regarded as near-incident since it could have led to serious injury.The remaining events are listed.Considering that the injury and reported material defect occurred at essure insertion procedure a causal relationship with the suspect insert cannot be excluded.Regarding the event blood exposure accident for the operator following the check of the material (during essure insertion), given its nature it was considered as unrelated to essure.A product technical investigation concluded "unconfirmed quality defect", stated that medical event reported was due to handling error and that a detachment difficulty event is an anticipated event.Based on the information available, there is no reason to suspect a quality defect.Follow-up information is expected.

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: 4005626
• MDR Text Key: 12485133
• Report Number: 2951250-2014-00323
• 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: Pharmacist
• 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: 08/13/2014
• 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?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR