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

Model Number ESS305

Device Problems Difficult to Insert (1316); Stretched (1601); Material Deformation (2976)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a gynecologist/obstetrician in (b)(6) on 23-jan-2015 which refers to a (b)(6) female patient who had an attempt to insert essure (fallopian tube occlusion insert) on (b)(6) 2015.The physician reported that on (b)(6) 2015, during the insertion of essure, the passage through the operating canal was easy; however bilateral insertion was not done.A subsequent laparoscopy was proposed.During insertion, a small black fragment (inferior to 1mm) was exteriorized at distal extremity of an implant.There was no cause related to the patient.The postoperative period was simple.The two complete (delivery handle and implant) devices were stored in pharmacy.The lot number of this product is c61989.The surgery report from (b)(6) 2015 mentioned that before doing the procedure, the patient made a pregnancy test which was negative.At that moment, she was under microprogestative contraception.She was gravida 1, para 2 and she has an anteverted uterus.On that day, the patient was submitted to a surgical intervention to place the permanent contraceptive essure through hysteroscopy under sedation.During the hysteroscopic exploration, the visualization of ostia was correct.During tubal occlusion, the insertion on the right side was impossible.Despite good ostium visualization, of classic aspect, the tubal catheterization was impossible.Distal extremity of essure implant had an immediate deformation and the implant spread out without any manipulation of the thumbwheel.On the left side, the insertion was impossible.There was an inexplicable failure identical to the one seen on the right side.The procedure took 20 minutes.Incidents included the bilateral insertion failure with two different essure inserts.There is a doubt about device defect and therefore two inserts were kept.At pre-operative appointment, the patient has shown the interest of having a tubal sterilization through hysteroscopy in case of essure insertion failure.This would be done soon.No further information was provided.Result and assessment of the product technical complaint investigation received on 04-feb-2015: final assessment: 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 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, outer catheter, the inner catheter, and all parts within the handle assembly.In this case, we 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.We were unable to confirm any quality defect or device malfunction at this time.The possibility of micro-insert breaking during the procedure is an anticipated event.The risk to the patient for these types of breakage events were assessed during the design process, and adequate risk mitigation actions were taken to minimize the residual risk.Medical assessment: this ptc was initiated due to a usability issue and a product quality issue reported in the context of a complicated device insertion.However, no adverse events have been reported.The batch documentation of the reported batch was reviewed.No complaint sample was provided for a technical investigation.The technical assessment concluded unconfirmed quality defect.Since no adverse events have been reported, a batch investigation with respect to similar adverse event cases is not applicable.In summary, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.(b)(4).Company causality comment: this medically confirmed spontaneous report refers to a (b)(6) female patient who had an attempt to have essure (fallopian tube inserts) implanted, however a small black fragment (inferior to 1mm) was exteriorized at distal extremity of an implant on both sides during insertion and there was a bilateral insertion failure.The event small black fragment (inferior to 1mm) was exteriorized at distal extremity of an implant was interpreted as a suspicion of device breakage and is considered a non-serious event and unlisted according to essure's reference safety information.However, upon receipt of the product technical analysis, the breakage was amended to listed.During difficult insertion/removals, single cases have been reported of essure breakage.However, in this case, the physician stated the passage through the canal was easy.Furthermore, the physician stated that essure implants spread out without any manipulation of the thumbwheel.Based on the information received, and given the nature of the reported event a causal relationship with the suspect insert cannot be excluded.This case was regarded as other reportable incident due to the reported breakage.Although it did not lead to death or serious health deterioration it could have led to it under less fortunate circumstances.A review of the manufacturing batch record was conducted and confirmed that final product testing for this lot was performed per requirements and the product met all release requirements.As no adverse events were reported at this point in time, a causal relationship to a potential quality defect cannot be assessed.The product technical complaint analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.An updated ptc analysis is expected after receipt of complaint sample.

Manufacturer Narrative

Additional information received from product technical complaint investigation on 26-feb-2015: final assessment: no breakage of the returned devices was detected.Both devices were intact, but stretched.Rollback difficulty is defined as an event in which either the user is (1) unable to perform initial rollback of the thumbwheel due to very high resistance, or (2) able to perform initial rollback of the thumbwheel, but the activity is difficult due to higher than expected level of resistance.Since product was returned to us for investigation, we were able to conduct an investigation of the actual device involved in this complaint.We typically inspect the thumbwheel teeth, rack teeth, delivery wire to delivery wire holder solder bond, hypo-tube to handle solder bond, micro-insert condition, and condition of the outer catheter.As received, the distal end of the micro-insert was stretched on both devices.On one device, the physician had not initiated the initial rollback step, and on the other device, the physician had just started the initial rollback, but had not gotten to the button press step.This indicates the physician had not completed the proper ifu steps, likely due to the stretching issue.The stretching issue was likely cause by either a tubal spasm event in the patient where the tip of the insert was trapped within the fallopian tube and the physician attempted to move the catheter, thereby stretching the device.The devices returned were not broken.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.We were unable to confirm any quality defect or device malfunction at this time.Medical assessment: this ptc was initiated due to a usability issue and a product quality issue reported in the context of a complicated device insertion.However, no adverse events have been reported.The batch documentation of the reported batch was reviewed.The provided complaint sample was investigated.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.Company causality comment: this medically confirmed spontaneous report refers to a (b)(6) female patient who had an attempt to have essure (fallopian tube inserts) implanted, however a small black fragment (inferior to 1mm) was exteriorized at distal extremity of an implant during insertion and there was a bilateral insertion failure.The event small black fragment (inferior to 1mm) was exteriorized at distal extremity of an implant was interpreted initially as a suspicion of device breakage.However, after updated ptc results (sample was investigated) the event was updated to small black fragment (inferior to 1mm) was exteriorized at distal extremity of an implant/ both devices were intact, but stretched seen as device use error and considered a non-serious and listed event according to essure's reference safety information.In this case, the physician stated the passage through the canal was easy.Furthermore, the physician stated that essure implants spread out without any manipulation of the thumbwheel.Based on the information received, and given the nature of the reported event a causal relationship with the suspect insert cannot be excluded.Previously, this case was regarded as other reportable incident due to the reported breakage.However, the updated ptc analysis performed after receipt of complaint sample did not confirm breakage.Both devices were intact, but stretched.Therefore the event was updated and this case was downgraded to non-incident.The technical assessment concluded unconfirmed quality defect.There is no reason to suspect a causal relationship to a potential quality deficit.No further information is expected.

Manufacturer Narrative

Data correction: the product 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: 4527540
• MDR Text Key: 5493059
• Report Number: 2951250-2015-00128
• 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: Physician
• 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: 02/19/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Model Number: ESS305
• Device Lot Number: C61989
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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: 37 YR