MAUDE Adverse Event Report: BAYER HEALTHCARE LLC ESSURE; DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE

Model Number ESS305

Device Problems Device Slipped (1584); Material Twisted/Bent (2981)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

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 delivery catheter came out and was twisted at the extremity, plastic element found in the uterine cavity, and feeling of blockage in operator canal when the second essure system was inserted on the right side.No information given on patient's history, past drugs, concurrent conditions or concomitant medication.On an unspecified date the patient had essure (fallopian tube occlusion insert) inserted, lot number b 42 240.Insertion of essure system on the left side was satisfactory.During the second micro-insert insertion there was a feeling of blockage in operator canal on the right side.In the uterine cavity, the delivery catheter came out and was twisted at the extremity.Essure system was released.Plastic element was seen in the uterine cavity and was later removed at the end of the procedure.A third essure system was inserted on the right side; good tubal insertion and then when essure was released no coil development, the device completely came out of the fallopian tube.The relationship between events and essure was not reported.Follow-up information received on (b)(6) 2014 from pharmacist: the patient was fine but the reporter did not have further information because he did not place mirena.No further information available at the time of this report.

Manufacturer Narrative

Follow-up information received on (b)(6) 2014 - ptc investigation result provided: ptc global number: (b)(4).Medical assessment: this case reported a physical property issue with the delivery catheter being twisted when removed and breakage with plastic element in uterine cavity as well as device difficult to use due to a feeling of blockage in the device channel.These events are not necessarily indicative of a quality defect.No complaint sample was provided for a technical investigation.No additional ae case reports have been received to date in relation to batch number b42240.No batch signal can be identified at this time.The review of the lot history records confirmed that the product met product release specifications.At the time of this medical assessment the technical investigation concluded "unconfirmed quality defect".Based on the information available, there is no reason to suspect a quality defect., final assessment: lot history record (lhr) reviewed.Product met product release specifications.As of 04/23/2014, no device was returned; therefore, no device investigation could be completed.No conclusions can be drawn.Follow-up information received on (b)(6) 2014 from local affiliate: after internal review on (b)(6) 2014 it was noted that a mistake was performed on the fu received on (b)(6) 2014: mirena was written by mistake instead of essure.Correction (b)(6) 2014 following company internal review: case considered closed.Final report.

Manufacturer Narrative

Ptc investigation result was received on 29-sep-2015.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc global number 2014-009956/1.Lot number b42240 (production date 10-jun-2013; expiration date 30-jun-2016).Final assessment: 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 microinsert 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.As received, micro-insert of system 1 was stretched and still intact to delivery catheter.The final rollback was not performed.For system 2, micro-insert was bent.The initial rollback was not performed.For system 3, all ifu steps were completed.The device was returned without micro-insert.The catheter large tight pitch coil found to be stretched.We were unable to confirm any quality defect or device malfunction at this time.We also conducted a review of the manufacturing batch record b42240 (production date 10-jun-2013 and expiration date 30-jun-2016) 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 and detachment difficulty is an anticipated event and there was no event reported which indicates a new technical failure mode for the device.Medical assessment: this ptc was initiated due to a product technical issue reported in the context of a complicated device insertion.The ae case refers to a usability issue.However, no adverse events have been reported.The batch documentation of the reported batch was reviewed.The returned complaint sample was investigated.The technical investigation 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 essure reports received by bayer and older cases received by conceptus with similar events coded in meddra.In this particular case a search in the database was performed on 30-sep-2015 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 1127 cases.Bayer is closely monitoring the benefit-risk profile of essure.A recent cumulative review of all available data on essure has not yielded any new safety signal with regard to this meddra pt.Company causality comment: this medically confirmed, spontaneous case report, refers to a female patient who had essure (fallopian tube occlusion insert) inserted and experienced the delivery catheter came out and was twisted at the extremity, plastic element found in the uterine cavity, feeling of blockage in operator canal when the second essure system was inserted on the right side and device insertion complication.The reporter did not provide causality assessment.All events were considered non-serious.The event plastic element found in the uterine cavity was previously regarded as unlisted according to the reference safety information for essure; however upon receipt of the product technical analysis (ptc), which stated that micro-insert breaking off during the procedure is an anticipated event; it was amended to listed.The remaining events are listed.During difficult insertion, single cases have been reported of essure breakage.In this particular case, it was reported a device breakage and shape alteration during a difficult insertion.Considering that the reported events occurred during essure placement procedure, a causal relationship between them and suspect product cannot be excluded.This case was regarded as other reportable incident due to the device breakage, as although it did not lead to death or serious health deterioration this might have occurred under less fortunate circumstances.Product technical complaint (ptc) analysis concluded to an unconfirmed quality defect.Medical ptc assessment considered that, based on the available information, there is no reason to suspect a causal relationship to a potential quality deficit based on this report.

Manufacturer Narrative

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

• Brand Name: ESSURE
• Type of Device: DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE
• Manufacturer (Section D): BAYER HEALTHCARE LLC; milpitas CA
• 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: 3820084
• MDR Text Key: 4451132
• Report Number: 2951250-2014-00154
• Device Sequence Number: 1
• Product Code: KNH
• 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: Foreign,Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/19/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2016
• Device Model Number: ESS305
• Device Lot Number: B42240
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2013
• 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): Required Intervention
• Patient Sex: Female