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

Model Number ESS305

Device Problems Break (1069); Component Falling (1105)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a gynecologist/obstetrician in (b)(6) on (b)(6) 2014 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.A couple of weeks before this report essure was inserted for a patient.Essure´s external spirals were completely broken at the place of 5th spiral.A part dropped and it was managed to remove from the patient´s uterus (it was thrown away).2 spirals left visible in tube, when these 5 spirals dropped.The inserting physician concluded that if the implant would have been in one part, 7 spirals were visible, so it should not be consequence to the effect.No further information was provided.Ptc investigation result was received on (b)(6) 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: since no product was returned for investigation, we cannot confirm this quality complaint; however, based on the complaint description provided, we are able to conclude that a quality issue is plausible.It is possible during the manufacturing assembly process a small gap was left between the inner coil and inner catheter (they should be butted together during assembly).When the outer coil of the micro-insert is wound down a small portion of the coil can become trapped in the gap.If a device has this issue, when the physician presses the button to release the microinsert, the outer coil may sever itself as it is being deployed from the catheter.This severing occurs inside the catheter prior to the pieces being deployed from the catheter.The severing of the coils inside the catheter does not pose a significant risk to the health of the patient.The possibility of pieces of the delivery system or micro-insert breaking off during the procedure is an anticipated event.Medical assessment: this ptc was initiated due to a product quality issue.In addition, the ae case refers to a usability issue.However, at this point in time no adverse events have been reported.No complaint sample was provided for a technical investigation.No batch number was reported.Without this information no batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.According to the technical assessment a quality defect was not confirmed but considered plausible.Based on the provided information the defect type corresponds to the following meddra llt: device breakage.In summary, as no adverse events were reported at this point in time a causal relationship to a potential quality defect cannot be assessed.The list of similar cases contains reports with similar events coded in meddra.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 10-nov-2014 for the following meddra preferred term: device breakage.The analysis in the global safety database revealed 875 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 spontaneous and medically confirmed case report refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted and external spirals of essure were completely broken at the place of 5th spiral.The event, interpreted as device breakage, is non-serious and listed according to technical analysis.During difficult insertions, single cases have been reported of essure breakage.In this case, limited information was provided.The 5 broken external spirals dropped and were removed from the patient's uterus.2 spirals left visible in tube.Upon the breakage occurred during the insertion procedure (complication of device insertion) the event is assessed as related to essure.Device breakage (malfunction) was reported, so the case is regarded as other reportable incident.The technical analysis concluded that a quality defect was not confirmed but considered plausible.According to the medical technical assessment, as no adverse events were reported, a causal relationship to a potential quality defect cannot be assessed.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: 4244972
• MDR Text Key: 5109987
• Report Number: 2951250-2014-00480
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2014
• Initial Date FDA Received: 11/12/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2017
• 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