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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Difficult to Insert (1316); Stretched (1601); Separation Failure (2547)

Patient Problems Muscle Spasm(s) (1966); Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

This is a spontaneous case report received from a medical doctor in united states on (b)(6) 2015 which refers to a (b)(6) patient who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2015 for contraception.Reporter stated that she attempted to place insert in first tube but it was in spasm so she inserted the coil in the other tube which went fine.She went back to the first tube and was able to insert it but it never released and stayed connected and broke.There was a portion of the plastic sheath still attached to the coil.She also stated that during the procedure, the internal catheter stretched out and detached into the patient.The physician also pulled out "as much as she could".The essure coils remain in place.The physician also reported that the patient had a tubal spasm during the procedure.Ptc investigation result was received on (b)(6) 2015.This adverse event report is related to a product technical complaint (ptc).The bayer reference number for the ptc report is: ptc local number (b)(4) and ptc global number (b)(4).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 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 to confirm that all parts are accounted for.Since we have no valid lot number for this case, we were unable to conduct a review of the manufacturing batch record.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.Medical assessment: this ptc was initiated due to a reported product quality issue.Neither batch number nor complaint sample were available for a technical investigation.The technical investigation concluded unconfirmed quality defect.The reported adverse event is a known, possible, undesirable event and not indicative of a quality deficit per se.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.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 case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and it was reported that the coil never released and stayed connected and broke.There is a portion of the plastic sheath still attached to the coil (device breakage).During the procedure, she experienced a tubal spasm and the internal catheter stretched out and detached into patient.The event device breakage is non-serious and was considered listed upon receipt of the product technical analysis.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure insertion procedure, a causal relationship with suspect insert 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.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Further information is being sought.

Manufacturer Narrative

Follow-up from 10-sep-2015: follow-up attempts were done, with no response to date.Company causality comment: this medically confirmed, spontaneous case report refers to a female patient who had essure (fallopian tube occlusion insert) inserted and it was reported that the coil never released and stayed connected and broke.There is a portion of the plastic sheath still attached to the coil (device breakage).During the procedure, she experienced a tubal spasm and the internal catheter stretched out and detached into patient.The event device breakage is non-serious and was considered listed upon receipt of the product technical analysis.During difficult insertion/removals, single cases have been reported of essure breakage.As the device breakage occurred during essure insertion procedure, a causal relationship with suspect insert 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.The product technical analysis concluded there is no reason to suspect a causal relationship to a potential quality deficit based on this report.Despite follow-up attempts, no further information was obtained.

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: 4862058
• MDR Text Key: 20756345
• Report Number: 2951250-2015-00431
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,health professional,oth
• 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

• Date FDA Received: 06/23/2015
• 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: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 38 YR