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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Occlusion Within Device (1423); Material Perforation (2205); Chemical Spillage (2894)

Patient Problem Pain (1994)

Event Date 01/01/2015

Event Type  Injury  

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) female patient who had essure (fallopian tube occlusion insert) inserted on (b)(6) 2010 permanent sterilization.On (b)(6) 2010, first hsg (hysterosalpingogram) was done and showed spillage of contrast of the left side.Right side appeared to be occluded and intact.No mention of device location.On (b)(6) 2011, second hsg was done and bilateral occlusion was reported.Proximal end of device was at utj (uterine tubal junction).Contrast seemed to fill the cavity; no filling defects.On (b)(6) 2015, physician did laparoscopy because patient complained of pain.Physician found that device was actually perforated on left side and was not in the fallopian tube.It was not removed at the time; patient opted not to have it removed.Ptc investigation result was received on 14-sep-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: 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 to look for any manufacturing deficiencies.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.There was no event reported which indicates a new technical failure mode for the device.Medical assessment: no product quality defect was confirmed therefore a relationship to the reported adverse events is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported adverse events and a quality defect.Company causality comment: this medically confirmed, spontaneous case report; refers to a (b)(6) female patient who was submitted to a laparoscopy due to pain, 5 years after essure (fallopian tube occlusion insert) insertion.During this surgery, the device was found perforated on left side and was not in the fallopian tube.Essure was not removed.The reported events were considered serious due to medical importance and are listed according to essure's reference safety information.Fallopian tube perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).If a perforation occurs, patient may experience pain during and after the procedure.In this particular case, although the exact mechanism of essure perforation was unknown; given events nature causality with the suspect insert cannot be excluded.This case was considered an incident, as although essure was not removed; a surgical intervention was required (laparoscopy).The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported adverse events and a quality defect.Follow-up information is being sought.

Manufacturer Narrative

Follow up information (tubal perforation questionnaire) received on 01-oct-2015 from physician: the patient is non-smoker.She had nkda (understood as no known drug allergies).She had no previous gynecological interventions, problem or procedures.The patient was gravida 2 and para 2.The patient was not post-partum at time of the insertion.During the insertion procedure cervical dilation and sounding were not done; but local anesthesia was applied.The procedure was considered easy with easy visualization of both tubal ostium.The fluid loss during hysteroscopy was no more than 1500cc.The hsg test was done to confirm esure placement.She used depo-provera after essure insertion until before total occlusion confirmation.On (b)(6) 2015, during laparoscopy it was confirmed the incorrect essure position.It was also diagnosed that partial perforation occurred on left side.There was no perforation organ or intra-abdominal structure.The perforation did not occur during sounding, cervical dilation or hysteroscopy prior to essure.The patient also presented pelvic and abdominal pain.At time of the report, essure devices were not removed since patient wanted to leave alone.Company causality comment: this medically confirmed, spontaneous case report; refers to a (b)(6) female patient who was submitted to a laparoscopy due to pelvic and abdominal pain, 5 years after essure (fallopian tube occlusion insert) insertion.During this surgery, the device was found perforated on left side and was not in the fallopian tube.Essure was not removed.The reported events were considered serious due to their medical importance and are listed according to essure's reference safety information.Fallopian tube perforation may occur with any trans-cervical intrauterine procedure; including insertion of a fallopian tubal occlusion insert (essure).If a perforation occurs, patient may experience pain during and after the procedure.In this particular case, although the exact mechanism of essure perforation was unknown; given events nature causality with the suspect insert cannot be excluded.This case was considered an incident, as although essure was not removed; a surgical intervention was required (laparoscopy).The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported adverse events and a quality defect.

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: 5094596
• MDR Text Key: 26428240
• Report Number: 2951250-2015-01041
• 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: health professional,other
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 01/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: Not provided
• Initial Date FDA Received: 09/22/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/26/2015; 01/20/2017
• 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 Outcome(s): Other; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 61