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

Model Number ESS305

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Simon m, ubeda a, cusido mt.Pelvic pain after transcervical tubal occlusion: a case report.Gynecological surgery 10 (suppl.1): s39-s40 (2013), 22nd annual congress of the european society of gynaecological endoscopy (esge), october 16-19, 2013, berlin.A patient underwent transcervical tubal occlusion in 2008.After an unexpected pregnancy in 2010, she underwent an uneventful laparoscopic bilateral tubal binding (btb).In october 2010, she complained of a two years chronic pain.Ultrasound showed the absence of the intramural portion of the device.She was suggested to undergo a diagnostic laparoscopy.During surgery both devices were found to be subserous at the level of both uterine cornual regions.They were both easily removed.See scanned page.

Manufacturer Narrative

(b)(6)-2014: several attempts to contact author, who refused to provide further information.Case closed.Ptc results were received on 22-aug-2014, a new device similar case listing was generated and this case was re-distributed as a final report.This adverse event report is related to a product technical complaint (ptc).(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 confirm that all parts are accounted for and inspect the device 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.Medical assessment: the events reported are known possible undesirable events and not indicative of a quality deficit per se.In this particular case a lack of efficacy (pregnancy) was reported.A contraceptive failure may occur under the use of any contraceptive and is not indicative of a quality deficit per se.No batch number was reported.Without this information neither a technical batch evaluation nor a batch signal cluster review in the gpv database for a more detailed statistical medical evaluation is possible.No complaint sample was provided for further technical investigation.The technical assessment concluded unconfirmed quality defect.In summary, there is no suspicion of a quality deficit based on the limited available information.The list of similar cases contains reports with similar events coded in (b)(4).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.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 re-coded legacy reports has not yielded any new safety signal.Correction on 26-aug-2014 based on information from 22-aug-2014.The list of similar cases was amended after a company internal review.Company causality comment: this case report was derived from medical literature article entitled "pelvic pain after transcervical tubal occlusion: a case report" and refers (b)(6) female patient who had essure (fallopian tube occlusion insert) inserted and experienced pelvic pain, then during a diagnostic laparoscopy the devices were found to be subserous at the level of both uterine cornual regions (embedded device /expulsion to uterus).In addition an unexpected pregnancy was reported.All reported events are listed in the reference safety information for essure and were considered serious, except for the reported pregnancy which is non-serious.Unintended pregnancies may occur during any contraceptive use and have been reported in women with essure micro-inserts in place, therefore a causal relation between this event and essure therapy cannot be excluded, and it was considered a non-incident.Abdominal, pelvic and uncharacterized pain may occur with essure therapy, also during essure micro-insert therapy there is a risk that the device could move out of fallopian tubes, this movement could be an expulsion (into uterus or out of the body) and sometimes embeddedment in uterine wall, mainly during difficult insertions.In this case, the patient complained of two years chronic pain, an ultrasound showed the absence of the intramural portion of essure.She was submitted to a diagnostic laparoscopy and during surgery both devices were found to be subserous at the level of both uterine cornual regions.They were both easily removed.Based on available information and due to lack of an alternative explanation these events were considered related to essure therapy; and due to the required intervention the event pelvic pain was regarded as incident.According to ptc analysis; the technical assessment concluded unconfirmed quality defect.In summary, there is no suspicion of a quality deficit based on the limited available information.(b)(4).

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: 3649178
• MDR Text Key: 4196939
• Report Number: 2951250-2014-00042
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,foreign,health pr
• Reporter Occupation: Other
• 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

• 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?: No
• Initial Date Manufacturer Received: 08/22/2014
• Initial Date FDA Received: 02/19/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/18/2014; 01/19/2017
• 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: 47 YR