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

Model Number ESS305

Device Problems Occlusion Within Device (1423); Material Perforation (2205)

Patient Problem Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

This is a spontaneous case report received from a medical doctor in united states on 01-oct-2015 which refers to a female patient of unspecified age who had essure (fallopian tube occlusion insert) inserted.Hsg (hysterosalpingogram) confirmation test was performed - one insert had perforated the tube and tube was patent, contralateral side was occluded.Salpingectomy was performed for contraception and insert removal was successful.Follow-up information received on 05-oct-2015: the initial receipt date was confirmed.Follow-up received on 16-oct-2015: the ptc (product technical complaint) investigation result was provided.(b)(4).Final assessment: for cases where a device failure during insertion is reported, we conduct an investigation of any returned device.For cases where an insert is removed at a later time after insertion, we typically do not conduct an inspection of the insert.In this case, no product was returned.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 medical events is excluded.The technical assessment concluded unconfirmed quality defect.Based on the available information, there is no relationship between the reported medical events and a quality defect.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 one insert had perforated the tube.A salpingectomy was performed for contraception and insert removal was successful.This event is serious due to its medical importance and listed in the reference safety information for essure.In this particular case, the exact date and mechanism of the reported event were not known, however given its nature and considering that fallopian tube perforation may occur with trans-cervical intrauterine procedure (e.G.Hysteroscopy, curettage) or most often during insertion, a causal relationship with essure therapy cannot be excluded.Since a surgical intervention was performed, this case was regarded as incident.The product technical analysis concluded that based on the available information, there is no relationship between the reported medical events and a quality defect.Further information is being sought.

Manufacturer Narrative

Follow-up information received on 11-jan-2016: 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 one insert had perforated the tube.A salpingectomy was performed for contraception and insert removal was successful.This event is serious due to its medical importance and listed in the reference safety information for essure.In this particular case, the exact date and mechanism of the reported event were not known, however given its nature and considering that fallopian tube perforation may occur with trans-cervical intrauterine procedure (e.G.Hysteroscopy, curettage) or most often during insertion, a causal relationship with essure therapy cannot be excluded.Since a surgical intervention was performed, this case was regarded as incident.The product technical analysis concluded that based on the available information, there is no relationship between the reported medical events and a quality defect.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: 5180535
• MDR Text Key: 29379956
• Report Number: 2951250-2015-01255
• 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: Initial,Followup,Followup
• Report Date: 01/23/2017

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: 10/01/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/08/2016; 01/23/2017
• 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