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

Catalog Number ESS205

Device Problems Material Protrusion/Extrusion (2979); Appropriate Term/Code Not Available (3191)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Hemorrhage/Bleeding (1888)

Event Date 01/01/2014

Event Type  Injury  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of uterine haemorrhage ("doctor believe the coils are nicking the sides of the uterus causing the patient to bleed") and embedded device ("one of the coils is sticking out and digging into endometrium") in an adult female patient who received essure (ess205) for female sterilization.On (b)(6) 2004, the patient started essure (ess205) at an unspecified dose and frequency.In 2014, the patient experienced uterine haemorrhage (seriousness criteria medically significant and clinically significant/intervention required).On an unknown date, the patient experienced embedded device (seriousness criterion medically significant).The patient was treated with surgery (hysteroscopy and d&c (dilation and curettage) done in (b)(6) 2015.Endometrial biopsy done in 2017).Essure (ess205) treatment was not changed.At the time of the report, the uterine haemorrhage and embedded device had not resolved.The reporter considered uterine haemorrhage to be related to essure (ess205).The reporter provided no causality assessment for embedded device with essure (ess205).The reporter commented: the patient was still having issues so the doctor wanted to nick essure off and potentially do an endometrial ablation.Diagnostic results (normal ranges are provided in parenthesis if available): in (b)(6) 2015: hysteroscopy result was one coil sticking out and digging into endometrium.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that one of the coils is sticking out and digging into endometrium (seen as embedded device).Doctor believe that this was causing the patient to bleed (considered as uterine bleeding).A hysteroscopy, d&c (dilation and curettage) and an endometrial biopsy were performed.Essure was not removed.The events are regarded as anticipated according to the reference safety information for essure.Uterine bleeding may occur with essure therapy.In addition, 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), dislocation (distal fallopian tube or peritoneal cavity) or occur as a result of uterine perforation, mainly during insertion.Based on their nature, a causal relationship with essure cannot be excluded.This case was regarded as incident because surgical intervention was performed.Further information and product technical analysis are being sought.

Manufacturer Narrative

Quality-safety evaluation of ptc: sample not available.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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.No specific quality issue was defined, therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known, possible, undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 15-mar-2017: quality safety evaluation of ptc.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that one of the coils is sticking out and digging into endometrium (seen as embedded device).Doctor believe that this was causing the patient to bleed (considered as uterine bleeding).A hysteroscopy, d&c (dilation and curettage) and an endometrial biopsy were performed.Essure was not removed.The events are regarded as anticipated according to the reference safety information for essure.Uterine bleeding may occur with essure therapy.In addition, 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), dislocation (distal fallopian tube or peritoneal cavity) or occur as a result of uterine perforation, mainly during insertion.Based on their nature, a causal relationship with essure cannot be excluded.This case was regarded as incident because surgical intervention was performed.The product quality analysis concluded that as a defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Further information is being sought.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of uterine haemorrhage ("doctor believe the coils are nicking the sides of the uterus causing the patient to bleed") and embedded device ("one of the coils is sticking out and digging into endometrium") in an adult female patient who received essure (ess205) for female sterilization.On (b)(6) 2004, the patient started essure (ess205).In 2014, the patient experienced uterine haemorrhage (seriousness criteria medically significant and clinically significant/intervention required).On an unknown date, the patient experienced embedded device (seriousness criterion medically significant).The patient was treated with surgery (hysteroscopy and d and c (dilation and curettage) done in (b)(6) 2015.Endometrial biopsy done in 2017).Essure (ess205) treatment was not changed.At the time of the report, the uterine haemorrhage and embedded device had not resolved.The reporter considered uterine haemorrhage to be related to essure (ess205).The reporter provided no causality assessment for embedded device with essure (ess205).The reporter commented: the patient was still having issues so the doctor wanted to nick essure off and potentially do an endometrial ablation.Diagnostic results (normal ranges are provided in parenthesis if available): in (b)(6) 2015: hysteroscopy result was one coil sticking out and digging into endometrium.Quality-safety evaluation of ptc: sample not available.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.Although we were unable to confirm this complaint, we cannot exclude the possibility of having a technical issue involved in the complaint.There was no event reported which indicates a new technical failure mode for the device.No specific quality issue was defined, therefore no meddra llt can be provided.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.However, the reported medical events are known, possible, undesirable events and not indicative of a quality deficit per se.Since no batch number was reported, a batch investigation with respect to similar ae cases is not applicable.Most recent follow-up information incorporated above includes: on 10-may-2017: despite several requests no response was received from reporter.Company causality comment: a female patient had essure (fallopian tube occlusion insert) inserted and it was reported that one of the coils is sticking out and digging into endometrium (seen as embedded device).Doctor believe that this was causing the patient to bleed (considered as uterine bleeding).A hysteroscopy, d and c (dilation and curettage) and an endometrial biopsy were performed.Essure was not removed.The events are regarded as anticipated according to the reference safety information for essure.Uterine bleeding may occur with essure therapy.In addition, 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), dislocation (distal fallopian tube or peritoneal cavity) or occur as a result of uterine perforation, mainly during insertion.Based on their nature, a causal relationship with essure cannot be excluded.This case was regarded as incident because surgical intervention was performed.The product quality analysis concluded that as a defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.No further information is expected.

• Brand Name: ESSURE
• Type of Device: INSERT, TUBAL OCCLUSION
• Manufacturer (Section D): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer (Section G): BAYER PHARMA AG; müllerstr. 178; berlin, 13353 ; GM 13353
• Manufacturer Contact: k. shaw lamberson ; 100 bayer blvd, p.o. box 915; whippany, NJ 07981-0915
• MDR Report Key: 6345288
• MDR Text Key: 67836781
• Report Number: 2951250-2017-00645
• 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: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2017

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 Catalogue Number: ESS205
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/11/2017; 05/31/2017
• 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: 50 YR