MAUDE Adverse Event Report: BAYER PHARMA AG ESSURE; TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE

Model Number ESS305

Device Problems Difficult to Remove (1528); Use of Device Problem (1670); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Type  Injury  

Event Description

On 15-feb-2017: this spontaneous case was reported by a physician and describes the occurrence of medical device removal ("removal of left essure coil") and device dislocation ("unable to locate the right coil / right coil was not in the fallopian tube") in an adult female patient who received essure for female sterilization.The occurrence of additional non-serious events is detailed below.On (b)(6) 2015, the patient started essure.On an unknown date, the patient experienced medical device removal (seriousness criteria medically significant and clinically significant/intervention required), device dislocation (seriousness criterion medically significant) and device difficult to use ("not able to remove the right coil").The patient was treated with surgery (surgery to remove).At the time of the report, the medical device removal, device dislocation and device difficult to use outcome was unknown.The reporter provided no causality assessment for medical device removal, device dislocation and device difficult to use with essure.The reporter commented: the provider had to go in and remove and locate one of the coils; he removed the left coil.Diagnostic results: ultrasound scan: found the right coil but he said the uterus is so vascular that he was not able to remove the right coil.Company causality comment: this case report was received from a lawyer on behalf of a female consumer who underwent a surgery to remove essure approximately two years after insertion, due to unspecified injuries.She had removal of left essure coil but was unable to locate the right coil / right coil was not in the fallopian tube (device dislocation).Both removal of essure coil and device dislocation are anticipated according to the reference safety information for essure.The exact date and mechanism of dislocation are not known.Considering the nature of event, it was considered related to essure.Despite of the lack of details for a comprehensive causality assessment, considering essure removal was required, a causal relationship between its removal and the suspect device cannot be excluded.Therefore, this case was regarded as incident.A product technical analysis and additional information (essure device removal questionnaire) were requested.

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.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.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 7-mar-2017: quality-safety evaluation of ptc.Company causality comment: this case report was received from a physician and refers to a female patient who underwent a surgery to remove essure approximately two years after insertion, due to unspecified injuries.She had removal of left essure coil but was unable to locate the right coil / right coil was not in the fallopian tube (device dislocation).Both removal of essure coil and device dislocation are anticipated according to the reference safety information for essure.The exact date and mechanism of dislocation are not known.Considering the nature of event, it was considered related to essure.Despite of the lack of details for a comprehensive causality assessment, considering essure removal was required, a causal relationship between its removal and the suspect device cannot be excluded.Therefore, this case was regarded as incident.As a product quality defect could not be confirmed but is considered plausible a relationship with the reported medical events cannot be totally excluded.Additional information (essure device removal questionnaire) was requested.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of medical device removal ("removal of left essure coil") and device dislocation ("unable to locate the right coil / right coil was not in the fallopian tube") in an adult female patient who had essure inserted for female sterilization.Other product or product use issues identified: device difficult to use "not able to remove the right coil".On (b)(6) 2015, the patient had essure inserted.On an unknown date, the patient underwent medical device removal (seriousness criteria medically significant and intervention required) and device dislocation (seriousness criterion medically significant).The patient was treated with surgery (surgery to remove).At the time of the report, the medical device removal and device dislocation outcome was unknown.The reporter provided no causality assessment for device dislocation and medical device removal with essure.The reporter commented: the provider had to go in and remove and locate one of the coils; he removed the left coil.Diagnostic results: ultrasound scan: found the right coil but he said the uterus is so vascular that he was not able to remove the right coil.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.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.No specific quality issue was defined, therefore no meddra llt can be provided.Most recent follow-up information incorporated above includes: on 27-oct-2017: reporter did not respond to final fu attempt.Consider case closed.Incident: no lot number or sample available for investigation.There is no evidence that a device-related defect or malfunction caused a death or serious injury.If additional information becomes available it will be provided on a supplemental report.

• Brand Name: ESSURE
• Type of Device: TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE
• 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: 6408866
• MDR Text Key: 70064463
• Report Number: 2951250-2017-00848
• 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: 11/22/2017

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/16/2017
• Supplement Dates Manufacturer Received: Not provided; 10/27/2017
• Supplement Dates FDA Received: 04/04/2017; 11/23/2017
• 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