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

Model Number ESS305

Device Problems Break (1069); Detachment Of Device Component (1104); Stretched (1601); Device Operates Differently Than Expected (2913)

Patient Problems Muscle Spasm(s) (1966); Device Embedded In Tissue or Plaque (3165)

Event Date 10/16/2017

Event Type  malfunction  

Event Description

This spontaneous case was reported by a physician and describes the occurrence of the first episode of device breakage ("when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke - pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr") in a female patient who had essure (batch no.E66864) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke - pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr" on (b)(6) 2017.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced the first episode of device breakage (seriousness criterion medically significant), the second episode of device breakage ("when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke - pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr") and complication of device insertion ("device insertion failed").At the time of the report, the last episode of device breakage and complication of device insertion outcome was unknown.The reporter considered the first episode of device breakage and the second episode of device breakage to be related to essure.The reporter provided no causality assessment for complication of device insertion with essure.The reporter commented: the essure coil was being placed on patient's right tube and when the device was being wheeled back, the catheter appeared to not come back.After the hard stop, the doctor decided to push the button and wheel back for the 2nd time.When he came out with the device, the tube appeared to grab the coil and then stretched.The doctor had to go in with graspers and remove pieces of the coil.He said he would like to bring the patient back in 3 months.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-nov-2017: quality safety evaluation of ptc.Company causality comment.Incident.At the time of reporting, 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.

Manufacturer Narrative

This spontaneous case was reported by a physician and describes the occurrence of the first episode of device breakage ("when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke  pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr") in a female patient who had essure (batch no.E66864) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke  pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr" on (b)(6) 2017.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced the first episode of device breakage (seriousness criterion medically significant), the second episode of device breakage ("when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke  pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr") and complication of device insertion ("device insertion failed").At the time of the report, the last episode of device breakage and complication of device insertion outcome was unknown.The reporter considered the first episode of device breakage and the second episode of device breakage to be related to essure.The reporter provided no causality assessment for complication of device insertion with essure.The reporter commented: the essure coil was being placed on patient's right tube and when the device was being wheeled back, the catheter appeared to not come back.After the hard stop, the doctor decided to push the button and wheel back for the 2nd time.When he came out with the device, the tube appeared to grab the coil and then stretched.The doctor had to go in with graspers and remove pieces of the coil.He said he would like to bring the patient back in 3 months.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 9-nov-2017: quality safety evaluation of ptc.Incident.At the time of reporting, 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.

Manufacturer Narrative

Ntaneous case was reported by a physician and describes the occurrence of device breakage ("when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke ¿ pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr") in a female patient who had essure (batch no.E66864) inserted.The occurrence of additional non-serious events is detailed below.Other product or product use issues identified: device physical property issue "when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke ¿ pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr" on (b)(6) 2017.On (b)(6) 2017, the patient had essure inserted.On the same day, the patient experienced device breakage (seriousness criterion medically significant), fallopian tube spasm ("when he came out with the device the tube appeared to grab the coil and stretched/ the outer coil stretched & broke ¿ pieces seemed to break off.The fallopian tube seemed to spasm & grab the insert & the inner rod of the coil came out & separated fr") and complication of device insertion ("device insertion failed").At the time of the report, the device breakage, fallopian tube spasm and complication of device insertion outcome was unknown.The reporter provided no causality assessment for complication of device insertion with essure.The reporter considered device breakage and fallopian tube spasm to be related to essure.The reporter commented: the essure coil was being placed on patient's right tube and when the device was being wheeled back, the catheter appeared to not come back.After the hard stop, the doctor decided to push the button and wheel back for the 2nd time.When he came out with the device, the tube appeared to grab the coil and then stretched.The doctor had to go in with graspers and remove pieces of the coil.He said he would like to bring the patient back in 3 months.Quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on (b)(6) 2018: quality safety evaluation of ptc.Incident: at the time of reporting, 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
• MDR Report Key: 7020870
• MDR Text Key: 91888686
• Report Number: 2951250-2017-06370
• Device Sequence Number: 1
• Product Code: HHS
• Combination Product (y/n): N
• PMA/PMN Number: P020014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Model Number: ESS305
• Device Lot Number: E66864
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other