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

Model Number ESS305

Device Problems Break (1069); Migration or Expulsion of Device (1395); Difficult to Remove (1528); Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Event Description

This literature case describes the occurrence of allergy to metals ("erythematous,papular, pruritic rash developed on her lower abdomen consistent with a nickel hypersensitivity") and device breakage ("the coil broke away from the rest of the device") in a (b)(6) -year-old female patient who had essure inserted for sterilization.The occurrence of additional non-serious events is detailed below.Literature reference: goldthwaite, lm; edwards, l; tocce, k, early hysteroscopic removal of intratubal micro-inserts with urologic stone retrieval forceps, the american college of obstetricians and gynecologists, 2014, 124:2:2:441-444.Other product or product use issues identified: device use issue "patient had two essure devices on one side" and device use issue "attempt at hysteroscopic removal of the micro-inserts ten days after insertion".The patient's past medical history included gravida ii and parity 2.Patient had no significant medical history.She reported no allergies.On an unknown date, the patient had essure inserted.On an unknown date, 3 days after insertion of essure, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required) with rash papular.On an unknown date, the patient experienced device breakage (seriousness criteria medically significant and intervention required), complication of device removal ("attempt at hysteroscopic removal of the micro-inserts ten days after insertion") and device expulsion ("expulsion on the other side").The patient was treated with hydrocortisone, antihistamines and surgery (hysteroscopic essure removal).Essure was removed.At the time of the report, the allergy to metals had resolved and the device breakage, complication of device removal and device expulsion outcome was unknown.The reporter considered allergy to metals, complication of device removal, device breakage and device expulsion to be related to essure.The reporter commented: she reported a history of suspected metal sensitivities, although she had never undergone confirmatory skin patch testing.For many years she avoided metal jewelry because of skin irritation and described long-standing "tongue irritation" that ultimately resolved after the replacement of her metal dental fillings with composite resins.The hysteroscopic removal was unsuccessful and laparoscopy was required.In the case presented here, after hysteroscopic grasping forceps failed to reach the deeply positioned left micro-insert, successful removal was accomplished with the aid of 1-mm tri-prong urologic stone retrieval forceps.Although laparoscopic procedures are the only option for permanent sterilization in patients who have intratubal micro-inserts removed, the technique we describe here is valuable for patients like ours who no longer desire permanent sterilization or who strongly wish to avoid abdominal incisions.During hysteroscopy, after pulling the micro-insert approximately 1 cm out of the ostium, the hysteroscopic grasping fórceps was then used to remove the micro-insert.Significant traction was required, which led to a fracture of the left micro-insert; the first four turns of the coil broke away from the rest of the device.The patient reported complete resolution of the rash and pruritus within 36 hours of bilateral micro-insert removal.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray of pelvis and hip - on an unknown date: confirmed complete removal of devices bilaterally.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.

Manufacturer Narrative

This literature case describes the occurrence of device breakage ("the coil broke away from the rest of the device") and allergy to metals ("erythematous,papular, pruritic rash developed on her lower abdomen consistent with a nickel hypersensitivity") in a 48-year-old female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.Literature reference: goldthwaite, lm; edwards, l; tocce, k, early hysteroscopic removal of intratubal microinserts with urologic stone retrieval forceps, the american college of obstetricians and gynecologists, 2014, 124:2:2:441-444.Other product or product use issues identified: device use issue "attempt at hysteroscopic removal of the microinserts ten days after insertion" and device use issue "patient had two essure devices on one side".The patient's past medical history included gravida ii and parity 2 (2 vaginal delivery).Patient had no significant medical history.She reported no allergies.On an unknown date, the patient had essure inserted.On an unknown date, 3 days after insertion of essure, the patient experienced device breakage (seriousness criteria medically significant and intervention required), device expulsion ("expulsion on the other side") and complication of device removal ("attempt at hysteroscopic removal of the microinserts ten days after insertion").On an unknown date, the patient experienced allergy to metals (seriousness criteria medically significant and intervention required) with dermatitis contact.The patient was treated with hydrocortisone, antihistamines, surgery (hysteroscopic essure removal).Essure was removed.At the time of the report, the device breakage, device expulsion and complication of device removal outcome was unknown and the allergy to metals had resolved.The reporter considered allergy to metals, complication of device removal, device breakage and device expulsion to be related to essure.The reporter commented: she reported a history of suspected metal sensitivities, although she had never undergone confirmatory skin patch testing.For many years she avoided metal jewelry because of skin irritation and described long-standing "tongue irritation" that ultimately resolved after the replacement of her metal dental fillings with composite resins.The hysteroscopic removal was unsuccessful and laparoscopy was required.In the case presented here, after hysteroscopic grasping forceps failed to reach the deeply positioned left microinsert, successful removal was accomplished with the aid of 1-mm tri-prong urologic stone retrieval forceps.Although laproscopic procedures are the only option for permanent sterilization in patients who have intratubal microinserts removed, the technique we describe here is valuable for patients like ours who no longer desire permanent sterilization or who strongly wish to avoid abdominal incisions.During hysteroscopy, after pulling the microinsert approximately 1 cm out of the ostium, the hysteroscopic grasping fórceps was then used to remove the microinsert.Significant traction was required, which led to a fracture of the left microinsert; the first four turns of the coil broke away from the rest of the device.The patient reported complete resolution of the rash and pruritus within 36 hours of bilateral microinsert removal.Diagnostic results (normal ranges are provided in parenthesis if available): x-ray of pelvis and hip - on an unknown date: confirmed complete removal of devices bilaterally quality-safety evaluation of ptc: unable to confirm complaint.Most recent follow-up information incorporated above includes: on 20-aug-2018: quality-safety evaluation of product technical complaint.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
• MDR Report Key: 7211782
• MDR Text Key: 97977319
• Report Number: 2951250-2018-00460
• 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,literatur
• Type of Report: Initial,Followup
• Report Date: 08/22/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2018
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 08/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR