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

Model Number ESS305

Device Problems Break (1069); Entrapment of Device (1212); Material Fragmentation (1261); Migration or Expulsion of Device (1395)

Patient Problems Pain (1994); Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

This literature case describes the occurrence of pelvic pain ("pelvic pain"), device breakage ("retained fragments after laparoscopic salpingectomy/2-3mm metallic remnant was confirmed by x-ray") and embedded device ("remnants deep within the myometrium") in a female patient who had essure inserted for contraception.The occurrence of additional non-serious events is detailed below.Literature reference: lazorwitz a; tocce k, a case series of removal of nickel-titanium sterilization microinserts from the uterine cornua using laparoscopic electrocautery for salpingectomy., contraception, 2017, xx:xx.Other product or product use issues identified: device use error "the devices were grasped and stretched to their full capacity".On an unknown date, the patient had essure inserted.On an unknown date, the patient experienced pelvic pain (seriousness criteria medically significant and intervention required), device breakage (seriousness criteria medically significant and intervention required), embedded device (seriousness criterion medically significant), device difficult to use ("micro insert could not be removed despite considerable traction/metallic remnant was left in situ") and complication of device removal ("retained fragments after laparoscopic salpingectomy/2-3mm metallic remnant was confirmed by x-ray").The patient was treated with surgery (laparoscopic salpingectomy and diagnostic hysteroscopy and attempted retained fragment removal).At the time of the report, the pelvic pain was resolving and the device breakage, embedded device, device difficult to use and complication of device removal had not resolved.The reporter considered complication of device removal, device breakage, device difficult to use, embedded device and pelvic pain to be related to essure.The reporter commented: diagnostic hysteroscopy was performed in 3/20 (15%) of our cases due to retained fragments after laparoscopic salpingectomy.In each of these cases, we were able to grasp the cornual portion of the micoinsert easily, but were not successful in removing the entire insert.The devices were grasped and stretched to their full capacity when spontaneous fracture occurred.When the platinum band could not be identified on device inspection, we proceeded with hysteroscopy.In one case (current report), the device was visualized hysteroscopically but could not be removed despite considerable traction.A 2-3mm metallic remnant was confirmed by postoperative x-ray and left in situ.All patients who underwent surgery for pelvic pain reported complete or significant improvement in their pain post-operatively, including the 3 patients with small metallic fragments left in situ.In our cases where spontaneous fracture of the microinsert occurred, we suspect that the microinserts would have broken during removal regardless of technique (salpingectomy versus salpingostomy) due to deep embedment in the myometrium.Given the position of these remnants deep within the myometrium, removal would have required extensive dissection into the myometrium, cornuectomy, or hysterectomy.All of these techniques would have posed additional morbidity to these patients.For those with pelvic pain, all had their symptoms improve post-operatively.Diagnostic results: all patients had undergone a prior hysterosalpingogram or transvaginal ultrasound examination to confirm device placement.Unspecified date: diagnostic hysteroscopy: the device was visualized hysteroscopically but could not be removed despite considerable traction.Post operative x-ray: 2-3mm metallic remnant was confirmed and left in situ.Abstract: nickel-titanium sterilization microinserts are surgically removed for various indications, including persistent pain.Previously described removal techniques include salpingostomy and cornuectomy with judicious use of electrocautery to avoid potential injury to adjacent structures or fracturing the micoinsert.This case series presents our technique of laparoscopic salpingectomy, utilizing electrocautery on the microinsert.Company causality comment: 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: 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: 6663014
• MDR Text Key: 78290821
• Report Number: 2951250-2017-02278
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/23/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: ESS305
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 06/23/2017
• 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