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

Model Number ESS305

Device Problems Migration or Expulsion of Device (1395); Expulsion (2933); Material Protrusion/Extrusion (2979)

Patient Problems Abdominal Pain (1685); Fatigue (1849); Pain (1994); Uterine Perforation (2121); Cramp(s) (2193); Urinary Frequency (2275); Weight Changes (2607)

Event Type  Injury  

Event Description

This spontaneous case was reported by a lawyer and describes the occurrence of uterine perforation ("migration of essure device- through my uterus against my colon/ perforation (other)- displaced / migrated to uterus with the tip protruding outside the funds against my colon, on my left side/ right coil displaced, anterior to the ascending colon") and device expulsion ("migration of essure device- through my uterus against my colon/ perforation (other)- displaced / migrated to uterus with the tip protruding outside the funds against my colon, on my left side/ right coil displaced, anterior to the ascending colon") in a female patient who had essure inserted for female sterilization.The occurrence of additional non-serious events is detailed below.The patient's past medical history included gravida ii, live birth on (b)(6) 2003 and miscarriage.Concurrent conditions included body mass index normal.Concomitant products included dicycloverine (dicyclomine), gabapentin, intestinal adsorbents (kaopectate), loperamide hydrochloride (imodium) and phentermine.On (b)(6) 2008, the patient had essure inserted.On an unknown date, the patient experienced uterine perforation (seriousness criteria medically significant and intervention required), device expulsion (seriousness criteria medically significant and intervention required), injury ("severe injuries"), dysmenorrhoea ("dysmenorrhea (cramping)"), dyspareunia ("dyspareunia (painful sexual intercourse)"), fatigue ("fatigue"), irritable bowel syndrome ("gastrointestinal or digestive system condition- ibs-d"), pelvic pain ("severe and persistent pain pelvic region"), weight increased ("weight gain/loss- gain"), bladder disorder ("bladder or problems or changes"), urinary tract disorder ("urinary problems or changes"), abdominal pain lower ("severe and persistent lower abdomen") and pollakiuria ("frequent urination").The patient was treated with surgery (robotic surgery total hysterectomy) and surgery (robotic surgery total hysterectomy).Essure was removed on (b)(6) 2017.At the time of the report, the uterine perforation, device expulsion, injury, dyspareunia, fatigue, pelvic pain, weight increased, bladder disorder and urinary tract disorder outcome was unknown, the dysmenorrhoea had resolved and the irritable bowel syndrome, abdominal pain lower and pollakiuria was resolving.The reporter considered abdominal pain lower, bladder disorder, device expulsion, dysmenorrhoea, dyspareunia, fatigue, injury, irritable bowel syndrome, pelvic pain, pollakiuria, urinary tract disorder, uterine perforation and weight increased to be related to essure.Diagnostic results (normal ranges are provided in parenthesis if available): body mass index was 20.8 kg/sqm.Most recent follow-up information incorporated above includes: on 27-feb-2018: reporters added and updated patient demographics.Historical condition, concomitant disease, laboratory data, concomitant drug were added.Updated suspect drug indication.On (b)(6) 2008, she implanted essure (previously reported as (b)(6) 2008).Added events bladder or urinary problems or changes, dysmenorrhea (cramping), dyspareunia (painful sexual intercourse), fatigue, gastrointestinal or digestive system condition- isb-d, pain, perforation (uterus)/ migration of essure device- through my uterus against my colon/ perforation (other)- displaced / migrated to my uterus with the tip protruding outside the funds against my colon, on my left side/ the right side coil also displaced, anterior to the ascending colon in the right lower quadrant, weight gain/loss- gain.In (b)(6) 2017, she had removed essure device.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
• MDR Report Key: 7391400
• MDR Text Key: 104194256
• Report Number: 2951250-2018-01408
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/03/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: ESS305
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 04/03/2018
• 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
• Treatment: DICYCLOMINE; GABAPENTIN; IMODIUM; KAOPECTATE; PHENTERMINE
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 57