ESSURE
Report
- Report Number
- 2951250-2014-00195
- Event Type
- Injury
- Date Received
- June 6, 2014
- Report Date
- August 13, 2014
- Manufacturer
- BAYER HEALTHCARE LLC
- Product Code
- HHS
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
REPORT SOURCE LITERATURE DESCRIPTION. JOURNAL: JOURNAL OF MINIMALLY INVASIVE GYNECOLOGY. AUTHOR: ADELMAN MR, DASSEL MW, SHARP HT. TITLE: MANAGEMENT OF COMPLICATIONS ENCOUNTERED WITH ESSURE HYSTEROSCOPIC STERILIZATION: A SYSTEMATIC REVIEW. VOLUME: XX YEAR: 2014 PAGES: XX. JOURNAL: ANNALS OF EMERGENCY MEDICINE. AUTHOR: BJORNSSON HM, GRAFFEO CS, DAVIS SS. TITLE: RUPTURED ECTOPIC PREGNANCY AFTER PREVIOUSLY CONFIRMED TUBAL OCCLUSION BY THE ESSURE PROCEDURE. VOLUME: 57(3) YEAR: 2011 PAGE: 310-311.
THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED ON 31-MAY-2014: (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. 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 AT THIS TIME. MEDICAL ASSESSMENT: THE MEDICAL EVENTS REPORTED ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. LACK OF EFFECTIVENESS IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT AS IT MAY OCCUR WITH THE USE OF ANY PRODUCT. ADDITIONALLY, PREGNANCY MAY OCCUR DURING ANY CONTRACEPTIVE USE. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. NO BATCH NUMBER WAS REPORTED. NEITHER A TECHNICAL BATCH INVESTIGATION NOR A BATCH CLUSTER REVIEW IN THE GPV DATABASE FOR A MORE DETAILED STATISTICAL MEDICAL EVALUATION IS POSSIBLE WITHOUT A BATCH NUMBER. AT THE TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED "UNCONFIRMED QUALITY DEFECT". BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED CASE REPORT DERIVED FROM MEDICAL LITERATURE REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND FOLLOWING (PRECISE DATE NOT SPECIFIED) WAS DIAGNOSED WITH A RUPTURED ECTOPIC PREGNANCY IN THE LEFT FALLOPIAN TUBE WITH HEMORRHAGIC SHOCK DESPITE CONFIRMED TUBAL OCCLUSION BY A HYSTEROSALPINGOGRAM CONDUCTED THREE MONTHS AFTER PLACEMENT. AN EMERGENCY EXPLORATORY LAPAROTOMY WAS PERFORMED. LEFT ECTOPIC PREGNANCY WITH ESSURE AND ASSOCIATED COMPLICATIONS RUPTURED LEFT ECTOPIC PREGNANCY AND HEMORRHAGIC SHOCK ARE CLASSIFIED SERIOUS DUE TO HOSPITALIZATION AND MEDICAL IMPORTANCE. ECTOPIC PREGNANCY IS LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) WHILE COMPLICATIONS RUPTURED ECTOPIC PREGNANCY AND HEMORRHAGIC SHOCK ARE UNLISTED. DEVICE INEFFECTIVE IS NON-SERIOUS AND LISTED. ECTOPIC PREGNANCIES HAVE BEEN REPORTED AMONG WOMEN WITH ESSURE MICRO-INSERTS IN PLACE. WHEN PREGNANCY DOES OCCUR AFTER ESSURE PLACEMENT, THE RELATIVE RISK THAT IT WILL BE AN ECTOPIC PREGNANCY IS HIGHER THAN FOR WOMEN WHO DO NOT HAVE THE INSERT IN PLACE. IN ECTOPIC PREGNANCY AS THE GESTATION ENLARGES IT CREATES THE POTENTIAL FOR ORGAN RUPTURE. CONSIDERING A POSITIVE TEMPORAL RELATIONSHIP AND BASED ON AVAILABLE INFORMATION, A CAUSAL RELATIONSHIP BETWEEN EVENTS AND ESSURE CANNOT BE EXCLUDED. CASE IS CLASSIFIED AS INCIDENT (SERIOUS INJURY DUE TO EVENTS REQUIRED SURGICAL INTERVENTION AND HOSPITALIZATION, RELATED TO ESSURE). THE PRODUCT TECHNICAL ANALYSIS CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE; THERE IS NO REASON TO SUSPECT A QUALITY DEFECT OF THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED. (B)(4).
THIS CASE REPORT FROM UNITED STATES WAS DERIVED FROM MEDICAL LITERATURE ON MAY 7, 2014, ARTICLE ENTITLED "MANAGEMENT OF COMPLICATIONS ENCOUNTERED WITH ESSURE HYSTEROSCOPIC STERILIZATION: A SYSTEMATIC REVIEW." IT REFERS TO A FEMALE PATIENT OF UNSPECIFIED AGE WHO HAD FALLOPIAN TUBE OCCLUSION INSERT INSERTED FOR HYSTEROSCOPIC STERILIZATION AND EXPERIENCED LEFT ECTOPIC PREGNANCY WITH ESSURE (DEVICE INEFFECTIVE) AND RUPTURED LEFT ECTOPIC PREGNANCY WITH ESSURE. ESSURE WAS REPORTED AS THE TRADE NAME. CASE REPORT: THIS FEMALE PATIENT WITH TUBAL RUPTURE, UNDERWENT AN EMERGENCY EXPLORATORY LAPAROTOMY, WITH IDENTIFICATION OF A LEFT ECTOPIC PREGNANCY, AND FINDINGS OF APPROPRIATELY PLACED MICRO-INSERTS. SHE HAD PREVIOUSLY UNDERGONE A HSG (HYSTEROSALPINGOGRAM), WHICH CONFIRMED BILATERAL TUBAL OCCLUSION. REPEAT HSG 3 MONTHS AFTER THE RUPTURED ECTOPIC PREGNANCY SHOWED RIGHT TUBAL PATENCY. ABSTRACT: ESSURE HYSTEROSCOPIC STERILIZATION HAS BEEN FDA APPROVED IN THE UNITED STATES SINCE 2002. COMPLICATIONS ASSOCIATED WITH ESSURE INCLUDE IMPROPER PLACEMENT (MALPOSITIONING), UNINTENDED PREGNANCY, PAIN, INFECTIONS, AND NICKEL ALLERGY. THE RARITY OF COMPLICATIONS, COMPOUNDED BY UNDERREPORTING, MAKES IT DIFFICULT TO DETERMINE BEST PRACTICES WITH REGARDS TO MANAGEMENT. THIS SYSTEMATIC REVIEW SYNTHESIZES THE NATIONAL AND GLOBAL EXPERIENCE WITH MANAGEMENT OF ESSURE-RELATED COMPLICATIONS, AND SUGGESTS TREATMENT OPTIONS WHERE DATA ALLOW. AUTHORS COMMENT: THIS IS THE CASE REPORT OF ECTOPIC PREGNANCY WITH ESSURE, RESULTING IN RUPTURE. RELATED CASE: (B)(4). FOLLOW-UP RECEIVED ON (B)(4) 2014: THIS CASE REPORT IS FROM THE LITERATURE ARTICLE WHICH WAS PUBLISHED IN ANNALS OF EMERGENCY MEDICINE, TITLE AS "RUPTURED ECTOPIC PREGNANCY AFTER PREVIOUSLY CONFIRMED TUBAL OCCLUSION BY THE ESSURE PROCEDURE" AND AUTHORED BY BJORNSSON HM, GRAFFEO CS, DAVIS SS. CASE REPORT: THIS 43-YEAR-OLD BLACK WOMAN GRAVIDA 1 PARA 1 PRESENTED TO THE EMERGENCY DEPARTMENT (ED), COMPLAINING OF SEVERE LOWER ABDOMINAL PAIN THAT HAD BEGUN EARLY THAT SAME MORNING. THIS WAS ACCOMPANIED BY NAUSEA AND DIZZINESS BUT NO OTHER ASSOCIATED SYMPTOMS. THE PATIENT STATED THAT SHE HAD A HISTORY OF AN ESSURE PROCEDURE. ON ARRIVAL IN THE ED, THE PATIENT WAS IN HYPOVOLEMIC SHOCK. A URINE PREGNANCY TEST RESULT WAS POSITIVE, AND FREE FLUID WAS OBSERVED IN THE ABDOMEN ON BESIDE EMERGENCY ULTRASONOGRAPHY. RUPTURED ECTOPIC PREGNANCY WAS SUSPECTED, AND SHE UNDERWENT AN EMERGENCY EXPLORATORY LAPAROTOMY. AN ECTOPIC PREGNANCY WAS IDENTIFIED IN THE LEFT FALLOPIAN TUBE, BUT THE ESSURE DEVICES APPEARED TO BE CORRECTLY PLACED IN BOTH TUBES. THE PATIENT HAD AN UNEVENTFUL HOSPITAL COURSE AND WAS DISCHARGED HOME ON POSTOPERATIVE DAY 2. A REVIEW OF HER OUTPATIENT MEDICAL RECORDS CONFIRMED THAT TUBAL OCCLUSION HAD BEEN OBSERVED ON A HYSTEROSALPINGOGRAM 3 MONTHS AFTER THE ESSURE PROCEDURE BUT THE LEFT DEVICE MAY HAVE BEEN SLIGHTLY MORE DISTAL THAN THE IDEAL RECOMMENDED PLACEMENT. ON A REPEATED HYSTEROSALPINGOGRAM CONDUCTED 3 MONTHS AFTER HER RUPTURED ECTOPIC PREGNANCY, THE RIGHT FALLOPIAN TUBE THAT WAS OCCLUDED ON THE PREVIOUS HYSTEROSALPINGOGRAM WAS FOUND TO BE PATIENT. AUTHOR'S COMMENT: THIS IS A CASE OF RUPTURED ECTOPIC PREGNANCY WITH HEMORRHAGIC SHOCK IN A WOMAN WHO HAD PREVIOUSLY UNDERGONE HYSTEROSCOPIC STERILIZATION BY THE ESSURE PROCEDURE AND CONFIRMATION OF TUBAL OBSTRUCTION BY HYSTEROSALPINGOGRAM. THIS IS THE FIRST REPORT OF SUCH A CASE, ALTHOUGH PREGNANCY HAS BEEN REPORTED AFTER FAILURE OF THIS PROCEDURE. EMERGENCY PHYSICIANS SHOULD BE AWARE OF THE POTENTIAL FOR ECTOPIC PREGNANCY IN WOMEN WHO HAVE HAD AN ESSURE PROCEDURE DESPITE CONFIRMED TUBAL OCCLUSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331324 | ESSURE | KNH-DEVICE, OCCLUSION, TUBAL, CONTRACEPTIVE | HHS | BAYER HEALTHCARE LLC | ESS305 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization| O |