BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6669639 · Received June 27, 2017

    Report

    Report Number
    2951250-2017-02358
    Event Type
    Injury
    Date Received
    June 27, 2017
    Report Date
    June 27, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("ESSURE REMOVAL DUE TO AILMENTS, PUNCTIFORM PROTUBERANCE IN ONE FALLOPIAN TUBE CORRESPONDING TO ESSURE PART") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: GARRIGUET LOPEZ JOSE, MANRIQUE GOMEZ TM, EXOJO CANO GM, MONTILLA PRADOS IM, DURO GOMEZ J, TREJO BRAVO I, EXTRACTION TECHNIQUE OF ESSURE DEVICE AT OUR CENTER, 34TH NATIONAL EDITION TRAINING SEGO 12 - 16 JUNE 2017- OVIEDO, 2017:#267. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY USING BIPOLAR-MONOPOLAR COAGULATION AND SECTION IN 2016). ESSURE WAS REMOVED IN 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION WAS RESOLVING. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FROM THIS ABSTRACT LINKED CASES RECORDS WERE CREATED: (B)(4). DIAGNOSTIC RESULTS: IN 2016: -HYSTEROSCOPIC FINDINGS (PRE AND POST-SURGERY): MATERIALS IN OSTIA OR OTHER PATHOLOGY WERE NOT OBSERVED, INTRACAVITARY ESSURE WAS NOT OBSERVED. -LAPAROSCOPIC FINDINGS: PUNCTIFORM PROTUBERANCE IN ONE FALLOPIAN TUBE CORRESPONDING TO ESSURE PART. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 26_JUN_2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: FALLOPIAN TUBE PERFORATION: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 600 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. THIS CASE REPORT REFERS TO ONE OF EIGHT WOMEN (MEAN AGE 39,8±3,6 YEARS) WHO UNDERWENT SURGERY FOR ESSURE REMOVAL IN 2016. ENDOSCOPIC PROTOCOL AS REMOVAL TECHNIQUE BASED ON THREE STAGES WAS APPLIED: HYSTEROSCOPY-LAPAROSCOPY-HYSTEROSCOPY. -HYSTEROSCOPIC FINDINGS (PRE AND POST-SURGERY): MATERIALS IN OSTIA OR OTHER PATHOLOGY WERE NOT OBSERVED. -LAPAROSCOPIC FINDINGS: PUNCTIFORM PROTUBERANCE IN ONE FALLOPIAN TUBE CORRESPONDING TO ESSURE PART. -THREE ESSURE COMPONENTS WERE REMOVED: METALLIC SPIRAL, GUIDANCE ROD (ALSO METALLIC), AND PLASTIC (POLYESTER) COMPONENT. -LAPAROSCOPIC EXTRACTION TECHNIQUE: AFTER HYSTEROSCOPY UNFEASIBILITY AS INTRACAVITARY ESSURE WAS NOT OBSERVED, IT CONSISTED ON BILATERAL SALPINGECTOMY USING BIPOLAR-MONOPOLAR COAGULATION AND SECTION, ENSURING TO AVOID DEVICE SECTION, IDENTIFYING AND HOLDING IT WITH GRASPING FORCEPS FOR ITS REMOVAL. THEN, WITH THE USE OF FINE DISSECTOR, THE SMALL INTRAMURAL ANATOMIC SPACE WHICH COMMUNICATES THE UTERUS WITH FALLOPIAN TUBE IS SECTIONED WITH THE OBJECTIVE OF ENSURING TOTAL EXTRACTION OF DEVICE AND AVOID LEAVING ANY MINUSCULE REMNANT OF IT. INTERVENTION WAS FINALIZED BY VERIFYING HEMOSTASIS USING ELECTROCOAGULATION IF NEEDED IN THE INTERVENED CORNUAL ZONE. AILMENTS OF PATIENT IMPROVED AFTER PROCEDURE. EVEN IN EXPERIENCED HANDS, THE EXTRACTION IS NOT A TRIVIAL MATTER, HAVING TO GO THROUGH SURGERY WITH THE PERIOPERATIVE RISKS THAT ENTAILS ANY SURGICAL PROCEDURE, STEMMING FROM THE ANESTHESIA OR FROM THE INTERVENTION ITSELF. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUN-2017: TRANSLATION RECEIVED. PTC GLOBAL NUMBER RECEIVED. 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.

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("ESSURE REMOVAL DUE TO AILMENTS, PUNCTIFORM PROTUBERANCE IN ONE FALLOPIAN TUBE CORRESPONDING TO ESSURE PART") IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED. LITERATURE REFERENCE: GARRIGUET LOPEZ JOSE, MANRIQUE GOMEZ TM, EXOJO CANO GM, MONTILLA PRADOS IM, DURO GOMEZ J, TREJO BRAVO I, EXTRACTION TECHNIQUE OF ESSURE DEVICE AT OUR CENTER, 34TH NATIONAL EDITION TRAINING SEGO 12 - 16 JUNE 2017- OVIEDO, 2017:#267. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC BILATERAL SALPINGECTOMY USING BIPOLAR-MONOPOLAR COAGULATION AND SECTION IN 2016). ESSURE WAS REMOVED IN 2016. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION WAS RESOLVING. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: FROM THIS ABSTRACT LINKED CASES RECORDS WERE CREATED: 2017-120883, 2017-120885, 2017-120886, 2017-120913, 2017-120980, 2017-120979, 2017-120977. DIAGNOSTIC RESULTS: IN 2016: -HYSTEROSCOPIC FINDINGS (PRE AND POST-SURGERY): MATERIALS IN OSTIA OR OTHER PATHOLOGY WERE NOT OBSERVED, INTRACAVITARY ESSURE WAS NOT OBSERVED. -LAPAROSCOPIC FINDINGS: PUNCTIFORM PROTUBERANCE IN ONE FALLOPIAN TUBE CORRESPONDING TO ESSURE PART. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 23_JUN_2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: FALLOPIAN TUBE PERFORATION: THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 600 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. THIS CASE REPORT REFERS TO ONE OF EIGHT WOMEN (MEAN AGE 39,8±3,6 YEARS) WHO UNDERWENT SURGERY FOR ESSURE REMOVAL IN 2016. ENDOSCOPIC PROTOCOL AS REMOVAL TECHNIQUE BASED ON THREE STAGES WAS APPLIED: HYSTEROSCOPY-LAPAROSCOPY-HYSTEROSCOPY. -HYSTEROSCOPIC FINDINGS (PRE AND POST-SURGERY): MATERIALS IN OSTIA OR OTHER PATHOLOGY WERE NOT OBSERVED. -LAPAROSCOPIC FINDINGS: PUNCTIFORM PROTUBERANCE IN ONE FALLOPIAN TUBE CORRESPONDING TO ESSURE PART. -THREE ESSURE COMPONENTS WERE REMOVED: METALLIC SPIRAL, GUIDANCE ROD (ALSO METALLIC), AND PLASTIC (POLYESTER) COMPONENT. -LAPAROSCOPIC EXTRACTION TECHNIQUE: AFTER HYSTEROSCOPY UNFEASIBILITY AS INTRACAVITARY ESSURE WAS NOT OBSERVED, IT CONSISTED ON BILATERAL SALPINGECTOMY USING BIPOLAR-MONOPOLAR COAGULATION AND SECTION, ENSURING TO AVOID DEVICE SECTION, IDENTIFYING AND HOLDING IT WITH GRASPING FORCEPS FOR ITS REMOVAL. THEN, WITH THE USE OF FINE DISSECTOR, THE SMALL INTRAMURAL ANATOMIC SPACE WHICH COMMUNICATES THE UTERUS WITH FALLOPIAN TUBE IS SECTIONED WITH THE OBJECTIVE OF ENSURING TOTAL EXTRACTION OF DEVICE AND AVOID LEAVING ANY MINUSCULE REMNANT OF IT. INTERVENTION WAS FINALIZED BY VERIFYING HEMOSTASIS USING ELECTROCOAGULATION IF NEEDED IN THE INTERVENED CORNUAL ZONE. AILMENTS OF PATIENT IMPROVED AFTER PROCEDURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451280 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R