BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 6662858 · Received June 23, 2017

    Report

    Report Number
    2951250-2017-02275
    Event Type
    Injury
    Date Received
    June 23, 2017
    Report Date
    July 31, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("UNILATERAL RIGHT PERFORATION") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED. 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 DIFFICULT TO USE "THE INSERTION WAS DIFFICULT DUE TO TUBAL SPASM" ON (B)(6) 2014. THE PATIENT'S PAST MEDICAL HISTORY INCLUDED GRAVIDA II, PARITY 1, C-SECTION, SPONTANEOUS ABORTION, UTERINE ABRASION AND CERVICAL DILATATION ON (B)(6) 2014. ECTOPIC PREGNANCIES WERE DENIED. THERE WERE NO ABNORMAL UTERINE FINDINGS PRIOR TO ESSURE INSERTION. CONCURRENT CONDITIONS INCLUDED ENDOMETRIOSIS AND PELVIC ADHESIONS. ON (B)(6) 2014, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE SPASM ("THE INSERTION WAS DIFFICULT DUE TO TUBAL SPASM") AND COMPLICATION OF DEVICE INSERTION ("THE INSERTION WAS DIFFICULT DUE TO TUBAL SPASM"). ON (B)(6) 2014, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (LAPAROSCOPIC SALPINGECTOMY AND MICROINSERT REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2014. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, FALLOPIAN TUBE SPASM AND COMPLICATION OF DEVICE INSERTION HAD RESOLVED. THE REPORTER CONSIDERED COMPLICATION OF DEVICE INSERTION, FALLOPIAN TUBE PERFORATION AND FALLOPIAN TUBE SPASM TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE HYSTEROSALPINOGRAM SHOWED ABNORMAL POSITION OF THE COILS. ESSURE REMOVAL WAS MEDICALLY NECESSARY. THE SPECIFIC ESSURE POSITION ON RIGHT WAS DIFFICULT TO ACCESS DUE TO ADHESIONS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 45.6 KG/SQM. HYSTEROSALPINGOGRAM - ON (B)(6) 2014: ABNORMAL PLACEMENT/SUSPECTED PERFORATION PATHOLOGY REPORT: ADHESIONS. 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 MICROINSERT. THIS CASE SERIES PRESENTS OUR TECHNIQUE OF LAPAROSCOPIC SALPINGECTOMY, UTILIZING ELECTROCAUTERY ON THE MICROINSERT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2017: PERFORATION QUESTIONNAIRE RECEIVED: PATIENT DEMOGRAPHIC DATE AND HISTORICAL/CONCOMITANT CONDITIONS ADDED. EVENT ADDED:THE INSERTION WAS DIFFICULT DUE TO TUBAL SPASM. ESSURE REMOVAL DETAILS PROVIDED. OUTCOME REPORTED AS RECOVERED/RESOLVED. 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.

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ("ABNORMAL PLACEMENT/SUSPECTED PERFORATION OF ONE MICROINSERT") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. 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. 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 SALPINGECTOMY AND MICROINSERT REMOVAL). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FALLOPIAN TUBE PERFORATION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: REMOVAL WAS PERFORMED DUE TO ABNORMAL FINDINGS ON HYSTEROSALPINGOGRAMS (ABNORMAL PLACEMENT/SUSPECTED PERFORATION OF ONE MICROINSERT). ABSTRACT : NICKEL-TITANIUM STERILIZATION MICROINSERTS ARE SURGICALLY REMOVED FOR VARIOUS INDICATIONS, INCLUDING PERSISTENT PAIN. PREVIOUSLY DESCRIBED REMOVAL TECHNIQUES INCLUDE SALPINGOSTOMY AND CORONECTOMY WITH JUDICIOUS USE OF ELECTROCAUTERY TO AVOID POTENTIAL INJURY TO ADJACENT STRUCTURES OR FRACTURING THE MICROINSERT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444939 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R