BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7057157 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-08628
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    May 1, 2012
    Report Date
    September 19, 2018
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: SIDE OF FALLOPIAN TUBE") AND FALLOPIAN TUBE PERFORATION ("PERFORATION (OTHER) PLEASE DESCRIBE AND STATE THE LOCATION OF THE PERFORATION: RIGHT FALLOPIAN TUBE") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 12496680, 952114) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORMED". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HIGH CHOLESTEROL AND CHEST PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIONS AND DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED LISINOPRIL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS"). IN (B)(6) 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN PELVIC AREA"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND COMPLICATION OF DEVICE INSERTION ("THE GUN DID NOT RELEASE ANY COILS DURING (B)(6) 2012 ATTEMPTED IMPLANT"). THE PATIENT WAS TREATED WITH SURGERY (UNILATERAL SALPINGECTOMY - RIGHT SIDED, LAPAROSCOPIC LEFT TUBAL LIGATION USING BIPOLAR CAUTERY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, VAGINAL HEMORRHAGE, MENORRHAGIA, DEPRESSION, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHOEA, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY IN DATE OF INSERTION - (B)(6) 2012. ON (B)(6) 2012, THE GUN DID NOT RELEASE ANY COILS DURING (B)(6) 2012 ATTEMPTED IMPLANT: HE TRIED 2-3 TIMES BUT NOTHING SPRUNG OUT SO HE DECIDED TO CALL IT OFF. ON (B)(6) 2012, FAILED ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.5 KG/SQM. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 7-SEP-2018: PLAINTIFF FACT SHEET RECEIVED. EVENTS VAGINAL BLEEDING, MENORRHAGIA, DEPRESSION, DEVICE DISLOCATION, DYSMENORRHEA, VAGINAL DISCHARGE, PELVIC PAIN, FATIGUE, WEIGHT GAIN, RIGHT FALLOPIAN TUBE PERFORATION, ABDOMINAL PAIN, COMPLICATION OF DEVICE INSERTION AND DEVICE MONITORING PROCEDURE NOT PERFORMED WERE ADDED. LOT NUMBER & LAB DATA UPDATED. HISTORICAL & CONCOMITANT CONDITIONS DRUGS WERE UPDATED. PRODUCT, PATIENT & REPORTER INFORMATION UPDATED. INCIDENT: AT THE TIME OF REPORTING, 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.

    Additional Manufacturer Narrative · 0

    NTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF EMBEDDED DEVICE ("MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: SIDE OF FALLOPIAN TUBE") AND FALLOPIAN TUBE PERFORATION ("PERFORATION (OTHER) PLEASE DESCRIBE AND STATE THE LOCATION OF THE PERFORATION: RIGHT FALLOPIAN TUBE") IN A 40-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 12496680, 952114) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE MONITORING PROCEDURE NOT PERFORMED "ESSURE CONFIRMATION TEST NOT PERFORMED". THE PATIENT'S PAST MEDICAL HISTORY INCLUDED HIGH CHOLESTEROL AND CHEST PAIN. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: ORAL CONTRACEPTIVENOS AND DEPO PROVERA. CONCURRENT CONDITIONS INCLUDED OBESITY. CONCOMITANT PRODUCTS INCLUDED LISINOPRIL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). ON (B)(6) 2012, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). IN MAY 2012, THE PATIENT EXPERIENCED EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), VAGINAL DISCHARGE ("VAGINAL DISCHARGE"), FATIGUE ("FATIGUE") AND WEIGHT INCREASED ("WEIGHT GAIN / LOSS"). IN SEPTEMBER 2012, THE PATIENT EXPERIENCED DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN PELVIC AREA"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND COMPLICATION OF DEVICE INSERTION ("THE GUN DID NOT RELEASE ANY COILS DURING MAY2012 ATTEMPTED IMPLANT"). THE PATIENT WAS TREATED WITH SURGERY (UNILATERAL SALPINGECTOMY - RIGHT SIDED, LAPAROSCOPIC LEFT TUBAL LIGATION USING BIPOLAR CAUTERY) AND SURGERY (UNILATERAL SALPINGECTOMY - RIGHT SIDED, LAPAROSCOPIC LEFT TUBAL LIGATION USING BIPOLAR CAUTERY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, DYSMENORRHOEA, VAGINAL DISCHARGE, FATIGUE, WEIGHT INCREASED AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, COMPLICATION OF DEVICE INSERTION, DEPRESSION, DYSMENORRHOEA, EMBEDDED DEVICE, FALLOPIAN TUBE PERFORATION, FATIGUE, MENORRHAGIA, PELVIC PAIN, VAGINAL DISCHARGE, VAGINAL HAEMORRHAGE AND WEIGHT INCREASED TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: DISCREPANCY IN DATE OF INSERTION - (B)(6) 2012. ON (B)(6) 2012, THE GUN DID NOT RELEASE ANY COILS DURING MAY2012 ATTEMPTED IMPLANT: HE TRIED 2-3 TIMES BUT NOTHING SPRUNG OUT SO HE DECIDED TO CALL IT OFF. ON (B)(6) 2012, FAILED ESSURE PROCEDURE. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): BODY MASS INDEX WAS 31.5 KG/SQM. LOT NUMBER: 12496680, MANUFACTURE DATE: 2011/07, EXPIRATION DATE: 2014/04, LOT NUMBER: 952114, MANUFACTURE DATE: 2012/02, EXPIRATION DATE: 2015/02. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 18-SEP-2018: QUALITY SAFETY EVALUATION OF PTC INCIDENT AT THE TIME OF REPORTING, 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 SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF MEDICAL DEVICE REMOVAL ("UNDERWENT SURGERY TO REMOVE ESSURE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT UNDERWENT MEDICAL DEVICE REMOVAL (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE MEDICAL DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED MEDICAL DEVICE REMOVAL TO BE RELATED TO ESSURE. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834510 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 12496680, 952114

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other| R LISINOPRIL| LISINOPRIL