BEUDAMED
    FDA Adverse Event Summary report: N

    ESSURE

    MDR report key: 3872080 · Received May 29, 2014

    Report

    Report Number
    2951250-2014-00182
    Date Received
    May 29, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS GIVEN. FOLLOW-UP (B)(4) 2014: CONSUMER ANSWERED TO QUESTIONNAIRE. CONSUMER IS (B)(6) YEARS OLD, BODY MASS INDEX (B)(6). CONSUMER HAD NO PREVIOUS GYNECOLOGICAL PROBLEMS OR PROCEDURES, AND NO OTHER MEDICAL HISTORY OR CONCURRENT CONDITIONS. SHE HAD TWO PREVIOUS PREGNANCIES, WITH TWO NORMAL VAGINAL DELIVERIES, NO ABORTIONS, NO ECTOPIC PREGNANCIES. ESSURE WAS INSERTED IN (B)(6) 2012, YEARS AFTER PREGNANCY. CONSUMER HAS THREE ESSURE SERIAL NUMBERS SINCE WHEN DOCTOR WAS TRYING TO INSERT THEM, ONE OF THEM BROKE, IT WERE MODEL ESS305 ALL THREE OF THEM, WITH LOT NUMBERS 787226, 806702, 787226. CONSUMER HAD A MIRENA IUD LEFT IN PLACE AS BACK UP CONTRACEPTION, AND IT WAS NOT REMOVED UNTIL THE RIGHT FALLOPIAN TUBE AND COIL WERE REMOVED. HSG (HYSTEROSALPINGOGRAM) TEST WAS PERFORMED (DATE UNSPECIFIED), LEFT COIL WAS BLOCKED AND IN PLACE, RIGHT COIL RUPTURED THROUGH THE TUBE AND EMBEDDED IN SOFT TISSUE OF BOWEL. SYMPTOMS INCLUDED, IT HAD BEEN EXTREMELY PAINFUL THE FIRST THREE MONTHS AFTER ESSURE. SHE RETURNED TO HER DOCTOR TWICE WHEN HE STATED THAT WHEN HE WAS INSERTING THE COILS, TUBES WERE SPASMING, THAT WAS WHY SHE WAS HAVING THAT PAIN, BUT ACTUALLY IT WAS DUE TO RUPTURE. SHE USED TO HAVE A SHARP PAIN IN RIGHT AREA OF ABDOMEN. HER DOCTOR TOLD HER THAT IT WAS PIERCING WHEN BOWELS WOULD BE FULL AND THAT WAS WHERE THE COIL WAS EMBEDDED. IT WAS QUITE AWFUL. THE BOWEL WAS AFFECTED, NO OTHER ORGAN WAS AFFECTED. ON (B)(6) 2014, THE RIGHT COIL WAS REMOVED. THE REMAINING LEFT COIL WAS NOT PLANNED TO BE REMOVED, THE CONSUMER DID NOT WANT TO DO ANYTHING THAT WAS NOT MEDICALLY NECESSARY. NO OTHER DIAGNOSTIC TEST THAN HSG WAS DONE, THAT CONSUMER KNOWS OF. ESSURE WAS REMOVED BY LAPAROSCOPIC PROCEDURE, DOCTOR PERFORMED THE SURGERY WHEN HE FOUND OUT THAT THE COIL WAS BROKEN, HE HAD TO CALL A GENERAL SURGEON AS WELL. RIGHT SIDED TUBE WAS REMOVED ON (B)(6) 2014, ALONG WITH BROKEN COIL ON RIGHT SIDE ALONG WITH APPROXIMATELY ONE INCH SQUARE OF SOFT TISSUE OF THE BOWEL THAT WAS SURROUNDING IT. CONSUMER HAS X-RAYS, PICTURES OF THE SURGERY. CONSUMER STATED THERE WERE NO SYMPTOMS OF INFECTION, NO REDNESS AND INFLAMMATION. THE ESSURE WAS BROKEN ON RIGHT SIDE, SHE HAS PICTURES OF THAT. CONSUMER HAS RECOVERED, THE SYMPTOMS RESOLVED. CONSUMER ABSOLUTELY WOULD SAY THE CONDITION WAS CAUSED BY ESSURE, THAT WAS WHAT RUPTURED THE TUBE. IT CASTED HER DOUBLE SINCE A SURGEON HAD TO BE CALLED TO REMOVE THE BROKEN COIL. FOLLOW-UP INFORMATION RECEIVED ON (B)(4) 2014 FROM HEALTH CARE PROFESSIONAL: ESSURE WAS INSERTED FOR STERILIZATION ON (B)(6) 2011. CERVICAL DILATATION WAS PERFORMED. R (RIGHT) DIFFICULTY THREADING BUT IT DID NOT BREAK, RLG (RIGHT LOWER QUADRANT) PAIN SIMPLE, SIMPLE RIGHT OVARIAN CYST AND ENDOMETRIAL POLYPS WERE REPORTED AS ADVERSE EVENTS. IT WAS MENTIONED THAT 15-20 MINUTES WERE TAKEN FOR SPASM TO RELIEVE. ON (B)(6) 2013, HSG SHOWED LEFT SIDE IN PROPER PLACEMENT OF COIL AND NO SPILL NOTED. RIGHT SIDE SHOWED UNSATISFACTORY PLACEMENT OF COIL, DISTAL PLACEMENT >30M DISTANCE FROM THE PROXIMAL END OF THE INNER COIL TO THE CONTRAST FILL IN THE UTERINE CORNUA. ON (B)(6) 2014, MIRENA WAS REMOVED. LAPAROSCOPIC RIGHT SALPINGECTOMY AND REMOVAL OF INTRAPERITONEAL ESSURE DEVICE WERE ALSO PERFORMED- THE ESSURE SPRING WAS FOUND ADHERENT TO THE COLON AND THE FATTY EPIPLOICA OF THE ASCENDING. IT WAS SUPERFICIALLY EMBEDDED IN THE SEROSA OF FATTY TISSUES. ESSURE WAS IN THREE SEPARATE PIECES PRIOR TO THE REMOVAL. FU: RESULT AND ASSESSMENT OF THE PRODUCT TECHNICAL COMPLAINT INVESTIGATION RECEIVED ON (B)(4) 2014: THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: (B)(4) (GLOBAL) AND (B)(4) (LOCAL). FINAL ASSESSMENT: ALL LOT HISTORY RECORDS (LHR) REVIEWED. PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSIONS CAN BE DRAWN. MEDICAL ASSESSMENT: THE MEDICAL EVENT AS WELL AS THE REPORTED DISLOCATION OF THE DEVICE ARE POSSIBLE UNDESIRABLE EVENTS WITH THE USE OF ESSURE AND NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. TWO (2) ADDITIONAL AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER 787226 BUT NONE OF THESE CASES REFERS TO ANY SIMILAR TYPE OF MEDICAL EVENT. FIVE (5) ADDITIONAL AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER 806702 BUT NONE OF THESE CASES REFERS TO ANY SIMILAR TYPE OF MEDICAL EVENT. NO BATCH SIGNAL COULD BE IDENTIFIED FOR EITHER BATCH AT THIS TIME. THE REVIEW OF THE LOT HISTORY RECORDS FOR BOTH BATCHES CONFIRMED THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS FOR EACH BATCH. 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 REPORT REFERS TO A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND HER TUBE HAD RUPTURED, THE COIL EMBEDDED ITSELF IN THE SOFT TISSUE OF MY BOWEL AND THAT'S WHERE COIL WAS EMBEDDED. IT WAS PIERCING WHEN BOWELS WOULD BE FULL AND THATS WHERE COIL WAS EMBEDDED IS SERIOUS AS MEDICALLY SIGNIFICANT AND UNLISTED EVENT ACCORDING TO REFERENCE SAFETY INFORMATION FOR ESSURE. RUPTURED MY TUBE AND THE COIL EMBEDDED ITSELF IN THE SOFT TISSUE OF MY BOWEL ARE SERIOUS AND LISTED EVENTS. EVENTS WERE CONSIDERED INCIDENT AND A SURGICAL REMOVAL WAS NECESSARY. ALL EVENTS WERE CONSIDERED RELATED TO ESSURE. ADDITIONALLY, THE NON-SERIOUS EVENTS WERE REPORTED: COIL WAS BROKEN, WHEN HE WAS INSERTING THE COILS, TUBES WERE SPASMING, I HAD MIRENA LEFT IN PLACE AND IT WAS NOT REMOVED UNTIL RIGHT FALLOPIAN TUBE AND COIL WAS REMOVED, R DIFFICULTY THREADING BUT IT DID NOT BREAK, RLQ PAIN, ENDOMETRIAL POLYP AND SIMPLE RIGHT OVARIAN CYST. PTC FINAL ASSESSMENT: BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT. EVALUATION SUMMARY: FINAL ASSESSMENT: ALL LOT HISTORY RECORDS (LHR) REVIEWED. PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO DEVICE RETURNED; THEREFORE, NO DEVICE INVESTIGATION COULD BE COMPLETED. NO CONCLUSION CAN BE DRAWN.

    Additional Manufacturer Narrative · 1

    DATA CORRECTION FOR US REPORTING: THE CODE KNH WAS REPLACED WITH HHS.

    Description of Event or Problem · 1

    WHEN HE WAS INSERTING THE COILS, TUBES WERE SPASMING [DEVICE INSERTION DIFFICULT] R DIFFICULTY THREADING BUT IT DID NOT BREAK [DEVICE DIFFICULT TO USE] RUPTURED MY TUBE [FALLOPIAN TUBE PERFORATION] (PAIN, ABDOMINAL PAIN LOCALISED). IT WAS PIERCING WHEN BOWELS WOULD BE FULL AND THATS WHERE COIL WAS EMBEDDED (TRAUMATIC INTESTINAL PERFORATION). WHEN HE WAS INSERTING THE COILS, TUBES WERE SPASMING (FALLOPIAN TUBE SPASM). RLQ (RIGHT LOWER QUADRANT) PAIN (RIGHT LOWER QUADRANT PAIN) THE COIL EMBEDDED ITSELF IN THE SOFT TISSUE OF MY BOWEL (DEVICE DISLOCATION INTO ABDOMINAL CAVITY) COIL WAS BROKEN (DEVICE BREAKAGE). CASE DESCRIPTION: SERIOUS, RELATED, UNLISTED (INCIDENT). THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A CONSUMER VIA REGULATORY AUTHORITY (CASE# (B)(4)) IN UNITED STATES ON (B)(6) 2014 REFERRING TO HERSELF. THE FEMALE CONSUMER OF UNSPECIFIED AGE HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED RUPTURED MY TUBE AND THE COIL EMBEDDED ITSELF IN THE SOFT TISSUE OF MY BOWEL. NO INFORMATION GIVEN ON CONSUMER'S HISTORY, PAST DRUGS, CONCURRENT CONDITIONS AND CONCOMITANT MEDICATION RECEIVED. ON (B)(6) 2012 THE CONSUMER HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED, LOT NUMBER 787226. ON AN UNSPECIFIED DATE, THE CONSUMER STATED THAT ESSURE RUPTURED HER TUBE AND THE COIL EMBEDDED ITSELF IN THE SOFT TISSUE OF HER BOWEL. ESSURE WAS REMOVED ON (B)(6) 2014 (REMOVAL METHOD NOT PROVIDED). NO FURTHER INFORMATION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316792 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 787226, 806702, 787226

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other