BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 9871113 · Received March 24, 2020

    Report

    Report Number
    2951250-2020-02697
    Event Type
    Injury
    Date Received
    March 24, 2020
    Report Date
    April 2, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('ON INSPECTION OF THE LEFT TUBE, THE DEVICE WAS VISIBLE EXTENDING FROM THE TUBE INTO THE BLADDER'), BLADDER PERFORATION ('LEFT ESSURE MIGRATED INTO THE BLADDER DUE TO TISSUE REACTION'), DEVICE BREAKAGE ('DURING REMOVAL OF THE ESSURE, IT BROKE INTO TWO PIECES'), ABDOMINAL ADHESIONS ('ADHESIONS BETWEEN THE ASCENDING COLON, APPENDIX AND RIGHT FALLOPIAN TUBE, AND ALSO BETWEEN THE SIGMOID AND THE LEFT ADNEXA') AND CALCULUS BLADDER ('BLADDER STONE FORMED AROUND ESSURE DEVICE') IN A 47-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: D.M. VAN GASTEL, R.A. SMIT, J.W. VAN DER STEEG, BLADDER SYMPTOMS DUE TO PERFORATED ESSURE, NETHERLANDS JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 2020, 103:1-8. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "THE LEFT IMPLANT CURLED UP DURING INSERTION" AND DEVICE DIFFICULT TO USE "DIFFICULT INSERTION". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY (2), PARITY 2, TYPE 2 DIABETES MELLITUS, HYPERTENSION, HYPERCHOLESTEROLEMIA AND ADHESIVE TAPE ALLERGY. CONCURRENT CONDITIONS INCLUDED POSTMENOPAUSE. CONCOMITANT PRODUCTS INCLUDED METFORMIN AND SIMVASTATIN. 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), BLADDER PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL ADHESIONS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CALCULUS BLADDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("PAINFUL INSERTION ON THE LEFT SIDE") AND COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"). THE PATIENT WAS TREATED WITH SURGERY (ADHESIOLYSIS, CORNUAL EXCISION, CYSTOSCOPY AND LITHOTRIPSY AND CYSTOSCOPY, HYSTEROSCOPY, LAPAROSCOPY, AND UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, BLADDER PERFORATION, DEVICE BREAKAGE, ABDOMINAL ADHESIONS AND CALCULUS BLADDER HAD RESOLVED AND THE PROCEDURAL PAIN AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL ADHESIONS, BLADDER PERFORATION, CALCULUS BLADDER, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, FALLOPIAN TUBE PERFORATION AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT WAS REFERRED TO A UROLOGIST BY HER GENERAL PRACTITIONER IN CONNECTION WITH RECURRENT URINARY TRACT INFECTIONS AND BLADDER SYMPTOMS. THE BLADDER SYMPTOMS WERE: INCREASED URGENCY TO URINATE, STRANGURY, FREQUENT MACROHEMATURIA AND A CONTINUOUS SENSATION OF PRESSURE IN HER BLADDER. A DIFFICULT INSERTION WAS REPORTED, SO A SECOND PROCEDURE HAD TO BE PERFORMED. THE FIRST TIME, IT WAS INSERTED ON THE RIGHT AND NOT THE LEFT BECAUSE THE IMPLANT CURLED UP. ONE WEEK LATER, THE DEVICE WAS INSERTED ON THE LEFT SIDE WITHOUT ANY COMPLICATIONS. IT WAS AGREED TO PERFORM HYSTEROSALPINGOGRAPHY (HSG) THREE MONTHS AFTER INSERTION. HOWEVER, THE PATIENT MISSED SEVERAL APPOINTMENTS. FURTHER DIAGNOSTIC PROCEDURES WERE INITIATED BECAUSE OF SUSPECTED KIDNEY STONES. IT WAS SUSPECTED THAT THE LEFT ESSURE PERFORATED DURING INSERTION AND THEN MIGRATED INTO THE BLADDER DUE TO TISSUE REACTION. A COMBINED SURGICAL PROCEDURE WAS SCHEDULED FOR THE PATIENT, INCLUDING CYSTOSCOPY, HYSTEROSCOPY, AND LAPAROSCOPY. DURING THE HYSTEROSCOPY, THE UROLOGIST PERFORMED LITHOTRIPSY OF THE BLADDER STONE, THE PERFORATED PART OF THE ESSURE IN THE BLADDER WAS LIKEWISE REMOVED. IN THE LAPAROSCOPY, ADHESIOLYSIS WAS PERFORMED FIRST BETWEEN THE ASCENDING COLON, APPENDIX AND RIGHT FALLOPIAN TUBE, AND ALSO BETWEEN THE SIGMOID AND THE LEFT ADNEXA. IN VIEW OF THE ATYPICAL APPEARANCE OF THE APPENDIX AND SUSPICION OF A FISTULA, THE DECISION WAS MADE TO PERFORM AN APPENDECTOMY. TO CHECK FOR REMOVAL OF THE MARKERS, TRANSILLUMINATION WAS PERFORMED DURING THE PROCEDURE. FINALLY, NO FURTHER PIECES OF THE MARKER REMAINED VISIBLE.THE POSTSURGICAL RECOVERY WAS UNCOMPLICATED, AND THE PATIENT CAME IN SIX WEEKS LATER FOR FOLLOW-UP. SHE HAD NO FURTHER BLADDER SYMPTOMS AND WAS HIGHLY SATISFIED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CYSTOSCOPY - ON AN UNKNOWN DATE: NORMAL OSTIA WERE SEEN ON BOTH SIDES, AS WELL AS A BLADDER STONE ABOUT 2 CM IN SIZE, ALONG WITH PERFORATION OF THE ESSURE THROUGH THE BLADDER WALL. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RIGHT ESSURE IN THE CORRECT POSITION IN THE RIGHT HORN AND FALLOPIAN TUBE. THE LEFT ESSURE WAS NOT VISIBLE, THERE WERE NO SIGNS OF ANY OTHER PATHOLOGY. X-RAY - ON AN UNKNOWN DATE: THE IMAGE SEEN WAS THAT OF A LARGE CALCIFICATION LOW IN THE PELVIS, PRESUMABLY CONTAINING ONE OF THE MARKERS OF THE LEFT ESSURE. THE ESSURE ON THE RIGHT WAS NORMALLY POSITIONED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-MAR-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS LITERATURE CASE DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('ON INSPECTION OF THE LEFT TUBE, THE DEVICE WAS VISIBLE EXTENDING FROM THE TUBE INTO THE BLADDER'), BLADDER PERFORATION ('LEFT ESSURE MIGRATED INTO THE BLADDER DUE TO TISSUE REACTION'), DEVICE BREAKAGE ('DURING REMOVAL OF THE ESSURE, IT BROKE INTO TWO PIECES'), ABDOMINAL ADHESIONS ('ADHESIONS BETWEEN THE ASCENDING COLON, APPENDIX AND RIGHT FALLOPIAN TUBE, AND ALSO BETWEEN THE SIGMOID AND THE LEFT ADNEXA') AND CALCULUS BLADDER ('BLADDER STONE FORMED AROUND ESSURE DEVICE') IN A (B)(6) YEAR OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. LITERATURE REFERENCE: D.M. VAN GASTEL, R.A. SMIT, J.W. VAN DER STEEG, BLADDER SYMPTOMS DUE TO PERFORATED ESSURE, NETHERLANDS JOURNAL OF OBSTETRICS AND GYNAECOLOGY, 2020, 103:1-8. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "THE LEFT IMPLANT CURLED UP DURING INSERTION" AND DEVICE DIFFICULT TO USE "DIFFICULT INSERTION". THE PATIENT'S MEDICAL HISTORY INCLUDED VAGINAL DELIVERY (2), PARITY 2, TYPE 2 DIABETES MELLITUS, HYPERTENSION, HYPERCHOLESTEROLEMIA AND ADHESIVE TAPE ALLERGY. CONCURRENT CONDITIONS INCLUDED POSTMENOPAUSE. CONCOMITANT PRODUCTS INCLUDED METFORMIN AND SIMVASTATIN. 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), BLADDER PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL ADHESIONS (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), CALCULUS BLADDER (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PROCEDURAL PAIN ("PAINFUL INSERTION ON THE LEFT SIDE") AND COMPLICATION OF DEVICE REMOVAL ("COMPLICATION OF DEVICE REMOVAL"). THE PATIENT WAS TREATED WITH SURGERY (ADHESIOLYSIS, CORNUAL EXCISION, CYSTOSCOPY AND LITHOTRIPSY AND CYSTOSCOPY, HYSTEROSCOPY, LAPAROSCOPY, AND UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, BLADDER PERFORATION, DEVICE BREAKAGE, ABDOMINAL ADHESIONS AND CALCULUS BLADDER HAD RESOLVED AND THE PROCEDURAL PAIN AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL ADHESIONS, BLADDER PERFORATION, CALCULUS BLADDER, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, FALLOPIAN TUBE PERFORATION AND PROCEDURAL PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT WAS REFERRED TO A UROLOGIST BY HER GENERAL PRACTITIONER IN CONNECTION WITH RECURRENT URINARY TRACT INFECTIONS AND BLADDER SYMPTOMS. THE BLADDER SYMPTOMS WERE: INCREASED URGENCY TO URINATE, STRANGURY, FREQUENT MACROHEMATURIA AND A CONTINUOUS SENSATION OF PRESSURE IN HER BLADDER. A DIFFICULT INSERTION WAS REPORTED, SO A SECOND PROCEDURE HAD TO BE PERFORMED. THE FIRST TIME, IT WAS INSERTED ON THE RIGHT AND NOT THE LEFT BECAUSE THE IMPLANT CURLED UP. ONE WEEK LATER, THE DEVICE WAS INSERTED ON THE LEFT SIDE WITHOUT ANY COMPLICATIONS. IT WAS AGREED TO PERFORM HYSTEROSALPINGOGRAPHY (HSG) THREE MONTHS AFTER INSERTION. HOWEVER, THE PATIENT MISSED SEVERAL APPOINTMENTS. FURTHER DIAGNOSTIC PROCEDURES WERE INITIATED BECAUSE OF SUSPECTED KIDNEY STONES. IT WAS SUSPECTED THAT THE LEFT ESSURE PERFORATED DURING INSERTION AND THEN MIGRATED INTO THE BLADDER DUE TO TISSUE REACTION. A COMBINED SURGICAL PROCEDURE WAS SCHEDULED FOR THE PATIENT, INCLUDING CYSTOSCOPY, HYSTEROSCOPY, AND LAPAROSCOPY. DURING THE HYSTEROSCOPY, THE UROLOGIST PERFORMED LITHOTRIPSY OF THE BLADDER STONE, THE PERFORATED PART OF THE ESSURE IN THE BLADDER WAS LIKEWISE REMOVED. IN THE LAPAROSCOPY, ADHESIOLYSIS WAS PERFORMED FIRST BETWEEN THE ASCENDING COLON, APPENDIX AND RIGHT FALLOPIAN TUBE, AND ALSO BETWEEN THE SIGMOID AND THE LEFT ADNEXA. IN VIEW OF THE ATYPICAL APPEARANCE OF THE APPENDIX AND SUSPICION OF A FISTULA, THE DECISION WAS MADE TO PERFORM AN APPENDECTOMY. TO CHECK FOR REMOVAL OF THE MARKERS, TRANSILLUMINATION WAS PERFORMED DURING THE PROCEDURE. FINALLY, NO FURTHER PIECES OF THE MARKER REMAINED VISIBLE. THE POSTSURGICAL RECOVERY WAS UNCOMPLICATED, AND THE PATIENT CAME IN SIX WEEKS LATER FOR FOLLOW-UP. SHE HAD NO FURTHER BLADDER SYMPTOMS AND WAS HIGHLY SATISFIED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): CYSTOSCOPY - ON AN UNKNOWN DATE: NORMAL OSTIA WERE SEEN ON BOTH SIDES, AS WELL AS A BLADDER STONE ABOUT 2 CM IN SIZE, ALONG WITH PERFORATION OF THE ESSURE THROUGH THE BLADDER WALL. ULTRASOUND SCAN VAGINA - ON AN UNKNOWN DATE: RIGHT ESSURE IN THE CORRECT POSITION IN THE RIGHT HORN AND FALLOPIAN TUBE. THE LEFT ESSURE WAS NOT VISIBLE, THERE WERE NO SIGNS OF ANY OTHER PATHOLOGY. X-RAY - ON AN UNKNOWN DATE: THE IMAGE SEEN WAS THAT OF A LARGE CALCIFICATION LOW IN THE PELVIS, PRESUMABLY CONTAINING ONE OF THE MARKERS OF THE LEFT ESSURE. THE ESSURE ON THE RIGHT WAS NORMALLY POSITIONED. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338985 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other| R METFORMIN| METFORMIN| SIMVASTATIN| SIMVASTATIN