BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 3955141 · Received July 10, 2014

    Report

    Report Number
    2951250-2014-00272
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    January 19, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(4) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC) . (B)(4). FINAL ASSESSMENT: SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT AT THIS TIME. MEDICAL ASSESSMENT: THIS CASE REPORTED A DEPLOYMENT ISSUE DUE TO ONE (1) OF THE DEVICES COMPLETELY UNCOILING. THIS EVENT IS A POSSIBLE UNDESIRABLE EVENT WITH THE USE OF ESSURE AND IS NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. ONE (1) ADDITIONAL AE CASE REPORT HAS BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER 897492 WHICH ALSO REFERS TO A DEPLOYMENT ISSUE EVENT NO BATCH SIGNAL CAN BE IDENTIFIED AT THIS TIME. THE REVIEW OF THE LOT HISTORY RECORDS CONFIRMED THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION. 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. FOLLOW-UP FROM (B)(4) 2014: THE REQUIRED NUMBER OF FOLLOW-UP ATTEMPTS HAVE BEEN MADE, WITH NO RESPONSE TO DATE. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT; REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE ESSURE DEVICE UNCOILED INSIDE THE RIGHT FALLOPIAN TUBE. THE REPORTER DID NOT PROVIDE CAUSALITY ASSESSMENT. THE REPORTED EVENT, INTERPRETED AS A DEVICE DEPLOYMENT ISSUE IS LISTED ACCORDING TO REFERENCE SAFETY INFORMATION FOR ESSURE AND WAS CONSIDERED AS SERIOUS AND AN INCIDENT DUE TO RIGHT FALLOPIAN TUBE REMOVAL (REQUIRED INTERVENTION). DURING DIFFICULT INSERTIONS, ESSURE MICRO-INSERT PLACEMENT ATTEMPT MAY BE NOT SUCCESSFUL. IN THIS PARTICULAR CASE, IT WAS ONLY REPORTED THAT ESSURE COMPLETELY UNCOILED INSIDE THE RIGHT FALLOPIAN TUBE, CONTRIBUTORY CONDITIONS TO THIS EVENT WERE NOT PROVIDED; HOWEVER CONSIDERING THAT IT OCCURRED DURING THE INSERTION PROCEDURE, IT WAS CONSIDERED AS RELATED TO ESSURE THERAPY. A PRODUCT TECHNICAL COMPLAINT ANALYSIS WAS PERFORMED AND CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FOLLOW-UP INFORMATION WAS RECEIVED ON 09-JUL-2014. PATIENTS WEIGHT AND HEIGHT WERE PROVIDED. CONCOMITANT CONDITION INCLUDED OBESITY ((B)(6)). SHE DENIED ANY PREVIOUS GYNECOLOGICAL INTERVENTIONS, GYNECOLOGICAL PROBLEMS OR PROCEDURES. ON (B)(6) 2014 ESSURE LOT NUMBER B97492 AND EXPIRATION DATE NOV-2016 WAS EASILY INSERTED. CERVICAL DILATATION, SOUNDING, ANALGESIA AND GENERAL ANESTHESIA WERE APPLIED DURING INSERTION. THE VISUALIZATION OF THE TUBAL OSTIUM WAS EASY. FLUID LOSS DURING HYSTEROSCOPY WAS LESS THAN 1500 CC AND THE PROCEDURE DID NOT TAKE MORE THAN 20 MINUTES. NO IMAGING TESTS WERE PERFORMED TO CONFIRM ESSURE PLACEMENT. DEPO PROVERA WAS USED AS BACK-UP CONTRACEPTION. PHYSICIAN MEDICALLY CONFIRMED THE EVENTS. IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR BLOOD PRESSURE ISSUES. LAPAROSCOPY AND REMOVAL OF RIGHT FALLOPIAN TUBE AND ESSURE ON RIGHT HAS BEEN DONE. THE REMOVAL WAS NOT MEDICALLY NECESSARY. THE REPORTER CONSIDERED THE EVENTS RELATED TO ESSURE BECAUSE THE ESSURE DID NOT RELEASE PROPERLY. NO FURTHER INFORMATION WAS PROVIDED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT; REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE ESSURE DEVICE UNCOILED INSIDE THE RIGHT FALLOPIAN TUBE AND BLOOD PRESSURE ISSUES. THE REPORTED EVENT, INTERPRETED AS A DEVICE DEPLOYMENT ISSUE IS LISTED ACCORDING TO REFERENCE SAFETY INFORMATION FOR ESSURE AND WAS CONSIDERED AS SERIOUS. THE OTHER EVENT BLOOD PRESSURE ISSUES WAS CONSIDERED SERIOUS DUE TO HOSPITALIZATION REPORTED AND IS UNLISTED. THIS CASE WAS REGARDED INCIDENT DUE TO RIGHT FALLOPIAN TUBE REMOVAL (REQUIRED INTERVENTION). DURING DIFFICULT INSERTIONS, ESSURE MICRO-INSERT PLACEMENT ATTEMPT MAY BE NOT SUCCESSFUL. IN THIS PARTICULAR CASE, IT WAS ONLY REPORTED THAT ESSURE COMPLETELY UNCOILED INSIDE THE RIGHT FALLOPIAN TUBE, CONTRIBUTORY CONDITIONS TO THIS EVENT WERE NOT PROVIDED; HOWEVER CONSIDERING THAT IT OCCURRED DURING THE INSERTION PROCEDURE, IT WAS CONSIDERED AS RELATED TO ESSURE THERAPY. BLOOD PRESSURE ISSUES WAS CONSIDERED UNRELATED TO ESSURE THERAPY. A PRODUCT TECHNICAL COMPLAINT ANALYSIS WAS PERFORMED AND CONCLUDED THAT BASED ON THE INFORMATION AVAILABLE, THERE IS NO REASON TO SUSPECT A QUALITY DEFECT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A SURGERY CENTER IN UNITED STATES ON (B)(4) 2014 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND EXPERIENCED THE ADVERSE EVENTS AS DESCRIBED BELOW. ESSURE WAS INSERTED ON (B)(6) 2014 FOR STERILIZATION 2: (LOT NUMBER WAS B97492). SURGERY CENTER CALLED TO REQUEST REPLACEMENT FOR ONE ESSURE DEVICE AND REPORTED THAT ESSURE DEVICE COMPLETELY UNCOILED INSIDE THE RIGHT FALLOPIAN TUBE. THE SURGEON REMOVED THE RIGHT FALLOPIAN TUBE AND THEY HAD THE DEVICE AVAILABLE FOR RETURN. THE LEFT INSERTION WAS FINE. PATIENT WAS ASLEEP .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404105 ESSURE INSERT, TUBAL OCCLUSION HHS BAYER PHARMA AG ESS305 B97492

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other