BEUDAMED
    FDA Adverse Event Death Summary report: N

    ESSURE

    MDR report key: 6232484 · Received January 9, 2017

    Report

    Report Number
    2951250-2017-00104
    Event Type
    Death
    Date Received
    January 9, 2017
    Report Date
    February 4, 2020
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FATAL PREMATURE BABY ('BABY WAS BORN FOUR AND A HALF MONTHS EARLY AND LIVED ONLY (B)(6) DAYS') IN A NEONATE WHOSE MOTHER HAD INSERTED ESSURE DURING PREGNANCY. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: FOETAL EXPOSURE DURING PREGNANCY "EXPOSURE TO DEVICE IN UTERO". LAST MENSTRUAL PERIOD AND ESTIMATED DATE OF DELIVERY WERE NOT PROVIDED. THE NEONATE'S MOTHER WAS EXPOSED TO ESSURE DURING THE FIRST AND SECOND TRIMESTERS. ON AN UNKNOWN DATE, THE MOTHER HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE NEONATE WAS DIAGNOSED WITH PREMATURE BABY (SERIOUSNESS CRITERION DEATH). THE REPORTED CAUSE OF DEATH WAS PREMATURITY. AN AUTOPSY WAS NOT PERFORMED. THE REPORTER CONSIDERED PREMATURE BABY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TODAY WAS THE ONE YEAR ANNIVERSARY OF THE BIRTH AND DEATH OF AN ESSURE VICTIM. THE DAMAGE IS REAL. QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE.(MOTHER CASE). AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. AMENDMENT: THE REPORT WAS AMENDED FOR THE FOLLOWING REASON: THIS IS A DUPLICATE CASE OF CASE NUM (B)(4). THIS CASE SHOULD BE MARK FOR DELETION. NO NEW FOLLOW-UP INFORMATION WAS RECEIVED FROM THE REPORTER. THIS SPONTANEOUS NON-MEDICALLY CONFIRMED CASE REPORT WAS RECEIVED VIA LAY PRESS WITH VERY LIMITED INFORMATION. IT REFERS TO THE NEONATE OF A FEMALE CONSUMER WHO BECAME PREGNANT WITH ESSURE (FALLOPIAN TUBE OCCLUSION INSERT). THE BABY WAS BORN FOUR AND A HALF MONTHS EARLY AND LIVED ONLY (B)(6) DAYS. SEVERAL MATERNAL AND FETAL FACTORS MAY BE ASSOCIATED WITH PRETERM BIRTH. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. MOTHER´S MEDICAL HISTORY WAS NOT MENTIONED, NOR ANY NEONATE CONCURRENT CONDITION. RESPIRATORY FAILURE, INFECTION, AND CONGENITAL MALFORMATION ARE THE MAIN CAUSES ASSOCIATED WITH THE HIGH MORTALITY RATES IN EXTREME PREMATURE BABIES. IN THE PRESENT CASE, THE EXACT ETIOLOGY IS UNKNOWN. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE SERIOUS INJURY AND FATAL OUTCOME REPORTED. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED WITH NEITHER COMPLAINT SAMPLE NOR VALID LOT NUMBER. THUS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE AS IT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. FURTHER INFORMATION CANNOT BE OBTAINED DUE TO LACK OF REPORTER´S CONTACT INFORMATION.

    Additional Manufacturer Narrative · 1

    QUALITY-SAFETY EVALUATION OF PTC: SAMPLE NOT AVAILABLE. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, WE CANNOT EXCLUDE THE POSSIBILITY OF HAVING A TECHNICAL ISSUE INVOLVED IN THE COMPLAINT. THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE INEFFECTIVE.(MOTHER CASE). AS A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE A RELATIONSHIP WITH THE REPORTED MEDICAL EVENTS CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. SINCE NO BATCH NUMBER WAS REPORTED, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES IS NOT APPLICABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-JAN-2017: QUALITY SAFETY EVALUATION OF PTC. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED CASE REPORT WAS RECEIVED VIA LAY PRESS WITH VERY LIMITED INFORMATION. IT REFERS TO THE NEONATE OF A FEMALE CONSUMER WHO BECAME PREGNANT WITH ESSURE (FALLOPIAN TUBE OCCLUSION INSERT). THE BABY WAS BORN FOUR AND A HALF MONTHS EARLY AND LIVED ONLY FIVE DAYS. SEVERAL MATERNAL AND FETAL FACTORS MAY BE ASSOCIATED WITH PRETERM BIRTH. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. MOTHER´S MEDICAL HISTORY WAS NOT MENTIONED, NOR ANY NEONATE CONCURRENT CONDITION. RESPIRATORY FAILURE, INFECTION, AND CONGENITAL MALFORMATION ARE THE MAIN CAUSES ASSOCIATED WITH THE HIGH MORTALITY RATES IN EXTREME PREMATURE BABIES. IN THE PRESENT CASE, THE EXACT ETIOLOGY IS UNKNOWN. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE SERIOUS INJURY AND FATAL OUTCOME REPORTED. A PRODUCT TECHNICAL ANALYSIS WAS PERFORMED WITH NEITHER COMPLAINT SAMPLE NOR VALID LOT NUMBER. THUS, A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE AS IT CANNOT BE TOTALLY EXCLUDED. HOWEVER, THE REPORTED MEDICAL EVENTS ARE NOT INDICATIVE OF A QUALITY DEFICIT PER SE. FURTHER INFORMATION CANNOT BE OBTAINED DUE TO LACK OF REPORTER´S CONTACT INFORMATION.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A CONSUMER IN THE LAY PRESS, AND DESCRIBES THE OCCURRENCE OF PREMATURE BABY ("BABY WAS BORN FOUR AND A HALF MONTHS EARLY AND LIVED ONLY FIVE DAYS") IN A NEONATE EXPOSED TO ESSURE DURING PREGNANCY. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: FOETAL EXPOSURE DURING PREGNANCY ("EXPOSURE TO DEVICE IN UTERO"). ON AN UNKNOWN DATE, THE MOTHER STARTED ESSURE. THE NEONATE WAS EXPOSED TO ESSURE DURING THE FIRST AND SECOND TRIMESTERS OF PREGNANCY. THE NEONATE WAS A PREMATURE BABY (SERIOUS CRITERION DEATH). THE REPORTED CAUSE OF DEATH WAS PREMATURITY. AN AUTOPSY WAS NOT PERFORMED. THE REPORTER CONSIDERED PREMATURE BABY TO BE RELATED TO ESSURE. THIS CASE IS LINKED TO THE MOTHER CASE: (B)(4). COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS NON-MEDICALLY CONFIRMED CASE REPORT WAS RECEIVED VIA LAY PRESS WITH VERY LIMITED INFORMATION. IT REFERS TO THE NEONATE OF A FEMALE CONSUMER WHO BECAME PREGNANT WITH ESSURE (FALLOPIAN TUBE OCCLUSION INSERT). THE BABY WAS BORN FOUR AND A HALF MONTHS EARLY AND LIVED ONLY FIVE DAYS. SEVERAL MATERNAL AND FETAL FACTORS MAY BE ASSOCIATED WITH PRETERM BIRTH. IN THE PRESENT CASE, LIMITED INFORMATION WAS PROVIDED. MOTHER´S MEDICAL HISTORY WAS NOT MENTIONED, NOR ANY NEONATE CONCURRENT CONDITION. RESPIRATORY FAILURE, INFECTION, AND CONGENITAL MALFORMATION ARE THE MAIN CAUSES ASSOCIATED WITH THE HIGH MORTALITY RATES IN EXTREME PREMATURE BABIES. IN THE PRESENT CASE, THE EXACT ETIOLOGY IS UNKNOWN. THIS CASE WAS REGARDED AS INCIDENT DUE TO THE SERIOUS INJURY AND FATAL OUTCOME REPORTED. A PRODUCT TECHNICAL ANALYSIS IS EXPECTED. FURTHER INFORMATION CANNOT BE OBTAINED DUE TO LACK OF REPORTER´S CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18903 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA Death