BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESSURE

    MDR report key: 6534827 · Received May 1, 2017

    Report

    Report Number
    2951250-2017-01855
    Event Type
    Malfunction
    Date Received
    May 1, 2017
    Report Date
    November 9, 2017
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A HEALTH PROFESSIONAL ((B)(6) # (B)(4)) AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES") AND COMPLICATION OF DEVICE INSERTION ("THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882192) INSERTED. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE PHYSICAL PROPERTY ISSUE "THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES" ON (B)(6) 2011. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DEVICE BREAKAGE AND COMPLICATION OF DEVICE INSERTION. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE AND COMPLICATION OF DEVICE INSERTION OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION AND DEVICE BREAKAGE WITH ESSURE. THE REPORTER COMMENTED: NO CLINICAL CONSEQUENCES OBSERVED. THE LIST OF SIMILAR CASES CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS WITH SIMILAR EVENTS CODED IN MEDDRA. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 13-OCT-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE BREAKAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED 1.803 CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 12-OCT-2017: QUALITY SAFETY EVALUATION, ENTRY OF FDA CODES, ADDITION OF PTC GLOBAL NUMBER REFERENCE, ADDITION OF BATCH INFORMATION(EXP AND MANUFACTURE DATES): UNABLE TO CONFIRM COMPLAINT. 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 · 1

    ON MARCH 3, 2017, BAYER RECEIVED A CLUSTER OF ESSURE COMPLAINT REPORTS ORIGINATING FROM THE ANSM, HEALTH AUTHORITY OF (B)(4), DEVICE VIGILANCE DATABASE VIA LEGAL PROCEEDINGS. FOLLOWING RECEIPT, BAYER CONSULTED ANSM IN ORDER TO OBTAIN THE RELEVANT CASE REFERENCE NUMBER INFORMATION. ON MARCH 24, 2017, ANSM PROVIDED THE AVAILABLE CORRESPONDING CASE REFERENCE NUMBERS TO BAYER. UPON RECEIPT OF THIS INFORMATION BAYER EVALUATED AND PROCESSED THE CLUSTER OF ESSURE REPORTS WITHIN THE GLOBAL SAFETY DATABASE BY APRIL 12, 2017.

    Additional Manufacturer Narrative · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY AN OTHER HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES"), COMPLICATION OF DEVICE INSERTION ("THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES") AND DEVICE PHYSICAL PROPERTY ISSUE ("THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882192) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DEVICE BREAKAGE, COMPLICATION OF DEVICE INSERTION AND DEVICE PHYSICAL PROPERTY ISSUE. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, COMPLICATION OF DEVICE INSERTION AND DEVICE PHYSICAL PROPERTY ISSUE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION, DEVICE BREAKAGE AND DEVICE PHYSICAL PROPERTY ISSUE WITH ESSURE. THE REPORTER COMMENTED: NO CLINICAL CONSEQUENCES OBSERVED. THE LIST OF DEVICE SIMILAR INCIDENTS CONTAINS ESSURE REPORTS RECEIVED BY BAYER AND OLDER CASES RECEIVED BY CONCEPTUS CODED WITH THE SAME MEDRA PREFERRED TERM. IN THIS PARTICULAR CASE A SEARCH IN THE DATABASE WAS PERFORMED ON 16-JUN-2017 FOR THE FOLLOWING MEDDRA PREFERRED TERM: DEVICE BREAKAGE. THE ANALYSIS IN THE GLOBAL SAFETY DATABASE REVEALED (B)(4) CASES. BAYER IS CLOSELY MONITORING THE BENEFIT-RISK PROFILE OF ESSURE. A RECENT CUMULATIVE REVIEW OF ALL AVAILABLE DATA ON ESSURE HAS NOT YIELDED ANY NEW SAFETY SIGNAL WITH REGARD TO THIS MEDDRA PT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-JUN-2017: NO FURTHER INFORMATION WAS RECEIVED AFTER FOLLOW-UP ATTEMPTS. COMPANY CAUSALITY COMMENT: 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 AN OTHER HEALTH PROFESSIONAL AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES"), COMPLICATION OF DEVICE INSERTION ("THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES") AND DEVICE PHYSICAL PROPERTY ISSUE ("THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES") IN A FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 882192) INSERTED. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON THE SAME DAY, THE PATIENT EXPERIENCED DEVICE BREAKAGE, COMPLICATION OF DEVICE INSERTION AND DEVICE PHYSICAL PROPERTY ISSUE. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE, COMPLICATION OF DEVICE INSERTION AND DEVICE PHYSICAL PROPERTY ISSUE OUTCOME WAS UNKNOWN. THE REPORTER PROVIDED NO CAUSALITY ASSESSMENT FOR COMPLICATION OF DEVICE INSERTION, DEVICE BREAKAGE AND DEVICE PHYSICAL PROPERTY ISSUE WITH ESSURE. THE REPORTER COMMENTED: NO CLINICAL CONSEQUENCES OBSERVED. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND DURING THE PROCEDURE THE OUTER SHEATH OF THE INTRODUCER OF THE ESSURE DEVICE BECAME PARTIALLY UNRAVELLED WITH A PHENOMENON OF CRUMBLING AND RELEASE OF SMALL PLASTIC PARTICLES. THIS EVENT IS ANTICIPATED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. AS THE EVENT OCCURRED DURING ESSURE INSERTION PROCEDURE, A CAUSAL RELATIONSHIP WITH THE SUSPECT INSERT CANNOT BE EXCLUDED. ALTHOUGH THERE WAS NO REPORTED DEATH OR SERIOUS HEALTH DETERIORATION, THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES AND THEREFORE CASE WAS REGARDED AS A REPORTABLE INCIDENT. A PRODUCT TECHNICAL ANALYSIS AND FURTHER INFORMATION ARE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317211 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 882192

    Patients

    Seq Age Sex Outcome Treatment
    1