BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 7055888 · Received November 23, 2017

    Report

    Report Number
    2951250-2017-07691
    Event Type
    Injury
    Date Received
    November 23, 2017
    Date of Event
    September 1, 2017
    Report Date
    June 24, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF THE IMPLANT'), DEVICE BREAKAGE ('THERE ARE MULTIPLE FRAGMENTS OF METALLIC FOREIGN BODIES IN THE SPECIMEN') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISEASE') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 962114-INVALID,12520255) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "OTHER INJURY COMPLICATIONS: SHE COULDN¿T BE SURE THAT ALL 3 COILS WERE TOTALLY REMOVED" IN AUGUST 2017. THE PATIENT'S MEDICAL HISTORY INCLUDED DIAPHRAGM FROM 2009 TO MAY 2011, CONDOM IN 2012, NICOTINE DEPENDENCE, ANXIETY, DEPRESSION, MENARCHE (AGE 13), CESAREAN SECTION AND POST-TRAUMATIC STRESS DISORDER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA FROM 2006 TO 2007; FOR AN UNREPORTED INDICATION: PRENATAL VITAMINS. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ABDOMINAL PAIN LOWER WITH MIRENA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN: ABDOMEN"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: TINGLING IN EXTREMITIES"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: NUMBNESS IN EXTREMITIES") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ECZEMA ("RASHES OR SKIN CONDITIONS TYPE: ECZEMA") AND GRANULOMA ANNULARE ("RASHES OR SKIN CONDITIONS TYPE: GRANULOMA ANNULARE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE REMOVAL ("OTHER INJURY COMPLICATIONS: SHE COULDN¿T BE SURE THAT ALL 3 COILS WERE TOTALLY REMOVED"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTIONS NOS"), ABDOMINAL DISTENSION ("BLOATING") AND ASTHENIA ("WEAKNESS"). THE PATIENT WAS TREATED WITH SURGERY (ABDOMINAL SUPRACERVICAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, AUTOIMMUNE DISORDER, HYPERSENSITIVITY, HEADACHE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, FIBROMYALGIA, ECZEMA, GRANULOMA ANNULARE, MIGRAINE, TOOTH DISORDER, PARAESTHESIA, HYPOAESTHESIA, ASTHENIA, ALLERGY TO METALS, FATIGUE AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ASTHENIA, AUTOIMMUNE DISORDER, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, DEVICE DISLOCATION, ECZEMA, FATIGUE, FIBROMYALGIA, GRANULOMA ANNULARE, HEADACHE, HYPERSENSITIVITY, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, PARAESTHESIA, TOOTH DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEEDS ADDITIONAL SURGERY. INSERTION DETAIL: ESSURE WAS PLACED: THE DEVICE WAS IN GOOD POSITION WITH 4 TRAILING COILS ON THE LEFT SIDE. A SIMILAR TECHNIQUE WAS USED ON THE OPPOSITE SIDE WITH 6 TRAILING COILS ON THE RIGHT SIDE. RIGHT TUBE ESSURE PLACED BUT FAILED TO DEPLOY 2ND COIL (SIC). PATHOLOGY SPECIMEN REPORT REVEALED FALLOPIAN TUBES AT THE INSERTION POINT NEAR THE CORNU REVEALS COIL IN PLACE WITHIN THE FALLOPIAN TUBE AND TERMINATING AT THE CORNU BILATERALLY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. THERE WERE 2 COILS IN ONE FALLOPIAN TUBE AND 1 IN THE OTHER. FOR A TOTAL OF 3. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN, FATIGUE, PARESTHESIA, HYPOESTHESIA, MENORRHAGIA, MIGRAINE, ABDOMINAL PAIN." LOT NUMBER 962114 IS INVALID. LOT NUMBER:12520255 MANUFACTURE DATE: 2012-02 EXPIRATION DATE: 2014-08. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 24-JUN-2019: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF THE IMPLANT'), DEVICE BREAKAGE ('THERE ARE MULTIPLE FRAGMENTS OF METALLIC FOREIGN BODIES IN THE SPECIMEN') AND AUTOIMMUNE DISORDER ('AUTOIMMUNE DISEASE') IN A 31-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 12520255,962114) INSERTED FOR FEMALE STERILIZATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE USE ISSUE "OTHER INJURY COMPLICATIONS: SHE COULDN¿T BE SURE THAT ALL 3 COILS WERE TOTALLY REMOVED" IN (B)(6) 2017. THE PATIENT'S MEDICAL HISTORY INCLUDED DIAPHRAGM FROM 2009 TO MAY 2011, CONDOM IN 2012, TOBACCO USE DISORDER, CONTINUOUS USE, ANXIETY, DEPRESSION, MENARCHE (AGE 13), CESAREAN SECTION AND POST-TRAUMATIC STRESS DISORDER. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR BIRTH CONTROL: MIRENA FROM 2006 TO 2007; FOR AN UNREPORTED INDICATION: PRENATAL VITAMINS. PAST ADVERSE REACTIONS TO THE ABOVE PRODUCTS INCLUDED ABDOMINAL PAIN LOWER WITH MIRENA. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2012, THE PATIENT EXPERIENCED ABDOMINAL PAIN ("PAIN: ABDOMEN"), HEADACHE ("HEADACHES"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"), MIGRAINE ("MIGRAINES") AND FATIGUE ("FATIGUE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED FIBROMYALGIA ("AUTOIMMUNE DISORDER TYPE OF DISORDER: FIBROMYALGIA"), PARAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: TINGLING IN EXTREMITIES"), HYPOAESTHESIA ("NEUROLOGICAL CONDITIONS OR PROBLEMS TYPE: NUMBNESS IN EXTREMITIES") AND ALLERGY TO METALS ("NICKEL ALLERGY"). IN (B)(6) 2016, THE PATIENT EXPERIENCED TOOTH DISORDER ("DENTAL PROBLEMS"). IN (B)(6) 2017, THE PATIENT EXPERIENCED ECZEMA ("RASHES OR SKIN CONDITIONS TYPE: ECZEMA") AND GRANULOMA ANNULARE ("RASHES OR SKIN CONDITIONS TYPE: GRANULOMA ANNULARE"). IN (B)(6) 2017, THE PATIENT EXPERIENCED COMPLICATION OF DEVICE REMOVAL ("OTHER INJURY COMPLICATIONS: SHE COULDN¿T BE SURE THAT ALL 3 COILS WERE TOTALLY REMOVED"). IN (B)(6) 2017, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTIONS NOS"), ABDOMINAL DISTENSION ("BLOATING") AND ASTHENIA ("WEAKNESS"). THE PATIENT WAS TREATED WITH SURGERY (ABDOMINAL SUPRACERVICAL HYSTERECTOMY WITH BILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, DEVICE BREAKAGE, AUTOIMMUNE DISORDER, HYPERSENSITIVITY, HEADACHE, ABDOMINAL DISTENSION, VAGINAL HAEMORRHAGE, MENORRHAGIA, FIBROMYALGIA, ECZEMA, GRANULOMA ANNULARE, MIGRAINE, TOOTH DISORDER, PARAESTHESIA, HYPOAESTHESIA, ASTHENIA, ALLERGY TO METALS, FATIGUE AND COMPLICATION OF DEVICE REMOVAL OUTCOME WAS UNKNOWN AND THE ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, ABDOMINAL PAIN, ALLERGY TO METALS, ASTHENIA, AUTOIMMUNE DISORDER, COMPLICATION OF DEVICE REMOVAL, DEVICE BREAKAGE, DEVICE DISLOCATION, ECZEMA, FATIGUE, FIBROMYALGIA, GRANULOMA ANNULARE, HEADACHE, HYPERSENSITIVITY, HYPOAESTHESIA, MENORRHAGIA, MIGRAINE, PARAESTHESIA, TOOTH DISORDER AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEEDS ADDITIONAL SURGERY. INSERTION DETAIL: ESSURE WAS PLACED: THE DEVICE WAS IN GOOD POSITION WITH 4 TRAILING COILS ON THE LEFT SIDE. A SIMILAR TECHNIQUE WAS USED ON THE OPPOSITE SIDE WITH 6 TRAILING COILS ON THE RIGHT SIDE. RIGHT TUBE ESSURE PLACED BUT FAILED TO DEPLOY 2ND COIL (SIC). PATHOLOGY SPECIMEN REPORT REVEALED FALLOPIAN TUBES AT THE INSERTION POINT NEAR THE CORNU REVEALS COIL IN PLACE WITHIN THE FALLOPIAN TUBE AND TERMINATING AT THE CORNU BILATERALLY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2012: TOTAL BILATERAL OCCLUSION. THERE WERE 2 COILS IN ONE FALLOPIAN TUBE AND 1 IN THE OTHER. FOR A TOTAL OF 3. PREGNANCY TEST URINE - ON (B)(6) 2012: NEGATIVE. ¿CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD: PELVIC PAIN, FATIGUE, PARESTHESIA, HYPOESTHESIA, MENORRHAGIA, MIGRAINE, ABDOMINAL PAIN." MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-JUN-2019: PFS AND MR RECEIVED : THIS CASE IS MEDICALLY CONFIRMED. REPORTER INFORMATION WAS UPDATED. PATIENT DETAILS ADDED. LAB DATA WAS ADDED. HER HISTORICAL MEDICATION AND CONDITION WAS ADDED. ESSURE INSERTION DATE WAS UPDATED. ESSURE INDICATION WAS ADDED. ESSURE LOT NUMBER WAS ADDED. PER MEDICAL RECORD: THERE ARE MULTIPLE FRAGMENTS OF METALLIC FOREIGN BODIES IN THE SPECIMEN WERE ADDED. PER PLAINTIFF FACT SHEET FOLLOWING EVENTS: THERE ARE MULTIPLE FRAGMENTS OF METALLIC FOREIGN BODIES IN THE SPECIMEN, ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), FIBROMYALGIA, GRANULOMA ANNULARE, MIGRAINES, DENTAL PROBLEMS, TINGLING IN EXTREMITIES, NUMBNESS IN EXTREMITIES, WEAKNESS, NICKEL ALLERGY, FATIGUE, OTHER INJURY COMPLICATIONS: SHE COULDN'T¿T BE SURE THAT ALL 3 COILS WERE TOTALLY REMOVED AND PAIN: ABDOMEN WERE ADDED. SHE HAD RECOVERED FROM EVENT: PAIN: ABDOMEN. INCIDENT: WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WILL BE CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER NON-CONFORMANCES DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE AS A RESULT, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MIGRATION OF THE IMPLANT") AND AUTOIMMUNE DISORDER ("AUTOIMMUNE DISEASE") IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2017, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) WITH PELVIC PAIN, AUTOIMMUNE DISORDER (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), HYPERSENSITIVITY ("ALLERGIC REACTIONS NOS"), HEADACHE ("HEADACHES") AND ABDOMINAL DISTENSION ("BLOATING"). THE PATIENT WAS TREATED WITH SURGERY (TO REMOVE ESSURE IMPLANT). ESSURE WAS REMOVED ON (B)(6) 2017. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, AUTOIMMUNE DISORDER, HYPERSENSITIVITY, HEADACHE AND ABDOMINAL DISTENSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL DISTENSION, AUTOIMMUNE DISORDER, DEVICE DISLOCATION, HEADACHE AND HYPERSENSITIVITY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT NEED FOR ADDITIONAL SURGERY. INCIDENT. NO LOT NUMBER OR SAMPLE AVAILABLE FOR INVESTIGATION. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835689 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 962114-INVALID,12520255

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other| R