BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 11875819 · Received May 25, 2021

    Report

    Report Number
    2951250-2021-02412
    Event Type
    Injury
    Date Received
    May 25, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('ESSURE DEVICE ON THE RIGHT PROJECTS OVER THE RIGHT UTERINE FUNDUS AND LEFT ESSURE PROJECTS OVER A LOOP OF BOWEL WITHIN THE LEFT LOWER QUADRANT OF THE ABDOMEN.') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 637222, 654841) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ULCERATIVE COLITIS, CONDYLOMA ACUMINATUM, MIGRAINE, BUNIONECTOMY, COLECTOMY AND MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED DYSMENORRHEA, INSOMNIA, ESOPHAGEAL REFLUX, CYSTITIS, UTI, BACK PAIN AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN") AND PSYCHOLOGICAL TRAUMA ("PSYCH. INJURY"). THE PATIENT WAS TREATED WITH SURGERY (THERMACHOICE 3 BALLOON ABLATION). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT- NO RINGS VISIBLE OUTSIDE THE FALLOPIAN TUBE BUT THE RINGS WERE VISIBLE JUST AT THE OPENING, LEFT- 5 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2019: IMPRESSION: 1. NONOBSTRUCTING RIGHT NEPHROLITHIASIS. 2. ABNORMALLY POSITIONED LEFT ESSURE DEVICE AS DESCRIBED ABOVE, PROJECTING OVER BOWEL AND EXTENDING INTO A BOWEL FOLD WITHOUT DEFINITIVELY PENETRATING THE BOWEL WALL. 3. TWO BOWEL NODULES COMPOSED OF MACROSCOPIC FAT NEAR THE PROXIMAL BOWEL SURGICAL ANASTOMOSIS, PROBABLE SMALL LIPOMAS. 4. INTACT PROXIMAL AND DISTAL BOWEL ANASTOMOSIS.. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: 1. NO EVIDENCE OF INTRAMURAL OR INTRALUMINAL ABNORMALITY OF THE UTERINE CAVITY. 2. NO EVIDENCE OF CONTRAST EXTRAVASATION OR SPILLAGE INTO THE ADNEXA BILATERALLY. 3. NO CONTRAST DEMONSTRATION OF BOTH FALLOPIAN TUBES 4. STABLE PERSISTENT SUPEROLATERAL LOCATION OF THE LEFT ESSURE DEVICE RELATIVE TO THE UTERUS. 5. FINDINGS CONSISTENT WITH BILATERAL FALLOPIAN TUBE OCCLUSION. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION. LOT NUMBER: 637222 MANUFACTURING DATE: 2009-04 EXPIRATION DATE: 2012-04. LOT NUMBER: 654841 MANUFACTURING DATE: 2009-07 EXPIRATION DATE: 2012-07. QUALITY-SAFETY EVALUATION OF PTC: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL COMPONENT BATCHES USED FOR MANUFACTURING OF THIS PRODUCT BATCH FULFILLED THE SET SPECIFICATIONS. BATCH DOCUMENTATION DID NOT REVEAL ANY DEVIATIONS DURING THE MANUFACTURING PROCESS THAT COULD HAVE CAUSED THE DESCRIBED COMPLAINT REASON. TREND ANALYSES OF COMPLAINTS ARE REVIEWED REGULARLY, NO SIGNAL WAS OBSERVED WITH REGARD TO THE REPORTED COMPLAINT REASON. THE RISK MANAGEMENT FILE WAS REVIEWED AND AN UPDATE WAS NOT DEEMED REQUIRED. A TECHNICAL INVESTIGATION OF THE COMPLAINT SAMPLE COULD NOT BE CONDUCTED, AS NO SAMPLE WAS AVAILABLE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2021: QUALITY SAFETY EVALUATION OF PRODUCT TECHNICAL COMPLAINT. WE RECEIVED A LOT NUMBER IN THIS CASE. A TECHNICAL INVESTIGATION WAS CONDUCTED, INCLUDING A BATCH REVIEW, AND A REVIEW OF COMPLAINT RECORDS AND OTHER RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, 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 ('ESSURE DEVICE ON THE RIGHT PROJECTS OVER THE RIGHT UTERINE FUNDUS AND LEFT ESSURE PROJECTS OVER A LOOP OF BOWEL WITHIN THE LEFT LOWER QUADRANT OF THE ABDOMEN.') AND GENITAL HAEMORRHAGE ('ABNORMAL BLEEDING') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 637222, 654841) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED ULCERATIVE COLITIS, CONDYLOMA ACUMINATUM, MIGRAINE, BUNIONECTOMY, COLECTOMY AND MULTIPAROUS. CONCURRENT CONDITIONS INCLUDED DYSMENORRHEA, INSOMNIA, ESOPHAGEAL REFLUX, CYSTITIS, UTI, BACK PAIN AND MENORRHAGIA. CONCOMITANT PRODUCTS INCLUDED ORAL CONTRACEPTIVE NOS. ON (B)(6) 2009, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), GENITAL HAEMORRHAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PAIN") AND PSYCHOLOGICAL TRAUMA ("PSYCH. INJURY"). THE PATIENT WAS TREATED WITH SURGERY (THERMACHOICE 3 BALLOON ABLATION). AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN AND PSYCHOLOGICAL TRAUMA TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT- NO RINGS VISIBLE OUTSIDE THE FALLOPIAN TUBE BUT THE RINGS WERE VISIBLE JUST AT THE OPENING, LEFT- 5 COILS. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM ABDOMEN - ON (B)(6) 2019: IMPRESSION: NONOBSTRUCTING RIGHT NEPHROLITHIASIS. ABNORMALLY POSITIONED LEFT ESSURE DEVICE AS DESCRIBED ABOVE, PROJECTING OVER BOWEL AND EXTENDING INTO A BOWEL FOLD WITHOUT DEFINITIVELY PENETRATING THE BOWEL WALL. TWO BOWEL NODULES COMPOSED OF MACROSCOPIC FAT NEAR THE PROXIMAL BOWEL SURGICAL ANASTOMOSIS, PROBABLE SMALL LIPOMAS. INTACT PROXIMAL AND DISTAL BOWEL ANASTOMOSIS.. HYSTEROSALPINGOGRAM - ON (B)(6) 2010: NO EVIDENCE OF INTRAMURAL OR INTRALUMINAL ABNORMALITY OF THE UTERINE CAVITY. NO EVIDENCE OF CONTRAST EXTRAVASATION OR SPILLAGE INTO THE ADNEXA BILATERALLY. NO CONTRAST DEMONSTRATION OF BOTH FALLOPIAN TUBES STABLE PERSISTENT SUPEROLATERAL LOCATION OF THE LEFT ESSURE DEVICE RELATIVE TO THE UTERUS. FINDINGS CONSISTENT WITH BILATERAL FALLOPIAN TUBE OCCLUSION.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENT¿S MEDICAL RECORDS: DEVICE DISLOCATION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-MAY-2021: MR RECEIVED. CASE BECAME SERIOUS INCIDENT. EVENT ADDED: ESSURE DEVICE ON THE RIGHT PROJECTS OVER THE RIGHT UTERINE FUNDUS AND LEFT ESSURE PROJECTS OVER A LOOP OF BOWEL WITHIN THE LEFT LOWER QUADRANT OF THE ABDOMEN. LOT NUMBER, REPORTERS INFORMATION, CONCOMITANT DRUG, LAB DATA AND MEDICAL HISTORY WERE ADDED. 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 RELEVANT DATA; SHOULD ANY NEW AND REPORTABLE INFORMATION BECOME AVAILABLE FROM OUR INVESTIGATION, THIS WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774217 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS305 637222, 654841 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS