BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ESSURE

    MDR report key: 8535143 · Received April 22, 2019

    Report

    Report Number
    2951250-2019-01412
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    January 26, 2007
    Report Date
    April 23, 2019
    Manufacturer
    BAYER PHARMA AG
    Product Code
    HHS
    UDI-DI
    10888853003051
    PMA / PMN Number
    P020014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ("MALPOSITION / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN") IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 020764-INVALID) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POLYCYSTIC OVARIAN SYNDROME AND CHRONIC PAIN. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, PRE-DIABETIC AND HYPERLIPIDEMIA. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, LOSARTAN, ORAL CONTRACEPTIVE NOS AND OXYCODONE. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN") AND FATIGUE ("FATIGUE"). IN (B)(6) 2006, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). ON (B)(6) 2007, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GROIN PAIN ("GROIN PAIN"), ARTHRALGIA ("HIPS PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN") AND BACK PAIN ("LOWER BACK PAIN"). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, GROIN PAIN, ARTHRALGIA, ABDOMINAL PAIN UPPER AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ARTHRALGIA, BACK PAIN, DEVICE DISLOCATION, FATIGUE, GROIN PAIN, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED:-DATE OF IMPLANT: -2004, (B)(6) 2007 , (B)(6) 2006. THERE WAS NOTED TO BE 2 RINGS PRESENT INSIDE THE ENDOMETRIAL CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: A SCOUT IMAGE OF THE PELVIS DEMONSTRATES THE BALLOON CATHETER IN PLACE PRIOR TO CONTRAST INSTILLATION WITH A UNUSUAL ORIENTATION OF THE RIGHT SIDED ESSURE IMPLANT.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-APR-2019: UPDATE OF INFORMATION (BATCH IS INVALID) PRODUCT TECHNICAL COMPLIANT. INCIDENT: NO VALID LOT NUMBER OR DEVICE SAMPLE WAS RECEIVED IN THIS CASE. AT THIS TIME, WE HAVE NO INFORMATION SUGGESTING THAT THE DEVICE FAILED TO MEET ITS SPECIFICATIONS. WE WILL CONDUCT A REVIEW OF OUR COMPLAINT RECORDS AND OTHER NON-CONFORMANCES 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 ("MALPOSITION / MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN") IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (ESS205) (BATCH NO. 020764) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED POLYCYSTIC OVARIAN SYNDROME AND CHRONIC PAIN. CONCURRENT CONDITIONS INCLUDED HYPERTENSION, PRE-DIABETIC AND HYPERLIPIDEMIA. CONCOMITANT PRODUCTS INCLUDED ATORVASTATIN, LOSARTAN, ORAL CONTRACEPTIVE NOS AND OXYCODONE. ON (B)(6) 2006, THE PATIENT HAD ESSURE (ESS205) INSERTED. ON (B)(6) 2006, THE PATIENT EXPERIENCED PELVIC PAIN ("PAIN") AND FATIGUE ("FATIGUE"). IN (B)(6) 2006, THE PATIENT EXPERIENCED VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("MENORRHAGIA"). ON (B)(6) 2007, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GROIN PAIN ("GROIN PAIN"), ARTHRALGIA ("HIPS PAIN"), ABDOMINAL PAIN UPPER ("STOMACH PAIN") AND BACK PAIN ("LOWER BACK PAIN"). ESSURE (ESS205) TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, FATIGUE, GROIN PAIN, ARTHRALGIA, ABDOMINAL PAIN UPPER AND BACK PAIN OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN UPPER, ARTHRALGIA, BACK PAIN, DEVICE DISLOCATION, FATIGUE, GROIN PAIN, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE (ESS205). THE REPORTER COMMENTED: DISCREPANCY NOTED:-DATE OF IMPLANT: 2004, (B)(6) 2007 , (B)(6) 2006. THERE WAS NOTED TO BE 2 RINGS PRESENT INSIDE THE ENDOMETRIAL CAVITY. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2007: A SCOUT IMAGE OF THE PELVIS DEMONSTRATES THE BALLOON CATHETER IN PLACE PRIOR TO CONTRAST INSTILLATION WITH A UNUSUAL ORIENTATION OF THE RIGHT SIDED ESSURE IMPLANT. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 17-APR-2019: PFS RECEIVED. REPORTERS INFORMATION UPDATED. LOT NO. ADDED. EVENT: INJURY WERE UPDATED TO ABNORMAL BLEEDING (VAGINAL), MENORRHAGIA, FATIGUE, MALPOSITION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: UNKNOWN, PAIN WERE ADDED. CONCOMITANT DRUG, MEDICAL HISTORY AND LAB DETAILS WERE ADDED. INCIDENT: WE RECEIVED A LOT NUMBER. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329819 ESSURE TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE HHS BAYER PHARMA AG ESS205 020764-INVALID 10888853003051

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other ATORVASTATIN| ATORVASTATIN| LOSARTAN| LOSARTAN| ORAL CONTRACEPTIVE NOS| ORAL CONTRACEPTIVE NOS| OXYCODONE| OXYCODONE| ATORVASTATIN| LOSARTAN| ORAL CONTRACEPTIVE NOS| OXYCODONE