ESSURE
Report
- Report Number
- 2951250-2023-03534
- Event Type
- Injury
- Date Received
- December 10, 2023
- Date of Event
- December 20, 2018
- Report Date
- December 22, 2023
- 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
- Health Professional
- N
Narratives
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("THEY WERE REMOVED IN 3 PIECES AND ALL FROM THE COILS") IN A 54 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF PELVIC PAIN FEMALE, FOREIGN BODY IN UTERUS, ANY PART, LEIOMYOMA, MELANOMA (STAGE 1), DRUG ALLERGY, LEG PAIN AND ANKLE INJURY (THE PATIENT FELL FROM AN UPRIGHT POSITION. ONSET: THE SYMPTOMS/EPISODE JMM BEGAN/OCCURRED ACUTELY, JUST PRIOR TO ARRIVAL. ASSOCIATED INJURIES: THE PATIENT SUSTAINED RIGHT AND LEFT LOWER EXTREMITIES. IT IS UNKNOWN WHETHER OR NOT THE PATIENT HAS HAD SIMILAR SYMPTOMS IN THE PAST. THIS IS A 57-YEAR-OLD FEMALE WITH HISTORY OF HYPERTENSION THE PRESENTS EMERGED DEPARTMENT WITH COMPLAINTS OF BILATERAL LOWER EXTREMITY PAIN FOLLOWING A FALL WHICH OCCURRED JUST PRIOR TO ARRIVAL. PATIENT STATES SHE SLIPPED IN A PARKING LOT LANDING ONTO OUTSTRETCHED HANDS. PATIENT DENIES HITTING HER HEAD. PAIN IS MAINLY LOCALIZED TO THE RIGHT TIBIAL REGION AND THE LEFT FOOT.). ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2018,, SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (O TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND CYSTOSCOPY). ESSURE WAS REMOVED ON (B)(6) 2018.. AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] (DATE UNKNOWN): TISSUES A. UTERUS AND CERVIX, CS - CERVIX, UTERUS, (BIL) OVARIES AND FALLOPIAN TUBES B. FOREIGN BODY. - FOREIGN BODY ESSURE COIL LEFT FALLOPIAN TUBE DIAGNOSIS :CERVIX, UTERUS, BILATERAL OVARIES AND FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGOOOPHORECTOMY: UTERUS WEIGHT - 47.7 GRAMS CERVIX - NO SIGNIFICANT PATHOLOGIC CHANGES ENDOMETRIUM - CONSISTENT WITH PRIOR ABLATION MYOMETRIUM - CONSISTENT WITH A LEFT-SIDED SUBSEROSAL CELLULAR LEIOMYOMA (1.5 CM) SEROSA - NO SIGNIFICANT PATHOLOGIC CHANGES FOREIGN BODY (COIL) IDENTIFIED WITHIN THE UTERINE FUNDUS (GROSS ONLY) RIGHT OVARY - SMALL CORPUS LUTEUM CYST (4 MM) LEFT OVARY - NO SIGNIFICANT PATHOLOGIC CHANGES RIGHT AND LEFT FALLOPIAN TUBES - NO SIGNIFICANT PATHOLOGIC CHANGES FOREIGN BODY, ESSURE COIL LEFT FALLOPIAN TUBE, REMOVAL OF: - FOREIGN BODY (COIL) IDENTIFIED CLINICAL HISTORY: PRE-OP AND POST-OP DIAGNOSIS: PELVIC PAIN, STATUS POST ESSURE/ABLATION. GROSS DESCRIPTION: ON THE RIGHT SIDE OF THE UTERINE FUNDUS, THERE IS AN EMBEDDED METALLIC COIL THAT MEASURES APPROXIMATELY 2.5 CM IN LENGTH. THE COIL IS ANGLED TOWARDS THE LEFT SIDE OF THE UTERUS. SPECIMEN B IS RECEIVED FRESH, LABELED "FOREIGN BODY ESSURE COIL LEFT" AND CONSISTS OF TWO COILED METALLIC FOREIGN BODY FRAGMENTS MICROSCOPIC DESCRIPTION SECTIONS OF THE LEFT-SIDED NODULAR AREA AT THE FUNDUS SHOW FEATURES OF A CELLULAR LEIOMYOMA. THE NODULE IS WELL CIRCUMSCRIBED AND IS COMPOSED OF INTERLACING CLOSELY PACKED SMOOTH MUSCLE CELLS. NO SIGNIFICANT ATYPIA IS SEEN. THE SEROSA IS UNREMARKABLE. THE CERVIX IS UNREMARKABLE. THE ENDOMETRIUM SHOWS FEATURES CONSISTENT WITH PRIOR ABLATION. THE RIGHT OVARY SHOWS A SMALL CORPUS LUTEUM CYST. THE RIGHT FALLOPIAN TUBE IS UNREMARKABLE. THE LEFT OVARY AND FALLOPIAN TUBE ARE UNREMARKABLE. THERE IS A SMALL DETACHED FRAGMENT OF SMOOTH MUSCLE TISSUE. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. THE MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES DATA RECEIVED ON: (B)(6) 2023: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WAS CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
THIS SPONTANEOUS CASE WAS ORIGINALLY REPORTED BY A LAWYER ON BEHALF OF A CONSUMER (SUBSEQUENTLY MEDICALLY CONFIRMED) AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ("THEY WERE REMOVED IN 3 PIECES AND ALL FROM THE COILS") IN A 54 YEAR-OLD FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE PATIENT HAD A MEDICAL HISTORY OF PELVIC PAIN FEMALE, FOREIGN BODY IN UTERUS, ANY PART, LEIOMYOMA, MELANOMA (STAGE 1), DRUG ALLERGY, LEG PAIN AND ANKLE INJURY (THE PATIENT FELL FROM AN UPRIGHT POSITION. ONSET: THE SYMPTOMS/EPISODE JMM BEGAN/OCCURRED ACUTELY, JUST PRIOR TO ARRIVAL. ASSOCIATED INJURIES: THE PATIENT SUSTAINED RIGHT AND LEFT LOWER EXTREMITIES. IT IS UNKNOWN WHETHER OR NOT THE PATIENT HAS HAD SIMILAR SYMPTOMS IN THE PAST. THIS IS A 57-YEAR-OLD FEMALE WITH HISTORY OF HYPERTENSION THE PRESENTS EMERGED DEPARTMENT WITH COMPLAINTS OF BILATERAL LOWER EXTREMITY PAIN FOLLOWING A FALL WHICH OCCURRED JUST PRIOR TO ARRIVAL. PATIENT STATES SHE SLIPPED IN A PARKING LOT LANDING ONTO OUTSTRETCHED HANDS. PATIENT DENIES HITTING HER HEAD. PAIN IS MAINLY LOCALIZED TO THE RIGHT TIBIAL REGION AND THE LEFT FOOT.). ON (B)(6) 2018,, SHE EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY IMPORTANT AND INTERVENTION REQUIRED). ESSURE WAS REMOVED THE SAME DAY. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. THE PATIENT WAS TREATED WITH SURGERY (O TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGO-OOPHORECTOMY, AND CYSTOSCOPY). AT THE TIME OF THE REPORT, THE OUTCOME OF THE EVENT WAS UNKNOWN. THE REPORTER CONSIDERED DEVICE BREAKAGE TO BE RELATED TO ESSURE ADMINISTRATION. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): [PATHOLOGY TEST] (DATE UNKNOWN): TISSUES A. UTERUS AND CERVIX, CS - CERVIX, UTERUS, (BIL) OVARIES AND FALLOPIAN TUBES B. FOREIGN BODY. - FOREIGN BODY ESSURE COIL LEFT FALLOPIAN TUBE DIAGNOSIS :CERVIX, UTERUS, BILATERAL OVARIES AND FALLOPIAN TUBES, HYSTERECTOMY AND BILATERAL SALPINGOOOPHORECTOMY: UTERUS WEIGHT - 47.7 GRAMS CERVIX - NO SIGNIFICANT PATHOLOGIC CHANGES ENDOMETRIUM - CONSISTENT WITH PRIOR ABLATION MYOMETRIUM - CONSISTENT WITH A LEFT-SIDED SUBSEROSAL CELLULAR LEIOMYOMA (1.5 CM) SEROSA - NO SIGNIFICANT PATHOLOGIC CHANGES FOREIGN BODY (COIL) IDENTIFIED WITHIN THE UTERINE FUNDUS (GROSS ONLY) RIGHT OVARY - SMALL CORPUS LUTEUM CYST (4 MM) LEFT OVARY - NO SIGNIFICANT PATHOLOGIC CHANGES RIGHT AND LEFT FALLOPIAN TUBES - NO SIGNIFICANT PATHOLOGIC CHANGES FOREIGN BODY, ESSURE COIL LEFT FALLOPIAN TUBE, REMOVAL OF: - FOREIGN BODY (COIL) IDENTIFIED CLINICAL HISTORY: PRE-OP AND POST-OP DIAGNOSIS: PELVIC PAIN, STATUS POST ESSURE/ABLATION. GROSS DESCRIPTION: ON THE RIGHT SIDE OF THE UTERINE FUNDUS, THERE IS AN EMBEDDED METALLIC COIL THAT MEASURES APPROXIMATELY 2.5 CM IN LENGTH. THE COIL IS ANGLED TOWARDS THE LEFT SIDE OF THE UTERUS. SPECIMEN B IS RECEIVED FRESH, LABELED "FOREIGN BODY ESSURE COIL LEFT" AND CONSISTS OF TWO COILED METALLIC FOREIGN BODY FRAGMENTS MICROSCOPIC DESCRIPTION SECTIONS OF THE LEFT-SIDED NODULAR AREA AT THE FUNDUS SHOW FEATURES OF A CELLULAR LEIOMYOMA. THE NODULE IS WELL CIRCUMSCRIBED AND IS COMPOSED OF INTERLACING CLOSELY PACKED SMOOTH MUSCLE CELLS. NO SIGNIFICANT ATYPIA IS SEEN. THE SEROSA IS UNREMARKABLE. THE CERVIX IS UNREMARKABLE. THE ENDOMETRIUM SHOWS FEATURES CONSISTENT WITH PRIOR ABLATION. THE RIGHT OVARY SHOWS A SMALL CORPUS LUTEUM CYST. THE RIGHT FALLOPIAN TUBE IS UNREMARKABLE. THE LEFT OVARY AND FALLOPIAN TUBE ARE UNREMARKABLE. THERE IS A SMALL DETACHED FRAGMENT OF SMOOTH MUSCLE TISSUE. QUALITY-SAFETY EVALUATION OF PTC: FOR ESSURE: NO DEFECT COULD BE CONFIRMED BY THE MANUFACTURER. ALL PRODUCT BATCHES HAVE MET THE SPECIFICATIONS REGARDING LABELING, MATERIAL, AND PROCESS CONTROLS AT TIME OF RELEASE. 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 AND BATCH RECORD REVIEW COULD NOT BE CONDUCTED, AS NO SAMPLE OR BATCH NUMBER WERE AVAILABLE. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1979181 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female | Other| R |