ESSURE
Report
- Report Number
- 2951250-2019-09401
- Event Type
- Injury
- Date Received
- October 3, 2019
- Report Date
- December 6, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('THE COIL BROKE AND A PORTION OF THE ESSURE COIL REMAINED IN THE CORNUA / FREE FRAGMENTS') AND PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893088-NOT VALID, A893038-NOT, A57121) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DEPLOYMENT ISSUE "LEFT DEVICE DID NOT DEPLOY APPROPRIATELY". THE PATIENT'S MEDICAL HISTORY INCLUDED STRESS INCONTINENCE, CYSTITIS INTERSTITIAL, MENSES IRREGULAR, ABNORMAL WEIGHT GAIN, CHRONIC INTERSTITIAL CYSTITIS AND LIBIDO DECREASED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PARADGURD IN (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM, MIGRAINE HEADACHE AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, IBUPROFEN, PARACETAMOL (ACETAMINOPHEN), PROGESTERONE AND VALACICLOVIR (VALACYCLOVIR). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)."). THE PATIENT WAS TREATED WITH SURGERY (OVIDUCTAL SURGERY-ROBOTIC SALPINGECTOMY (BILATERAL) WITH REMOVAL OF ESSURE COILS/CORNUAL REPAIR (RW)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN, ABDOMINAL PAIN, DYSMENNORHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). INAPPROPRIATE DEPLOYMENT OF LEFT DEVICE HAD TO INSERT ANOTHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. SATISFACTORY POST ESSURE STUDY.. LOT NUMBER 893088 IS NOT VALID, LOT NUMBER: A57121 MANUFACTURE DATE: 2012-10 EXPIRATION DATE: 2015-10, LOT NUMBER : A57121 (RIGHT), A57121 (LEFT)-INAPPROPRIATE DEPLOYMENT, LOT NUMBER : 893038 (LEFT), LOTS NUMBER 893088 AND A893038 ARE NOT VALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-DEC-2019: UPDATE OF INFORMATION (BATCH IS INVALID). ON 5-DEC-2019: QUALITY-SAFETY EVALUATION OF PTC: PRODUCT TECHNICAL COMPLAINT. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE BREAKAGE ('THE COIL BROKE AND A PORTION OF THE ESSURE COIL REMAINED IN THE CORNUA / FREE FRAGMENTS') AND PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893088-INV, A893038-INV, A57121) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. OTHER PRODUCT OR PRODUCT USE ISSUES IDENTIFIED: DEVICE DEPLOYMENT ISSUE "LEFT DEVICE DID NOT DEPLOY APPROPRIATELY." THE PATIENT'S MEDICAL HISTORY INCLUDED STRESS INCONTINENCE, CYSTITIS INTERSTITIAL, MENSES IRREGULAR, ABNORMAL WEIGHT GAIN, CHRONIC INTERSTITIAL CYSTITIS AND LIBIDO DECREASED. PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PARAGARD IN (B)(6) 2012. CONCURRENT CONDITIONS INCLUDED HYPOTHYROIDISM, MIGRAINE HEADACHE AND DYSFUNCTIONAL UTERINE BLEEDING. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, IBUPROFEN, PARACETAMOL (ACETAMINOPHEN), PROGESTERONE AND VALACICLOVIR (VALACYCLOVIR). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE BREAKAGE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)") AND DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)."). THE PATIENT WAS TREATED WITH SURGERY (OVIDUCTAL SURGERY-ROBOTIC SALPINGECTOMY (BILATERAL) WITH REMOVAL OF ESSURE COILS/CORNUAL REPAIR (RW)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE BREAKAGE OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA AND DYSPAREUNIA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DEVICE BREAKAGE, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). INAPPROPRIATE DEPLOYMENT OF LEFT DEVICE HAD TO INSERT ANOTHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. SATISFACTORY POST ESSURE STUDY. LOT NUMBER 893088 IS NOT VALID. LOT NUMBER: A57121, MANUFACTURE DATE: 2012-10 EXPIRATION DATE: 2015-10. LOT NUMBER : A57121 (RIGHT), A57121 (LEFT): INAPPROPRIATE DEPLOYMENT. LOT NUMBER : 893038 (LEFT). LOTS NUMBER 893088 AND A893038 ARE INVALID. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-DEC-2019: UPDATE OF INFORMATION (BATCH IS INVALID). ON 5-DEC-2019: QUALITY-SAFETY EVALUATION OF PTC: PRODUCT TECHNICAL COMPLAINT. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893088,A57121) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PARADGURD IN (B)(6) 2012. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, PROGESTERONE AND VALACICLOVIR (VALACYCLOVIR). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)."), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHOEA AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN, ABDOMINAL PAIN, DYSMENNORHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). INAPPROPRIATE DEPLOYMENT OF LEFT DEVICE HAD TO INSERT ANOTHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: PFS RECEIVED- REPORTER INFORMATION AND SEVERITY OF THE EVENT PELVIC PAIN WAS ADDED. LOT NUMBER AND CONCOMITANT DRUG WERE ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 893088-NOT VALID,A57121) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S PREVIOUSLY ADMINISTERED PRODUCTS INCLUDED FOR AN UNREPORTED INDICATION: PARADGURD IN (B)(6) 2012. CONCOMITANT PRODUCTS INCLUDED ALPRAZOLAM, PROGESTERONE AND VALACICLOVIR (VALACYCLOVIR). ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE)."), DYSMENORRHOEA ("DYSMENNORHEA (CRAMPING)") AND BACK PAIN ("BACK PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA, DYSMENORRHOEA AND BACK PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN, ABDOMINAL PAIN, DYSMENNORHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). INAPPROPRIATE DEPLOYMENT OF LEFT DEVICE HAD TO INSERT ANOTHER. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: TOTAL BILATERAL OCCLUSION.. LOT NUMBER 893088 IS INV. LOT NUMBER: A57121 MANUFACTURE DATE: 2012-10 EXPIRATION DATE: 2015-10 QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2019: QUALITY SAFETY EVALUATION OF PTC(PRODUCT TECHNICAL COMPLAINT). 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF PELVIC PAIN ('PELVIC PAIN') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PELVIC PAIN (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN"), DYSPAREUNIA ("DYSPAREUNIA(PAINFUL SEXUAL INTERCOURSE).") AND DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY (BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE PELVIC PAIN, ABDOMINAL PAIN, DYSPAREUNIA AND DYSMENORRHOEA HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, DYSMENORRHOEA, DYSPAREUNIA AND PELVIC PAIN TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: PATIENT RECEIVED TREATMENT FOR EVENTS ¿ PELVIC PAIN, ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE). DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE - ON (B)(6) 2013: ESSURE CONFIRMATION TEST(S) (UNSPECIFIED) BILATERAL OCCLUSION. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 09/16/2019: PFS RECEIVED-EVENT INJURY WAS SPECIFIED AS PELVIC PAIN. ABDOMINAL PAIN, DYSMENORRHEA (CRAMPING),DYSPAREUNIA (PAINFUL SEXUAL INTERCOURSE) AND THE OUTCOME WAS RECOVERED POST ESSURE REMOVAL ON (B)(6) 2013. PATIENT INFORMATION AND LAB DATA WERE ADDED NO 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 947026 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 893088 INV,A893038 INV,A57121 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ACETAMINOPHEN| ACETAMINOPHEN| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| ALPRAZOLAM| IBUPROFEN| IBUPROFEN| PROGESTERONE| PROGESTERONE| PROGESTERONE| PROGESTERONE| VALACYCLOVIR [VALACICLOVIR]| VALACYCLOVIR [VALACICLOVIR]| VALACYCLOVIR [VALACICLOVIR]| VALACYCLOVIR [VALACICLOVIR] |