ESSURE
Report
- Report Number
- 2951250-2019-03380
- Event Type
- Injury
- Date Received
- July 5, 2019
- Date of Event
- April 4, 2013
- Report Date
- June 12, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE: ABDOMEN/ ESSURE COILS NOT VISIBLE/ FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES/ ONE COIL HAD MIGRATED/ FAILED ESSURE (DEVICE EJECTED FROM RIGHT TUBE INTO PELVIC)') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, UNSPECIFIED VITAMIN B DEFICIENCY, PREGNANT, UTERINE FIBROID, IRREGULAR MENSTRUAL CYCLE, LOW BACK PAIN, FLANK PAIN, BLADDER PAIN, URINARY URGENCY, HESITANCY, CRAMP IN LOWER ABDOMEN, NAUSEA, LOOSE STOOLS, HYDRONEPHROSIS, URETEROVESICAL JUNCTION OBSTRUCTION, KIDNEY STONE, TUBAL LIGATION, HEMATURIA AND CERVICAL SPONDYLOSIS. CONCURRENT CONDITIONS INCLUDED INSOMNIA, PAPANICOLAOU SMEAR ABNORMAL, UNSPECIFIED ESSENTIAL HYPERTENSION, STRESS, BLOOD PRESSURE INCREASED, DEPRESSIVE DISORDER AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED CLONIDINE SINCE (B)(6) 2013 FOR DEPRESSION AND ANXIETY AND HYDROCHLOROTHIAZIDE SINCE (B)(6) 2013 FOR HYPERTENSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN / PAIN / PELVIC PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 1 MONTH 18 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL") AND URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) OTHER (PLEASE SPECIFY) - PARTIAL OMENTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL HAEMORRHAGE, VAGINAL INFECTION AND URINARY TRACT INFECTION HAD RESOLVED. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT TUBE INCORRECTLY PLACE LAPAROSCOPIC TUBAL LIGATION BILATERAL RIGHT REMOVAL OF RIGHT ESSURE AND TUBAL ON RIGHT ONLY / HYSTEROSCOPY, DILATION AND CURETTAGE, NOVASURE ABLATION. 3 COILS WERE NOTED TO EMERGE ON THE RIGHT HAND SIDE. ESSURE DEVICE COVERED IN OMENTUM ADJACENT TO RIGHT FALLOPIAN TUBE WITHOUT BOWEL INVOLVEMENT. THE COIL WAS SEEN BEYOND THE REGION OF THE RIGHT FALLOPIAN TUBE. AS PER MR IN INSERTION DETAILS:THERE WAS DIFFICULTY IN PLACEMENT THE ESSURE DEVICE ON THIS TUBE JUST BECAUSE THE TUBE WAS SPASMING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2012: RESULTS: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. ONE COIL HAD MIGRATED.. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: VAGINAL BLEEDING, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. OUTCOME FOR EVENT PELVIC PAIN, ABNORMAL BLEEDING (VAGINAL) AND INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE UPDATED TO RECOVERED. 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 DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMEN / ESSURE COILS NOT VISIBLE / FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES / ONE COIL HAD MIGRATED / FAILED ESSURE- DEVICE EJECTED FROM RIGHT TUBE INTO PELVIC') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, UNSPECIFIED VITAMIN B DEFICIENCY, PREGNANT, UTERINE FIBROID, IRREGULAR MENSTRUAL CYCLE, LOW BACK PAIN, FLANK PAIN, BLADDER PAIN, URINARY URGENCY, HESITANCY, CRAMP IN LOWER ABDOMEN, NAUSEA, LOOSE STOOLS, HYDRONEPHROSIS, URETEROVESICAL JUNCTION OBSTRUCTION, KIDNEY STONE, TUBAL LIGATION, HEMATURIA AND CERVICAL SPONDYLOSIS. CONCURRENT CONDITIONS INCLUDED INSOMNIA, PAPANICOLAOU SMEAR ABNORMAL, UNSPECIFIED ESSENTIAL HYPERTENSION, STRESS, BLOOD PRESSURE INCREASED, DEPRESSIVE DISORDER AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED CLONIDINE SINCE (B)(6) 2013 FOR DEPRESSION AND ANXIETY AND HYDROCHLOROTHIAZIDE SINCE (B)(6) 2013 FOR HYPERTENSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN / PAIN / PELVIC PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 1 MONTH 18 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) OTHER (PLEASE SPECIFY) - PARTIAL OMENTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, URINARY TRACT INFECTION, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT TUBE INCORRECTLY PLACE LAPAROSCOPIC TUBAL LIGATION BILATERAL RIGHT REMOVAL OF RIGHT ESSURE AND TUBAL ON RIGHT ONLY / HYSTEROSCOPY, DILATION AND CURETTAGE, NOVASURE ABLATION. 3 COILS WERE NOTED TO EMERGE ON THE RIGHT HAND SIDE. ESSURE DEVICE COVERED IN OMENTUM ADJACENT TO RIGHT FALLOPIAN TUBE WITHOUT BOWEL INVOLVEMENT. THE COIL WAS SEEN BEYOND THE REGION OF THE RIGHT FALLOPIAN TUBE. AS PER MR IN INSERTION DETAILS:THERE WAS DIFFICULTY IN PLACEMENT THE ESSURE DEVICE ON THIS TUBE JUST BECAUSE THE TUBE WAS SPASMING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2012: RESULTS: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. ONE COIL HAD MIGRATED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: VAGINAL BLEEDING, PELVIC PAIN. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JUL-2019: QUALITY-SAFETY EVALUATION OF PTC. 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 DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMEN / ESSURE COILS NOT VISIBLE / FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES / ONE COIL HAD MIGRATED / FAILED ESSURE- DEVICE EJECTED FROM RIGHT TUBE INTO PELVIC') IN A (B)(6) YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 880431) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, UNSPECIFIED VITAMIN B DEFICIENCY, PREGNANT, UTERINE FIBROID, IRREGULAR MENSTRUAL CYCLE, LOW BACK PAIN, FLANK PAIN, BLADDER PAIN, URINARY URGENCY, HESITANCY, CRAMP IN LOWER ABDOMEN, NAUSEA, LOOSE STOOLS, HYDRONEPHROSIS, URETEROVESICAL JUNCTION OBSTRUCTION, KIDNEY STONE, TUBAL LIGATION, HEMATURIA AND CERVICAL SPONDYLOSIS. CONCURRENT CONDITIONS INCLUDED INSOMNIA, PAPANICOLAOU SMEAR ABNORMAL, UNSPECIFIED ESSENTIAL HYPERTENSION, STRESS, BLOOD PRESSURE INCREASED, DEPRESSIVE DISORDER AND PERITONEAL ADHESIONS. CONCOMITANT PRODUCTS INCLUDED CLONIDINE SINCE (B)(6) 2013 FOR DEPRESSION AND ANXIETY AND HYDROCHLOROTHIAZIDE SINCE (B)(6) 2013 FOR HYPERTENSION. ON (B)(6) 2011, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN / PAIN / PELVIC PAIN"), MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)") AND VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)"), 1 MONTH 18 DAYS AFTER INSERTION OF ESSURE. ON (B)(6) 2013, THE PATIENT EXPERIENCED VAGINAL INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: VAGINAL"), URINARY TRACT INFECTION ("INFECTION (BLADDER/ URINARY TRACT/VAGINAL) TYPE: UTI"), ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: ANXIETY AND MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS CONDITION: DEPRESSION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED). THE PATIENT WAS TREATED WITH SURGERY (SURGICAL REMOVAL OF COIL(S) OTHER (PLEASE SPECIFY) - PARTIAL OMENTOMY). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, MENORRHAGIA, VAGINAL HAEMORRHAGE, VAGINAL INFECTION, URINARY TRACT INFECTION, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, DEVICE DISLOCATION, MENORRHAGIA, PELVIC PAIN, URINARY TRACT INFECTION, VAGINAL HAEMORRHAGE AND VAGINAL INFECTION TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: RIGHT TUBE INCORRECTLY PLACE LAPAROSCOPIC TUBAL LIGATION BILATERAL RIGHT REMOVAL OF RIGHT ESSURE AND TUBAL ON RIGHT ONLY / HYSTEROSCOPY, DILATION AND CURETTAGE, NOVASURE ABLATION. 3 COILS WERE NOTED TO EMERGE ON THE RIGHT HAND SIDE. ESSURE DEVICE COVERED IN OMENTUM ADJACENT TO RIGHT FALLOPIAN TUBE WITHOUT BOWEL INVOLVEMENT. THE COIL WAS SEEN BEYOND THE REGION OF THE RIGHT FALLOPIAN TUBE. AS PER MR IN INSERTION DETAILS:THERE WAS DIFFICULTY IN PLACEMENT THE ESSURE DEVICE ON THIS TUBE JUST BECAUSE THE TUBE WAS SPASMING. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED; ON (B)(6) 2012: RESULTS: FAILURE TO OCCLUDE (CLOSE) FALLOPIAN TUBES. ONE COIL HAD MIGRATED. CONCERNING THE INJURIES REPORTED IN THIS CASE, THE FOLLOWING ONES WERE DESCRIBED IN PATIENTS MEDICAL RECORD CONFIRMING: VAGINAL BLEEDING, PELVIC PAIN. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 25-JUN-2019: PFS AND MR RECEIVED: LOT NUMBER WAS ADDED. DATE OF REMOVAL, PATIENTS DOB, DEMOGRAPHICS, RACE WERE ADDED. NEW EVENTS: MENORRHAGIA, VAGINAL BLEEDING, UTI, VAGINAL INFECTION, DEPRESSION, ANXIETY, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMEN WERE ADDED. UPDATED OUTCOME OF EVENT PELVIC PAIN TO RECOVERING/RESOLVING. EVENTS ONSET DATE, MEDICAL HISTORY, CONCOMITANT CONDITION AND DRUGS WERE ADDED. REPORTER INFORMATION WERE ADDED. REPORTER CAUSALITY COMMENTS 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 558003 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 880431 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | CLONIDINE| CLONIDINE| CLONIDINE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| HYDROCHLOROTHIAZIDE| CLONIDINE| HYDROCHLOROTHIAZIDE |