ESSURE
Report
- Report Number
- 2951250-2019-04606
- Event Type
- Injury
- Date Received
- August 9, 2019
- Date of Event
- July 2, 2012
- Report Date
- July 9, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE)/ESSURE COIL PENETRATED CAVITY FROM RIGHT/ESSURE COIL PERFORATING THE RIGHT FALLOPIAN TUBE') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, GASTROINTESTINAL ISCHEMIA AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) IN 2012 FOR BIRTH CONTROL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 18 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (SURGICAL REMOVAL OF COIL, BILATERAL TUBAL CAUTERY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS WERE VISIBLE ON THE RIGHT. INSERTION DETAILS- THE LEFT OSTIA COULD NOT BE CANNULIZED DESPITE REPEATED ATTEMPTS WITH SEVERAL ESSURES (ATTEMPTS WITH 3 ESSURES WERE ATTEMPTED, BUT THE OSTIA COULD NEVER BE PASSED BENDING 3 ESSURES, SO THE PROCEDURE WAS ABORTED). REMOVAL DETAILS - THE ESSURE COIL WAS VISUALIZED THROUGH THE RIGHT PROXIMAL PORTION OF THE FALLOPIAN TUBE ADHERENT TO SMALL BOWEL. DISCREPANCY NOTED. IN PFS PLAINTIFF REPORTED THAT ESSURE CONFIRMATION TEST WAS NOT CONDUCTED BUT IN SUMMONS HSG RESULTS WERE PROVIDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2012: CT SCAN REVEALED ESSURE COIL PENETRATED CAVITY FROM RIGHT. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 13-AUG-2019: QUALITY-SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE)/ESSURE COIL PENETRATED CAVITY FROM RIGHT/ESSURE COIL PERFORATING THE RIGHT FALLOPIAN TUBE'), UTERINE PERFORATION ('PERFORATION: UTERUS') AND DEVICE DISLOCATION ('MIGRATION, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMINAL CAVITY') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, GASTROINTESTINAL ISCHEMIA AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) IN 2012 FOR BIRTH CONTROL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GASTROINTESTINAL DISORDER ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: BOWEL INJURY."), 18 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENTAL DISORDER ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (SURGICAL REMOVAL OF COIL,BILATERAL TUBAL CAUTERY AND UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, DEPRESSION, ANXIETY, MENTAL DISORDER AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, GASTROINTESTINAL DISORDER, MENORRHAGIA, MENTAL DISORDER, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS WERE VISIBLE ON THE RIGHT. INSERTION DETAILS- THE LEFT OSTIA COULD NOT BE CANNULIZED DESPITE REPEATED ATTEMPTS WITH SEVERAL ESSURES (ATTEMPTS WITH 3 ESSURES WERE ATTEMPTED, BUT THE OSTIA COULD NEVER BE PASSED BENDING 3 ESSURES, SO THE PROCEDURE WAS ABORTED ) REMOVAL DETAILS - THE ESSURE COIL WAS VISUALIZED THROUGH THE RIGHT PROXIMAL PORTION OF THE FALLOPIAN TUBE ADHERENT TO SMALL BOWEL. DISCREPANCY NOTED. IN PFS PLAINTIFF REPORTED THAT ESSURE CONFIRMATION TEST WAS NOT CONDUCTED BUT IN SUMMONS HSG RESULTS WERE PROVIDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2012: CT SCAN REVEALED ESSURE COIL PENETRATED CAVITY FROM RIGHT. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-JAN-2020: PIF RECEIVED. NEW EVENTS ADDED: PERFORATION: UTERUS. OUTCOME OF PREVIOUSLY ADDED EVENTS MENORRHAGIA, ABNORMAL BLEEDING(VAGINAL) WERE UPDATED TO RECOVERED/RESOLVED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE)/ESSURE COIL PENETRATED CAVITY FROM RIGHT/ESSURE COIL PERFORATING THE RIGHT FALLOPIAN TUBE') AND DEVICE DISLOCATION ('MIGRATION, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMINAL CAVITY') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, GASTROINTESTINAL ISCHEMIA AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) IN 2012 FOR BIRTH CONTROL. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GASTROINTESTINAL DISORDER ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: BOWEL INJURY."), 18 DAYS AFTER INSERTION OF ESSURE. IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENTAL DISORDER ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (SURGICAL REMOVAL OF COIL,BILATERAL TUBAL CAUTERY AND UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY, MENTAL DISORDER AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, GASTROINTESTINAL DISORDER, MENORRHAGIA, MENTAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS WERE VISIBLE ON THE RIGHT. INSERTION DETAILS- THE LEFT OSTIA COULD NOT BE CANNULIZED DESPITE REPEATED ATTEMPTS WITH SEVERAL ESSURES (ATTEMPTS WITH 3 ESSURES WERE ATTEMPTED, BUT THE OSTIA COULD NEVER BE PASSED BENDING 3 ESSURES, SO THE PROCEDURE WAS ABORTED ) REMOVAL DETAILS - THE ESSURE COIL WAS VISUALIZED THROUGH THE RIGHT PROXIMAL PORTION OF THE FALLOPIAN TUBE ADHERENT TO SMALL BOWEL. DISCREPANCY NOTED. IN PFS PLAINTIFF REPORTED THAT ESSURE CONFIRMATION TEST WAS NOT CONDUCTED BUT IN SUMMONS HSG RESULTS WERE PROVIDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6)2012: CT SCAN REVEALED ESSURE COIL PENETRATED CAVITY FROM RIGHT.. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-DEC-2019: PFS RECEIVED EVENT " OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: BOWEL INJURY" WAS ADDED. 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE)/ESSURE COIL PENETRATED CAVITY FROM RIGHT/ESSURE COIL PERFORATING THE RIGHT FALLOPIAN TUBE'), UTERINE PERFORATION ('PERFORATION: UTERUS') AND DEVICE DISLOCATION ('MIGRATION, MIGRATION OF ESSURE DEVICE LOCATION OF DEVICE: ABDOMINAL CAVITY') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, GASTROINTESTINAL ISCHEMIA AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) IN 2012 FOR BIRTH CONTROL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN 2012, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), UTERINE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED) AND GASTROINTESTINAL DISORDER ("OTHER INJURY(IES) OR COMPLICATION (S) PLEASE DESCRIBE: BOWEL INJURY."), 18 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENTAL DISORDER ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (SURGICAL REMOVAL OF COIL, BILATERAL TUBAL CAUTERY AND UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, UTERINE PERFORATION, DEVICE DISLOCATION, DEPRESSION, ANXIETY, MENTAL DISORDER AND GASTROINTESTINAL DISORDER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, GASTROINTESTINAL DISORDER, MENORRHAGIA, MENTAL DISORDER, PELVIC PAIN, UTERINE PERFORATION AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS WERE VISIBLE ON THE RIGHT. INSERTION DETAILS- THE LEFT OSTIA COULD NOT BE CANNULIZED DESPITE REPEATED ATTEMPTS WITH SEVERAL ESSURES (ATTEMPTS WITH 3 ESSURES WERE ATTEMPTED, BUT THE OSTIA COULD NEVER BE PASSED BENDING 3 ESSURES, SO THE PROCEDURE WAS ABORTED). REMOVAL DETAILS - THE ESSURE COIL WAS VISUALIZED THROUGH THE RIGHT PROXIMAL PORTION OF THE FALLOPIAN TUBE ADHERENT TO SMALL BOWEL. DISCREPANCY NOTED. IN PFS PLAINTIFF REPORTED THAT ESSURE CONFIRMATION TEST WAS NOT CONDUCTED BUT IN SUMMONS HSG RESULTS WERE PROVIDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2012: CT SCAN REVEALED ESSURE COIL PENETRATED CAVITY FROM RIGHT. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 22-JUN-2020: 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.
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE)/ESSURE COIL PENETRATED CAVITY FROM RIGHT/ESSURE COIL PERFORATING THE RIGHT FALLOPIAN TUBE') AND DEVICE DISLOCATION ('MIGRATION') IN A 34-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, GASTROINTESTINAL ISCHEMIA AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) IN 2012 FOR BIRTH CONTROL. ON (B)(6)2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6)2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 18 DAYS AFTER INSERTION OF ESSURE. IN (B)(6)2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), DEPRESSION ("DEPRESSION"), ANXIETY ("MENTAL ANGUISH"), ABDOMINAL PAIN ("ABDOMINAL PAIN") AND MENTAL DISORDER ("PSYCH INJURY"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (SURGICAL REMOVAL OF COIL,BILATERAL TUBAL CAUTERY AND UNILATERAL SALPINGECTOMY). ESSURE WAS REMOVED ON (B)(6)2012. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, DEVICE DISLOCATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION, ANXIETY AND MENTAL DISORDER OUTCOME WAS UNKNOWN AND THE PELVIC PAIN AND ABDOMINAL PAIN HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, MENTAL DISORDER, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: (B)(4) COILS WERE VISIBLE ON THE RIGHT. INSERTION DETAILS- THE LEFT OSTIA COULD NOT BE CANNULIZED DESPITE REPEATED ATTEMPTS WITH SEVERAL ESSURES (ATTEMPTS WITH 3 ESSURES WERE ATTEMPTED, BUT THE OSTIA COULD NEVER BE PASSED BENDING 3 ESSURES, SO THE PROCEDURE WAS ABORTED ) REMOVAL DETAILS - THE ESSURE COIL WAS VISUALIZED THROUGH THE RIGHT PROXIMAL PORTION OF THE FALLOPIAN TUBE ADHERENT TO SMALL BOWEL. DISCREPANCY NOTED. IN PFS PLAINTIFF REPORTED THAT ESSURE CONFIRMATION TEST WAS NOT CONDUCTED BUT IN SUMMONS HSG RESULTS WERE PROVIDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6)2012: CT SCAN REVEALED ESSURE COIL PENETRATED CAVITY FROM RIGHT.. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 3-SEP-2019: PFS RECEIVED : EVENTS ADDED- ABDOMINAL PAIN, DEVICE DISLOCATION, MENTAL DISORDER. EVENTS OUTCOME UPDATED. 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 FALLOPIAN TUBE PERFORATION ('PERFORATION (FALLOPIAN TUBE)/ESSURE COIL PENETRATED CAVITY FROM RIGHT/ESSURE COIL PERFORATING THE RIGHT FALLOPIAN TUBE') IN A (B)(6)-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 952109) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. THE PATIENT'S CONCURRENT CONDITIONS INCLUDED LOWER ABDOMINAL PAIN, ABDOMINAL PAIN, GASTROINTESTINAL ISCHEMIA AND OVARIAN CYST. CONCOMITANT PRODUCTS INCLUDED INTRAUTERINE CONTRACEPTIVE DEVICE (IUD NOS) IN 2012 FOR BIRTH CONTROL. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED FALLOPIAN TUBE PERFORATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), 18 DAYS AFTER INSERTION OF ESSURE. IN (B)(6) 2012, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN/PAIN"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL)") AND MENORRHAGIA ("ABNORMAL BLEEDING (MENORRHAGIA)"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEPRESSION ("DEPRESSION") AND ANXIETY ("MENTAL ANGUISH"). THE PATIENT WAS TREATED WITH NSAIDS, PARACETAMOL (ACETAMINOPHEN) AND SURGERY (SURGICAL REMOVAL OF COIL,BILATERAL TUBAL CAUTERY). ESSURE WAS REMOVED ON (B)(6) 2012. AT THE TIME OF THE REPORT, THE FALLOPIAN TUBE PERFORATION, VAGINAL HAEMORRHAGE, MENORRHAGIA, DEPRESSION AND ANXIETY OUTCOME WAS UNKNOWN AND THE PELVIC PAIN WAS RESOLVING. THE REPORTER CONSIDERED ANXIETY, DEPRESSION, FALLOPIAN TUBE PERFORATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: 3 COILS WERE VISIBLE ON THE RIGHT. INSERTION DETAILS- THE LEFT OSTIA COULD NOT BE CANNULIZED DESPITE REPEATED ATTEMPTS WITH SEVERAL ESSURES (ATTEMPTS WITH 3 ESSURES WERE ATTEMPTED, BUT THE OSTIA COULD NEVER BE PASSED BENDING 3 ESSURES, SO THE PROCEDURE WAS ABORTED ) REMOVAL DETAILS - THE ESSURE COIL WAS VISUALIZED THROUGH THE RIGHT PROXIMAL PORTION OF THE FALLOPIAN TUBE ADHERENT TO SMALL BOWEL. DISCREPANCY NOTED. IN PFS PLAINTIFF REPORTED THAT ESSURE CONFIRMATION TEST WAS NOT CONDUCTED BUT IN SUMMONS HSG RESULTS WERE PROVIDED. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): COMPUTERISED TOMOGRAM - ON (B)(6) 2012: CT SCAN REVEALED ESSURE COIL PENETRATED CAVITY FROM RIGHT. HYSTEROSALPINGOGRAM - ON AN UNKNOWN DATE: ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-2019: PLAINTIFF FACT SHEET AND MEDICAL RECORD RECEIVED- EVENTS: ¿ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA), PERFORATION (FALLOPIAN TUBE), DEPRESSION, MENTAL ANGUISH,SHE DID NOT UNDERWENT ESSURE CONFIRMATION TEST ¿,LOT NUMBER , LAB DATA. TREATMENT DRUGS, CONCOMITANT DRUGS AND REPORTER'S INFORMATION WERE ADDED. OUTCOME OF EVENT ¿PHYSICAL PAIN/PAIN¿ UPDATED TO ¿RECOVERING / RESOLVING¿ 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 |
|---|---|---|---|---|---|---|---|
| 671366 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 952109 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR | Other| R | IUD NOS| IUD NOS| IUD NOS| IUD NOS| IUD NOS| IUD NOS |