ESSURE
Report
- Report Number
- 2951250-2019-04599
- Event Type
- Injury
- Date Received
- August 9, 2019
- Date of Event
- September 13, 2013
- Report Date
- September 16, 2019
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MIGRATION OF ESSURE DEVICE - UNKNOWN LOCATION / FAILURE TO OCCLUDE FALLOPIAN TUBE (S)') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A78087) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: RADIOLOGIST TOLD THE PATIENT THAT HER RIGHT TUBE WAS NOT OCCLUDED. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM 2002 TO 2005 FOR CONTRACEPTION AS WELL AS FENTANYL CITRATE (NARCO) SINCE (B)(6) 2013, IBUPROFEN SINCE (B)(6) 2013, NSAIDS SINCE (B)(6) 2013 AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) SINCE (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN / PAIN PELVIC AREA"), ABDOMINAL PAIN ("ABDOMINAL PAIN / ABDOMINAL AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - DEPRESSION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 5 MONTHS 5 DAYS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT DID NOT HAVE HER ESSURE REMOVED, HOWEVER, IS CURRENTLY PLANNING FOR REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2013: RIGHT TUBE WAS NOT OCCLUDED ON HSG X 2. NON-VISUALIZATION OF THE RIGHT ESSURE. NORMAL CONTRAST FILLING OF THE PATENT RIGHT FALLOPIAN TUBE. LEFT FACIAL ARE IN GOOD POSITION WITH OCCLUSION OF THE LEFT FALLOPIAN TUBE.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 14-AUG-2019: QUALITY-SAFETY EVALUATION OF 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 DISLOCATION ('MIGRATION OF ESSURE DEVICE - UNKNOWN LOCATION / FAILURE TO OCCLUDE FALLOPIAN TUBE (S)/MIGRATION') AND GENITAL HAEMORRHAGE ('GENERAL ABNORMAL BLEEDING') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A78087) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: RADIOLOGIST TOLD THE PATIENT THAT HER RIGHT TUBE WAS NOT OCCLUDED. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM 2002 TO 2005 FOR CONTRACEPTION AS WELL AS FENTANYL CITRATE (NARCO) SINCE (B)(6) 2013, IBUPROFEN SINCE (B)(6) 2013, NSAIDS SINCE (B)(6) 2013 AND OXYCODONE HYDROCHLORIDE; PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) SINCE (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN / PAIN PELVIC AREA"), ABDOMINAL PAIN ("ABDOMINAL PAIN / ABDOMINAL AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA)"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - DEPRESSION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 5 MONTHS 5 DAYS AFTER INSERTION OF ESSURE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED GENITAL HAEMORRHAGE (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT). THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, GENITAL HAEMORRHAGE, PELVIC PAIN, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, GENITAL HAEMORRHAGE, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT DID NOT HAVE HER ESSURE REMOVED, HOWEVER, IS CURRENTLY PLANNING FOR REMOVAL. IF NO REMOVAL PLANNED: UNABLE TO AFFORD SURGERY DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2013: RIGHT TUBE WAS NOT OCCLUDED ON HSG X 2. NON-VISUALIZATION OF THE RIGHT ESSURE. NORMAL CONTRAST FILLING OF THE PATENT RIGHT FALLOPIAN TUBE. LEFT FACIAL ARE IN GOOD POSITION WITH OCCLUSION OF THE LEFT FALLOPIAN TUBE.. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 4-SEP-2019: PFS RECEIVED: EVENTS GENERAL ABNORMAL BLEEDING ADDED. 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 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 - UNKNOWN LOCATION / FAILURE TO OCCLUDE FALLOPIAN TUBE (S)') IN A 42-YEAR-OLD FEMALE PATIENT WHO HAD ESSURE (BATCH NO: A78087) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: RADIOLOGIST TOLD THE PATIENT THAT HER RIGHT TUBE WAS NOT OCCLUDED. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM 2002 TO 2005 FOR CONTRACEPTION AS WELL AS FENTANYL CITRATE (NARCO) SINCE ON (B)(6) 2013, IBUPROFEN SINCE ON (B)(6) 2013, NSAIDS SINCE ON (B)(6) 2013 AND OXYCODONE HYDROCHLORIDE; PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) SINCE ON (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. ON (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN / PAIN PELVIC AREA"), ABDOMINAL PAIN ("ABDOMINAL PAIN / ABDOMINAL AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"). ON (B)(6) 2013, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - DEPRESSION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 5 MONTHS 5 DAYS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT DID NOT HAVE HER ESSURE REMOVED, HOWEVER, IS CURRENTLY PLANNING FOR REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM: ON (B)(6) 2013: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2013: RIGHT TUBE WAS NOT OCCLUDED ON HSG X 2. NON-VISUALIZATION OF THE RIGHT ESSURE. NORMAL CONTRAST FILLING OF THE PATENT RIGHT FALLOPIAN TUBE. LEFT FACIAL ARE IN GOOD POSITION WITH OCCLUSION OF THE LEFT FALLOPIAN TUBE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 10-SEP-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 - UNKNOWN LOCATION / FAILURE TO OCCLUDE FALLOPIAN TUBE (S)') IN A (B)(6) FEMALE PATIENT WHO HAD ESSURE (BATCH NO. A78087) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. MEDICAL CONDITIONS: RADIOLOGIST TOLD THE PATIENT THAT HER RIGHT TUBE WAS NOT OCCLUDED. CONCOMITANT PRODUCTS INCLUDED MEDROXYPROGESTERONE ACETATE (DEPO PROVERA) FROM 2002 TO 2005 FOR CONTRACEPTION AS WELL AS FENTANYL CITRATE (NARCO) SINCE (B)(6) 2013, IBUPROFEN SINCE (B)(6) 2013, NSAIDS SINCE (B)(6) 2013 AND OXYCODONE HYDROCHLORIDE;PARACETAMOL (OXYCODONE AND ACETAMINOPHEN) SINCE (B)(6) 2013. ON (B)(6) 2013, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED PELVIC PAIN ("PHYSICAL PAIN / PAIN PELVIC AREA"), ABDOMINAL PAIN ("ABDOMINAL PAIN / ABDOMINAL AREA"), VAGINAL HAEMORRHAGE ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA") AND MENORRHAGIA ("ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ANXIETY ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - MENTAL ANGUISH") AND DEPRESSION ("PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - DEPRESSION"). ON (B)(6) 2013, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERION MEDICALLY SIGNIFICANT), 5 MONTHS 5 DAYS AFTER INSERTION OF ESSURE. THE PATIENT WAS TREATED WITH PARACETAMOL (ACETAMINOPHEN). ESSURE TREATMENT WAS NOT CHANGED. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, ABDOMINAL PAIN, VAGINAL HAEMORRHAGE, MENORRHAGIA, ANXIETY AND DEPRESSION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ANXIETY, DEPRESSION, DEVICE DISLOCATION, MENORRHAGIA, PELVIC PAIN AND VAGINAL HAEMORRHAGE TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: THE PATIENT DID NOT HAVE HER ESSURE REMOVED, HOWEVER, IS CURRENTLY PLANNING FOR REMOVAL. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - ON (B)(6) 2013: CONFIRMED THAT THE ESSURE DEVICE WAS SUCCESSFULLY OCCLUDED.; ON (B)(6) 2013: RIGHT TUBE WAS NOT OCCLUDED ON HSG X 2. NON-VISUALIZATION OF THE RIGHT ESSURE. NORMAL CONTRAST FILLING OF THE PATENT RIGHT FALLOPIAN TUBE. LEFT FACIAL ARE IN GOOD POSITION WITH OCCLUSION OF THE LEFT FALLOPIAN TUBE. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 31-JUL-2019: PFS AND MR RECEIVED: EVENT OF PHYSICAL PAIN UPDATED TO PHYSICAL PAIN / PAIN PELVIC AREA. NEW EVENTS ADDED:- ABNORMAL BLEEDING (VAGINAL, MENORRHAGIA); FAILURE TO OCCLUDE FALLOPIAN TUBE; MIGRATION OF ESSURE DEVICE - UNKNOWN LOCATION, PSYCHOLOGICAL OR PSYCHIATRIC PROBLEMS - DEPRESSION AND MENTAL ANGUISH WERE ADDED. LAB DATA, LOT NUMBER, CONCOMITANT AND TREATMENT DRUGS WERE ADDED. 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 |
|---|---|---|---|---|---|---|---|
| 671894 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | A78087 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other | DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| DEPO PROVERA| IBUPROFEN| IBUPROFEN| IBUPROFEN| IBUPROFEN| NARCO| NARCO| NARCO| NARCO| NSAIDS| NSAIDS| NSAIDS| NSAIDS| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| OXYCODONE AND ACETAMINOPHEN| DEPO PROVERA| DEPO PROVERA| IBUPROFEN| NARCO| NSAIDS| OXYCODONE AND ACETAMINOPHEN |