ESSURE
Report
- Report Number
- 2951250-2019-08029
- Event Type
- Injury
- Date Received
- September 24, 2019
- Report Date
- February 25, 2020
- Manufacturer
- BAYER PHARMA AG
- Product Code
- HHS
- UDI-DI
- 10888853003051
- PMA / PMN Number
- P020014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE/FAILURE TO OCCLUDE FALLOPIAN TUBES') AND EMBEDDED DEVICE ('EMBEDDED PORTION OF ESSURE COIL IN RIGHT FALLOPIAN TUBE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR FROM 2014 TO 2018 AND NALTREXONE SINCE 2018. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) OF 2013, THE PATIENT EXPERIENCED OSTEOARTHRITIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: JOINT FAILURE"). IN (B)(6) OF 2013, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN ISSUES/ PAIN MANAGEMENT FOR (FOR JOINT PAIN), KNEE PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC/CHRONIC/OTHER"), ABDOMINAL PAIN ("CHRONIC,OTHER,PELVIC/ABDOMINAL"), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), TISSUE INJURY ("TISSUE DAMAGE"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), NECK PAIN ("NECK PAIN") AND SPINAL PAIN ("SPINE PAIN"). THE PATIENT WAS TREATED WITH SURGERY (SALPINGECTOMY BILATERAL),HYSTERECTOMY(PARTIAL) (B)(6)2019. ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, MENORRHAGIA, ARTHRALGIA, TISSUE INJURY, MUSCULOSKELETAL PAIN, NECK PAIN AND SPINAL PAIN OUTCOME WAS UNKNOWN AND THE OSTEOARTHRITIS HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, EMBEDDED DEVICE, MENORRHAGIA, MUSCULOSKELETAL PAIN, NECK PAIN, OSTEOARTHRITIS, PELVIC PAIN, SPINAL PAIN AND TISSUE INJURY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TYPE OF AUTOIMMUNE DIAGNOSED: NOT FORMALLY DIAGNOSED, SUSPECTED RECEIVED TREATMENT FOR PAIN, BLEEDING, AUTOIMMUNE AND OTHER INJURIES :YES (B)(6) 2013 (1 ST REMOVAL). (B)(6) 2019 (2ND REMOVAL) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) OF 2012: RESULT- UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED). RIGHT FALLOPIAN TUBE OCCLUDED. LEFT FALLOPIAN TUBE OPEN BECAUSE THEY WERE NOT ABLE TO INSERT COIL ON LEFT SIDE. IMAGING PROCEDURE - ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) RESULTS: FAILURE TO OCCLUDE,MALPOSITION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT . MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON (B)(6) 2020: QUALITY SAFETY EVALUATION OF PTC (PRODUCT TECHNICAL COMPLAINT). 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 DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE/FAILURE TO OCCLUDE FALLOPIAN TUBES') AND EMBEDDED DEVICE ('EMBEDDED PORTION OF ESSURE COIL IN RIGHT FALLOPIAN TUBE') IN AN ADULT FEMALE PATIENT WHO HAD ESSURE (BATCH NO. 922606) INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. CONCOMITANT PRODUCTS INCLUDED ACICLOVIR FROM 2014 TO 2018 AND NALTREXONE SINCE 2018. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. IN (B)(6) 2013, THE PATIENT EXPERIENCED OSTEOARTHRITIS ("AUTOIMMUNE DISORDER TYPE OF DISORDER: JOINT FAILURE"). IN (B)(6) 2013, THE PATIENT EXPERIENCED ARTHRALGIA ("JOINT PAIN ISSUES/ PAIN MANAGEMENT FOR (FOR JOINT PAIN)/ KNEE PAIN"). ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), EMBEDDED DEVICE (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC/CHRONIC/OTHER"), ABDOMINAL PAIN ("CHRONIC,OTHER,PELVIC/ABDOMINAL"), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), TISSUE INJURY ("TISSUE DAMAGE"), MUSCULOSKELETAL PAIN ("SHOULDER PAIN"), NECK PAIN ("NECK PAIN") AND SPINAL PAIN ("SPINE PAIN"). THE PATIENT WAS TREATED WITH SURGERY ((SALPINGECTOMY BILATERAL),HYSTERECTOMY(PARTIAL)(B)(6) 2019). ESSURE WAS REMOVED ON (B)(6) 2019. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, EMBEDDED DEVICE, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, MENORRHAGIA, ARTHRALGIA, TISSUE INJURY, MUSCULOSKELETAL PAIN, NECK PAIN AND SPINAL PAIN OUTCOME WAS UNKNOWN AND THE OSTEOARTHRITIS HAD RESOLVED. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, EMBEDDED DEVICE, MENORRHAGIA, MUSCULOSKELETAL PAIN, NECK PAIN, OSTEOARTHRITIS, PELVIC PAIN, SPINAL PAIN AND TISSUE INJURY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TYPE OF AUTOIMMUNE DIAGNOSED: NOT FORMALLY DIAGNOSED, SUSPECTED. RECEIVED TREATMENT FOR PAIN, BLEEDING, AUTOIMMUNE AND OTHER INJURIES :YES. ON (B)(6) 2013 (1 ST REMOVAL). ON (B)(6) 2019 (2ND REMOVAL) . DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): HYSTEROSALPINGOGRAM - IN (B)(6) 2012: RESULT- UNILATERAL OCCLUSION (RIGHT TUBE OCCLUDED). RIGHT FALLOPIAN TUBE OCCLUDED. LEFT FALLOPIAN TUBE OPEN BECAUSE THEY WERE NOT ABLE TO INSERT COIL ON LEFT SIDE. IMAGING PROCEDURE - ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) RESULTS: FAILURE TO OCCLUDE,MALPOSITION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 27-JAN-2020: PFS AND MR RECEIVED: LOT NUMBER WAS ADDED, NEWLY ADDED EVENTS- OSTEOARTHRITIS, SHOULDER PAIN, NECK PAIN, SPINE PAIN, EMBEDDED DEVICE, ESSURE REMOVAL DATE WAS ADDED, REPORTER WAS ADDED, CONSUMER HEIGHT WAS ADDED, LAB DATA WERE UPDATED. 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 DEVICE DISLOCATION ('MALPOSITION OF ESSURE DEVICE/FAILURE TO OCCLUDE FALLOPIAN TUBES') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED FOR FEMALE STERILISATION. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON (B)(6) 2012, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DEVICE DISLOCATION (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), PELVIC PAIN ("PELVIC/CHRONIC/OTHER"), ABDOMINAL PAIN ("CHRONIC,OTHER,PELVIC/ABDOMINAL"), BACK PAIN ("BACK PAIN"), DYSMENORRHOEA ("DYSMENORRHEA (CRAMPING)"), MENORRHAGIA ("MENORRHAGIA (HEAVY MENSTRUAL BLEEDING)"), ARTHRALGIA ("JOINT PAIN ISSUES") AND TISSUE INJURY ("TISSUE DAMAGE"). THE PATIENT WAS TREATED WITH SURGERY ((B)(6) 2013 (SALPINGECTOMY BILATERAL)). ESSURE WAS REMOVED ON (B)(6) 2013. AT THE TIME OF THE REPORT, THE DEVICE DISLOCATION, PELVIC PAIN, ABDOMINAL PAIN, BACK PAIN, DYSMENORRHOEA, MENORRHAGIA, ARTHRALGIA AND TISSUE INJURY OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED ABDOMINAL PAIN, ARTHRALGIA, BACK PAIN, DEVICE DISLOCATION, DYSMENORRHOEA, MENORRHAGIA, PELVIC PAIN AND TISSUE INJURY TO BE RELATED TO ESSURE. THE REPORTER COMMENTED: TYPE OF AUTOIMMUNE DIAGNOSED: NOT FORMALLY DIAGNOSED, SUSPECTED RECEIVED TREATMENT FOR PAIN, BLEEDING, AUTOIMMUNE AND OTHER INJURIES: YES. DIAGNOSTIC RESULTS (NORMAL RANGES ARE PROVIDED IN PARENTHESIS IF AVAILABLE): IMAGING PROCEDURE ON AN UNKNOWN DATE: ESSURE CONFIRMATION TEST(S)(UNSPECIFIED) RESULTS: FAILURE TO OCCLUDE,MALPOSITION. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 9-SEP-2019: PFS RECEIVED: NEW EVENTS ADDED: "PELVIC/ABDOMINAL PAIN, BACK, DYSMENORRHEA (CRAMPING), MENORRHAGIA (HEAVY MENSTRUAL BLEEDING), JOINT PAIN ISSUES AND TISSUE DAMAGE, AND MALPOSITION OF ESSURE DEVICE". REPORTER CONTACT INFORMATION WAS ADDED. PATIENT'S DEMOGRAPHICS WERE ADDED. PRODUCT INDICATION UPDATED. ESSURE INSERTION REMOVAL DATE WAS ADDED. LAB DATA WAS ADDED. INCIDENT. 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 |
|---|---|---|---|---|---|---|---|
| 905562 | ESSURE | TRANSCERVICAL CONTRACEPTIVE TUBAL OCCLUSION DEVICE | HHS | BAYER PHARMA AG | ESS305 | 922606 | 10888853003051 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | ACICLOVIR.| ACICLOVIR.| NALTREXONE.| NALTREXONE. |