ESSURE

Report

Report Number: 2951250-2014-00386
Event Type: Malfunction
Date Received: September 16, 2014
Report Date: January 19, 2017
Manufacturer: BAYER PHARMA AG
Product Code: HHS
PMA / PMN Number: P020014
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DATA CORRECTION: THE PRODUCT CODE KNH WAS REPLACED WITH HHS.

Description of Event or Problem · 1

THIS IS A SPONTANEOUS CASE REPORT RECEIVED FROM A NURSE IN UNITED STATES ON (B)(4) 2014 WHICH REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED. ON (B)(6) 2014 ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) WAS INSERTED FOR PERMANENT STERILIZATION WITH LOT NUMBER C76446. IT WAS REPORTED THAT HCP INSERTED COIL AND THE TIP OF THE "DEVICE" BROKE OFF AND WENT IN WITH COIL AND DID NOT COME BACK OUT. IT WAS ASKED IF SHE MEANT THE TIP OF THE CATHETER AND SHE WAS NOT SURE. SHE SAID THE TIP OF THE DEVICE WAS TANGLED IN THE COIL AND THE DOCTOR HAD TO REMOVE BOTH, THE TIP OF THE DEVICE AND THE COIL (COMPLICATION OF DEVICE INSERTION). PATIENT HAD BILATERAL PLACEMENT. FOLLOW-UP INFORMATION WAS RECEIVED ON 02-SEP-2014. PATIENT'S WEIGHT AND HEIGHT WERE PROVIDED. CONCOMITANT CONDITION INCLUDED OVERWEIGHT (BMI (B)(6)). SHE DENIED ANY PREVIOUS GYNECOLOGICAL INTERVENTIONS. MEDICAL HISTORY INCLUDED CYSTITIS, AND VULVAR PRURITUS. CERVICAL DILATATION, ANALGESIA AND 10MG VALIUM WERE APPLIED DURING ESSURE INSERTION. GENERAL ANESTHESIA AND SOUNDING WERE DENIED. THE INSERTION WAS DIFFICULT BECAUSE THE DEVICE DID NOT DEPLOY PROPERLY UPON ROLLBACK. THE DEFECTIVE ESSURE WAS REMOVED BY HYSTEROSCOPY AND A NEW DEVICE WAS OPENED AND WAS SUCCESSFULLY IMPLANTED. HYSTERECTOMY OR SALPINGECTOMY WAS NOT NECESSARY. THE VISUALIZATION OF THE TUBAL OSTIUM WAS EASY AND THE FLUID LOSS DURING HYSTEROSCOPY WAS LESS THAN 1500CC. THE PROCEDURE TOOK 45 MINUTES. NO IMAGING TESTS WERE PERFORMED TO CONFIRM ESSURE PLACEMENT. OCPS (ORAL CONTRACEPTIVE PILLS) WERE USED AS BACK-UP CONTRACEPTION. HSG (HYSTEROSALPINGOGRAM) WAS SCHEDULED TO (B)(6) 2014. THE PHYSICIAN MEDICALLY CONFIRMED THE EVENTS. THERE WERE NO SIGNS OF INFECTION AND INFLAMMATION. HOSPITALIZATION WAS NOT REQUIRED. THE CONDITION WAS CAUSED BY ESSURE BECAUSE IT DID NOT DEPLOY PROPERLY. NO FURTHER INFORMATION WAS PROVIDED. FOLLOW-UP RECEIVED ON 04-SEP-2014. PRODUCT TECHNICAL COMPLAINT INVESTIGATION AND FINAL ASSESSMENT WERE RECEIVED: THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (REPORTED TECHNICAL DEFECT AND REGARDED AS OTHER REPORTABLE INCIDENT). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS (B)(4) AND THE LOCAL NUMBER IS (B)(4). FINAL ASSESSMENT: WHEN A TERM LIKE "BREAK", "BREAKAGE", "BROKE", "BROKEN", "FALLING APART", "FRACTURED", OR "SPLIT" IS USED WHEN DESCRIBING A DEVICE EVENT, IT IS DIFFICULT TO DETERMINE THE TRUE NATURE OF THE EVENT FROM THE COMPLAINT DESCRIPTION ALONE. UNLESS ADDITIONAL DETAIL IS PROVIDED IN THE EVENT DESCRIPTION, IT IS DIFFICULT TO DETERMINE IF THE REPORTER IS DESCRIBING AN EVENT WHERE THE MICRO-INSERT ACTUALLY BROKE INTO INDIVIDUAL PIECES, IF THE MICRO-INSERT BENT OR STRETCHED INTO AN UNINTENDED SHAPE, AND HENCE WAS CONSIDERED BY THE REPORTER TO BE "BROKEN", OR IF A DIFFERENT PORTION OF THE DELIVERY CATHETER WAS BROKEN OFF INSIDE THE PATIENT. FAILURE MODE/MECHANISM: THE ESSURE INSERT IS MADE UP OF A FLEXIBLE OUTER COIL THAT IS DEPLOYED INTO THE FALLOPIAN TUBE. THE INSERT'S OUTER COILS EXPAND TO CONFORM TO THE FALLOPIAN TUBE, ACUTELY ANCHORING ITSELF UNTIL THE INSERT ELICITS TISSUE INGROWTH. AFTER THE FIRST ROLL BACK IS COMPLETED AND THE BUTTON IS PRESSED, USER ATTEMPTS TO REPOSITION THE DEVICE COULD LEAD TO DETACHMENT DIFFICULTY, PREMATURE DEPLOYMENT, OR IMPROPER DEVICE FUNCTION. IF THE OUTER COILS OF THE MICRO-INSERT PARTIALLY DEPLOY DURING USER ATTEMPTS TO REPOSITIONING THE DEVICE AND THE COIL CATHETER IS NOT FULLY RETRACTED, THE OUTER COILS OF THE MICRO-INSERT COULD BECOME ENTANGLED WITHIN THE DISTAL PORTION OF THE COIL CATHETER. IF THE OUTER COILS ARE PARTIALLY DEPLOYED, THE INSERT WILL BEGIN TO ANCHOR ITSELF TO THE FALLOPIAN TUBE. IF THE INNER COIL IS STILL AFFIXED TO THE DELIVERY WIRE BECAUSE ALL IFU STEPS HAVE NOT YET BEEN COMPLETED, SUBSEQUENT ATTEMPTS BY THE USER TO REMOVE THE CATHETER ASSEMBLY MAY LEAD TO EITHER A STRETCHING OF THE MICRO-INSERT, STRETCHING OF THE INNER CATHETER LARGE TIGHT PITCH COIL, OR BREAKAGE OF THE LARGE TIGHT PITCH COIL. IF THE PHYSICIAN ATTEMPTS TO REMOVE A DEPLOYED MICRO-INSERT THAT IS LOCATED WITHIN THE FALLOPIAN TUBE BY PULLING ON THE OUTER COIL OF THE MICRO-INSERT WITH A GRASPER, THIS ACTION COULD ALSO LEAD TO BREAKAGE OF THE OUTER COIL OF THE MICRO-INSERT. SINCE NO PRODUCT WAS RETURNED TO US FOR INVESTIGATION, WE WERE UNABLE TO PERFORM AN INVESTIGATION OF THE ACTUAL DEVICE INVOLVED IN THIS COMPLAINT. TYPICALLY, WE WOULD INSPECT THE MICRO-INSERT, OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL PARTS ARE ACCOUNTED FOR AND INSPECT THE DEVICE TO LOOK FOR ANY MANUFACTURING DEFICIENCIES. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MANUFACTURING BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. CONCLUSIONS: THE POSSIBILITY OF PIECES OF THE DELIVERY SYSTEM OR MICRO-INSERT BREAKING OFF DURING THE PROCEDURE IS AN ANTICIPATED EVENT. ACCORDING TO THE DFMEA, THE MAIN CONSEQUENCE IS A PHYSICIAN INCONVENIENCE BECAUSE THE PROCEDURE COULD NEED TO BE ABORTED OR RESCHEDULED. MEDICAL ASSESSMENT: THE REPORTED ADVERSE EVENT IS A KNOWN, POSSIBLE, UNDESIRABLE EVENT AND NOT INDICATIVE OF A QUALITY DEFECT PER SE. THE CASE REFERS ALSO TO A TECHNICAL DEFECT IN THE CONTEXT OF THE REPORTED COMPLICATED INSERTION. HOWEVER, THE REPORTED DEFECT COULD NOT BE EVALUATED IN MORE DETAIL DUE TO LACK OF SAMPLE RETURN. THREE (3) FURTHER AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER C76446, OF WHICH 2 CASES REFER TO SIMILAR ADVERSE TYPES OF EVENTS BUT NONE TO SIMILAR TECHNICAL TYPES OF EVENTS. NO UNUSUAL PATTERN COULD BE IDENTIFIED. THE REVIEW OF THE MANUFACTURING AND RELEASE DOCUMENTATION OF THE CONCERNED BATCH GAVE NO REASON TO SUSPECT A QUALITY DEFECT (SEE TECHNICAL STATEMENT). THE TECHNICAL ASSESSMENT CONCLUDED "UNCONFIRMED QUALITY DEFECT." IN SUMMARY, THERE IS NO REASON TO SUSPECT A CAUSAL RELATIONSHIP TO A POTENTIAL QUALITY DEFICIT BASED ON THIS REPORT. COMPANY CAUSALITY COMMENT: THIS SPONTANEOUS, MEDICALLY CONFIRMED CASE REPORT REFERS TO A (B)(6) FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND TIP OF THE "DEVICE" BROKE OFF AND WENT IN WITH COIL AND DID NOT COME BACK OUT/TIP OF THE "DEVICE" WAS TANGLED IN THE COIL AND DOCTOR HAD TO REMOVE BOTH. THIS EVENT, INTERPRETED AS DEVICE BREAKAGE, IS NON-SERIOUS AND WAS PREVIOUSLY REGARDED AS UNLISTED ACCORDING TO REFERENCE SAFETY INFORMATION FOR ESSURE; HOWEVER, UPON RECEIPT OF PRODUCT TECHNICAL INVESTIGATION (PTC) IT WAS AMENDED TO LISTED (CONSIDERED AN ANTICIPATED EVENT). THIS CASE WAS REGARDED AS OTHER REPORTABLE INCIDENT DUE TO THE REPORTED DEVICE BREAKAGE. DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE IT WAS REPORTED THAT THE BREAKAGE OCCURRED DURING INSERTION. THEREFORE, A CAUSAL RELATIONSHIP BETWEEN THE REPORTED EVENT AND ESSURE CANNOT BE EXCLUDED. ALSO, NON-SERIOUS EVENTS COMPLICATION OF DEVICE INSERTION AND DEVICE DID NOT DEPLOY PROPERLY UPON ROLLBACK WERE REPORTED. A PTC ANALYSIS WAS PERFORMED AND CONCLUDED TO AN UNCONFIRMED QUALITY DEFECT. MEDICAL PTC ASSESSMENT CONSIDERED THAT, BASED ON THE AVAILABLE INFORMATION, THERE IS NO REASON TO SUSPECT QUALITY DEFECT OF THE PRODUCT. NO FURTHER INFORMATION IS EXPECTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
571422	ESSURE	INSERT, TUBAL OCCLUSION	HHS	BAYER PHARMA AG	ESS305	C76446

Patients

Seq	Age	Sex	Outcome	Treatment
1	27 YR