ESSURE

Report

Report Number: 2951250-2008-00023
Event Type: Injury
Date Received: September 18, 2008
Date of Event: May 15, 2008
Report Date: October 4, 2016
Manufacturer: BAYER HEALTHCARE LLC
Product Code: HHS
PMA / PMN Number: P020014
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: WI, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

REPORT SUBMITTED AFTER 30 DAYS BECAUSE REEVALUATION OF EVENT BY COMMITTEE DETERMINED THAT THIS EVENT WAS REPORTABLE.

Additional Manufacturer Narrative · 1

FOLLOW-UP INFORMATION RECEIVED ON 26-MAY-2016. THE CASE (B)(4) WAS IDENTIFIED AS DUPLICATE OF THIS PRESENT CASE, AND ALL OF ITS INFORMATION HAS BEEN TRANSFERRED. THIS CASE WAS RECEIVED FROM (B)(6) ((B)(4)). FOLLOW-UP INFORMATION RECEIVED ON 18-MAY-2016 AND 26-MAY-2016 REPORTERS ADDED. NO ADDITIONAL INFORMATION RECEIVED. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WAS REPORTED DIFFICULT DEPLOYING MICRO-INSERT DURING PROCEDURE. THE MICRO-INSERT PLACED TOO PROXIMALLY (SEEN AS DEVICE PLACEMENT AT INCORRECT LOCATION) AND THE PHYSICIAN ATTEMPTED WITHDRAWAL OF MICRO-INSERT THROUGH HYSTEROSCOPE. THE MICRO-INSERT BROKE AND PATIENT WAS TRANSFERRED TO OPERATING ROOM FOR REMOVAL OF THE REMAINDER OF THE MICRO-INSERT. THE EVENTS WERE CONSIDERED SERIOUS AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS CASE, THE DEVICE BREAKAGE OCCURRED DURING ESSURE INSERTION PROCEDURE. THEREFORE, A CAUSAL RELATIONSHIP WITH SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS PERFORMED. NO FURTHER INFORMATION IS EXPECTED.

Additional Manufacturer Narrative · 1

FOLLOW-UP RECEIVED ON 22-JUN-2016 - QUALITY-SAFETY EVALUATION OF PTC: (B)(4). THE ESSURE INSERT IS MADE UP OF A FLEXIBLE OUTER COIL THAT IS DEPLOYED INTO THE FALLOPIAN TUBE. THE INSERTS 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 ALL IFU STEPS HAVE NOT BEEN COMPLETED, USER ATTEMPTS TO REPOSITION OR REMOVE THE CATHETER ASSEMBLY COULD LEAD TO EITHER A STRETCHING OR BREAKAGE OF THE MICRO-INSERT OR A PART OF THE CATHETER. 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. DEPLOYMENT DIFFICULTY IS DEFINED AS A FAILURE OF THE MICRO-INSERT OUTER COILS TO EXPAND FROM THE WOUND DOWN POSITION. PER THE INSTRUCTIONS FOR USE (IFU), THE PHYSICIAN MUST PERFORM THE FOLLOWING STEPS IN ORDER TO ACHIEVE PROPER DEPLOYMENT: ROLLBACK TO INITIAL HARD STOP. DEPRESS BUTTON. PERFORM FINAL ROLLBACK. UNDER NORMAL CIRCUMSTANCES, WHEN THE PHYSICIAN COMPLETES THE PROPER ESSURE PLACEMENT STEPS, THE RELEASE RIBBON SHOULD DISENGAGE FROM THE PLATINUM HALF BAND (WELDED ONTO OUTER COILS OF MICRO-INSERT). ONCE DISENGAGEMENT OCCURS, THE OUTER COILS SHOULD EXPAND. IF IT DOES NOT, THIS IS REFERRED TO DEPLOYMENT DIFFICULTY. SEVERAL FACTORS CAN CONTRIBUTE TO A DEPLOYMENT DIFFICULTY EVENT. THE MOST LIKELY ROOT CAUSES ARE TUBAL SPASMS WHICH CAN CLAMP DOWN ON THE DISTAL END OF THE CATHETER AND PREVENT THE MICRO-INSERT FROM EXPANDING AND RELEASING FROM THE DELIVERY WIRE, STRETCHING OF MICRO-INSERT DURING PLACEMENT ATTEMPTS WHICH TIGHTENS THE INSERTS GRIP ON THE DELIVERY WIRE, REPOSITIONING OF THE CATHETER AFTER THE FIRST ROLLBACK AND BUTTON PRESS ARE COMPLETED WHICH CAN ALSO TIGHTEN THE INSERTS GRIP ON THE DELIVERY WIRE, AND POTENTIAL MANUFACTURING DEFICIENCIES. IN THIS CASE NO PRODUCT WAS RETURNED. SINCE WE HAVE NO VALID LOT NUMBER FOR THIS CASE, WE WERE UNABLE TO CONDUCT A REVIEW OF THE MANUFACTURING BATCH RECORD. WE ARE UNABLE TO CONFIRM ANY QUALITY DEFECT OR DEVICE MALFUNCTION AT THIS TIME. ALTHOUGH WE WERE UNABLE TO CONFIRM THIS COMPLAINT, IT IS POSSIBLE THE ESSURE DEVICE COULD HAVE BEEN DEFECTIVE PRIOR TO REMOVAL FROM THE PACKAGE. THE POSSIBILITY OF A DEPLOYMENT DIFFICULTY EVENT IS AN ANTICIPATED EVENT AND THERE WAS NO EVENT REPORTED WHICH INDICATES A NEW TECHNICAL FAILURE MODE FOR THE DEVICE. BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. BASED ON THE PROVIDED INFORMATION THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT: DEVICE BREAKAGE AND DEVICE MALFUNCTION. SINCE NO MEDICAL EVENTS WERE REPORTED AT THIS POINT IN TIME, THE ASSESSMENT OF A RELATIONSHIP WITH A QUALITY DEFECT, AS WELL AS, A BATCH INVESTIGATION WITH RESPECT TO SIMILAR AE CASES ARE NOT APPLICABLE. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WAS REPORTED DIFFICULT DEPLOYING MICRO-INSERT DURING PROCEDURE. THE MICRO-INSERT PLACED TOO PROXIMALLY (SEEN AS DEVICE PLACEMENT AT INCORRECT LOCATION) AND THE PHYSICIAN ATTEMPTED WITHDRAWAL OF MICRO-INSERT THROUGH HYSTEROSCOPE. THE MICRO-INSERT BROKE AND PATIENT WAS TRANSFERRED TO OPERATING ROOM FOR REMOVAL OF THE REMAINDER OF THE MICRO-INSERT. THE EVENTS WERE CONSIDERED SERIOUS AND LISTED IN THE REFERENCE SAFETY INFORMATION FOR ESSURE. ACCORDING TO PRODUCT INVESTIGATION IS ANTICIPATED. DURING DIFFICULT INSERTION/REMOVALS, SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS CASE, THE DEVICE BREAKAGE OCCURRED DURING ESSURE INSERTION PROCEDURE. THEREFORE, A CAUSAL RELATIONSHIP WITH SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS PERFORMED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED, BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.

Additional Manufacturer Narrative · 1

FOLLOW-UP FROM 08-SEP-2016: FOLLOW-UP ATTEMPTS HAVE BEEN COMPLETED, WITH NO RESPONSE TO DATE. COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT REFERS TO A FEMALE PATIENT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) INSERTED AND IT WAS REPORTED DIFFICULT DEPLOYING MICRO-INSERT DURING PROCEDURE. THE MICRO-INSERT PLACED TOO PROXIMALLY (SEEN AS DEVICE PLACEMENT AT INCORRECT LOCATION) AND THE PHYSICIAN ATTEMPTED WITHDRAWAL OF MICRO-INSERT THROUGH HYSTEROSCOPE. THE MICRO-INSERT BROKE AND PATIENT WAS TRANSFERRED TO OPERATING ROOM FOR REMOVAL OF THE REMAINDER OF THE MICRO-INSERT. THE EVENTS WERE CONSIDERED SERIOUS AND ANTICIPATED IN THE REFERENCE SAFETY INFORMATION AND ACCORDING TO PRODUCT INVESTIGATION. IN THIS CASE, THE DEVICE BREAKAGE OCCURRED DURING ESSURE INSERTION PROCEDURE. THEREFORE, A CAUSAL RELATIONSHIP WITH SUSPECT INSERT CANNOT BE EXCLUDED. THIS CASE WAS REGARDED AS INCIDENT SINCE DEVICE REMOVAL WAS PERFORMED. THE PRODUCT TECHNICAL ANALYSIS CONCLUDED, BASED ON THE AVAILABLE INFORMATION A PRODUCT QUALITY DEFECT COULD NOT BE CONFIRMED BUT IS CONSIDERED PLAUSIBLE. NO FURTHER INFORMATION IS EXPECTED.

Description of Event or Problem · 1

PHYSICIAN REPORTED DIFFICULTY DEPLOYING MICRO-INSERT DURING PROCEDURE. THE MICRO-INSERT WAS PLACED TOO PROXIMALLY, SO THE PHYSICIAN ATTEMPTED WITHDRAWAL OF MICRO-INSERT THROUGH HYSTEROSCOPE. THE MICRO-INSERT BROKE, SO THE PATIENT WAS TRANSFERRED TO OPERATING ROOM FOR REMOVAL OF THE REMAINDER OF THE MICRO-INSERT. THE REMAINDER OF THE MICRO-INSERT WAS REMOVED AND A NEW MICRO-INSERT WAS SUCCESSFULLY PLACED. DELIVERY SYSTEM WAS RETURNED TO CONCEPTUS. EVALUATION OF THE DELIVERY SYSTEM SHOWED THAT DEPLOYMENT DIFFICULTIES WERE MOST LIKELY CAUSED BY AN OUT-OF-SPECIFICATION LANDING AREA (DISTANCE BETWEEN INNER CATHETER AND INNER COIL). CONCEPTUS IS CURRENTLY ADDRESSING THE OUT-OF-SPECIFICATION LANDING AREA VIA CAPA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ESSURE	INSERT, TUBAL OCCLUSION	HHS	BAYER HEALTHCARE LLC	ESS305	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention