ESSURE

Report

Report Number: 2951250-2014-00319
Event Type: Malfunction
Date Received: August 7, 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: WA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

COMPANY CAUSALITY COMMENT: THIS MEDICALLY CONFIRMED, SPONTANEOUS CASE REPORT, REFERS TO A (B)(6) FEMALE PT WHO HAD AN ATTEMPT TO INSERT ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) AND DURING THE PROCEDURE FIVE COILS BROKE (IN ONE PIECE) FROM INSERT (COMPLICATION OF DEVICE INSERTION). THE REPORTED EVENT WAS CONSIDERED NON-SERIOUS, IS UNLISTED ACCORDING TO REF. SAFETY INFO FOR ESSURE AND WAS CONSIDERED A NEAR-INCIDENT DUE TO THE DEVICE BREAKAGE (AS ALTHOUGH IT DID NOT LEAD TO DEATH OR SERIOUS HEALTH DETERIORATION THIS MIGHT HAVE OCCURRED UNDER LESS FORTUNATE CIRCUMSTANCES). SINGLE CASES HAVE BEEN REPORTED OF ESSURE BREAKAGE. IN THIS PARTICULAR CASE, A DEVICE BREAKAGE WAS REPORTED, NO FURTHER INFO WAS PROVIDED, HOWEVER CONSIDERING THAT THIS EVENT OCCURRED DURING ESSURE INSERTION, A CAUSAL RELATIONSHIP WITH SUSPECT INSERT CANNOT BE EXCLUDED. ACCORDING TO THE PRODUCT TECHNICAL ANALYSIS A QUALITY DEFECT WAS PLAUSIBLE AND BASED ON THE PROVIDED INFO THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT DEVICE BREAKAGE. IN SUMMARY, BASED ON THE AVAILABLE INFO A CAUSAL RELATIONSHIP CANNOT BE EXCLUDED BETWEEN THE REPORTED DEVICE BREAKAGE AND A PRODUCT DEFECT.

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 MEDICAL DOCTOR IN UNITED STATES ON (B)(6) 2014 WHICH REFERS TO A (B)(6) FEMALE PT WHO HAD ESSURE (FALLOPIAN TUBE OCCLUSION INSERT) LOT NUMBER B76537 INSERTED ON (B)(6) 2014 AND FIVE COILS BROKE (IN ONE PIECE) DURING INSERTION. REPORTER STATED THAT EVERYTHING WAS FINE UNTIL HE CLICKED TO RELEASE (DEPLOY) INSERT. WHEN HE PULLED BACK, IT SEEMED FINE, THERE WAS NO TENSION BUT FIVE COILS BROKE (IN ONE PIECE) FROM INSERT. HE WAS ABLE TO REMOVE THE BROKEN PIECE WITH HYSTEROSCOPE. HE WILL AND DO AN HSG ON THIS PT. PTC INVESTIGATION RESULT WAS RECEIVED ON (B)(4) 2014. THIS ADVERSE EVENT REPORT IS RELATED TO A PRODUCT TECHNICAL COMPLAINT (PTC). THE BAYER REFERENCE NUMBER FOR THE PTC REPORT IS: PTC LOCAL NUMBER (B)(6) . FINAL ASSESSMENT: WHEN A TERM LIKE "BROKE" 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, OR IF THE MICRO-INSERT BENT OR STRETCHED INTO AN UNINTENDED SHAPE, AND HENCE WAS CONSIDERED BY THE REPORTER TO BE "BROKEN". 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, THE OUTER CATHETER, THE INNER CATHETER, AND ALL PARTS WITHIN THE HANDLE ASSEMBLY TO CONFIRM THAT ALL ARE WITHIN MFG SPECIFICATIONS. IN THIS CASE, WE CONDUCTED A REVIEW OF THE MFG BATCH RECORD AND CONFIRMED THAT FINAL PRODUCT TESTING FOR THIS LOT WAS PERFORMED PER REQUIREMENTS AND THE PRODUCT MET ALL RELEASE REQUIREMENTS. SINCE NO PRODUCT WAS RETURNED FOR INVESTIGATION, WE CANNOT CONFIRM THIS QUALITY COMPLAINT; HOWEVER, BASED ON THE COMPLAINT DESCRIPTION PROVIDED, WE ARE ABLE TO CONCLUDE THAT A QUALITY ISSUE IS PLAUSIBLE. IT IS POSSIBLE DURING THE MFG ASSEMBLY PROCESS A SMALL GAP WAS LEFT BETWEEN THE INNER COIL AND INNER CATHETER (THEY SHOULD BE BUTTED TOGETHER DURING ASSEMBLY). WHEN THE OUTER COIL OF THE MICRO-INSERT IS WOUND DOWN A SMALL PORTION OF THE COIL CAN BECOME TRAPPED IN THE GAP. IF A DEVICE HAS THIS ISSUE, WHEN THE PHYSICIAN PRESSES THE BUTTON TO RELEASE THE MICRO-INSERT, THE OUTER COIL MAY SEVER ITSELF AS IT IS BEING DEPLOYED FROM THE CATHETER. IN TYPICAL SITUATIONS, THIS SEVERING OCCURS INSIDE THE CATHETER PRIOR TO THE PIECES BEING DEPLOYED FROM THE CATHETER. THE SEVERING OF THE COILS INSIDE THE CATHETER DOES NOT POSE A SIGNIFICANT RISK TO THE HEALTH OF THE PT. MEDICAL ASSESSMENT: THIS CASE REPORTED COMPLICATION OF INSERTION DUE TO BREAKAGE BUT THESE REPORTED EVENTS ARE NOT NECESSARILY INDICATIVE OF A QUALITY DEFECT. THREE (3) ADDITIONAL AE CASE REPORTS HAVE BEEN RECEIVED TO DATE IN RELATION TO BATCH NUMBER B76537 BUT ONLY TWO (2) OF THESE CASES REFER TO A BREAKAGE EVENT AS WELL AS COMPLICATION OF INSERTION. NO UNUSUAL PATTERN CAN BE IDENTIFIED AT THIS TIME. THE REVIEW OF THE LOT HISTORY RECORDS CONFIRMED THAT THE PRODUCT MET PRODUCT RELEASE SPECIFICATIONS. NO COMPLAINT SAMPLE WAS PROVIDED FOR A TECHNICAL INVESTIGATION BUT BASED ON THE COMPLAINT DESCRIPTION PROVIDED, THE RQU WAS ABLE TO CONCLUDE THAT A QUALITY ISSUE IS PLAUSIBLE DUE TO THE CAUSE OF THE DESCRIBED BREAKAGE HAS BEEN PREVIOUSLY INVESTIGATED AND IS WELL UNDERSTOOD. AT TIME OF THIS MEDICAL ASSESSMENT THE TECHNICAL INVESTIGATION CONCLUDED" UNCONFIRMED QUALITY DEFECT - BUT PLAUSIBLE" WITH A FINAL RISK CATEGORY IV, A DEFECT WHICH DOES NOT POSE A HAZARD TO PT'S HEALTH AS THE SEVERING OF THE COILS DOES NOT POSE A SIGNIFICANT RISK TO THE HEALTH OF THE PT. ACCORDING TO THE TECHNICAL ASSESSMENT A QUALITY DEFECT WAS PLAUSIBLE AND BASED ON THE PROVIDED INFO THE DEFECT TYPE CORRESPONDS TO THE FOLLOWING MEDDRA LLT DEVICE BREAKAGE. IN SUMMARY, BASED ON THE AVAILABLE INFO A CAUSAL RELATIONSHIP CANNOT BE EXCLUDED BETWEEN THE REPORTED DEVICE BREAKAGE AND A PRODUCT DEFECT. FOLLOW UP INFO RECEIVED ON 07/23/2014: ALL FOLLOW UP ATTEMPTS DONE WITH NO RESPONSE TO DATE. CASE CLOSED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
464130	ESSURE	INSERT, TUBAL OCCLUSION	HHS	BAYER PHARMA AG	ESS305	B76537

Patients

Seq	Age	Sex	Outcome	Treatment
1	25 YR