HANAROSTENT?? ESOPHAGUS TTS (CCC)

Description of Event or Problem

AREA SALESPERSON (B)(6) REPORTS ITEM NUMBER EBA-20-080-180 IS BROKEN IN HALF INSIDE THE PATIENT DURING A PROCEDURE. (B)(6) ACKNOWLEDGED THAT STENT WAS USED OFF-LABEL SINCE THERE ARE NO STENTS DESIGNED FOR THE SPECIFIC PROCEDURE THEY NEEDED TO DO. THE PATIENT WAS ABLE TO EAT FOR SEVERAL WEEKS AFTER THE STENT WAS IMPLANTED. THE PATIENT HAD PAIN AND CAME BACK FOR A FOLLOW UP APPOINTMENT. THE PHYSICIAN FOUND THE CIRCUMFERENCE OF THE STENT WAS COMPLETELY BROKEN. THEY USED A RAPTOR FORCEPS TO REMOVE THE STENT. THE STENT WAS SUCCESSFULLY REMOVED. THE PATIENT HAS A LOT OF MEDICAL ISSUES, BUT HE IS OK. UPDATE: PER DILIGENCE LOG # (B)(4), THE OFF-LABEL THERAPEUTIC PROCEDURE WAS A GASTRIC BYPASS POUCH STENTING. FLUOROSCOPIC AND ENDOSCOPIC IMAGES CONFIRMED THE ENTIRE STENT WAS RETRIEVED. AN EXTENDED LENGTH OF STAY AFTER THE STENT WAS RETRIEVED WAS NOT REQUIRED. PT WAS A 46 V/O WHITE MALE. AS OF 9/11 ANOTHER STENT WAS NOT PLACED.

Additional Manufacturer Narrative

THIS FOLLOW-UP REPORT IS INTENDED TO CORRECT THE CODING TERMS THAT WERE EITHER INCORRECTLY ENTERED OR OMITTED IN THE PREVIOUS REPORT. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. BECAUSE THE STENT WAS USED OFF-LABEL AND NO PRODUCT WAS MADE AVAILABLE FOR ANALYSIS, THE MANUFACTURER IS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED FRACTURE. NO ADDITIONAL INFORMATION IS EXPECTED AT THIS TIME.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. BECAUSE THE STENT WAS USED OFF-LABEL AND NO PRODUCT WAS MADE AVAILABLE FOR ANALYSIS, THE MANUFACTURER IS UNABLE TO DETERMINE A ROOT CAUSE FOR THE REPORTED FRACTURE. NO ADDITIONAL INFORMATION IS EXPECTED AT THIS TIME. THE INITIAL MDR SUBMISSION WAS DELAYED BECAUSE M.I.TECH WAS NOT AWARE OF THE DISTRIBUTOR-SUBMITTED MDRS AT THE TIME OF THE EVENTS, AS SEVERAL NOTIFICATIONS WERE SENT TO AN INACTIVE EMAIL ACCOUNT AND NO INTERNAL PROCEDURE YET EXISTED TO PERIODICALLY VERIFY INDEPENDENTLY SUBMITTED DISTRIBUTOR REPORTS; THIS ISSUE HAS SINCE BEEN ADDRESSED THROUGH OLYMPUS CAPA ACTIONS, STAFF RETRAINING, AND M.I.TECH'S ESTABLISHMENT OF A REGULAR REVIEW PROCESS.

Description of Event or Problem

AREA SALESPERSON (B)(4) REPORTS ITEM NUMBER EBA-20-080-180 IS BROKEN IN HALF INSIDE THE PATIENT DURING A PROCEDURE. DR. (B)(6) ACKNOWLEDGED THAT STENT WAS USED OFF-LABEL SINCE THERE ARE NO STENTS DESIGNED FOR THE SPECIFIC PROCEDURE THEY NEEDED TO DO. THE PATIENT WAS ABLE TO EAT FOR SEVERAL WEEKS AFTER THE STENT WAS IMPLANTED. THE PATIENT HAD PAIN AND CAME BACK FOR A FOLLOW UP APPOINTMENT. THE PHYSICIAN FOUND THE CIRCUMFERENCE OF THE STENT WAS COMPLETELY BROKEN. THEY USED A RAPTOR FORCEPS TO REMOVE THE STENT. THE STENT WAS SUCCESSFULLY REMOVED. THE PATIENT HAS A LOT OF MEDICAL ISSUES, BUT HE IS OK. UPDATE: PER DILIGENCE LOG # (B)(6), THE OFF-LABEL THERAPEUTIC PROCEDURE WAS A GASTRIC BYPASS POUCH STENTING. FLUOROSCOPIC AND ENDOSCOPIC IMAGES CONFIRMED THE ENTIRE STENT WAS RETRIEVED. AN EXTENDED LENGTH OF STAY AFTER THE STENT WAS RETRIEVED WAS NOT REQUIRED. PT WAS A 46 V/O WHITE MALE. AS OF 9/11 ANOTHER STENT WAS NOT PLACED.