Description of Event or Problem · 0
DESCRIPTION OF EVENT PER REP - (B)(6) 2025 - DURING FOLLOW-UP, THERE WAS A TYPE 3 ENDOLEAK OBSERVED THAT IS LIKELY ORIGINATING FROM THE CROTCH OF THE GRAFT SYSTEM. NO INTERVENTION HAS BEEN PERFORMED AS OF YET. A PROCEDURE WILL LIKELY BE SCHEDULED TO ADDRESS THIS ISSUE. PATIENT OUTCOME. A PROCEDURE WILL LIKELY BE SCHEDULED TO ADDRESS THIS ISSUE. (B)(6) 2025. GENERAL QUESTIONS: WHAT DEVICE WAS IMPLANTED? (PROVIDE DEVICE LOT #) G32554-ZFEN-D-12-28-91-C (E # FROM QUICKBASE SYSTEM: E112737), REP COULD NOT CONFIRM LOT #. WHAT DATE WAS THE DEVICE IMPLANTED? (B)(6) 2025. WHAT OTHER DEVICES WERE USED OR IMPLANTED DURING THE PROCEDURE? (BALLOON, GRAFT, ETC.) N/A. PLEASE PROVIDE MANUFACTURER, DEVICE LOT #, RPN, AND SIZE IF APPLICABLE. DID THE PATIENT HAVE ANY PRE-EXISTING CONDITIONS RELATED TO THE EVENT? AAA. DATE THE DEFICIENCY/NONCONFORMANCE WAS IDENTIFIED: (B)(6) 2025. WAS THE DEVICE IFU FOLLOWED? HAS THE DEVICE FUNCTIONED AS EXPECTED WHILE FOLLOWING THE IFU? YES, YES. PROVIDE SPECIFIC DETAILS OF THE NONCONFORMANCE: HOW IT WAS DISCOVERED AND DURING WHICH STEP IN THE IFU WAS THE NONCONFORMANCE FIRST IDENTIFIED? FOLLOW UP. HOW IT RELATES TO THE DEVICE (E.G., WHAT POINT IN THE PROCEDURE WAS THE DIFFICULTY/NONCONFORMANCE EXPERIENCED, WHAT PART OF THE ANATOMY WAS INVOLVED, WAS IT AT THE PROXIMAL END/DISTAL END/FENESTRATION OF THE DEVICE, DOES PATIENT ANATOMY HAVE AN IMPACT, WERE THERE ANY DEVIATIONS/DIFFICULTIES EXPERIENCED DURING THE PROCEDURE). FOLLOW-UP, BODY. WAS ANY INTERVENTION PERFORMED TO CORRECT THE NONCONFORMANCE? (PROVIDE DETAILS) NOT YET. CAN ANY PLANNING AND/OR SIZING INFORMATION BE PROVIDED? PRE AND POST OP SCANS (SECURE SHUTTLE). ARE PRE-OPERATIVE AND/OR POST-OPERATIVE IMAGES AVAILABLE? YES. WERE THERE ANY ADVERSE EVENTS? TYPE 3 ENDOLEAK. HAS IT BEEN DETERMINED IF THE ADVERSE EVENT IS POTENTIALLY DEVICE RELATED AND/OR PATIENT CONDITION RELATED? DEVICE RELATED. WHAT WAS THE PATIENT OUTCOME? TYPE 3 ENDOLEAK. WILL THERE BE, OR WAS THERE ANY ADDITIONAL PROCEDURES REQUIRED DUE TO THE REPORTED ISSUE? LIKELY FUTURE INTERVENTION. QUESTIONS WHERE PATIENT DEATH OCCURRED: N/A. WILL THE AUTOPSY REPORT BE PROVIDED? IS THERE A DEATH CERTIFICATE AVAILABLE? WHAT WAS THE CAUSE OF DEATH DETERMINED BY THE PHYSICIAN? DID THE DEVICE CONTRIBUTE IN SOME WAY TO THE PATIENT DEATH (? IF SO, HOW?). CAN IT BE CONFIRMED IF THE DEVICE IS AVAILABLE FOR RETURN OR NOT? HAS IT BEEN DETERMINED IF THE PATIENT DEATH IS POTENTIALLY DEVICE RELATED AND/OR PATIENT CONDITION RELATED? IF THE EVENT OCCURRED DURING ORIGINAL IMPLANT: N/A. WAS A COOK REPRESENTATIVE PRESENT FOR THE CASE? WAS ANY PART OF THE PROCEDURE PERFORMED OFF-LABEL OR OUT OF THE PATIENT SELECTION CRITERIA? (IF YES, PLEASE DESCRIBE). WAS ANY DIFFICULTY EXPERIENCED DURING DEPLOYMENT? WAS A PATIENT'S ANATOMY TORTUOUS? WHAT DOES THE PHYSICIAN THINK CAUSED THE ISSUE? WAS THE PATIENT ON ANTICOAGULANTS OR ANY OTHER MEDICATION DURING THE PROCEDURE? ARE ANY 'PROCEDURAL NOTES' AVAILABLE? WAS THE DEVICE INSPECTED PRIOR TO USE IN ORDER TO ENSURE NO DAMAGE HAS OCCURRED? IF THE EVENT OCCURRED DURING A FOLLOW UP PROCEDURE: WHAT WAS THE PREVIOUSLY IMPLANTED DEVICE? G32554-ZFEN-D-12-28-91-C (E # FROM QUICKBASE SYSTEM: E112737), REP COULD NOT CONFIRM LOT #. WHY WAS A FOLLOW UP PROCEDURE NECESSARY? (PLANNED FOLLOW UP OR DUE TO COMPLICATIONS?) PLANNED FOLLOW UP. WHAT PROMPTED THE ADDITIONAL PROCEDURE? STANDARD FOLLOW UP. WAS THE ISSUE RESOLVED AFTER THE ADDITIONAL PROCEDURE? NO. INVOLVES AN ENDOLEAK QUESTIONS: WHAT WAS THE SHAPE OF THE NECK ANATOMY? (I.E., PARALLEL, INVERSE FUNNEL, FUNNEL, NARROWED, ETC.) SHORT INFRARENAL NECK. WHERE IN THE GRAFT WAS THE BALLOONING PERFORMED? WITHIN THE GRAFT AT THE PROXIMAL AND DISTAL SEAL SITES AND OVERLAP SITES. WHERE THERE ANY PRE OR POST IMPLANTATION OR ADJUNCTIVE PROCEDURES? (I.E., EXTRA BALLOONING, STENTING, ETC.) NO. WHAT KIND OF ANTI-PLATELET OR ANTI-COAGULATION THERAPY WAS THE PATIENT ON? UNKR. WHERE THERE ANY GRAFT OBSTRUCTION OR HIGH BLOOD PRESSURE WITHIN THE GRAFT DURING THE ENDOLEAK? NONE REPORTED. WAS THE GRAFT ABLE TO BE DEPLOYED IN THE TARGET ZONE? YES. WAS ANY OF THE FOLLOWING IDENTIFIED BY THE TREATING PHYSICIAN/COOK REP: STENT DETACHMENT OR BREAKAGE OF Z-STENTS: NO. INADEQUATE BARB ENGAGEMENT WITH VESSEL WALL: NO. PROGRESSION OF THE ANEURISM: NO. DID PATIENT ANATOMY HAVE AN IMPACT ON THIS COMPLAINT? NO. ANY MATERIAL FRACTURE OF THE GRAFT -POSSIBLY A FABRIC FRACTURE IF THE EVENT INVOLVES A TYPE III ENDOLEAK (JUNCTURE), REQUEST THE FOLLOWING: N/A. PLEASE PROVIDE ANY IMAGING AVAILABLE. AT WHAT GRAFT OVERLAP WAS THE TYPE III ENDOLEAK? BETWEEN THE PROXIMAL GRAFT AND COVERED RENAL STENT? BETWEEN THE PROXIMAL GRAFT AND DISTAL GRAFT? BETWEEN THE DISTAL GRAFT AND LEG GRAFT? WERE COVERED STENTS PLACED IN THE RENAL ARTERIES THROUGH THE SMALL FENESTRATIONS? IF SO, WHAT SIZE COVERED RENAL STENTS (DIAMETER AND LENGTH) WERE USED IN THE RENAL FENESTRATIONS? HOW MUCH OVERLAP OF THE COVERED STENT WAS LEFT INSIDE THE AORTA? WAS THE INTRA-AORTIC SEGMENT OF THE COVERED STENT FLARED WITH AN OVERSIZED ANGIOPLASTY BALLOON? WHAT WAS DONE TO FIX THE LEAK? IF THE EVENT INVOLVES A TYPE III ENDOLEAK (HOLE/TEAR), REQUEST THE FOLLOWING: PLEASE PROVIDE ANY IMAGING AVAILABLE: PER REP: (B)(6) 2025. INVESTIGATORS SHOULD REACH OUT TO REP FOR SECURE SHUTTLE FILE TRANSFER OF IMAGING. WHEN WAS THE PUNCTURE IDENTIFIED? (I.E., DURING DEPLOYMENT, OR DURING FOLLOW-UP?): FOLLOW UP. WAS ANY DIFFICULTY EXPERIENCED DURING DEPLOYMENT? NO. WAS THE PATIENT'S ANATOMY TORTUOUS? NO. SPECIFICALLY, WHERE WAS THE PUNCTURE? (I.E., AT THE PROXIMAL END, AT THE BIFURCATION, AT THE DISTAL END?) BIFURCATION. WHAT DOES THE PHYSICIAN THINK CAUSED THE PUNCTURE? (I.E., ALREADY ON THE GRAFT, OR OCCURRED DURING DEPLOYMENT?) UNKR. WHAT WAS DONE TO FIX THE LEAK? NOTHING YET. IF THE EVENT INVOLVES A TYPE I ENDOLEAK, REQUEST THE FOLLOWING: N/A. PLEASE PROVIDE ANY IMAGING AVAILABLE. WHAT DOES THE PHYSICIAN THINK CAUSED THE TYPE I ENDOLEAK? HOW WAS THE ENDOLEAK TREATED?