ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
Report
- Report Number
- 1820334-2017-03784
- Event Type
- Death
- Date Received
- November 17, 2017
- Date of Event
- June 15, 2017
- Report Date
- July 20, 2023
- Manufacturer
- COOK INC
- Product Code
- MIH
- UDI-DI
- 10827002552392
- PMA / PMN Number
- P020018
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
INVESTIGATION-EVALUATION: PREVIOUS FINAL REPORTS FOR THE SAME DEVICE (RPN: ZSLE-16-90-ZT, LOT 7821406) HAVE BEEN SUBMITTED FOR THE FAILURE MODES TYPE 1B ENDOLEAK AND OCCLUSION OF THE ILIAC LEG GRAFT. THE ADDITIONAL INFORMATION PROVIDED ON 10MAY2023 DID NOT CHANGE THE INVESTIGATION FINDINGS FOR THE TYPE 1B ENDOLEAK OR THE OCCLUSION OF THE ILIAC LEG GRAFT. THEREFORE, THE FOCUS OF THIS INVESTIGATION IS THE REPORTED INFECTION OF THE ILIAC LEG GRAFT (RPN: ZSLE-16-90-ZT, LOT 7821406). A LOSS OF PATENCY, A TYPE 1B ENDOLEAK, AND A GRAFT INFECTION WAS REPORTED FOR PATIENT (1560035) PARTICIPATING IN STUDY AT C.H.U. RENNES PONTCHAILLOU, RENNES, CEDEX, FRANCE. THE MALE PATIENT WAS 77-YEARS-OLD AND WEIGHED 100 KILOGRAMS. HE HAD A HISTORY OF ENDOVASCULAR ABDOMINAL ANEURYSM REPAIR, CARDIAC ARRHYTHMIA, THROMBOEMBOLIC EVENT, HYPERTENSION, CAROTID ENDARTERECTOMY, HYPERLIPIDEMIA, CAROTID ARTERY DISEASE, STROKE, AND DIABETES. THE PRE-PROCEDURE COMPUTED TOMOGRAPHY (CT) SHOWED A STABLE, JUXTA RENAL, ABDOMINAL AORTIC ANEURYSM (AAA) WITH A MAXIMUM DIAMETER OF 70 MM. THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY (SMA), RIGHT RENAL ARTERY, AND LEFT RENAL ARTERY WERE PATENT. THERE WERE NO RENAL INFARCTS. ON 15JUN2017 THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR (EVAR) WHERE THE FOLLOWING COOK DEVICES WERE PLACED: CUSTOM-MADE FENESTRATED/BRANCHED DEVICE (RPN: PRE-LOADED-FENESTRATED-PROX, LOT NUMBER AC992097). UNIVERSAL DISTAL BODY (RPN: AAA-REINFORCED-FEN-PROX, LOT NUMBER AC992056). ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-16-90-ZT, LOT 7821406) PLACED ON THE LEFT. NON-COOK DEVICES WERE ALSO IMPLANTED DURING THE PROCEDURE IN THE SUPERIOR MESENTERIC ARTERY (SMA), RIGHT AND LEFT RENAL ARTERIES AND ILIAC LEG, THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICES. THE POST-PROCEDURE IMAGING REVEALED NO EVIDENCE OF DEVICE INTEGRITY ISSUES. HOWEVER, THERE WAS EVIDENCE OF LOSS OF PATENCY IN THE LEFT ILIAC LEG GRAFT AND A TYPE 1B ENDOLEAK. THE PATIENT HAD BOTH A NON-COOK AND A COOK DEVICE IMPLANTED IN THE LEFT ILIAC ARTERY. IMAGING COMPLETED AT THE 12-MONTH FOLLOW-UP VISIT IDENTIFIED A TYPE 1B ENDOLEAK ON THE LEFT AND RIGHT ILIAC LEG GRAFTS. ON (B)(6) 2019 THE PATIENT HAD A 2-YEAR CLINICAL ASSESSMENT COMPLETED THAT INCLUDED A CT SCAN. THE DEVICE, CELIAC ARTERY, SMA, RIGHT RENAL ARTERY, AND LEFT RENAL ARTERY WERE ALL PATENT. THERE WERE NO SEPARATIONS OF COMPONENTS, NO EVIDENCE OF MIGRATION, AND NO DEVICE INTEGRITY ISSUES. THE CT SHOWED THE TYPE 1B ENDOLEAK WAS STILL PRESENT ON THE LEFT ILIAC LEG GRAFT. ON (B)(6) 2019 THE PATIENT UNDERWENT A SECONDARY INTERVENTION TO TREAT A TYPE 1B ENDOLEAK DISTAL FOR BOTH THE LEFT AND RIGHT ILIAC LEG GRAFTS. A COMPETITOR¿S ILIAC LEG GRAFT WAS PLACED ON THE RIGHT AND THE LEFT. THE INTERVENTION WAS CONSIDERED SUCCESSFUL. ON (B)(6) 2020 (967 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT IMAGING FOR CLINICAL SYMPTOMS OF LOWER EXTREMITY WEAKNESS. IMAGING REVEALED, ¿OCCLUSION OF THE LEFT ILIAC LEG OF THE STENT¿. ON (B)(6) 2020 (968 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT TREATMENT OF THE OCCLUDED LEG GRAFT WITH ¿LEFT TO THE RIGHT FEMORAL BYPASS¿. THIS INTERVENTION WAS CONSIDERED NOT SUCCESSFUL. THE OPERATIVE FOLLOW-UP WAS MARKED BY SEVERAL ADDITIONAL SURGERIES. THE FIRST SURGERY WAS REQUIRED FOR ¿MESENTERIC ISCHEMIA AT D1 OF THE DISOBLITERATION OF THE LEFT LIMB, ON EMBOLUS IN THE ARTERY WHICH WILL BE DISOBLITERATED BY LAPAROTOMY.¿ DURING THE SAME OPERATION, THE DIGESTIVE SURGERY TEAM COMPLETED A RESECTION OF THE SIGMOID COLON AND A HARTMANN PROCEDURE. DISLOCATIONS OF THE LEFT LEG AND THE CROSS-BRIDGE WERE IDENTIFIED ON (B)(6) 2020 WHICH CAUSED ACUTE BILATERAL ISCHEMIA. THE LEFT LEG WAS THROMBOSED FOR A FOURTH TIME DURING THE PATIENT¿S HOSPITALIZATION, DESPITE HEPARIN THERAPY. A LEFT AXILLOFEMORAL BYPASS WAS COMPLETED ON (B)(6) 2020. THE LOWER LIMBS WERE VASCULARIZED BY THIS BYPASS FOR THE LEFT, AND BY THE LEFT-TO-RIGHT CROSS BYPASS FOR THE RIGHT LOWER LIMB. UNFORTUNATELY, THE LEFT SCARPA, WHICH HAD BEEN DAMAGED SEVERAL TIMES, DID NOT HEAL. AN ADDITIONAL OPERATION WAS NECESSARY TO OBTAIN BACTERIAL SAMPLES. AN ABUNDANT LAVAGE, AS WELL AS A SARTORIUS MYOPLASTY, WERE COMPLETED. ON (B)(6) 2020, (993 DAYS POST-PROCEDURE) THE SAMPLES COLLECTED WERE IDENTIFIED POSITIVE FOR PSEUDOMONAS AERUGINOSA. ON (B)(6) 2020 (997 DAYS POST-PROCEDURE), THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM IN EMERGENCY FOR HEMORRHAGIC SHOCK DUE TO AN ANASTOMOTIC RUPTURE OF SEPTIC ORIGIN. "THE ANASTOMOTIC RUPTURE OF SEPTIC ORIGIN OF THE ANASTOMOSIS OF THE PROSTHESIS PUT IN PLACE ON (B)(6) 2020 (968 DAYS POST-PROCEDURE), TO REPAIR THE LEFT FEMORAL TRIPOD, ON WHICH THE LEFT AXILLOFEMORAL BYPASS OPENED AND THE LEFT TO RIGHT CROSS-BRACHIAL BYPASS (RUPTURE OF THE ANASTOMOSIS OF THE SUPERFICIAL FEMORAL). GIVEN THE ABSENCE OF VENOUS MATERIAL A NEW PROSTHESIS WAS INSERTED, KNOWING THAT THE RUPTURE HAD OCCURRED IN A SEPTIC ENVIRONMENT. THE LEFT SCARPA DID NOT HEAL, AND THE LEFT AXILLOFEMORAL BYPASS REMAINED EXTERNALIZED. THE ENTIRE PROSTHETIC MATERIAL IS THEREFORE INFECTED WITH PSEUDOMONAS AERUGINOSA, AND THE PATIENT WAS UNDER ANTIBIOTICS FOR 5 MONTHS, WITHOUT SUCCESS. IT WAS DECIDED TO TRANSFER THE PATIENT TO PALLIATIVE CARE, AND HE DIED ON (B)(6) 2020 (1107 DAYS POST-PROCEDURE)." REVIEWS OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DRAWING, DEVICE HISTORY RECORD (DHR), QUALITY CONTROL PROCEDURES, SPECIFICATIONS, MANUFACTURING INSTRUCTIONS (MI), AND INSTRUCTIONS FOR USE (IFU) OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE (DHF) SHOWED THAT THIS DEVICE IS BOTH SAFE AND EFFECTIVE FOR ITS INTENDED USE. A REVIEW OF THE DHRS FOR THE REPORTED COMPLAINT DEVICE LOT 7821406 REVEALED NO RECORDED NON-CONFORMANCES RELEVANT TO THE FAILURE MODE. BASED ON THE AVAILABLE INFORMATION, COOK HAS CONCLUDED THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION AND THAT THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE IFU PACKAGED WITH THE DEVICE CONTAINS THE FOLLOWING IN RELATION TO THE REPORTED FAILURE MODE: 3 CONTRAINDICATIONS. THE ZENITH SPIRAL-Z AAA ILIAC LEG WITH THE Z-TRAK INTRODUCTION SYSTEM IS CONTRAINDICATED IN: PATIENTS WITH A SYSTEMIC OR LOCAL INFECTION THAT MAY INCREASE THE RISK OF ENDOVASCULAR GRAFT INFECTION. 5 ADVERSE EVENTS: 5.2 POTENTIAL ADVERSE EVENTS: ENDOPROSTHESIS: IMPROPER COMPONENT PLACEMENT; INCOMPLETE COMPONENT DEPLOYMENT; COMPONENT MIGRATION; COMPONENT SEPARATION FROM ANOTHER GRAFT COMPONENT; SUTURE BREAK; OCCLUSION; INFECTION; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; AND CORROSION. INFECTION OF THE ANEURYSM, DEVICE OR ACCESS SITE, INCLUDING ABSCESS FORMATION, TRANSIENT FEVER AND PAIN. VASCULAR ACCESS SITE COMPLICATION, INCLUDING INFECTION, PAIN, HEMATOMA, PSEUDOANEURYSM, ARTERIOVENOUS FISTULA. WOUND COMPLICATION AND SUBSEQUENT ATTENDANT PROBLEMS (E.G., DEHISCENCE, INFECTION). 9 HOW SUPPLIED: THE ZENITH SPIRAL-Z AAA ILIAC LEGS ARE STERILIZED BY ETHYLENE OXIDE GAS, ARE PRE-LOADED INTO THE Z-TRAK INTRODUCTION SYSTEM, AND ARE SUPPLIED IN PEEL-OPEN PACKAGES. THE PRODUCT IS STERILE IF THE PACKAGE IS UNOPENED AND UNDAMAGED. INSPECT THE DEVICE AND PACKAGING TO VERIFY THAT NO DAMAGE HAS OCCURRED AS A RESULT OF SHIPPING. DO NOT USE THIS DEVICE IF DAMAGE HAS OCCURRED OR IF THE STERILIZATION BARRIER HAS BEEN DAMAGED OR BROKEN. IF DAMAGE HAS OCCURRED, DO NOT USE THE PRODUCT AND RETURN TO COOK. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF THE INVESTIGATION A DEFINITIVE ROOT CAUSE FOR THE INFECTION COULD NOT BE ESTABLISHED. THE PSEUDOMONAS AERUGINOSA INFECTION MAY HAVE BEEN INTRODUCED DURING ANY OF THE MULTIPLE SURGICAL PROCEDURES AND HOSPITALIZATION IN THE MONTHS PRECEDING THE PATIENT'S DEATH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. ADDITIONAL INFORMATION: B5, H6. THIS ADDITIONAL INFORMATION IS CURRENTLY BEING INVESTIGATED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING PATIENT AND/OR EVENT DETAILS HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
ON (B)(6) 2020 (967 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT IMAGING FOR CLINICAL SYMPTOMS OF LOWER EXTREMITY WEAKNESS. IMAGING REVEALED, ¿OCCLUSION OF THE LEFT ILIAC LEG OF THE STENT¿. ON (B)(6) 2020 (968 DAYS POST-PROCEDURE), THE PATIENT UNDERWENT TREATMENT OF THE OCCLUDED LEG GRAFT WITH ¿LEFT TO THE RIGHT FEMORAL BYPASS¿. THIS INTERVENTION WAS CONSIDERED NOT SUCCESSFUL. THE OPERATIVE FOLLOW-UP WAS MARKED BY SEVERAL REOPERATIONS IN THE OPERATING ROOM. FIRST, FOR MESENTERIC ISCHEMIA AT D1 OF THE DISOBLITERATION OF THE LEFT LIMB, ON EMBOLUS IN THE ARTERY ARTERY WHICH WILL BE DISOBLITERATED BY LAPAROTOMY. DURING THE SAME OPERATION, THE DIGESTIVE SURGERY TEAM RESECTION OF THE SIGMOID COLON AND A HARTMANN. SECOND, TWO NEW DISLOCATIONS OF THE LEFT LEG AND THE CROSS-BRIDGE (ON (B)(6) 2020), WHICH CLINICALLY CAUSED ACUTE BILATERAL ISCHEMIA. AT THE 4TH THROMBOSIS OF THE LEFT LEG DURING THE HOSPITALIZATION, IT WAS DECIDED TO PERFORM A PROSTHETIC LEFT AXILLOFEMORAL BYPASS (B)(6) 2020), IN VIEW OF THE THROMBOSIS DESPITE HEPARIN THERAPY. THE LOWER LIMBS ARE THEREFORE VASCULARIZED BY THIS BYPASS FOR THE LEFT, AND BY THE LEFT TO RIGHT CROSS-BYPASS FOR THE RIGHT LOWER LIMB. UNFORTUNATELY, THE LEFT SCARPA, WHICH HAD BEEN DAMAGED SEVERAL TIMES, DID NOT HEAL AND A NEW OPERATION WAS NECESSARY TO TAKE BACTERIAL SAMPLES. IN ORDER TO COLLECT THE BACTERIOLOGICAL SAMPLES, AN ABUNDANT LAVAGE AND A SARTORIUS PLASTY ((B)(6) 2020 (993 DAYS POST-PROCEDURE)) WAS NEEDED. THE SAMPLES CAME BACK POSITIVE FOR PSEUDOMONAS AERUGINOSA. ON (B)(6) 2020 (997 DAYS POST-PROCEDURE), THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM IN EMERGENCY FOR HEMORRHAGIC SHOCK DUE TO ANASTOMOTIC RUPTURE OF SEPTIC ORIGIN. ANASTOMOTIC RUPTURE OF SEPTIC ORIGIN OF THE ANASTOMOSIS OF THE PROSTHESIS PUT IN PLACE ON (B)(6) 2020 (968 DAYS POST-PROCEDURE), TO REPAIR THE LEFT FEMORAL TRIPOD, ON WHICH THE LEFT AXILLOFEMORAL BYPASS OPENED AND THE LEFT TO RIGHT CROSS-BRACHIAL BYPASS (RUPTURE OF THE ANASTOMOSIS OF THE SUPERFICIAL FEMORAL). GIVEN THE ABSENCE OF VENOUS MATERIAL A NEW PROSTHESIS WAS INSERTED, KNOWING THAT THE RUPTURE HAD OCCURRED IN A SEPTIC ENVIRONMENT. THE LEFT SCARPA DID NOT HEAL, AND THE LEFT AXILLOFEMORAL BYPASS REMAINED EXTERNALIZED. THE ENTIRE PROSTHETIC MATERIAL IS THEREFORE INFECTED WITH PSEUDOMONAS AERUGINOSA AND THE PATIENT WAS UNDER ANTIBIOTICS FOR 5 MONTHS, WITHOUT SUCCESS. IT WAS DECIDED TO TRANSFER THE PATIENT TO PALLIATIVE CARE, AND HE DIED ON (B)(6) 2020 (1107 DAYS POST-PROCEDURE). AT THIS TIME, IT IS UNKNOWN IF THE PATIENT'S DEATH WAS RELATED TO USE OF THE COOK DEVICE.
CONCOMITANT DEVICES: IMPLANTED ON (B)(6) 2017 COOK: ¿ CUSTOM MADE FENESTRATED/BRANCHED DEVICE (LOT # AC992097). ¿ UNIVERSAL DISTAL BODY (LOT # AC992056). IMPLANTED ON (B)(6) 2017 NON-COOK: ¿ SMA STENT (CATALOG # BGP3709_1; LOT # 106266). ¿ ILIAC LEG GRAFT (CATALOG # ETLW-16-16.C93-EE; LOT # V07331649). ¿ RENAL STENT, RIGHT (CATALOG # BGP3707_1; LOT # 106433). ¿ RENAL STENT, LEFT (CATALOG # BGP2708_1; LOT # 106455). IMPLANTED ON 15JUN2017 NON-COOK: ¿ ILIAC LEG GRAFT RIGHT: MEDTRONIC ETLW1616C93EE LOT V29786491. ¿ ILIAC LEG GRAFT, LEFT: MEDTRONIC ETLW1613C124 LOT V29788896. INVESTIGATION - EVALUATION: THE ACTUAL COMPLAINT DEVICE WAS NOT RETURNED. WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. NO FURTHER EVENT DETAILS OR IMAGING WAS PROVIDED. A DOCUMENTATION INVESTIGATION WAS PERFORMED. A REVIEW OF COMPLAINT HISTORY, THE DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE, MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL DATA WAS CONDUCTED. BASED ON THE INVESTIGATION EVALUATION, THERE IS NO INDICATION THAT A DESIGN OR PROCESS RELATED FAILURE MODE CONTRIBUTED TO THIS EVENT. CURRENT CONTROLS FOR MANUFACTURING ARE IN PLACE TO ASSURE FUNCTIONALITY; DEVICE INTEGRITY PRIOR TO SHIPPING. A REVIEW OF PRODUCTION AND QUALITY DOCUMENTATION DID NOT IDENTIFY ANY SPECIFIC ISSUES WITH CURRENT MANUFACTURING OR QUALITY CONTROLS THAT MAY HAVE CONTRIBUTED TO THIS INCIDENT. THE DEVICE HISTORY RECORD WAS REVIEWED, FOR LOT 7821406 (FINISHED ASSEMBLY) AND SA599660 (GRAFT), AND N NON-CONFORMANCES RELATING TO THE REPORTED FAILURE MODE WERE NOTED. TYPE I ENDOLEAKS CAN BE ATTRIBUTED TO INAPPROPRIATE SIZING, INAPPROPRIATE DEPLOYMENT PROCEDURE FOLLOWED (DEPLOYMENT OF THE SUPRARENAL STENT IN THE INFRARENAL ABDOMINAL AORTA RATHER THAN IN SUPRARENAL ABDOMINAL AORTA) AND PATIENT¿S ANATOMICAL CONDITIONS. A TYPE I ENDOLEAK OCCURS WHEN THERE IS A GAP BETWEEN THE GRAFT AND THE VESSEL WALL AT ¿SEAL ZONES.¿ THE GAP ALLOWS BLOOD TO FLOW ALONG THE SIDE OF THE GRAFT INTO THE ANEURYSM SAC, WHICH CREATES PRESSURE WITHIN THE SAC AND INCREASES THE RISK OF SAC RUPTURE. A TYPE I ENDOLEAK OFTEN OCCURS WHEN THE ANATOMY OF THE ANEURYSM IS UNSUITABLE FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR) OR INAPPROPRIATE DEVICE SELECTION. IT WAS REPORTED THAT THE PATIENT HAD HISTORY OF CARDIAC ARRHYTHMIA, THROMBOEMBOLIC EVENT, HYPERTENSION, CAROTID ENDARTERECTOMY, HYPERLIPIDEMIA, CAROTID ARTERY DISEASE, STROKE AND DIABETES. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF INTERNAL ILIAC ARTERIES. IT IS POSSIBLE THAT DUE TO THE PATIENT'S PRE-EXISTING CONDITION OF HYPERTENSION, THE FORCE OF THE BLOOD AGAINST THE WALL WOULD HAVE BEEN HIGH AND OTHER CARDIAC COMPLICATIONS LIKE HYPERLIPIDEMIA WOULD HAVE REDUCED THE LUMEN DIAMETER. THIS ALONG WITH THROMBOEMBOLIC EVENT WOULD HAVE COMPROMISED THE APPROPRIATE SEALING OF THE GRAFT TO THE VESSEL WALL DUE TO LIPID MOLECULES OR THROMBUS IN THE VESSEL WALL INCREASING THE RISK OF TYPE I ENDOLEAK. POSSIBLE CAUSES FOR THE REPORTED LOSS OF PATENCY CAN BE DUE TO ILIAC TORTUOSITY, GRAFT COMPRESSION, CHANGE IN THE VESSEL DIAMETER DUE TO INAPPROPRIATE BALLOONING, REPETITIVE STENOSIS, NARROW INNER ILIAC LUMEN, VESSEL DAMAGE/ROUGH SURFACES AND PATIENTS PRE-EXISTING CONDITIONS SUCH AS OCCLUSIVE DISEASE/CALCIFICATION CAUSING NARROW LUMEN. PER THE IFU, INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF INTERNAL ILIAC ARTERIES. EACH ZENITH DEVICE IS SHIPPED WITH INSTRUCTIONS FOR USE (IFU), LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. PER THE IFU: ¿ INSPECT THE DEVICE AND PACKAGING TO VERIFY THAT NO DAMAGE HAS OCCURRED AS A RESULT OF SHIPPING. IF DAMAGE HAS OCCURRED, DO NOT USE THE PRODUCT AND RETURN TO COOK. ¿ EXCESSIVE OVERLAP 10 MM ABOVE THE MAIN BODY BIFURCATION MAY INCREASE THE RISK OF LIMB THROMBOSIS. IT IS POSSIBLE THAT THE PRE-EXISTING CONDITION OF HYPERLIPIDEMIA AND A THROMBOEMBOLIC EVENT WOULD HAVE COMPRESSED THE GRAFT AND REDUCED THE LUMEN DIAMETER DUE TO LIPID MOLECULES OR THROMBUS LINING THE WALL LEADING TO NARROW LUMEN AND LOSS OF GRAFT PATENCY. THERE WAS NO PLANNING AND SIZING SHEET, PROCEDURAL IMAGING OR BALLOONING INFORMATION PROVIDED. BASED ON THE AVAILABLE INFORMATION A POSSIBLE ROOT CAUSE FOR TYPE I ENDOLEAK IN THE LEFT ZSLE ILIAC LEG IS PROCEDURE RELATED; PATIENT CONDITION RELATED TO OCCURRENCE. A POSSIBLE ROOT CAUSE FOR LOSS OF GRAFT PATENCY IN THE LEFT ZSLE ILIAC LEG IS ALSO PROCEDURE RELATED; PATIENT CONDITION RELATED TO OCCURRENCE. AS OF 27AUG2018, TWO SUBTRACTED COMPLETION ANGIOGRAMS WERE PROVIDED FOR REVIEW. THE PRESENCE OF A PRE-EXISTING GRAFT, SUBTRACTION AND OVERALL LOW IMAGE RESOLUTION PRECLUDED DEFINITIVE IDENTIFICATION OF THE CUSTOM FENESTRATED DEVICE AND THE UDB. ONE CHECKMARK WAS IDENTIFIABLE. BECAUSE IT WAS ONLY ONE TO 1.5 STENT SEGMENT LENGTHS INFERIOR TO THE RENAL GATES, A SHORTER THAN STOCK UDB OR A CUSTOM FENESTRATED UDB COMBINATION WAS SUGGESTED. THE CUSTOM MADE FENESTRATED GRAFT, UNIBODY, AND LEFT ZSLE WERE IMPLANTED INSIDE OF A FAILED ENDURANT ENDOGRAFT AND BILATERAL ENDURANT ILIAC LIMBS, TWO ON THE LEFT AND LIKELY, TWO ON THE RIGHT. THE ZSLE WAS IMPLANTED INSIDE OF MID LEFT ENDURANT LIMB. AN ENDOLEAK WAS OBSERVED NEAR THE RIGHT SIDE OF THE ZSLE INSIDE THE FAILED ENDURANT. ENDOLEAK ALSO WAS OBSERVED NEAR THE DISTAL END OF THE PRE-EXISTING ENDURANT INTO A LEFT COMMON ILIAC ANEURYSM. DISTINGUISHING BETWEEN A TYPE II OR TYPE 1B ENDOLEAK IS IMPOSSIBLE ON THE PROVIDED IMAGING. IMPRESSIONS OF THE IMAGING REVIEWER: ALTHOUGH ENDOLEAK IS CONFIRMED, ITS ORIGIN FROM THE ZSLE CANNOT BE CONFIRMED ON THE PROVIDED IMAGING. IT COULD HAVE REPRESENTED A COMPONENT/ COMPONENT ENDOLEAK BETWEEN THE UDB AND THE RIGHT ENDURANT LIMBS OR A ZSLE SUTURE HOLE ENDOLEAK. THERE IS NO INFORMATION REGARDING THE FAILED ENDURANT DEVICE OR IF THERE WAS ANY DAMAGE THAT MAY HAVE BEEN A CONTRIBUTING FACTOR TO THE ZSLE-16-90-ZT ENDOLEAK. THE IMAGING REVIEWER SUGGESTS THAT SIZING OR PLACEMENT MAY HAVE BEEN A FACTOR. AS FOUND IN THE INSTRUCTIONS FOR USE: ¿ IFU STRICT ADHERENCE TO THE ZENITH SPIRAL-Z AAA ILIAC LEG IFU SIZING GUIDE IS STRONGLY RECOMMENDED WHEN SELECTING THE APPROPRIATE DEVICE SIZE. APPROPRIATE DEVICE OVERSIZING HAS BEEN INCORPORATED INTO THE IFU SIZING GUIDE. SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING OR COMPRESSION. ¿ INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH SPIRAL-Z AAA ILIAC LEG WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. THE TYPE IB ENDOLEAK COULD NOT BE CONFIRMED AND THE IMAGING REVIEWER SUGGESTS THIS COULD BE A TYPE II ENDOLEAK. AT THIS TIME, THE MOST PROBABLE CAUSES OF THIS EVENT ARE MEDICAL PROCEDURE, OTHER DEVICE COMPATIBILITY AND/OR DISEASE PROGRESSION RELATED. THIS COMPLAINT WAS RE-OPENED AND THE DEVICE FAILURE ANALYSIS WAS UPDATED, BASED ON THE IMAGING PROVIDED. TWO SUBTRACTED COMPLETION ANGIOGRAMS WERE PROVIDED. IMAGE REVIEW CONDUCTED ON THE IMAGES PROVIDED, INDICATED THAT ALTHOUGH ENDOLEAK IS CONFIRMED, ITS ORIGIN FROM THE ZSLE CANNOT BE CONFIRMED ON THE PROVIDED IMAGING. PER THE IMAGE REVIEW, THE LEFT ZSLE WAS IMPLANTED INSIDE OF MID LEFT ENDURANT LIMB. AN ENDOLEAK WAS OBSERVED NEAR THE RIGHT SIDE OF THE ZSLE INSIDE THE FAILED ENDURANT. ENDOLEAK WAS ALSO OBSERVED NEAR THE DISTAL END OF THE PRE-EXISTING ENDURANT INTO A LEFT COMMON ILIAC ANEURYSM. DISTINGUISHING BETWEEN A TYPE II OR TYPE IB ENDOLEAK IS IMPOSSIBLE ON THE PROVIDED IMAGING. THE ORIGIN OF ENDOLEAK FROM THE LEFT ZSLE CANNOT BE CONFIRMED FROM THE IMAGING PROVIDED. IT COULD HAVE REPRESENTED A COMPONENT/COMPONENT ENDOLEAK BETWEEN THE UDB AND THE RIGHT ENDURANT LIMBS OR A ZSLE TYPE IIIB SUTURE HOLE ENDOLEAK. IN ADDITION, THROMBUS IN THE DISTAL ZSLE WAS CONFIRMED. BASED ON THE INFORMATION PROVIDED IN THE IMAGE REVIEW, RISK ASSESSMENT FOR THIS COMPLAINT IS PERFORMED FOR TYPE IB AND TYPE IIIB SUTURE HOLE ENDOLEAK, AS THE ENDOLEAK ORIGIN FROM THE ZSLE LEG COULD NOT BE CONFIRMED. BASED ON THE INFORMATION PROVIDED AND THE IMAGE REVIEW, THE CAUSE FOR THE FAILURE COULD NOT BE ESTABLISHED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS. THE APPROPRIATE COOK PERSONNEL HAVE BEEN NOTIFIED OF THIS EVENT.
(B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.
IN ADDITIONAL INFORMATION RECEIVED ON 25NOV2019, IT WAS REPORTED THAT THE PATIENT HAD A 2-YEAR CLINICAL ASSESSMENT ON (B)(6) 2019 WITH A COMPUTED TOMOGRAPHY (CT) SCAN. THIS SCAN REVEALED THAT THE DEVICE, CELIAC, SUPERIOR MESENTERIC ARTERY (SMA), AND RIGHT AND LEFT RENAL WERE ALL PATENT. THE SCAN STILL SHOWED A DISTAL TYPE 1 ENDOLEAK PRESENT ON THE LEFT ILIAC LEG GRAFT. THERE WAS NO SEPARATION OF COMPONENTS, EVIDENCE OF MIGRATION, OR DEVICE INTEGRITY ISSUES. ON (B)(6) 2019, IT WAS ALSO REPORTED THAT THE PATIENT UNDERWENT A SECONDARY INTERVENTION ON (B)(6) 2019. THIS WAS PERFORMED TO TREAT A DISTAL TYPE 1 ENDOLEAK ON THE DEVICE, INCLUDING BOTH THE LEFT AND RIGHT ILIAC LEG GRAFTS. THIS ENDOLEAK WAS FOUND ON IMAGING OBTAINED AT A 12-MONTH FOLLOW UP VISIT. TWO ANCILLARY ILIAC LEG GRAFTS FROM ANOTHER MANUFACTURER WERE PLACED, ONE ON EACH SIDE. THIS INTERVENTION WAS CONSIDERED TO BE SUCCESSFUL.
THE USER FACILITY REPORTED A PRODUCT MALFUNCTION DURING A CLINICAL TRIAL. AS REPORTED ON (B)(6) 2017, A (B)(6)-YEAR-OLD, MALE PATIENT UNDERWENT A PRE-PROCEDURE COMPUTERIZED TOMOGRAPHY (CT) SCAN. THE CT SHOWED A STABLE, JUXTARENAL, ABDOMINAL AORTIC ANEURYSM (AAA) WITH A MAXIMUM DIAMETER OF 70 MM. THE CELIAC, SUPERIOR MESENTERIC ARTERY (SMA), AND RIGHT AND LEFT RENAL ARTERIES WERE PATENT. NO RENAL INFARCTION WAS PRESENT. THE PATIENT UNDERWENT AN INDEX PROCEDURE AND HAD THREE COOK DEVICES IMPLANTED AND FOUR NON-COOK DEVICES IMPLANTED. THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICES. THE POST-PROCEDURE IMAGING REVEALED NO EVIDENCE OF DEVICE INTEGRITY ISSUES BUT THERE WAS EVIDENCE OF LOSS OF PATENCY IN THE LEFT ILIAC LEG GRAFT AND A DISTAL TYPE 1 ENDOLEAK ALSO LOCATED IN THE LEFT ILIAC LEG GRAFT. NO INFORMATION REGARDING THE RELATIONSHIP TO DEVICE OR PROCEDURE WAS PROVIDED. THE PATIENT REMAINS IN THE STUDY. THE PATIENT HAD BOTH A NON-COOK AND A COOK DEVICE IMPLANTED IN THE LEFT ILIAC LEG. ADDITIONAL EVENT DETAIL AND DEVICE INFORMATION HAS BEEN REQUESTED BUT NOT RECEIVED TO INCLUDE IMAGING FOR REVIEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 820144 | ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG | MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | COOK INC | N/A | 7821406 | 10827002552392 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Male | Required Intervention| D | BENTLEY (CATALOG # BGP2708_1, LOT 106455)| BENTLEY (CATALOG # BGP3707_1, LOT 106433)| BENTLEY (CATALOG # BGP3709_1, LOT 106266)| COOK (PRE-LOADED-FENESTRATED-PROX, LOT AC992097)| COOK (RPN: AAA-REINFORCED-FEN-PROX, LOT AC992056)| MEDTRONIC (CAT: ETLW-16-16.C93-EE, LOT V07331649)| SEE H10. |