BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 18660451 · Received February 7, 2024

    Report

    Report Number
    1820334-2024-00178
    Event Type
    Injury
    Date Received
    February 7, 2024
    Date of Event
    July 6, 2023
    Report Date
    April 11, 2024
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    CORRECTION: THE EVENT IS NO LONGER REPORTABLE. IMAGING WAS PROVIDED FOR THE INVESTIGATION. THE IMAGE REVIEWER CONCLUDED THAT THE NARROWED DISTAL AORTA AND NARROWED COMMON ILIAC ARTERIES INCREASED THE RISK OF EXTERNAL COMPRESSION AND THAT RAPID ADDITIONAL STENT IMPLANTATION INDICATES THAT NARROWING WAS LIKELY ANTICIPATED." ADDITIONALLY, THE CUSTOMER INDICATED IN THE INITIAL REPORT THAT THERE WAS " EXTRINSIC COMPRESSION OF THE ORIGIN OF BOTH LIMB EXTENSIONS" AND THIS WAS CONSIDERED RELATED TO CALCIFIED ARTERIES. THE EVENT DID NOT LEAD TO A SERIOUS DETERIORATION IN HEALTH AND WAS NOT CONSIDERED DUE TO A DEVICE DEFICIENCY. BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND THE IMAGING PROVIDED, COOK HAS CONCLUDED THAT THE STENOSIS OF THE DEVICE/EXTRINSIC COMPRESSION WAS NOT DUE TO A DEVICE DEFICIENCY. THE STENT PLACEMENT IN THE INITIAL PROCEDURE WAS DUE TO PATIENT ANATOMY AND WAS MOST LIKELY ANTICIPATED. THE COOK DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE MEDICAL INTERVENTION PERFORMED TO PRECLUDE PERMANENT IMPAIRMENT OR DEATH. 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.

    Description of Event or Problem · 0

    THE PATIENT WHO PARTICIPATED IN THE STUDY WAS A 71-YEAR-OLD MALE THAT WEIGHED 97 KILOGRAMS. HE WAS CLASSIFIED AS ASA III IN THE ASA (ANESTHESIOLOGISTS SOCIETY OF AMERICA) CLASSIFICATION SYSTEM. ASA III IS DEFINED FOR AN ADULT AS A PATIENT WITH SEVERE SYSTEMIC DISEASE. HE WAS LIVING INDEPENDENTLY WITH MODERATE FRAILTY. HIS AMBULATORY STATUS WAS NORMAL, AND HE WAS CONSIDERED STABLE. HE HAD HISTORY OF TOBACCO USE (CESSATION AT MORE THAN ONE YEAR AGO) AND CONSUMES TWO GLASSES OF ALCOHOL PER DAY. PRE-PROCEDURE COMPUTED TOMOGRAPHY (CT) IMAGING WITH CONTRAST WAS COMPLETED ON (B)(6)2023. THE INNOMINATE ARTERY, RIGHT COMMON CAROTID ARTERY, RIGHT SUBCLAVIAN ARTERY, LEFT COMMON CAROTID ARTERY, LEFT SUBCLAVIAN ARTERY, CELIAC ARTERY WERE ALL PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE SUPERIOR MESENTERIC ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE RIGHT RENAL ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE LEFT RENAL ARTERY WAS PATENT AND NO STENOSIS GREATER THAN 50% WAS IDENTIFIED. THE FIFTH AND SIXTH VISCERORENAL VESSELS WERE NOT INCORPORATED INTO THE REPAIR. THE RIGHT COMMON ILIAC ARTERY WAS PATENT. THE LEFT COMMON ILIAC ARTERY WAS PATENT. THE LEFT AND RIGHT INTERNAL ILIAC ARTERY ARTERIES WERE BOTH PATENT. THE MAXIMUM DIAMETER OF THE DISEASED AORTA ON CENTERLINE WAS 69 MM. THE INTENDED PROXIMAL LANDING ZONE WAS ZONE 5: MID DESCENDING AORTA TO CELIAC. THE INTENDED DISTAL LANDING ZONE WAS FOR BOTH LEFT AND RIGHT ILIAC ARTERIES WAS ZONE 10: COMMON ILIAC ARTERIES. ON (B)(6) 2023, THE PATIENT UNDERWENT AN ENDOVASCULAR AORTIC REPAIR UNDER GENERAL ANESTHESIA. THE PATIENT WAS PRESCRIBED ANTIPLATELET MEDICATION (ASPIRIN, SALICYLIC ACID) AT THE TIME OF THE PROCEDURE. PERCUTANEOUS ACCESS WAS OBTAINED IN THE LEFT AND RIGHT FEMORAL ARTERIES. NO CUTDOWN OF THE ACCESS VESSELS WERE REQUIRED. AN ILIAC CONDUIT WAS NOT PERFORMED AT THE TIME OF THE CUSTOM-MADE DEVICE PROCEDURE. THE TOTAL CONTRAST VOLUME USED DURING THE PROCEDURE WAS 40 ML. THE CONTRAST DOSE WAS 320 ML/KG. FLUOROSCOPY TIME WAS 34 MINUTES. TOTAL GRAY USED 673 MGY. TOTAL DOSE AREA PRODUCT: 66 GY/CM2. FUSION WAS USED DURING THE PROCEDURE. THE ESTIMATED TOTAL BLOOD LOSS DURING THE PROCEDURE WAS 100 ML. NO CARDIAC OUTPUT REDUCTION WAS USED. THE PROXIMAL SEAL ZONE WAS THE NATIVE AORTA. PROCEDURAL TIME (24-HOUR CLOCK): TIME ARRIVES IN ROOM: 12:14, TIME OF FIRST INCISION OR ARTERIAL PUNCTURE: 12:52, TIME OF LAST ACCESS CLOSURE: 14:35, TIME LEAVES ROOM: 14:51, DURATION OF PROCEDURE (FROM FIRST INCISION TO LAST ACCESS CLOSURE) 103 MINUTES. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF ALL BRIDGING STENTS WAS SUCCESSFUL. AN UNPLANNED ANGIOPLASTY WAS REQUIRED ON THE LEFT AND RIGHT ILIAC ARTERIES. COMPETITOR'S GRAFTS WERE PLACED IN THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY (SMA), RIGHT RENAL ARTERY, AND THE LEFT RENAL ARTERY. THE ARTERIES WERE REVASCULARIZED WITH THE FENESTRATED-BRANCHED DEVICE. THE COVERED STENTS WERE NOT RELINED WITH A BARE METAL STENT AND WERE NOT EXTENDED DISTALLY WITH A BARE METAL STENT. THE SIDE BRANCH CATHETERIZATION AND PLACEMENT OF THE BRIDGING STENT WERE CONSIDERED SUCCESSFUL. THE STENTS PATENCY WAS MAINTAINED WITH NORMAL END ARTERY PERFUSION. COOK DEVICES PLACED IN THE PROCEDURE: COOK PRE-LOADED-FENESTRATED-PROX, (DEVICE WAS PLANNED FOR THIS PATIENT). THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE MAIN CUSTOM-MADE DEVICE. DELIVERY AND DEPLOYMENT OF THE DEVICE WAS CONSIDERED SUCCESSFUL. CMD ARTERY COMPONENT INFORMATION: CELIAC COMPONENT, LARGE FENESTRATION/SUPPORTED. DISTANCE FROM FABRIC EDGE TO FENESTRATION CENTER OR ANTEGRADE BRANCH DISTAL ASPECT OR RETROGRADE BRANCH PROXIMAL ASPECT WAS 52 MM. THE CLOCK POSITION WAS 12:30. THE FENESTRATION OR BRANCH MEASURED 8 MM. THE DEVICE WAS NOT PRELOADED WITH A CATHETER OR WIRE AND CANNULATION WAS NOT INTENDED FROM ABOVE OR BELOW. SMA COMPONENT, LARGE FENESTRATION/SUPPORTED. DISTANCE FROM FABRIC EDGE TO FENESTRATION CENTER OR ANTEGRADE BRANCH DISTAL ASPECT OR RETROGRADE BRANCH PROXIMAL ASPECT WAS 64 MM. THE CLOCK POSITION WAS 12:30. THE FENESTRATION OR BRANCH MEASURED 8 MM. THE DEVICE WAS NOT PRELOADED WITH A CATHETER OR WIRE AND CANNULATION WAS NOT INTENDED FROM ABOVE OR BELOW. RIGHT RENAL COMPONENT, SMALL FENESTRATION/UNSUPPORTED. DISTANCE FROM FABRIC EDGE TO FENESTRATION CENTER OR ANTEGRADE BRANCH DISTAL ASPECT OR RETROGRADE BRANCH PROXIMAL ASPECT WAS 67 MM. THE CLOCK POSITION WAS 10:00. THE FENESTRATION OR BRANCH MEASURED 6 MM. THE DEVICE WAS PRELOADED WITH A CATHETER OR WIRE AND CANNULATION WAS INTENDED FROM BELOW. LEFT RENAL COMPONENT, SMALL FENESTRATION/UNSUPPORTED. DISTANCE FROM FABRIC EDGE TO FENESTRATION CENTER OR ANTEGRADE BRANCH DISTAL ASPECT OR RETROGRADE BRANCH PROXIMAL ASPECT WAS 80 MM. THE CLOCK POSITION WAS 03:00. THE FENESTRATION OR BRANCH MEASURED 6 MM. THE DEVICE WAS PRELOADED WITH A CATHETER OR WIRE AND CANNULATION WAS INTENDED FROM BELOW. COOK AAA-BIFURCATED-GRAFT. COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-11-39-ZT). COOK ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-11-74-ZT). THERE WERE NO TECHNICAL DIFFICULTIES IN THE DELIVERY AND DEPLOYMENT OF THE DEVICES AND WAS CONSIDERED SUCCESSFUL. THE COOK ANCILLARY DEVICES USED IN THE PROCEDURE SUCCESSFULLY ACCESSED THE TARGET VASCULATURE AND PERFORMED AS INTENDED. NO DEVICE DEFICIENCIES WERE IDENTIFIED. THE PATIENT DID NOT HAVE ANY SIGNIFICANT MEDICAL PROBLEMS OR COMPLICATIONS DURING THE STUDY PROCEDURE. PROCEDURAL IMAGING (ANGIOGRAM AND CONE BEAM CT WITH CONTRAST) WAS COMPLETED ON (B)(6) 2023. ALL STENTS AND INTENDED SIDE BRANCH STENTS WERE PATENT AT THE CONCLUSION OF THE PROCEDURE. THIS WAS CONFIRMED USING THE ANGIOGRAM AND CONE BEAM CT. ALL TARGET VESSELS WERE PATENT. THIS WAS CONFIRMED BY ANGIOGRAM. NO ENDOLEAKS WERE PRESENT AT THE CONCLUSION OF THE CASE. THIS WAS CONFIRMED BY ANGIOGRAM. NO EVIDENCE OF STENT GRAFT INTEGRITY ISSUES WERE PRESENT AT THE CONCLUSION OF THE PROCEDURE. THIS WAS CONFIRMED BY THE ANGIOGRAM AND CONE BEAM CT. ALL TARGET SIDE BRANCH STENTS WERE INTACT. DURING THE PROCEDURE, STENOSIS GREATER THAN 50 % WAS IDENTIFIED AND REQUIRED STENTING OF THE MOST PROXIMALLY PLACED LEFT AND RIGHT ILIAC LIMB DEVICES. IT WAS REPORTED THAT THERE WAS " EXTRINSIC COMPRESSION OF THE ORIGIN OF BOTH LIMB EXTENSIONS" AND THIS WAS CONSIDERED RELATED TO CALCIFIED ARTERIES. THE EVENT DID NOT LEAD TO A SERIOUS DETERIORATION IN HEALTH AND WAS NOT CONSIDERED DUE TO A DEVICE DEFICIENCY. THE EVENT WAS CONSIDERED TO BE RELATED TO THE STUDY PROCEDURE. THE PATIENT WAS EXTUBATED IN THE OPERATING ROOM AND DID NOT REQUIRE REINTUBATION. HE REMAINED ONE NIGHT IN THE INTENSIVE CARE UNIT (ICU) AND WAS DISCHARGED ON (B)(6) 2023. THE PATIENT'S CREATININE DURING INDEX HOSPITALIZATION WAS 15 MG/DL. HIS EGFR UPON DISCHARGE WAS 46 ML/MIN/1.73M2. THE LOWEST HEMATOCRIT DURING THE INDEX HOSPITALIZATION WAS 37% AND WAS 37% UPON DISCHARGE. HIS HIGHEST WHITE BLOOD COUNT DURING THE INDEX HOSPITALIZATION WAS 8 CELLS/MM3. THE PATIENT DID NOT REQUIRE ANY UNITS OF PACKED RED BLOOD CELLS DURING THE OPERATION AND OVER THE ENTIRE TIME OF HOSPITALIZATION. HIS LOWEST PLATELET COUNT DURING HOSPITALIZATION WAS 146 (COUNT X1000/ML). UPON DISCHARGE THE PATIENT WAS PRESCRIBED ACETYLSALICYLIC ACID (ASA), LOW WEIGHT MOLECULAR HEPARIN, AND A STATIN. THE PATIENT WAS DISCHARGED TO HIS HOME. THE FOCUS OF THIS COMPLAINT REPORT: DURING THE PROCEDURE ON (B)(6) 2023 STENOSIS GREATER THAN 50 % WAS IDENTIFIED IN THE CONTRALATERAL, LEFT COOK ILIAC LEG GRAFT (ZSLE-11-74-ZT) AND REQUIRED STENTING OF THE MOST PROXIMALLY PLACED LEFT AND RIGHT ILIAC LIMB DEVICES. IT WAS REPORTED THAT THERE WAS " EXTRINSIC COMPRESSION OF THE ORIGIN OF BOTH LIMB EXTENSIONS" AND THIS WAS CONSIDERED RELATED TO CALCIFIED ARTERIES. THE EVENT DID NOT LEAD TO A SERIOUS DETERIORATION IN HEALTH AND WAS NOT CONSIDERED DUE TO A DEVICE DEFICIENCY. AN ADDITIONAL REPORT WILL BE SUBMITTED FOR THE RIGHT IPSILATERAL COOK ILIAC LEG GRAFT (ZSLE-11-39-ZT) AND WILL BE SUBMITTED UNDER PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 0

    THIS EVENT NO LONGER MEETS THE QUALIFICATIONS FOR A REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192585 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A 15283900

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention ADVANTA V12, 6 MM X 22 MM.| BEGRAFT PERIPHERAL 8 MM X 27 MM.| COOK TSCF-35-180-3, LOT 15248750.| COOK AAA-BIFURCATED-GRAFT, LOT AC1133428.| COOK CODA-2-9.0-35-120-32, LOT 15366698.| COOK HNBR5.0-38-65-P-NS-KMP, LOT 15288274.| COOK HNBR5.0-38-80-P-NS-VS1, LOT 15057939.| COOK JCDS-2022-EDS-HC, LOT 15403511.| COOK KCFW-6.0-18/38-90-RB-ANL1-HC, LOT 15236628.| COOK KCFW-6.0-35-55-RB-HFANL1-HC, LOT 15465250.| COOK RPN: TSCMG-35-300-7-LES, LOT E4003007.| COOK THSCF-35-260-1.5-ROSEN, LOT 13593961.| COOK THSCF-35-260-1.5-ROSEN, LOT.| COOK TSCF-35-180-3, LOT 15203837.| COOK TSCMG-35-260-7-LES, LOT E4389062.| COOK ZSLE-11-39-ZT, LOT 15468052.| KCFW-6.0-35-55-RB-HFANL1-HC, LOT 15378889.| PRE-LOADED-FENESTRATED-PROX, LOT AC1133426.