BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION

    MDR report key: 10017756 · Received May 1, 2020

    Report

    Report Number
    1820334-2020-00894
    Event Type
    Malfunction
    Date Received
    May 1, 2020
    Date of Event
    April 13, 2020
    Report Date
    November 11, 2020
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002427836
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. H6- ADDITIONAL METHOD CODE: ANALYSIS OF DATA PROVIDED BY USER/THIRD PARTY (4112). INVESTIGATION - EVALUATION: THE COMPLAINANT, (B)(6), INFORMED COOK ON 15APR2020 OF AN INCIDENT THAT OCCURRED ON (B)(6) 2020 AT THE (B)(6) HOSPITAL LOCATED IN CHINA INVOLVING A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION WITH RPN ESBE-22-58 FROM LOT 8871056. THE 62-YEAR-OLD FEMALE PATIENT HAD A SEVERELY TORTUOUS TUMOR NECK. AN ENDOVASCULAR AORTIC REPAIR (EVAR) PROCEDURE TOOK PLACE ON (B)(6) 2020. THE PHYSICIAN USED A COMPETITOR¿S (GORE C3) STENT AND SUCCESSFULLY DEPLOYED IT, BUT DUE TO THE TORTUOSITY OF THE TUMOR NECK, AN EXTENSION STENT WAS NEEDED TO EXPAND THE ANCHORING ZONE. THE COMPLAINT DEVICE WAS SELECTED AND INTRODUCED VIA THE LEFT FEMORAL ARTERY. THE DEVICE COULD NOT BE ADVANCED TO THE TARGET LOCATION AFTER MULTIPLE ATTEMPTS. THE DIFFICULTY WAS NOTICED AS THE DEVICE WAS ADVANCED THROUGH THE TUMOR NECK, WHICH IS ALSO THE PROXIMAL CURVE PART OF THE COMPETITOR¿S STENT. AFTER REMOVING THE DEVICE, AN OBVIOUS BEND NEAR THE SHEATH DILATOR TIP WAS NOTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER COMPETITOR¿S (MEDTRONIC) STENT. ACCORDING TO THE PHYSICIAN, NO SHEATH DAMAGE WAS NOTED PRIOR TO USE. THE PATIENT RECOVERED WELL AFTER THE PROCEDURE. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL AND SPECIFICATIONS, AS WELL AS A VISUAL INSPECTION, FUNCTIONAL TEST AND DIMENSIONAL VERIFICATION OF THE RETURNED DEVICE AND IMAGING, WAS CONDUCTED DURING THE INVESTIGATION. ONE USED ESBE DEVICE WAS RETURNED TO COOK FOR EVALUATION. UPON VISUAL INSPECTION, BIOMATTER WAS NOTED THROUGHOUT THE DEVICE. THE GRAFT WAS PRESENT WITHIN THE DELIVERY SYSTEM AND THE FLEXOR SHEATH AND INNER CANNULA WERE NOTED TO BE KINKED NEAR THE DISTAL TIP OF THE GRAY DILATOR. NO OTHER VISIBLE DAMAGE WAS NOTED. DURING A FUNCTIONAL TEST, THE SHEATH WAS PULLED BACK AND THE GRAFT WAS DEPLOYED, SHOWING NO VISIBLE DAMAGE ON THE GRAFT. AN APPROPRIATE-SIZED WIRE GUIDE WAS INSERTED THROUGH THE TIP OF THE GRAY DILATOR BUT WAS UNABLE TO ADVANCE PAST THE KINK IN THE INNER CANNULA. THE SHEATH OUTER DIAMETER WAS MEASURED AND FOUND TO BE WITHIN MANUFACTURING TOLERANCE. MEDICAL IMAGING WAS PROVIDED AS WELL AND WAS SENT FOR EXPERT IMAGE REVIEW. THE REVIEW FOUND THAT THE PATIENT'S INFRARENAL AORTIC NECK WAS SEVERELY TORTUROUS WITH BOTH ANGULATION AND COUNTER-ANGULATION GREATER THAN 90 DEGREES. THE BEND/KINK SEEN IN THE PROXIMAL SHEATH CONFIRMS THE DELIVERY DEVICE COULD NOT BE PASSED BEYOND THIS SEVERE ANGULATION TO THE TARGET LOCATION DESPITE SIGNIFICANT APPLIED FORCE. THE IMAGE REVIEWER NOTES THAT THIS RESTRICTIVE ANATOMY IS THE MOST LIKELY CAUSE FOR THE KINK IN THE COMPLAINT DEVICE. BASED ON THE EVIDENCE PROVIDED AND OBSERVED, COOK HAS CONCLUDED THAT THE COMPLAINT DEVICE WAS MANUFACTURED TO CURRENT SPECIFICATIONS. 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 (8871056) AND THE RELATED SHEATH AND DELIVERY SYSTEM SUBASSEMBLY LOTS REVEALED ONE RECORDED NONCONFORMANCE FOR DAMAGED TIP IN WHICH ONE DEVICE WAS SCRAPPED. A DATABASE SEARCH FOUND NO OTHER EVENTS ASSOCIATED WITH THE REPORTED DEVICE LOT. IT SHOULD BE NOTED THAT ESBE DEVICES ARE DISTRIBUTED VIA ONE-DEVICE LOTS. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES IN PLACE, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, OBJECTIVE EVIDENCE THAT ALL RELEVANT NON-CONFORMING PRODUCT WAS SCRAPPED, AND NO OTHER LOT-RELATED COMPLAINTS RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT INSTRUCTIONS FOR USE (IFU), ¿ZENITH® AAA ANCILLARY COMPONENTS¿, PROVIDES THE FOLLOWING INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE: ¿WARNINGS AND PRECAUTIONS GENERAL THE ZENITH AAA ANCILLARY COMPONENTS HAVE NOT BEEN EVALUATED FOR USE WITH GRAFTS OTHER THAN ZENITH AAA STENT GRAFTS. PATIENT SELECTION, TREATMENT AND FOLLOW-UP KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE SEVERE PROXIMAL NECK ANGULATION (>60 DEGREES FOR INFRARENAL NECK TO AXIS OF AAA OR >45 DEGREES FOR SUPRARENAL NECK RELATIVE TO THE IMMEDIATE INFRARENAL NECK); SHORT PROXIMAL AORTIC NECK (<15 MM); AN INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OVER 15 MM OF PROXIMAL AORTIC NECK LENGTH); SHORT DISTAL FIXATION SITE (<10 MM); AND CIRCUMFERENTIAL THROMBUS AND/OR CALCIFICATION AT THE ARTERIAL IMPLANTATION SITES, SPECIFICALLY THE PROXIMAL AORTIC NECK AND DISTAL ILIAC ARTERY INTERFACE. IN THE PRESENCE OF ANATOMICAL LIMITATIONS, A LONGER NECK MAY BE REQUIRED TO OBTAIN ADEQUATE SEALING AND FIXATION. IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE THE FIXATION AND SEALING OF THE IMPLANTATION SITES. NECKS EXHIBITING THESE KEY ANATOMIC ELEMENTS MAY BE MORE CONDUCIVE TO GRAFT MIGRATION. ACCESS VESSEL DIAMETER (MEASURED INNER WALL TO INNER WALL) AND MORPHOLOGY (MINIMAL TORTUOSITY, OCCLUSIVE DISEASE AND/OR CALCIFICATION) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND DELIVERY SYSTEMS OF THE PROFILE OF A 14 FRENCH TO 20 FRENCH VASCULAR INTRODUCER SHEATH. VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ANCILLARY COMPONENTS AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. A VASCULAR CONDUIT TECHNIQUE MAY BE NECESSARY TO ACHIEVE SUCCESS IN SOME PATIENTS. IMPLANT PROCEDURE DO NOT BEND OR KINK THE DELIVERY SYSTEM. DOING SO MAY CAUSE DAMAGE TO THE DELIVERY SYSTEM AND THE ZENITH AAA ANCILLARY COMPONENTS. DO NOT CONTINUE ADVANCING ANY PORTION OF THE DELIVERY SYSTEM IS RESISTANCE IS FELT DURING ADVANCEMENT OF THE WIRE GUIDE OR DELIVERY SYSTEM. STOP AND ASSESS THE CAUSE OF RESISTANCE; VESSEL, CATHETER OR GRAFT DAMAGE MAY OCCUR. EXERCISE PARTICULAR CARE IN AREAS OF STENOSIS, INTRAVASCULAR THROMBOSIS OR IN CALCIFIED OR TORTUOUS VESSELS. PATIENT SELECTION AND TREATMENT ADDITIONAL CONSIDERATIONS FOR PATIENT SELECTION INCLUDE, BUT ARE NOT LIMITED TO: FOR MAIN BODY EXTENSION, NON-ANEURYSMAL INFRARENAL AORTIC SEGMENT (NECK) PROXIMAL TO THE ANEURYSM: WITH A DIAMETER MEASURED OUTER WALL TO OUTER WALL OF NO GREATER THAN 32 MM AND NO LESS THAN 18 MM, WITH AN ANGLE LESS THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM, AND WITH AN ANGLE LESS THAN 45 DEGREES RELATIVE TO THE AXIS OF THE SUPRARENAL AORTA. DIRECTIONS FOR USE ANATOMICAL REQUIREMENTS ILIOFEMORAL ACCESS VESSEL SIZE AND MORPHOLOGY (MINIMAL THROMBUS, CALCIUM AND/OR TORTUOSITY) SHOULD BE COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES AND ACCESSORIES. ARTERIAL CONDUIT TECHNIQUES MAY BE REQUIRED. MAIN BODY EXTENSIONS INTRODUCE THE MAIN BODY DELIVERY SYSTEM INTO THE IPSILATERAL FEMORAL ARTERY. ADVANCE SLOWLY UNTIL THE MAIN BODY EXTENSION IS AT THE SITE OF THE REQUIRED INTERVENTION.¿ BASED ON THE INFORMATION PROVIDED, EVALUATION OF THE RETURNED DEVICE, AND THE RESULTS OF THE INVESTIGATION, DEFINITIVE ROOT CAUSES FOR THIS EVENT WERE NOT TRACED TO THE DEVICE BUT RATHER TO BOTH THE PATIENT'S CONDITION AND UNINTENDED USE ERROR. IT WAS REPORTED THAT THE PATIENT HAD A SEVERELY TORTUOUS TUMOR NECK, WHICH WAS CONFIRMED IN THE PROVIDED IMAGING. THE IMAGE REVIEWER OBSERVED THAT THE INFRARENAL NECK HAD A GREATER THAN 90-DEGREE ANGULATION FOLLOWED BY A GREATER THAN 90-DEGREE COUNTER ANGULATION. THIS SEVERE ANGULATION IS OUTSIDE OF THE RECOMMENDED PATIENT SELECTION CRITERIA FOR THIS DEVICE, AS LISTED IN THE IFU. IT IS LIKELY THAT ATTEMPTING TO ADVANCE THE COMPLAINT DEVICE THROUGH THIS ANATOMY WAS THE CAUSE OF THE DELIVERY SYSTEM KINKING. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    (B)(6). OCCUPATION: AGENT. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIFFICULTY ADVANCING THE DELIVERY SYSTEM OF A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION DURING A PROCEDURE. THE PROCEDURE IN QUESTION WAS TO TREAT A "COMPLICATED" ABDOMINAL AORTIC ANEURYSM IN A (B)(6) YEAR OLD FEMALE PATIENT. AFTER THE INITIAL MEASUREMENTS AND ANGIOGRAPHY, A COMPETITOR'S STENT WAS CHOSEN FOR IMPLANTATION DUE TO ITS "ELASTICITY" AND WAS SUCCESSFULLY DEPLOYED. THE PATIENT REPORTEDLY HAD SEVERE TORTUOSITY IN THE "TUMOR NECK", SO A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION WAS USED TO EXPAND THE ANCHORING ZONE. THE DEVICE WAS INTRODUCED IN THE LEFT FEMORAL ARTERY, BUT COULDN'T BE ADVANCED THROUGH THE "TUMOR NECK" TO THE TARGET POSITION EVEN AFTER MULTIPLE ATTEMPTS. THE DELIVERY SYSTEM WAS WITHDRAWN AND WAS OBSERVED TO BE BENT NEAR THE "SHEATH DILATOR TIP" UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S STENT. NO SHEATH DAMAGE WAS NOTED PRIOR TO USE. THE PATIENT RECOVERED WELL AFTER THE PROCEDURE. NO ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481680 ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G42783 8871056 10827002427836

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR GORE C3 STENT