BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 9208694 · Received October 18, 2019

    Report

    Report Number
    1820334-2019-02644
    Event Type
    Malfunction
    Date Received
    October 18, 2019
    Date of Event
    June 26, 2012
    Report Date
    February 14, 2020
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D- PRODUCT IDENTIFIER: TYPE 1B ENDOLEAK: G55242-ZSLE-20-74-ZT, TYPE IA/IIIB ENDOLEAK: G48407-TFFB-24-82-ZT. D4- RPN: TYPE 1B ENDOLEAK: ZSLE-20-74-ZT, TYPE IA/IIIB ENDOLEAK: TFFB-24-82-ZT. D4- EXPIRATION DATE: TFFB-24-82-ZT- 02/01/2014. D4- PRODUCT LOT #: TFFB-24-82-ZT- 3143973, ZSLE-20-74-ZT- EITHER 3180913 OR 3249597. INVESTIGATION - EVALUATION A REVIEW OF DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS (MI) AND QUALITY CONTROL, AS WELL AS A REVIEW OF IMAGING PROVIDED OF THE DEVICE, WAS CONDUCTED DURING THE INVESTIGATION. SEVEN YEAR POST-OPERATIVE MULTIPHASE CTA IMAGING WAS RETURNED AND SUBMITTED FOR EXPERT IMAGE REVIEW. ADDITIONAL TO THE REPORTED TYPE IB ENDOLEAK ON THE ZSLE-20-74-ZT, A SMALLER, PROXIMAL ENDOLEAK ON THE TFFB-24-82-ZT WAS OBSERVED BETWEEN THE SEALING STENT AND THE SECOND MAIN BODY STENT AND IS SUSPECTED TO BE EITHER TYPE IIIB SUTURE HOLE OR TYPE IA. THE MAIN BODY WAS FOUND TO HAVE BEEN DEPLOYED FROM THE RIGHT SIDE, MEANING THAT THE TYPE IB ENDOLEAK WAS RELATED TO THE IPSILATERAL STENT GRAFT. IMAGE REVIEW CONFIRMED THAT THE TWO INDEPENDENT ENDOLEAKS DO NOT JOIN. THE ANEURYSM NECK WAS FOUND TO HAVE A REVERSE FUNNEL SHAPE AND THE PATIENT'S COMMON ILIAC ARTERY WAS FOUND TO BE "ABNORMALLY THICK". ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF CURRENT DOCUMENTATION FROM THE DEVICE MASTER RECORDS REVEALED NO GAPS IN THE MANUFACTURING PROCESS WHICH INCLUDES CONTROLS AND INSPECTIONS TO PREVENT THE RELEASE OF NON-CONFORMING PRODUCT. THE DESIGN HISTORY FILES FOR EACH DEVICE SHOW THAT THE ZSLE-20-74-ZT AND TFFB-24-82-ZT ARE BOTH SAFE AND EFFECTIVE FOR THEIR INTENDED USE. A REVIEW OF THE DHRS FOR EACH POTENTIAL DEVICE LOT, AS WELL AS THE RELATED SUB-ASSEMBLY COMPONENT LOTS, REVEALED NO NON-CONFORMANCES. IT SHOULD BE NOTED THAT EACH DEVICE IS A ONE-DEVICE-LOT. FURTHERMORE, THERE IS NO EVIDENCE THAT SUGGESTS THAT NON-CONFORMING PRODUCT EXISTS EITHER IN HOUSE OR IN FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT LABELING SENT WITH THE DEVICE, INCLUDING THE SAMPLE LABEL AND THE PRODUCT INSTRUCTIONS FOR USE (IFU), WAS REVIEWED. THE SAMPLE LABEL FOR BOTH 3180913 AND 3249597 LOTS CORRECTLY DEPICT THE DIMENSIONS OF THE RELEVANT STENT GRAFT LEGS. THE IFU INCLUDES THE FOLLOWING INFORMATION TO THE USER AS RELATED TO THE FAILURE MODE IDENTIFIED: "WARNINGS AND PRECAUTIONS 4.1 GENERAL ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING ANEURYSMS, UNACCEPTABLE DECREASE IN FIXATION LENGTH (VESSEL AND COMPONENT OVERLAP) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK OR MIGRATION MAY LEAD TO ANEURYSM RUPTURE. 4.2 PATIENT SELECTION, TREATMENT AND FOLLOW-UP ¿ ZENITH SPIRAL-Z ILIAC ARTERY DISTAL FIXATION SITE GREATER THAN 10 MM IN LENGTH AND 7.5-20 MM IN DIAMETER (MEASURED OUTER WALL TO OUTER WALL) IS REQUIRED. THESE SIZING MEASUREMENTS ARE CRITICAL TO THE PERFORMANCE OF THE ENDOVASCULAR REPAIR. 4.5 IMPLANT PROCEDURE ¿ 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 INTERNAL ILIAC ARTERIES. AVOID DAMAGING THE GRAFT OR DISTURBING GRAFT POSITIONING AFTER PLACEMENT IN THE EVENT REINSTRUMENTATION (SECONDARY INTERVENTION) OF THE GRAFT IS NECESSARY. ADVERSE EVENTS 5.2 POTENTIAL ADVERSE EVENTS ¿ ENDOLEAK DIRECTIONS FOR USE 11.1.5 IPSILATERAL ILIAC LEG PLACEMENT AND DEPLOYMENT 3. CONFIRM POSITION OF DISTAL END OF THE ILIAC LEG GRAFT. ¿ 11.1.6 MOLDING BALLOON INSERTION 5. EXPAND THE MOLDING BALLOON WITH DILUTED CONTRAST MEDIA (AS DIRECTED BY THE MANUFACTURER) IN THE AREA OF THE MOST PROXIMAL COVERED STENT AND THE INFRARENAL NECK, STARTING PROXIMALLY AND WORKING IN THE DISTAL DIRECTION. 6. WITHDRAW THE MOLDING BALLOON TO THE IPSILATERAL LIMB OVERLAP REGION AND EXPAND. 7. WITHDRAW THE MOLDING BALLOON TO THE IPSILATERAL DISTAL FIXATION SITE AND EXPAND. A FINAL ANGIOGRAM IS INSTRUCTED TO ENSURE PATENCY OF VESSELS, PLACEMENT OF GRAFTS, AND NO ENDOLEAKS. IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP GENERAL ¿ ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFELONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ADDITIONAL FOLLOW-UP. ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR: ¿ ANEURYSMS WITH TYPE I ENDOLEAK" THE PRODUCT LABELING FOR THE TFFB-24-82-ZT, INCLUDING THE SAMPLE LABEL AND THE PRODUCT INSTRUCTIONS FOR USE (IFU), T_ZAAAF_REV5, WAS REVIEWED. THE SAMPLE LABEL FOR THE LOT CORRECTLY DEPICTS THE DIMENSIONS THE MAIN BODY GRAFT. THE IFU INCLUDES THE FOLLOWING INFORMATION TO THE USER AS RELATED TO THE FAILURE MODE IDENTIFIED: "WARNINGS AND PRECAUTIONS GENERAL ADDITIONAL ENDOVASCULAR INTERVENTIONS OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING ANEURYSMS, UNACCEPTABLE DECREASE IN FIXATION LENGTH (VESSEL AND COMPONENT OVERLAP) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK OR MIGRATION MAY LEAD TO ANEURYSM RUPTURE. PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OR SURGICAL PROCEDURES. PATIENT SELECTION, TREATMENT AND FOLLOW-UP KEY ANATOMICAL ELEMENTS THAT MAY AFFECT SUCCESSFUL EXCLUSION OF THE ANEURYSM INCLUDE. AN INVERTED FUNNEL SHAPE (GREATER THAN 10% INCREASE IN DIAMETER OVER 15 MM OF PROXIMAL AORTIC NECK LENGTH). NECKS EXHIBITING THESE KEY ANATOMICAL ELEMENTS MAY BE MORE CONDUCIVE TO GRAFT MIGRATION OR ENDOLEAK. PRE-PROCEDURE MEASUREMENT TECHNIQUES AND IMAGING PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSM OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ENHANCED FOLLOW-UP. DEVICE SELECTION SIZING OUTSIDE OF THIS RANGE CAN RESULT IN ENDOLEAK, FRACTURE, MIGRATION, DEVICE INFOLDING OR COMPRESSION. IMPLANT PROCEDURE INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FLEX AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK. AVOID DAMAGING THE GRAFT OR DISTURBING GRAFT POSITIONING AFTER PLACEMENT IN THE EVENT REINSTRUMENTATION (SECONDARY INTERVENTION) OF THE GRAFT IS NECESSARY. 5 ADVERSE EVENTS POTENTIAL ADVERSE EVENTS : ENDOLEAK, ENDOPROSTHESIS: SUTURE BREAK; STENT FRACTURE; GRAFT MATERIAL WEAR; DILATATION; EROSION; PUNCTURE; PERIGRAFT FLOW; BARB SEPARATION AND CORROSION DIRECTIONS FOR USE MAIN BODY PROXIMAL (TOP) DEPLOYMENT PERFORM ANGIOGRAPHY THROUGH AN ANGIOGRAPHIC CATHETER TO VERIFY POSITION OF THE ENDOVASCULAR GRAFT WITH RESPECT TO THE RENAL ARTERIES. MOLDING BALLOON INSERTION EXPAND THE MOLDING BALLOON WITH DILUTED CONTRAST MEDIA (AS DIRECTED BY THE MANUFACTURER) IN THE AREA OF THE MOST PROXIMAL COVERED STENT AND THE INFRARENAL NECK, STARTING PROXIMALLY AND WORKING IN THE DISTAL DIRECTION. A FINAL ANGIOGRAM IS INSTRUCTED TO ENSURE PATENCY OF VESSELS, PLACEMENT OF GRAFTS, AND NO ENDOLEAKS. IMAGING GUIDELINES AND POSTOPERATIVE FOLLOW-UP GENERAL ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFELONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT) SHOULD RECEIVE ADDITIONAL FOLLOW-UP. ADDITIONAL SURVEILLANCE AND POSSIBLE TREATMENT IS RECOMMENDED FOR: ANEURYSMS WITH TYPE I ENDOLEAK" BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE WAS NOT ESTABLISHED; HOWEVER, ENDOLEAKS ARE A KNOWN INHERENT RISK OF THE DEVICE. 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

    THE USER FACILITY PROVIDED MULTIPHASE CTA IMAGING FROM SEVEN YEARS POST-OPERATIVE WHICH WAS SUBMITTED FOR EXPERT IMAGE REVIEW. THE REVIEW REVEALED A "SMALLER PROXIMAL ENDOLEAK" BETWEEN THE SEALING STENT AND THE SECOND MAIN BODY STENT WHICH WAS LIKELY TO BE EITHER A TYPE IIIB SUTURE HOLE OR A TYPE IA.

    Additional Manufacturer Narrative · 1

    IMPLANT DATE: 2012. CONCOMITANT PRODUCTS: THE SPECIFIC COMPLAINT DEVICE IS CURRENTLY KNOWN. INVOLVED PRODUCTS INCLUDE: ZSLE-20-74-ZT QTY: 2, TFFB-24-82-ZT. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ENDOLEAK OCCURRED AFTER AN INFRARENAL EVAR PROCEDURE INCLUDING IMPLANTATION OF TWO ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEGS OF THE SAME SIZE (CATALOG NUMBER: ZSLE-20-74-ZT) AND A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (CATALOG NUMBER: TFFB-24-82-ZT) IN 2012. SINCE THEN, ONYX GLUE HAS BEEN USED TO OCCLUDE POTENTIAL SOURCES OF A TYPE II ENDOLEAK. THE PATIENT'S LATEST COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) ON (B)(6) 2019 SHOWS CONTINUED ANEURYSM SAC EXPANSION. THE PHYSICIAN IS UNABLE TO CONFIRM THE SOURCE OF THE ENDOLEAK. THE PHYSICIAN HAS ALSO ATTEMPTED "ON TABLE ANGIO DIAGNOSTIC" BUT WAS UNABLE TO SEE ANY ENDOLEAKS PRESENT. ADDITIONALLY, THREE SONOGRAPHERS HAVE REVIEWED THE IMAGING- TWO BELIEVE THAT THE ENDOLEAK WAS ORIGINATING FROM THE TOP OF THE RIGHT LEG AND SUSPECTED IT TO BE TYPE III WHILE THE THIRD BELIEVES THAT IT IS TYPE IB ON THE LEFT SIDE. THE PHYSICIAN HAS SUPPLIED THE IMAGING TO HAVE A PLAN FORMULATED FOR RELINING THE GRAFT. NO ADVERSE EFFECTS TO THE PATIENT HAVE BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004463 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR