BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 7557895 · Received May 31, 2018

    Report

    Report Number
    1820334-2018-01559
    Event Type
    Injury
    Date Received
    May 31, 2018
    Report Date
    September 11, 2018
    Manufacturer
    COOK INC
    Product Code
    MIH
    UDI-DI
    10827002552460
    PMA / PMN Number
    P020018
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. EVALUATION METHOD CODES: 4117, DEVICE NOT ACCESSIBLE FOR TESTING. EVALUATION CONCLUSION CODES: 4310, CAUSE CANNOT BE TRACED TO DEVICE. EVALUATION / INVESTIGATION WITHOUT THE COMPLAINT DEVICE, A PHYSICAL INVESTIGATION WAS NOT ABLE TO BE COMPLETED. A DOCUMENT BASED INVESTIGATION HAS BEEN PERFORMED. A REVIEW OF IMAGING (PROVIDED WITH THE INITIAL COMPLAINT), DEVICE HISTORY RECORDS, INSTRUCTIONS FOR USE AND QUALITY CONTROL DATA WAS CONDUCTED. EACH ZENITH DEVICE IS SHIPPED WITH THE INSTRUCTIONS FOR USE (IFU), LISTING THE INDICATIONS FOR USE, CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, AND THE CORRECT DEPLOYMENT PROCEDURE. THE IFU PROVIDED WITH THE ZSLE DEVICE STATES THAT VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. LACK OF NON-CONTRAST CT IMAGING MAY RESULT IN FAILURE TO APPRECIATE ILIAC OR AORTIC CALCIFICATION, WHICH MAY PRECLUDE ACCESS OR RELIABLE DEVICE FIXATION AND SEAL. A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS DEVICE. THIS COMPLAINT FOCUSES ON AN IPSILATERAL TYPE 1B ENDOLEAK REPORTED ON 17MAY2018 FOR A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG (RPN: ZSLE-24-74-ZT, LOT: 6385452). THE TIMELINE OF PROCEDURES TO TREAT THE IPSILATERAL TYPE 1B ENDOLEAK INCLUDE: (B)(6) 2017: SELECTIVE DIAGNOSTIC ANGIOGRAM. (B)(6) 2017: EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY WITH AN AMPLATZ PLUG. (B)(6) 2017: THE AMPLATZ PLUG FAILED AND THE PHYSICIAN USED GLUE IN THE INTERNAL ILIAC ARTERY. A GORE LIMB EXTENSION WAS THEN EXTENDED INTO THE EXTERNAL ILIAC ARTERY. THE ADDITIONAL PROCEDURES FOR THE TYPE 1B ENDOLEAK WERE PERFORMED BETWEEN 04NOV2017 AND 11DEC2017. SINCE THE IMAGING PROVIDED FOR THE ORIGINAL EVENT (PR193827) WAS THE IMPLANTATION ANGIOGRAPHY DATED (B)(6) 2017 IT DID NOT CAPTURE THE TYPE 1B ENDOLEAK. ADDITIONAL IMAGING OF THIS EVENT WAS REQUESTED. ON (B)(6) 2018, COOK WAS ADVISED THAT THE PHYSICIAN WAS UNABLE TO GET CONSENT FROM THE PATIENT AND THEY ARE NO LONGER INTERESTED IN PURSUING THE MATTER. IMPLANTATION ANGIOGRAPHY WAS PROVIDED FOR THE IMAGE REVIEW FOR PR193827. RELEVANT FINDINGS FOR THIS COMPLAINT CONCERNING THE TYPE 1B ENDOLEAK INCLUDE SEVERELY TORTUOUS AND CALCIFIED ILIAC ARTERIES. AS REPORTED BY THE IMAGING REVIEWER, THE RIGHT EXTERNAL AND COMMON ILIAC ARTERIES WERE SEVERELY TORTUOUS WITH COMPLETE S-CURVES INVOLVING EACH. THE ACCESS SITE WAS ALSO MODERATELY NARROWED BY MOUND-SHAPED CALCIFIED PLAQUE. MODERATE CALCIFIED PLAQUE AFFECTED THE EIA AND CIA. EACH ARTERY WAS CAPACIOUS WITH NO LESS THAN 12MM EIA AND 14MM CIA INNER DIAMETERS. DESPITE THESE CAPACIOUS DIAMETERS, SO MUCH EXCESS ARTERY LENGTH WAS PRESENT THAT UPON STRAIGHTENING BY THE SECOND INTRODUCER SHEATH, THE EIA WAS OCCLUDED AND THE CIA NEARLY OCCLUDED. THE OCCLUSION WAS THE RESULT OF ARTERY KINKING, FOLDING, AND TWISTING AS THE WIRES AND SHEATH STRAIGHTENED THE EXCESSIVELY REDUNDANT ARTERIES. THE IFU PROVIDED WITH THE ZSLE DEVICE STATES THAT VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION" AND "LACK OF NON-CONTRAST CT IMAGING MAY RESULT IN FAILURE TO APPRECIATE ILIAC OR AORTIC CALCIFICATION, WHICH MAY PRECLUDE ACCESS OR RELIABLE DEVICE FIXATION AND SEAL. THE TORTUOSITY AND CALCIFICATION PRESENT IN THE ILIAC ARTERIES LIKELY COMPROMISED THE DISTAL SEAL ZONE OF THE ZSLE-24-74, RESULTING IN THE TYPE 1B ENDOLEAK. THERE IS NO EVIDENCE INDICATING THAT THE ZSLE-24-74-ZT (LOT: 6385452) WAS MANUFACTURED OUT OF SPECIFICATIONS. ALTHOUGH THE IMAGING PROVIDED DID NOT CONFIRM THIS ENDOLEAK, IT DID INDICATE ADVERSE PATIENT ANATOMY THAT CONTRIBUTED TO THIS EVENT. DUE TO THE TORTUOSITY AND CALCIFICATION FOUND FROM THE PROVIDED IMAGING, THE INVESTIGATION CONCLUSION CAN BE ESTABLISHED AS CAUSE CANNOT BE TRACED TO DEVICE - ADVERSE EVENT RELATED TO PATIENT CONDITION. A QUALITY ENGINEER RISK ASSESSMENT WAS CONDUCTED TO ASSESS THE RISK OF THIS FAILURE MODE AND CONCLUDED A CHANGE IS NOT REQUIRED, THUS NO RISK REDUCTION ACTIVITIES ARE REQUIRED AT THIS TIME. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

    THERE HAS BEEN NO NEW EVENT INFORMATION RECEIVED SINCE SUBMISSION OF THE LAST REPORT ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: ZALB-36-108 (MAIN BODY - NOT DEPLOYED), ZALB-36-84 (MAIN BODY), ZSLE-20-90-ZT (CONTRALATERAL SIDE), ZSLE-24-74-ZT (IPSILATERAL SIDE), ZSLE-13-74-ZT (BRIDGING). CODA, INTRODUCERS, LUNDERQUIST WIRES, TERUMO GUIDE WIRES, 16FR INTRODUCER. (B)(4). 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 INITIALLY REPORTED ON (B)(6) 2017, DURING REPAIR OF AN ABDOMINAL AORTIC ANEURYSM (AAA), THE DOCTOR HAD DIFFICULTY IN ADVANCING THE ZALB-36-108 DEVICE UP THE RIGHT SIDE. IT WOULD NOT TRACK UP THE TORTUOUS ANATOMY. THE DECISION WAS THEN MADE TO PUT IN A BUDDY LUNDERQUIST WIRE TO HOPEFULLY STRAIGHTEN OUT THE TORTUOSITY. WHEN THE DOCTOR REMOVED THE ZALB, IT WAS NOTICED THAT THE MAIN BODY FLEXOR SHEATH WAS KINKED AND NOT INTACT. PERFORATIONS AND WIRE BRAIDING WERE VISIBLE. A 16 FRENCH INTRODUCER WAS THEN INSERTED AND A SECOND LUNDERQUIST WIRE INSERTED. THERE WAS A ZALB-36-84 (NOT THE SAME LENGTH) AVAILABLE TO USE. THIS ONE TRACKED UP NICELY WITH THE BUDDY WIRE IN SITU. THE PROCEDURE THEN PROCEEDED AS PLANNED. DUE TO THE SHORTER BODY BEING USED, A BRIDGING ZSLE-13-74-ZT WAS USED FOLLOWED BY ZSLE-20-90-ZT FOR THE CONTRALATERAL SIDE AND ZSLE-24-74-ZT FOR THE IPSILATERAL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. A MEDWATCH REPORT WAS NOT FILED ON THE ZENITH LOW PROFILE AAA ENDOVASCULAR GRAFT MAIN BODY THAT WOULD NOT TRACK UP THE TORTUOUS ANATOMY AS THIS DEVICE IS NOT SOLD IN THE U.S. AND THERE IS NOT A SIMILAR DEVICE MANUFACTURED BY COOK INC. THAT IS MARKETED IN THE U.S.A. DURING THE MANUFACTURER¿S INVESTIGATION OF THIS COMPLAINT, A TYPE 1A ENDOLEAK WAS IDENTIFIED ON THE PROVIDED IMAGING. THE CUSTOMER WAS ADVISED OF THIS FINDING AND A RESPONSE WAS RECEIVED STATING THAT DUE TO THE AMOUNT OF HEPARIN THE PATIENT HAD RECEIVED IT MAY HAVE APPEARED AS A TYPE 1A ENDOLEAK DURING THE PROCEDURAL IMAGING, HOWEVER THE PHYSICIAN HAS NOT REPORTED ANY ENDOLEAK ON FOLLOW UP IMAGING OF THIS PATIENT, SO IT LIKELY DISAPPEARED WHEN THE HEPARIN WAS REVERSED. THE MEDICAL DIRECTOR CONFIRMED THAT WHEN A PATIENT IS FULLY HEPARINIZED DURING A PROCEDURE SMALL ENDOLEAKS APPEAR IN THE IMAGING, BUT SELF-SEAL ON THE REVERSAL OF HEPARIN. ON (B)(6) 2018, IT WAS REPORTED THIS PATIENT DID HAVE A TYPE 1B ENDOLEAK INVOLVING THE IPSILATERAL ZSLE-24-74-ZT ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG. AS REPORTED, THE FOLLOWING SECONDARY PROCEDURES WERE PERFORMED. ON (B)(6) 2017, THE FIRST PROCEDURE WAS A SELECTIVE DIAGNOSTIC ANGIOGRAM. ON (B)(6) 2017, THE SECOND PROCEDURE WAS EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY ANEURYSM WITH AN AMPLATZ PLUG. ON (B)(6) 2017, A THIRD PROCEDURE WAS PERFORMED TO TREAT THE ENDOLEAK AS THE AMPLATZ PLUG FAILED. GLUE WAS USED IN THE INTERNAL AND ANOTHER MANUFACTURER'S LIMB EXTENSION EXTENDED INTO THE EXTERNAL. THE PHYSICIAN SAID THE THIRD PROCEDURE FINALLY FIXED THE ENDOLEAK. THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401260 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC G55246 10827002552460

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention