BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

    MDR report key: 6383054 · Received March 7, 2017

    Report

    Report Number
    3001845648-2017-00079
    Event Type
    Malfunction
    Date Received
    March 7, 2017
    Date of Event
    February 1, 2017
    Report Date
    February 8, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002352831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G. 1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. PMA/510(K) #P100022/S014. THE ZISV6-35-125-6.0-80-PTX DEVICE OF LOT C1306081 WAS IMPLANTED IN THE PATIENT, AND WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE COMPLAINT DEVICE WAS ADVANCED OVER 0.035¿ DIAMETER ADVANTAGE TERUMO WIRE GUIDE. THE PATIENT DID NOT HAVE A TORTUOUS OR CALCIFIED ANATOMY. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING TO THE TARGET LOCATION. LESS THAN 20CM OF THE COMPLAINT DEVICE WAS ADVANCED INTO THE PATIENT, AS THE LESION WAS VERY PROXIMAL. THERE WAS NO RESISTANCE ENCOUNTERED WHEN DEPLOYING THE STENT. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION AND WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER. FINDINGS: 1. A SINGLE IMAGE OF THE COMPLAINT STENT PHOTOGRAPHED OFF OF A MONITOR IS PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE COMPLAINT REPORT DESCRIBES IMPLANTATION IN THE PROXIMAL SFA FROM AN ANTEGRADE APPROACH. APPROXIMATELY HALF THE 13CM COOK PERFORMER ACCESS SHEATH NEEDED TO BE RETRACTED TO DEPLOY THE STENT. THIS INDICATED THAT THE PROXIMAL STENT WAS INTENDED TO LAND APPROXIMATELY 7CM INFERIOR THE COMMON FEMORAL ARTERY ACCESS. 3. THE GUIDE WIRE WAS A TERUMO GLIDE ADVANTAGE. THIS IS AN EXTRA, ALTHOUGH NOT SUPER STIFF WIRE, THAT CAN STORE TENSION IN TORTUOUS ANATOMY AS WOULD BE ENCOUNTERED IN AN ANTEGRADE APPROACH. THIS WIRE TENSION IS OFTEN SENSIBLE TO THE OPERATOR AS BACKPRESSURE. THE OPERATOR MUST COUNTERACT THIS BY EXERTING FORWARD PRESSURE ON THE ENTIRE SYSTEM. IN THE CASE OF A SHORT PURCHASE ANTEGRADE ACCESS, PRESSURE IS OFTEN NECESSARY ON THE SHEATH ITSELF TO KEEP THE SHEATH FROM BEING BACKED OUT OF THE VESSEL. 4. THE STENT IS POSITIONED HORIZONTAL ON THE LANDSCAPE ORIENTATION IMAGE. 5. NO BONEY LANDMARKS OR OTHER ANATOMIC SIGNS WERE PRESENT TO DETERMINE WHICH END OF THE STENT WAS INFERIOR AND WHICH SUPERIOR OTHER THAN DIFFUSELY INCREASED DENSITY ON THE RIGHT OF THE IMAGE CONSISTENT WITH GREATER TISSUE THICKNESS NEAR THE HIP JOINT. 6. THE RIGHT END OF THE STENT WAS CONCERTINAED OVER A 6MM LENGTH 13MM FROM THE END. THE RIGHT END WAS FLARED RELATIVE TO THE LEFT. OVERALL STENT LENGTH WAS APPROXIMATELY 60MM. THE FLARING AND THE CONCERTINAED SEGMENT ARE INDICATIVE OF FORWARD PRESSURE ON THE DELIVERY SYSTEM DURING INITIAL DEPLOYMENT. IT IS MORE DIFFICULT TO COMPRESS THE PROXIMAL END OF THE STENT UPON DEPLOYMENT. OF THE CONCERTINAED STENTS REVIEWED AS COMPLAINTS, PROXIMAL END COMPRESSION HAS NOT BEEN OBSERVED. 7. AN UNEXPANDED 80MM LONG ANGIOPLASTY BALLOON CENTERED ON THE STENT WAS LOADED ON THE GUIDE WIRE. IMPRESSION: 1. THERE IS NO EVIDENCE THAT THE STENT WAS NOT ITS STATED LENGTH. INSTEAD, STENT WAS DEPLOYED IN APPROXIMATELY 20MM OF COMPRESSION WITH 6MM LENGTH OF CONCERTINAED STENT ADJACENT THE FLARED AND LIKELY DISTAL END. THESE FINDINGS INDICATE FORWARD DELIVERY SYSTEM PRESSURE DURING DEPLOYMENT. FORWARD PRESSURE OFTEN MUST BE APPLIED USING A GLIDE ADVANTAGE THROUGH TORTUOUS ANATOMY. CONTROLLING THIS PRESSURE IS MADE EVEN MORE DIFFICULT IN SHORT PURCHASE SITUATIONS WITH A SIGNIFICANT LENGTH OF DEVICE OUTSIDE THE PATIENT SIMILAR TO WHAT WOULD HAVE BEEN ENCOUNTERED IN THIS SITUATION. 2. SIGNIFICANT FINDINGS RELATIVE TO THE PATIENT ANATOMY WERE STATED IN THE COMPLAINT REPORT. THE STENT WAS DEPLOYED WITH VERY SHORT PURCHASE VIA ANTEGRADE FEMORAL ACCESS USING AN EXTRA STIFF WIRE. 3. SIGNIFICANT FINDINGS RELATIVE TO THE DISEASE STATE WERE NOT OBSERVED. 4. SIGNIFICANT FINDINGS RELATIVE TO THE USE OF THE DEVICE WERE OBSERVED. THE STENT WAS DEPLOYED IN COMPRESSION LIKELY AS RESULT OF INADVERTENT FORWARD PRESSURE ON THE DELIVERY SYSTEM. 5. SIGNIFICANT FINDINGS RELATIVE TO THE DESIGN OR PERFORMANCE OF THE DEVICE WERE NOT OBSERVED. 6. CAUSE OF ADVERSE EVENTS WAS NOT OBSERVED. THE CUSTOMER COMPLAINT IS CONFIRMED AS THE STENT WAS OBSERVED TO BE CONCERTINAED IN THE IMAGE REVIEW, AS SUCH THE STENT APPEARED TO BE SHORTENED (APPROX. 60MM). POSSIBLE CAUSES OF THIS OCCURRENCE COULD INCLUDE THE USE OF A NON-SUPER STIFF WIRE GUIDE, THE PROXIMAL LESION AND THE ANTEGRADE APPROACH. THESE FACTORS COULD HAVE CAUSED TENSION AND BACKPRESSURE DURING THE PROCEDURE. THIS MAY HAVE RESULTED IN THE PHYSICIAN APPLYING FORWARD PRESSURE ON THE DELIVERY SYSTEM DURING DEPLOYMENT, TO COUNTERACT THE BACK PRESSURE. THE FORWARD PRESSURE ON THE DELIVERY SYSTEM COULD HAVE CAUSED OR CONTRIBUTED TO THE CONCERTINAED STENT. HOWEVER, AS THE CONDITIONS OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. PRIOR TO DISTRIBUTION ALL ZILVER PTX DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE RELEVANT MANUFACTURING RECORDS REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1306081. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. QUALITY ENGINEERING WILL CONTINUE TO MONITOR COMPLAINTS OF THIS NATURE FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THEY HAVE A VERY PROXIMAL ACCESS, WITH ONLY HALF SHORT INTRODUCER INSIDE THE PATIENT BECAUSE THE LESION WAS VERY PROXIMAL. WHEN THEY DELIVERED THE STENT, THEY DIDN'T NOTICE ANY DIFFICULTY, BUT WHEN THEY ANGIOPLASTY LATER THE STENT WITH A BALLOON OF THE SAME LENGTH, THEY NOTICED THE STENT WAS SHORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168166 ZILVER PTX DRUG-ELUTING PERIPHERAL STENT NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING NIU COOK IRELAND LTD 10827002352831

    Patients

    Seq Age Sex Outcome Treatment
    1