BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZILVER 635 VASCULAR SELF-EXPANDING STENT

    MDR report key: 7937668 · Received October 5, 2018

    Report

    Report Number
    3001845648-2018-00470
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    March 29, 2018
    Report Date
    June 14, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIO
    UDI-DI
    10827002438337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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) # OF SIMILAR DEVICE: P050017/S002 AND S003. PROBLEM STATEMENT: "TWO DEVICES WERE PLACED IN THE PATIENT. IT IS UNKNOWN IF ONE DEVICE IS TOO LONG, OR ONE DEVICE IS TOO SHORT; HOWEVER, ONE DEVICE IS THE INCORRECT LENGTH." DEVICE EVALUATION: THERE ARE TWO DEVICES RELATED TO THIS COMPLAINT. FOR DETAILS OF THE SECOND DEVICE REFER TO PR 222849. THE TWO ZIV6-35-125-8-80 STENTS OF LOT NUMBERS C1117723 (PR 239461) AND C1260575 (PR222849) INVOLVED IN THIS COMPLAINT WERE IMPLANTED IN THE PATIENT, AND WERE NOT AVAILABLE FOR EVALUATION. THE DEVICE DELIVERY SYSTEMS WERE RETURNED, WITHOUT THE ORIGINAL PACKAGING. WITH THE INFORMATION PROVIDED, A PHYSICAL EXAMINATION AND DOCUMENT BASED INVESTIGATION WAS CONDUCTED. FROM CUSTOMER TESTIMONY, IT IS KNOWN THAT THE STENT WAS USED WITH A FEMORAL ENDARTERECTOMY IN THE EXTERNAL ILIAC ARTERIES (EIA) FOR A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A POST DEPLOYMENT PTA WAS CONDUCTED, WHICH RESULTED IN EXTRAVASATION OF BLOOD FROM THE STENTED PORTION OF THE VESSEL. ANOTHER STENT WAS PLACED TO COVER THE AREA OF EXTRAVASATION. THERE WERE NO ADVERSE EFFECTS AS A RESULT OF THE IMPLANTED STENTS SHORTENING. THE PATIENT ULTIMATELY REQUIRED ADDITIONAL SURGERIES AND EVENTUALLY AMPUTATION OF THE LOWER LIMB. HOWEVER, ACCORDING TO THE DISTRICT MANAGER, THIS WAS LIKELY DUE TO PROGRESSION OF PERIPHERAL VASCULAR DISEASE, DISTAL TO THE FEMORAL ARTERIES. THE CUSTOMER STATED THAT BOTH STENTS WERE MEANT TO BE 80MM LONG. ONE OF THE IMPLANTED STENTS APPEARED TO BE HALF ITS SPECIFIED LENGTH. THE STENTS WERE MEASURED VISUALLY. IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: IMPRESSION: 1. IMPLANTATION OF A SHORT STENT WAS NOT CONFIRMED. IMPLANTATION OF THE COMPLAINT STENT TO HALF ITS DESIGN LENGTH IS CONFIRMED. THE SHORTENING WAS SECONDARY TO A CONCERTINAED STENT RATHER THAN AN INCORRECTLY PACKAGED STENT. THIS TYPE OF MALDEPLOYMENT HAS BEEN OBSERVED IN OTHER CASES WHERE STENTS ARE DEPLOYED WITH LIMITED DIAMETER OR NO PRE-IMPLANTATION ANGIOPLASTY IN STENOSES WITH SIMILAR CHARACTERISTICS. THESE CHARACTERISTICS INCLUDE MODERATE TO SEVERE OR WORSE STENOSES CONTAINING HEAVILY CALCIFIED IRREGULAR PLAQUE. RATHER THAN BEING ALLOWED TO EXPAND WITHOUT CONTACTING PLAQUE UNTIL RELATIVELY PARALLEL TO THE LUMEN, THE PLAQUE TURNS EACH STENT ROW PERPENDICULAR TO THE LUMEN. THIS CONTINUOUS SHORTENING OF THE DEPLOYING STENT EXTRACTS THE STENT FROM THE DEPLOYMENT SHEATH. 2. ALTHOUGH NOT A SUBJECT OF THE COMPLAINT, THE SECOND STENT ALSO DEPLOYED SHORTER THAN ITS DESIGN LENGTH. THIS LIKELY OCCURRED THROUGH THE SAME MECHANISM EXCEPT THAT IT WAS EXTRACTED BY THE CONCERTINAED FIRST STENT RATHER THAN PLAQUE. THE TWO DEVICES RELATED TO THIS OCCURRENCE UNDERWENT A LABORATORY EVALUATION ON THE 14TH JUNE 2018. ON EVALUATION OF THE FIRST RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE WAS RETURNED WITHOUT THE STENT. THE DISTANCE BETWEEN THE PROXIMAL END OF THE DISTAL WHITE TIP AND THE PUSHER RING WAS 94MM, WHICH WAS WITHIN SPECIFICATION. THE DEVICE WAS FLUSHED BOTH PORTS, AND A 0.035¿ DIAMETER WIRE GUIDE WAS PASSED THROUGH THE DEVICE WITHOUT RESISTANCE. NO TACTILE DAMAGE WAS OBSERVED ON THE FLEXOR. ON EVALUATION OF THE SECOND RETURNED DEVICE, IT WAS NOTED THAT THE DEVICE WAS RETURNED WITHOUT THE STENT. THE DISTANCE BETWEEN THE PROXIMAL END OF THE DISTAL WHITE TIP AND THE PUSHER RING WAS 91MM, WHICH WAS OUTSIDE SPECIFICATION, LIKELY DUE TO COMPRESSION OF THE INNER PEEK CATHETER DURING ADVANCEMENT. THE DEVICE WAS FLUSHED BOTH PORTS WITHOUT ISSUES. A 0.035¿ DIAMETER WIRE GUIDE WAS PASSED THROUGH THE DEVICE AND ENCOUNTERED RESISTANCE DUE TO CONGEALED BLOOD IN THE DEVICE LUMEN. THE CUSTOMER COMPLAINT OF INCORRECT STENT LENGTH IS NOT CONFIRMED FROM THE IMAGE REVIEWED. HOWEVER, IMPLANTATION OF THE COMPLAINT STENTS TO HALF THEIR DESIGN LENGTH WAS CONFIRMED IN THE IMAGE(S). FROM THE IMAGE REVIEW, POSSIBLE CAUSES FOR THIS OCCURRENCE INCLUDE THE DIFFICULT PATIENT ANATOMY. THE IMAGE REVIEW FOUND THE COMPLAINT STENTS WERE DEPLOYED IN A SEVERELY CALCIFIED, IRREGULAR, AND MODERATE TO SEVERELY NARROW EXTERNAL ILIAC ARTERY (EIA). THIS COULD CAUSE OR CONTRIBUTE TO THE STENTS BECOMING SHORTENING UPON DEPLOYMENT. HOWEVER, AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN A LABORATORY ENVIRONMENT, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. DOCUMENT REVIEW A REVIEW OF THE RELEVANT MANUFACTURING RECORDS (C1117723) REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THESE LOT NUMBERS. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1117723. SUMMARY: THE CUSTOMER COMPLAINT OF INCORRECT STENT LENGTH IS NOT CONFIRMED FROM THE IMAGE REVIEWED. HOWEVER, IMPLANTATION OF THE COMPLAINT STENTS TO HALF THEIR DESIGN LENGTH WAS CONFIRMED IN THE IMAGE(S). THE RISK ASSOCIATED WITH THE COMPLAINT IS NO RISK (CATEGORY III). THERE WERE NO ADVERSE EFFECTS TO THE PATIENT REPORTED DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    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 (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). PMA/510(K) # OF SIMILAR DEVICE: P050017/S002 AND S003. THIS CORRECTION REPORT IS BEING SUBMITTED TO UPDATE THE DATE OR REPORT (DATE AWARE) TO (B)(6) 2018. THIS WAS THE FIRST DATE A COOK EMPLOYEE BECAME AWARE THAT THE 2 DEVICES INVOLVED HAD DIFFERENT RPNS.

    Description of Event or Problem · 0

    MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: "STENT SHORTENING/ COMPRESSION DURING DEPLOYMENT". TWO DEVICES WERE PLACED IN THE PATIENT. IT IS UNKNOWN IF ONE DEVICE IS TOO LONG, OR ONE DEVICE IS TOO SHORT; HOWEVER, ONE DEVICE IS THE INCORRECT LENGTH. TWO LOT# WERE IDENTIFIED WHICH TRIGGERED AN ADDITIONAL REPORT.

    Description of Event or Problem · 0

    CORRECTION REPORT IS BEING SUBMITTED TO UPDATE THE REPORT DATE TO (B)(6) 2018 MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: "STENT SHORTENING/ COMPRESSION DURING DEPLOYMENT". TWO DEVICES WERE PLACED IN THE PATIENT. IT IS UNKNOWN IF ONE DEVICE IS TOO LONG, OR ONE DEVICE IS TOO SHORT; HOWEVER, ONE DEVICE IS THE INCORRECT LENGTH. TWO LOT# WERE IDENTIFIED WHICH TRIGGERED AN ADDITIONAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780371 ZILVER 635 VASCULAR SELF-EXPANDING STENT NIO STENT, ILIAC NIO COOK IRELAND LTD G43833 C1117723 10827002438337

    Patients

    Seq Age Sex Outcome Treatment
    1