BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE RX NITINOL STENT

    MDR report key: 1062875 · Received June 18, 2008

    Report

    Report Number
    9616099-2008-01552
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    July 3, 2007
    Report Date
    July 3, 2007
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POST-DILATION WAS PERFORMED WITH A 6MM AVIATOR RX BALLOON. THE BALLOON WAS INFLATED FOR APPROX 15 TO 20 SECONDS. THE PT WAS COUNTING AS PER ROUTINE AND STOPPED AT AROUND 10 WITH NOTED SEVERE BRADYCARDIA, MOMENTARY ASYSTOLE. THE BALLOON WAS QUICKLY DEFLATED AND THE PT WAS ABLE TO COUNT AND MENTATE APPROX. THREE SECONDS AFTER DEFLATION. THE PT'S HEART RATE RESUMED IN 40'S AND ANOTHER DOSE OF ATROPINE WAS GIVEN. THE PT STABILIZED WELL. THERE WERE NO OBVIOUS SIGNS OF STROKE. POST PROCEDURE ANGIOGRAPHY SHOWED APPROX. 30% WASTING OF THE STENT. THE FILTER WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS COMPLETED AND THE PT WAS TAKEN TO THE INTENSIVE CARE IN STABLE CONDITION. THE PRODUCT IS NOT AVAILABLE FOR EVAL AND TESTING. ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOT THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9610978-2008-00151, 1016427-2008-00174 AND 9616099-2008-01552.

    Description of Event or Problem · 1

    UPON DEPLOYING THE STENT IN THE CAROTID ARTERY, THE PT EXPERIENCED A SLIGHT TRANSIENT DROP IN HER HEART RATE FROM THE 60'S TO THE HIGH FORTIES. ONE-HALF AN AMP OF ATROPINE WAS GIVEN AT THAT POINT. DURING POST-DILATION, THE PT HAD AN EPISODE OF SEVERE BRADYCARDIA, MOMENTARY ASYSTOLE. HEART RATE DID RESUME TO THE 40'S AND AN ADD'L HALF AMP OF ATROPINE WAS GIVEN. THE PT IS A FEMALE WITH AN ASYMPTOMATIC HIGH-GRADE STENOSIS IN THE RIGHT INTERNAL CAROTID ARTERY (ICA). THE PHYSICIAN MADE ACCESS TO THE PT IN THE RIGHT COMMON FEMORAL ARTERY. AN ARCH AORTOGRAM WAS PERFORMED. FOLLOWING ANGIOGRAPHY, THE RIGHT CAROTID WAS ACCESSED WITH A H2 CATHETER AND A SHEATH WAS ADVANCED OVER THE H2 INTO THE RIGHT COMMON CAROTID ARTERY. A SELECTIVE CAROTID ANGIOGRAM DEMONSTRATED A 90% STENOSIS OF THE RIGHT ICA. THE PT WAS THEN HEPARINIZED WITH 5000 UNITS OF HEPARIN. AN ANGIOGUARD DISTAL PROTECTION DEVICE WAS THEN PASSED THROUGH THE SHEATH WITH SOME DIFFICULTY INTO THE RIGHT COMMON CAROTID. IT WAS NOTICED THAT THE DISTAL TIP OF THIS CATHETER WAS BENT AT 90 DEGREES AND COULD NOT BE USED IN THE PROCEDURE. THEREFORE, THIS DEVICE WAS REMOVED AND ANOTHER ANGIOGUARD WAS ADVANCED WITH SOME DIFFICULTY, BUT WAS ABLE TO BE PLACED AND DEPLOYED IN THE DISTAL RIGHT ICA. NEXT, PRE-DILATION WAS PERFORMED WITH A 4X4 AVIATOR BALLOON. FOLLOWING PRE-DILATION, A PRECISE STENT WAS PLACED IN THE LESION. UPON DEPLOYMENT, THE PT EXPERIENCED A SLIGHT TRANSIENT DROP IN HEART FROM THE 60'S TO HIGH 40'S, BUT THEN RECOVERED. ONE-HALF AN AMP OF ATROPINE WAS GIVEN AT THIS POINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISE RX NITINOL STENT SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 13198558

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| L| R 4X4 AVIATOR BALLOON| 6MM AVIATOR RX BALLOON