BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISE PRO RX CAROTID STENT SYSTEM

    MDR report key: 2892220 · Received January 2, 2013

    Report

    Report Number
    9616099-2013-00002
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 7, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIM
    PMA / PMN Number
    P030047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORAMTION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS PATIENT UNDERWENT CAROTID ARTERY REVASCULARIZATION AND DURING THE PROCEDURE THERE WAS WITHDRAWAL DIFFICULTY OF THE SDS. CAS: THE TARGET LESION WAS INTERNAL CAROTID ARTERY (ICA). THE PATIENT'S AGE WAS UNKNOWN AND THERE WAS HEAVY CALCIFICATION AND NO TORTUOSITY. THE RATE OF STENOSIS WAS UNKNOWN. APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. THE TARGET LESION WAS PRE-DILATED WITH THE UNKNOWN BALLOON CATHETER. THE PRECISE PRO RX STENT (CATALOG #PC1040RXC, LOT#15700468, COMPLAINT PRODUCT) WAS PLACED AT THE LESION AND THE STENT DEPLOYED. AND THEN THE PHYSICIAN ATTEMPTED TO WITHDRAW THE SDS. HOWEVER, THERE WAS A DIFFICULTY. IT WAS CONFIRMED THAT THE DISTAL TIP OF SDS HAD LODGED IN THE STENT. DURING THE ATTEMPTS TO RELEASE THE DISTAL TIP, AN ADDITIONAL ATRIAL ACCESS STICK WAS MADE WITH NON-CORDIS SHEATH INTRODUCER (PRODUCT UNKNOWN) FROM THE LEFT FEMORAL ARTERY/LEFT COMMON ILIAC ARTERY. THE DISTAL TIP WAS FINALLY RELEASED BY ROTATING THE PATIENT'S NECK AND PULLING THE SDS. THE SDS WAS REMOVED INTACT FROM THE PATIENT. AFTER THAT, HEMOSTASIS OF BOTH RIGHT AND LEFT PUNCTURE SITES WAS PERFORMED WITH THE ANGIOSEALS (ST. JUDE MEDICAL). HOWEVER, DURING THE HEMOSTASIS PROCEDURE, THE ANGIOGRAM REVEALED THE BLEEDING FROM THE LEFT COMMON ILIAC ARTERY (CIA). HEMOSTASIS WAS ATTEMPTED BY OBSTRUCTING THE LEFT CIA WITH COILS (PRODUCT UNKNOWN). DURING THAT TIME, THE PATIENT DEVELOPED HEMORRHAGIC SHOCK AND EXPIRED. THE PHYSICIAN'S COMMENT: IT WAS NON-CORDIS SHEATH INTRODUCER THAT CAUSED THE VESSEL PERFORATION OF LEFT CIA. THERE WAS NO RELATIONSHIP BETWEEN THE COMPLAINT PRODUCT AND THE VESSEL PERFORATION. REGARDING THE WITHDRAWAL DIFFICULTY, THE PRE-DILATATION OF THE LESION MIGHT BE INSUFFICIENT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15700468 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINT COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY AND THE DHR REVIEW CONFIRMED THAT THE PRODUCT MET SPECIFICATIONS. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE. HOWEVER, THERE ARE POSSIBLE VESSEL CHARACTERISTICS, SPECIFICALLY THE HEAVY CALCIFICATION THAT MAY HAVE CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A PROCEDURE, APPROACH WAS MADE FROM THE RIGHT FEMORAL ARTERY. THE INTERNAL CAROTID ARTERY (TARGET LESION) WAS PRE-DILATED WITH AN UNKNOWN BALLOON CATHETER. THE PROCEDURE WAS CAS USING THE PRECISE STENT AND NON-CORDIS EMBOLIC PROTECTION DEVICE (FILTERWIRE EZ). A PRECISE PRO RX STENT WAS PLACED AT THE LESION AND THE SDS WAS BEING RETRIEVED, HOWEVER, DIFFICULTY OF WITHDRAW WAS EXPERIENCED. IT WAS CONFIRMED THAT THE DISTAL TIP OF SDS LODGED TO THE STENT. DURING AN ATTEMPT TO RELEASE THE DISTAL TIP, AN ADDITIONAL STICK WAS MADE WITH A NON-CORDIS SHEATH INTRODUCER (PRODUCT UNKNOWN) FROM THE LEFT FEMORAL ARTERY. AT THIS POINT, THE DISTAL TIP WAS FINALLY RELEASED BY ROTATING THE PATIENT'S NECK AND PULLING THE SDS. THE SDS WAS REMOVED INTACT FROM THE PATIENT. HEMOSTASIS OF BOTH RIGHT AND LEFT PUNCTURE SITES WAS PERFORMED WITH THE ANGIOSEALS (ST. JUDE MEDICAL). IT WAS REPORTED VESSEL PERFORATION OCCURRED IN LEFT CIA AND WAS TREATED FIRST BY BALLOONING AND STENT (WALL STENT, BOSTON SCIENTIFIC) PLACEMENT. IN SPITE OF THIS, HEMOSTASIS COULD NOT BE ACHIEVED AS PER ANGIOGRAM. THEN, COIL EMBOLIZATION OF CIA WAS PERFORMED AND HEMOSTASIS WAS ACHIEVED. HOWEVER, REBLEEDING FROM CIA OCCURRED LATER AT NIGHT, WHICH BROUGHT ABOUT DEATH DUE TO HEMORRHAGIC SHOCK TO THE PATIENT. IT WAS NOTED THAT THE TARGET LESION WAS HEAVILY CALCIFIED AND NO TORTUOSITY. THE PERCENTAGE OF STENOSIS IS UNKNOWN. PER THE PHYSICIAN'S COMMENTS, IT WAS NON-CORDIS SHEATH INTRODUCER THAT CAUSED THE VESSEL PERFORATION OF LEFT CIA. THERE WAS NO RELATIONSHIP BETWEEN THE PRECISE PRO RX DEVICE AND THE VESSEL PERFORATION. THE FILTER BASKET WAS NOT SUCTIONED PRIOR TO BEING WITHDRAWN INTO THE CAPTURE SHEATH. THERE IS NO INFORMATION OF ANY DEBRIS IN THE FILTER BASKET AFTER REMOVAL. NO NEUROLOGICAL DEFICIT OCCURRED TO THE PATIENT AFTER THE FILTER BASKET WAS REMOVED. IT WAS NOTED THAT WITHDRAWAL DIFFICULTY MIGHT HAVE BEEN DUE TO INSUFFICIENT PRE-DILATATION OF THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298 PRECISE PRO RX CAROTID STENT SYSTEM SELF EXPANDING STENTS (NIM) NIM CORDIS DE MEXICO NA 15700468

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R