BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS OPTA PRO

    MDR report key: 1951871 · Received January 7, 2011

    Report

    Report Number
    9610978-2011-00005
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INTERVENTIONAL PROCEDURE, THE PALMAZ GENESIS STENT WAS DISLODGED FROM THE SDS WHILE IN THE PATIENT. THIS IS A (B)(6) OLD MALE WITH UNKNOWN MEDICAL HISTORY. A 7.0 X 24MM PALMAZ GENESIS STENT ON OPTA PRO SDS DISLODGED FROM THE BALLOON PRIOR TO ATTEMPTING TO CROSS THE DISTAL COMMON FEMORAL ARTERY LESION. ACCESS WAS VIA THE IPSILATERAL BRACHIAL ARTERY. THE VESSEL WAS NOT TORTUOUS AND THE LESION WAS 99% STENOSED, 24MM IN LENGTH, AND WAS NOT CALCIFIED. THE DEVICE WAS DELIVERED VIA A 6F SHEATH, BUT THE SDS HAD NOT BEEN PULLED BACK INTO THE GUIDE CATHETER AT THE TIME OF THE DISLODGEMENT. IT WAS UNKNOWN IF NEGATIVE PRESSURE HAD BEEN APPLIED TO THE DEVICE. AN ATTEMPT WAS MADE TO CAPTURE THE STENT WITH ANOTHER BALLOON, BUT IT COULD NOT BE SNARED THROUGH THE SHEATH AND THE MIDDLE OF THE STENT BECAME KINKED WHILE TRYING TO RETRIEVE IT. IT WAS FINALLY SNARED THROUGH AN 8F SHEATH INTRODUCER THROUGH THE LEFT BRACHIAL ARTERY. SINCE IT TOOK APPROXIMATELY THREE HOURS TO RETRIEVE THE STENT, THE PATIENT WAS RESCHEDULED FOR ANOTHER ANGIOPLASTY. THERE WAS NO INJURY TO THE PATIENT. A NON STERILE STENT FROM A PALMAZ GENESIS ON OPTA PRO 7MMX24MM, 135 CM WAS RECEIVED INSIDE A BAG. NO BALLOON/CATHETER DEVICE WAS INCLUDED WITH THE RETURNED STENT. THE STENT PRESENTS DAMAGE, IT WAS RECEIVED TOTALLY BENT AND CRUSHED. THE STENT DOES NOT PRESENT EVIDENCE THAT IT WAS EXPANDED. NO OTHER ANOMALY WAS OBSERVED IN THE RETURNED UNIT. AS PART OF THE INVESTIGATION OF THE RECENT COMPLAINT RECEIVED FOR STENT DISLODGED FOR THE PG ON OPTA PRO, IT WAS REVIEWED REGARDING WHAT CONTROLS ARE IN PLACE. AND AFTER A VISIT TO THE PG ON OPTA PRO PROCESS, IT WAS FOUND WHAT CONTROLS ARE IN PLACED IN ORDER TO DETECT ANY STENT ANOMALY BEFORE LEAVING THE FACILITY. REFER TO MANUFACTURING WORK (B)(4) REV 16 AND (B)(4) REV 9. 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. THE REPORTED STENT DISLODGED FAILURE WAS CONFIRMED. HOWEVER THE EXACT CAUSE COULD NOT BE DETERMINED; NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE REPORTED FAILURE REPORTED BY THE CUSTOMER IS RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN. THE COMPLAINT OF STENT DISLODGEMENT WAS CONFIRMED; HOWEVER, THE EXACT CAUSE OF THE FAILURE COULD NOT BE DETERMINED. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE CONFIRMED DISLODGEMENT. A NON STERILE STENT FROM A PALMAZ GENESIS ON OPTA PRO 7MMX24MM, 135 CM WAS RECEIVED INSIDE A BAG. NO BALLOON/CATHETER DEVICE WAS INCLUDED WITH THE RETURNED STENT. THE STENT PRESENTS DAMAGE, IT WAS RECEIVED TOTALLY BENT AND CRUSHED. THE STENT DOES NOT PRESENT EVIDENCE THAT IT WAS EXPANDED. NO OTHER ANOMALY WAS OBSERVED IN THE RETURNED UNIT. AS PART OF THE INVESTIGATION OF THE RECENT COMPLAINT RECEIVED FOR STENT DISLODGED FOR THE PG ON OPTA PRO, IT WAS REVIEWED REGARDING WHAT CONTROLS ARE IN PLACE. AND AFTER A VISIT TO THE PG ON OPTA PRO PROCESS, IT WAS FOUND WHAT CONTROLS ARE IN PLACED IN ORDER TO DETECT ANY STENT ANOMALY BEFORE LEAVING THE FACILITY. REFER TO MANUFACTURING WORK (B)(4) REV 16 AND (B)(4) REV 9. 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. THE REPORTED STENT DISLODGED FAILURE WAS CONFIRMED. HOWEVER, THE EXACT CAUSE COULD NOT BE DETERMINED; NEITHER THE DHR REVIEW NOR THE ANALYSIS SUGGESTS THAT THE REPORTED FAILURE REPORTED BY THE CUSTOMER IS RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE STENT WAS RETURNED FOR ANALYSIS; HOWEVER, THE ANALYSIS HAS NOT YET BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A 7.0 X 24MM PALMAZ GENESIS OPTA PRO STENT DISLODGED FROM THE BALLOON PRIOR TO ATTEMPTING TO CROSS THE DISTAL COMMON FEMORAL ARTERY LESION. ACCESS WAS VIA THE IPSILATERAL BRACHIAL ARTERY. THE VESSEL WAS NOT TORTUOUS AND THE LESION WAS 99% STENOSED, 24MM IN LENGTH, AND WAS NOT CALCIFIED. THE DEVICE WAS DELIVERED VIA A 6F SHEATH, BUT THE SDS HAD NOT BEEN PULLED BACK INTO THE GUIDE CATHETER AT THE TIME OF THE DISLODGEMENT. IT WAS UNKNOWN IF NEGATIVE PRESSURE HAD BEEN APPLIED TO THE DEVICE. AN ATTEMPT WAS MADE TO CAPTURE THE STENT WITH ANOTHER BALLOON, BUT IT COULD NOT BE SNARED THROUGH THE SHEATH AND THE MIDDLE OF THE STENT BECAME KINKED WHILE TRYING TO RETRIEVE IT. IT WAS FINALLY SNARED THROUGH AN 8F SHEATH INTRODUCER THROUGH THE LEFT BRACHIAL ARTERY. THERE WAS NO INJURY TO THE PATIENT. SINCE IT TOOK APPROXIMATELY THREE HOURS TO RETRIEVE THE STENT, THE PATIENT WAS RESCHEDULED FOR ANOTHER ANGIOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS OPTA PRO ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA 15218634

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention 6F SHEATH