BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 3102856 · Received May 9, 2013

    Report

    Report Number
    9616099-2013-00279
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    January 8, 2006
    Report Date
    April 19, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "MAHADEVAN ET AL ENDOVASCULAR AORTIC COARCTION STENTING IN ADOLESCENTS AND ADULTS: ANGIOGRAPHIC AND HEMODYNAMIC OUTCOMES; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS" 67:268-275 (2006) REPORTED THAT A PATIENT WITH RECOARCTATION EXPERIENCED AORTIC RUPTURE FOLLOWING POST-DILATION OF A PALMAZ STENT, ANOTHER PATIENT HAD A PALMAZ STENT DISLODGE DURING IMPLANTATION, AND A THIRD PATIENT WITH A PALMAZ STENT DEVELOPED AN ANEURYSM OF THE STENTED SEGMENT OF THE AORTA. THE FIRST PATIENT, TREATED FOR RECOARCTATION, EXPERIENCED AN AORTIC RUPTURE FOLLOWING POST DILATATION OF A STENT WITH THE SAME BALLOON USED FOR STENT DEPLOYMENT. THE AORTIC LEAK WAS COVERED RAPIDLY USING A COVERED CPNUMED STENT AND HE REQUIRED EVACUATION OF A LEFT HAEMOTHORAX BY THE THORACIC SURGEONS. THIS PATIENT MADE A FULL CLINICAL RECOVERY AND HAS CONTINUED TO REMAIN WELL. IN A SECOND PATIENT, A PALMAZ DISLODGED INTO THE AORTA DURING IMPLANTATION AND WAS DEPLOYED SAFELY. ANOTHER STENT WAS USED TO TREAT THE AORTIC COARCTATION. THE THIRD PATIENT DEVELOPED AN ANEURYSM LOCATED WITHIN THE STENTED AORTIC SEGMENT. THE ANEURYSM WAS LESS THAN 5MM IN MAXIMUM DIAMETER. THERE WERE NO REPORTED DEATHS INVOLVING A PALMAZ STENT. NO FURTHER DETAILS ARE AVAILABLE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOST HISTORY COULD NOT BE PERFORMED AS THE LOT NUMBER WAS NOT PROVIDED. THE REPORTS NOTED DURING REVIEW OF THIS ARTICLE COULD NOT BE CONFIRMED AS THE PALMAZ STENTS WERE IMPLANTED IN THE PATIENTS AND, THEREFORE, WERE NOT RETURNED FOR ANALYSIS. WITHOUT FURTHER DETAILS IN REGARD TO VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS FOR EACH PATIENT, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN EACH DEVICE AND THE ASSOCIATED EVENT. IN REGARD TO ANEURYSMS, WHILE THE EXACT CAUSE IS UNKNOWN, FACTORS SUCH AS ATHEROSCLEROSIS, INFLAMMATORY CONDITIONS, INFECTION AND VESSEL INJURY MAY CONTRIBUTE TO THE DEVELOPMENT OF THIS CONDITION. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. PLEASE NOTE THAT THIS MEDWATCH REPORT REPRESENTS ONE OF THREE PRODUCTS INVOLVED WITH THIS EVENT WHICH IS ASSOCIATED WITH MFG. REPORT # 9616099-2013-00279, 9616099-2013-00280 AND 9616099-2013-00281.

    Description of Event or Problem · 1

    MAHADEVAN ET AL ENDOVASCULAR AORTIC COARCTION STENTING IN ADOLESCENTS AND ADULTS: ANGIOGRAPHIC AND HEMODYNAMIC OUTCOMES; CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 67:268-275 (2006); REPORT AN AORTIC RUPTURE FOLLOWING POST-DILATION OF A PALMAZ STENT, EMBOLIZATION OF A PALMAZ 4014 STENT IN ANOTHER PATIENT, ONE PATIENT WITH A PALMAZTM STENT DEVELOPED AN ANEURYSM AND RESTENOSIS OF STENTED SEGMENT OF THE AORTA AND THERE WERE SEVEN CASES OF RESTENOSIS WITH THE PALMAZ STENT. THERE WERE NO DEATHS REPORTED. THERE WAS AORTIC RUPTURE IN A PATIENT WITH RECOARCTATION FOLLOWING POST DILATATION OF A P4014TM STENT WITH THE SAME BALLOON USED FOR STENTING. THE AORTIC LEAK WAS COVERED RAPIDLY USING A COVERED CPNUMEDTM STENT AND HE REQUIRED EVACUATION OF A LEFT HAEMOTHORAX BY THE THORACIC SURGEONS. THIS PATIENT MADE A FULL CLINICAL RECOVERY AND HAS CONTINUED TO REMAIN WELL. IN ONE PATIENT A PALMAZ 4014 SLIPPED INTO THE AORTA AND WAS DEPLOYED SAFELY THERE AND A FURTHER STENT WAS USED TO TREAT THE AORTIC COARCTION (COA). TWO OF THE PATIENTS WITH ANEURYSMS HAD A CPTM STENT AND ONE HAD A PALMAZTM STENT IMPLANTED. IN ALL CASES THE ANEURYSMS WERE LOCATED WITHIN THE STENTED AORTIC SEGMENT, TWO OF THEM AT THE SITE OF COARCTATION AND ONE OF THEM AT THE DISTAL END OF THE STENT. ALL ANEURYSMS WERE LESS THAN 5 MM IN MAXIMUM DIAMETER. ONE PATIENT HAD AN ANEURYSMAL COLLATERAL VESSEL ARISING FROM THE STENTED SEGMENT, PRIOR TO THE INTERVENTION PROCEDURE AND THIS REMAINED UNCHANGED ON FOLLOW UP ANGIOGRAPHY. SPECIFIC DETAILS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203350 PALMAZ STENT UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R