BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 3109655 · Received May 13, 2013

    Report

    Report Number
    9616099-2013-00292
    Event Type
    Injury
    Date Received
    May 13, 2013
    Date of Event
    April 1, 2004
    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

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. IN-STENT RESTENOSIS (ISR) IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS, IT IS NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ARTERIAL DISEASE. WILLIAMS SYNDROME IS A CONTIGUOUS GENE SYNDROME CAUSED BY A DELETION OF MULTIPLE GENES ON THE LONG ARM OF CHROMOSOME 7. ARTERIOPATHY IS CAUSED BY DEFICIENCY OF ELASTIN, AND AFFECTS BOTH SMALL AND LARGE. VESSEL OCCLUSION, RESTENOSIS, INTIMAL HYPERPLASIA OR RECURRENT STRICTURES ARE WELL KNOWN DOCUMENTED POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. 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.

    Description of Event or Problem · 1

    MOOKERJEE ET AL RESTENOSIS AFTER AORTIC STENTING; CARDIOLOGY IN THE YOUNG / VOLUME 14 / ISSUE 02 / APRIL 2004, PP 210-211; PRESENT AN ADOLESCENT WITH WILLIAMS' SYNDROME WHO DEVELOPED RAPID RESTENOSIS AFTER PRIMARY STENTING OF COARCTATION OF THE AORTA. THE PATIENT IS A (B)(6) MALE WHO HAS WILLIAMS SYNDROME WITH MILD SUPRAVALVAR AORTIC STENOSIS AND HAS BEEN FOLLOWED SINCE INFANCY. HE WAS NOTED TO BE HYPERTENSIVE WHEN HE WAS ADMITTED TO HIS LOCAL HOSPITAL WITH MENINGOCOCCAL MENINGITIS AT THE AGE OF (B)(6). FURTHER INVESTIGATIONS WERE PERFORMED DURING FOLLOW-UP, AND SHOWED WIDESPREAD ARTERIOPATHY. AN ECHOCARDIOGRAM, AND SUBSEQUENT ANGIOGRAPHY, REVEALED COARCTATION OF THORACIC AORTA DISTAL TO ORIGIN OF LEFT SUBCLAVIAN ARTERY. HE ALSO HAD BILATERAL INTRARENAL VASCULAR DISEASE, GENERALISED MILD CEREBROVASCULAR DISEASE. PRIMARY STENTING OF THE AREA OF COARCTATION WAS PERFORMED IN 2001 USING A CORDIS PALMAZ P308 STENT PREMOUNTED ON AN 8MM BALLOON, AND DILATED TO 10 MM WITH A CORDIS POWER FLEX PLUS BALLOON. ANGIOGRAPHY WAS REPEATED AFTER 18 MONTHS BECAUSE OF PERSISTENT HYPERTENSION. THERE WAS RESTENOSIS WITHIN THE STENT, WITH A GRADIENT MEASURED OF 32MMHG. THE DESCENDING AORTA WAS ALSO MILDLY HYPOPLASTIC. INTERVENTION WAS THOUGHT TO BE UNNECESSARY AT THIS STAGE, AND THE PATIENT IS BEING FOLLOWED UP CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    210501 PALMAZ STENT UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R