BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKPALMAZCORONARY

    MDR report key: 11814203 · Received May 12, 2021

    Report

    Report Number
    9616099-2021-04541
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    February 8, 1995
    Report Date
    May 12, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY ING, F. F., GRIFKA, R. G., NIHILL, M. R., & MULLINS, C. E. (1995). REPEAT DILATION OF INTRAVASCULAR STENTS IN CONGENITAL HEART DEFECTS. CIRCULATION, 92(4), 893¿897. HTTPS://DOI.ORG/10.1161/01.CIR.92.4.893, AFTER PLACEMENT OF AN UNKNOWN PALMAZ STENT, THE STENT DEVELOPED ADDITIONAL AREAS OF STENOSIS THAT WERE FOUND AT FOLLOW UP CATHETERIZATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿STENT STENOSIS¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. THE IMPLANTATION OF A STENT IS KNOWN TO PRECIPITATE NEOINTIMAL HYPERPLASIA. RESTENOSIS IS THE RECURRENCE OF STENOSIS, A NARROWING OF A BLOOD VESSEL, LEADING TO RESTRICTED BLOOD FLOW. RESTENOSIS USUALLY PERTAINS TO AN ARTERY OR OTHER LARGE BLOOD VESSEL THAT HAS BECOME NARROWED, RECEIVED TREATMENT TO CLEAR THE BLOCKAGE AND SUBSEQUENTLY BECOME RENARROWED. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PERIPHERAL ARTERY STENT IMPLANTATION MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: RESTENOSIS OF THE STENTED ARTERY.¿ THE USE OF PALMAZ STENTS IN THE PEDIATRIC PULMONARY SYSTEM IS NOT INDICATED IN THE LABELING AND AS SUCH IS CONSIDERED OFF LABEL USAGE. THE VERY LIMITED INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE BY ING, F. F., GRIFKA, R. G., NIHILL, M. R., & MULLINS, C. E. (1995). REPEAT DILATION OF INTRAVASCULAR STENTS IN CONGENITAL HEART DEFECTS. CIRCULATION, 92(4), 893¿897. HTTPS://DOI.ORG/10.1161/01.CIR.92.4.893, AFTER PLACEMENT OF AN UNKNOWN PALMAZ STENT, THE STENT DEVELOPED ADDITIONAL AREAS OF STENOSIS THAT WERE FOUND AT FOLLOW UP CATHETERIZATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708699 UNKPALMAZCORONARY STENT, CORONARY MAF CORDIS CORPORATION UNKPALMAZCORONARY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R