BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKPALMAZCORONARY

    MDR report key: 11717446 · Received April 23, 2021

    Report

    Report Number
    9616099-2021-04460
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    February 8, 1995
    Report Date
    April 23, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: 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. SPECIFIC PRODUCT DETAILS ARE NOT AVAILABLE. THE EXACT EVENT DATE IS UNKNOWN. THE PUBLICATION IS ATTACHED. COMPLAINT CONCLUSION: 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 RESTENOSIS. INITIAL REDILATION DID NOT RELIEVE THE SEVERE RESTENOSIS. THE PATIENT UNDERWENT A REPEAT CATHERIZATION 26 MONTHS LATER AND REQUIRED PLACEMENT OF A STENT INSIDE THE INITIAL STENT TO TREAT THE RESTENOSIS. 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 RESTENOSIS¿ 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. ACCORDING TO THE PRECAUTIONS IN THE SAFETY INFORMATION PROVIDED IN THE INSTRUCTIONS FOR USE ¿SUBSEQUENT STENT BLOCKAGE MAY REQUIRE REPEAT DILATATION OF THE ARTERIAL SEGMENT CONTAINING THE STENT. THE LONG-TERM OUTCOME FOLLOWING REPEAT DILATATION OF ENDOTHELIALIZED STENTS IS NOT WELL CHARACTERIZED.¿ 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. 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 RESTENOSIS. INITIAL REDILATION DID NOT RELIEVE THE SEVERE RESTENOSIS. THE PATIENT UNDERWENT A REPEAT CATHERIZATION 26 MONTHS LATER AND REQUIRED PLACEMENT OF A STENT INSIDE THE INITIAL STENT TO TREAT THE RESTENOSIS. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609582 UNKPALMAZCORONARY STENT, CORONARY MAF CORDIS CORPORATION UNKPALMAZCORONARY UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R