BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN PALMAZ STENT

    MDR report key: 11736728 · Received April 28, 2021

    Report

    Report Number
    9616099-2021-04474
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    February 20, 1996
    Report Date
    April 28, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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: MENDELSOHN, A. M., DOROSTKAR, P. C., MOOREHEAD, C. P., LUPINETTI, F. M., REYNOLDS, P. I., LUDOMIRSKY, A., ¿ BEEKMAN, R. H. (1996). STENT REDILATION IN CANINE MODELS OF CONGENITAL HEART DISEASE: PULMONARY ARTERY STENOSIS AND COARCTATION OF THE AORTA. CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS, 38(4), 430¿440. HTTPS://DOI.ORG/10.1002/(SICI)1097-0304(199608)38:4<430::AID-CCD24>3.0.CO;2-H. SPECIFIC PRODUCT DETAILS ARE NOT AVAILABLE. THE EXACT EVENT DATE IS UNKNOWN. THE PUBLICATION IS ATTACHED. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE ARTICLE, MENDELSOHN, A. M., DOROSTKAR, P. C., MOOREHEAD, C. P., LUPINETTI, F. M., REYNOLDS, P. I., LUDOMIRSKY, A., LLOYD, T. R., HEIDELBERGER, K., & BEEKMAN, R. H., 3RD (1996). STENT REDILATION IN CANINE MODELS OF CONGENITAL HEART DISEASE: PULMONARY ARTERY STENOSIS AND COARCTATION OF THE AORTA. CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS, 38(4), 430¿440. HTTPS://DOI.ORG/10.1002/(SICI)1097-0304(199608)38:4<430::AID-CCD24>3.0.CO;2-H, IN ONE OF THE EXPERIMENTAL ANIMALS, THE STENT PROTRUDED INTO THE MAIN PULMONARY ARTERY AND COULD NOT CROSS TO THE INTENDED LOCATION. THE NON-CORDIS BALLOON WAS INFLATED TO 4-7ATM. 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 INACCURATE PLACEMENT¿ AND ¿STENT DELIVERY SYSTEM (SDS) FAILURE TO CROSS¿ 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. DEPLOYING A STENT PRIOR TO SUCCESSFULLY CROSSING THE TARGET LESION IS NOT STANDARD PRACTICE AND IS LIKELY TO RESULT IN INACCURATE PLACEMENT AND DAMAGE TO OTHERWISE HEALTHY INTIMA. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿TO ASSURE FULL EXPANSION, INFLATE TO AT LEAST THE NOMINAL PRESSURE RECOMMENDED ON THE CATHETER LABEL. INSPECT THE CRIMPED STENT FOR ADHERENCE TO THE BALLOON AND CENTERED PLACEMENT IN RELATION TO THE BALLOON MARKER BANDS. DO NOT REPOSITION THE STENT OR HAND CRIMP. CAUTION: IF STRONG RESISTANCE IS MET DURING ADVANCEMENT OR WITHDRAWAL OF THE CATHETER, DISCONTINUE MOVEMENT AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING.¿ 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, MENDELSOHN, A. M., DOROSTKAR, P. C., MOOREHEAD, C. P., LUPINETTI, F. M., REYNOLDS, P. I., LUDOMIRSKY, A., LLOYD, T. R., HEIDELBERGER, K., & BEEKMAN, R. H., 3RD (1996). STENT REDILATION IN CANINE MODELS OF CONGENITAL HEART DISEASE: PULMONARY ARTERY STENOSIS AND COARCTATION OF THE AORTA. CATHETERIZATION AND CARDIOVASCULAR DIAGNOSIS, 38(4), 430¿440. HTTPS://DOI.ORG/10.1002/(SICI)1097-0304(199608)38:4<430::AID-CCD24>3.0.CO;2-H, IN ONE OF THE EXPERIMENTAL ANIMALS, THE STENT PROTRUDED INTO THE MAIN PULMONARY ARTERY AND COULD NOT CROSS TO THE INTENDED LOCATION. THE NON-CORDIS BALLOON WAS INFLATED TO 4-7ATM. THE DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635803 UNKNOWN PALMAZ STENT CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CORPORATION PXXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 7F BERMAN ANGIOGRAPHIC CATHETER| COOK 10FR 80-100CM SHEATH| NUMED BALLOON CATHETER| UNKNOWN 0.035¿ GUIDEWIRE| UNKNOWN 7F SHEATH