BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKPALMAZCORONARY

    MDR report key: 11736721 · Received April 28, 2021

    Report

    Report Number
    9616099-2021-04473
    Event Type
    Death
    Date Received
    April 28, 2021
    Date of Event
    February 20, 1996
    Report Date
    April 28, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    Adverse Event
    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 BY 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 PALMAZ STENT WAS EXTENDED INTO AN AREA OF POST STENOTIC DILATATION AND WAS NOT WELL-APPOSED TO THE AORTIC WALL. THE NON-CORDIS BALLOON WAS INFLATED TO 4-7ATM. STENT COULD NOT BE RE-DILATED. TO AVOID DISTORTION OF THE STENT AND DISRUPTION OF THE AORTA NO ATTEMPTS WERE MADE TO REMOVE THE ANGIOGRAPHIC CATHETER AND THE ANIMAL WAS SACRIFICED. 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 UNDEREXPANDED¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS COMPLICATED THIS PROCEDURE WITH THE PRESENCE OF A POST STENOTIC DILATATION AND WAS NOT WELL APPOSED TO THE ARTERY WALL. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. DURING A BRANCH PULMONARY ARTERY STENOSIS STENTING PROCEDURE, IT IS STANDARD PRACTICE TO INITIALLY PLACE A STENT THAT CAN BE FURTHER EXPANDED DUE TO SOMATIC GROWTH OVER TIME, THEREFORE THEY ARE USUALLY PLACED AND DELIBERATELY UNDEREXPANDED TO TAKE INTO ACCOUNT THE YOUNG AGE OF THE RECIPIENT AND THUS A SMALLER TARGET VESSEL AND TO ALLOW FOR THE FURTHER EXPANSIONS EXPECTED. 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 BY 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 PALMAZ STENT WAS EXTENDED INTO AN AREA OF POST STENOTIC DILATATION AND WAS NOT WELL-APPOSED TO THE AORTIC WALL. THE NON-CORDIS BALLOON WAS INFLATED TO 4-7ATM. STENT COULD NOT BE RE-DILATED. TO AVOID DISTORTION OF THE STENT AND DISRUPTION OF THE AORTA NO ATTEMPTS WERE MADE TO REMOVE THE ANGIOGRAPHIC CATHETER AND THE ANIMAL WAS SACRIFICED. THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635472 UNKPALMAZCORONARY STENT, CORONARY MAF CORDIS CORPORATION UNKPALMAZCORONARY UNK

    Patients

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