BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 4965803 · Received August 4, 2015

    Report

    Report Number
    1016427-2015-00040
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    June 20, 2014
    Report Date
    July 14, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MAF
    PMA / PMN Number
    P900043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: PLAVIX 75MG ONCE A DAY, METFORMIN "SUGAR PILL" 500MG/TWICE A DAY, METOPROLOL "HEART PILL" 50MG/TWICE A DAY, AMLODIPINE 5 MG/ONCE A DAY, FENOFIBRIC UNKNOWN 135MG/ONCE A DAY, LOW DOSE ASPIRIN HEART-/ONCE DAILY THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2015-00342 AND # 1016427-2015-00040.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE PATIENT¿S SPOUSE THROUGH THE MEDICAL AFFAIRS DEPARTMENT, THE PATIENT HAD TWO (2 EACH) PALMAZ SCHATZ STENTS IMPLANTED DURING THE INDEX PROCEDURE AFTER PRESENTING WITH PAIN IN THE CHEST AND ARM NUMBNESS, WHICH WAS DIAGNOSED AS A HEART ATTACK. THE STENTS IMPLANTED WERE: A 3.0 X 15 AND A 4.0 X 15. THE TARGET LESION WAS UNKNOWN. APPROXIMATELY SEVENTEEN AND ONE-HALF YEARS AFTER THE INDEX PROCEDURE DURING A PRE-OP CHECK FOR TREATMENT OF AN AORTIC ANEURYSM, THE PATIENT WAS FOUND TO HAVE TWO BLOCKAGES. THE BLOCKAGES WERE TREATED BY IMPLANTATION OF TWO NON-CORDIS STENTS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL. THE DEVICES REMAIN IMPLANTED AND ARE NOT AVAILABLE FOR INSPECTION. (B)(4): LOT # 117303 PROVIDED IN THE COMPLAINT WAS NOT RECOGNIZED BY NORMAN NOBLE, INC. (NNI) AND THE ANALYST, THEREFORE NO DHR REVIEW COULD BE PERFORMED. WITHOUT THE RETURN OF THE ACTUAL COMPLAINT PRODUCT THE EVENT REPORTED BY THE CUSTOMER CANNOT BE CONFIRMED, NOR CAN ANY CONCLUSION REGARDING ROOT CAUSE BE DRAWN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CORONARY ARTERY DISEASE. BASED ON THE MINIMAL AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2015-00342 AND # 1016427-2015-00040.

    Description of Event or Problem · 1

    AS REPORTED BY THE PATIENT¿S SPOUSE THROUGH THE MEDICAL AFFAIRS DEPARTMENT, THE PATIENT HAD TWO (2 EACH) PALMAZ SCHATZ STENTS IMPLANTED DURING THE INDEX PROCEDURE AFTER PRESENTING WITH PAIN IN THE CHEST AND ARM NUMBNESS, WHICH WAS DIAGNOSED AS A HEART ATTACK. THE STENTS IMPLANTED WERE: A 3.0 X 15 AND A 4.0 X 15. THE TARGET LESION WAS UNKNOWN. APPROXIMATELY SEVENTEEN AND ONE-HALF YEARS AFTER THE INDEX PROCEDURE DURING A PRE-OP CHECK FOR TREATMENT OF AN AORTIC ANEURYSM, THE PATIENT WAS FOUND TO HAVE TWO BLOCKAGES. THE BLOCKAGES WERE TREATED BY IMPLANTATION OF TWO NON-CORDIS STENTS. MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508424 PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM CORONARY SDS/STENTS (MAF) MAF CORDIS CORPORATION 117303

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R