BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 2111637 · Received June 2, 2011

    Report

    Report Number
    9616099-2011-00377
    Event Type
    Injury
    Date Received
    June 2, 2011
    Date of Event
    April 1, 2010
    Report Date
    April 1, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    PMA / PMN Number
    P900043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE CATALOG NUMBER IS UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: HYOMAX 0.735MG, ASPIRIN 325MG ((B)(6) 2010), ENALAPRIL 40MG, ACTOS 30MG, METOPROLOL 100MG, ZETIA 10MG, LIPITOR 40MG, METFORMIN 1000MG, NORVASC 5MG, HYDROCHLORTHIAZIDE 25MG, PLAVIX 150MG ((B)(6) 2010), PLAVIX 75MG ((B)(6) 2010) ASPIRIN 325MG START DATE: (B)(6) 2011, ONGOING AND METFORMIN 750MG START DATE: (B)(6) 2010, ONGOING. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15112637 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. THIS IS ONE OF THREE PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2011-00210, 9616099-2011-00376 AND 9616099-2011-00377.

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT WITH MULTIPLE PRIOR PERCUTANEOUS INTERVENTIONS EXPERIENCED RESTENOSIS AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, ISCHEMIA, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, DIABETES AND AN UNKNOWN ALLERGY. THE PATIENT HAS HAD SEVEN INTERVENTION PERFORMED BETWEEN 1993- 2011, WITH A TOTAL OF NINE CATHETERIZATIONS. THE FIRST CARDIAC CATHETERIZATION IN 1993 REVEALED A 70% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD), 90% STENOSIS IN THE 2ND OBTUSE MARGINAL (OM), 90% STENOSIS IN THE POSTERIOR DESCENDING ARTERY (PDA), 70% STENOSIS IN OM1 AND 90% STENOSIS ON THE RIGHT PDA. THE PATIENT HAD SUCCESSFUL ANGIOPLASTY PERFORMED THE FOLLOWING DAY TO THE PDA AND OM2. IN 1997, THE PATIENT RECEIVED TWO PALMAZ SCHATZ STENTS TO THE MID RIGHT CORONARY ARTERY (RCA). IN 2000 THE PATIENT RECEIVED A 3.0MM X 18MM VELOCITY TO AN 80% MID LAD LESION. IN 2001, ANGINA INSPIRED ANGIOGRAPHY REVEALED 30% PROXIMAL RCA STENOSIS, 30% RPDA STENOSIS, AND 80% MID LAD RESTENOSIS. THE RESTENOSIS OF THE VELOCITY WAS TREATED WITH BALLOON ANGIOPLASTY. IN 2010 ENROLLMENT INTO THE STUDY, THE PATIENT HAD A 3.5MM X 18MM CYPHER STENT IMPLANTED IN THE PROXIMAL RCA AND A PROMUS STENT IMPLANTED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY (CFX). THE RCA WAS DESCRIBED AS DE NOVO, 14MM LONG 80% STENOSED AND MILDLY CALCIFIED. THE LESION WAS PRE-DILATED FOLLOWED BY THE IMPLANT OF A 3.5MM X 18MM CYPHER STENTS AT 20 ATMS. THE STENT WAS NOT POST-DILATED AND THE REPORTED RESIDUAL STENOSIS WAS 0%. APPROXIMATELY TEN MONTHS LATER, DUE TO EXERTIONAL ANGINA, ANGIOGRAPHY WAS PERFORMED AND REVEALED RESTENOSIS IN THE PROXIMAL RCA THAT WAS TREATED WITH THE IMPLANT OF A 3.0MM X 18MM XIENCE STENT. BECAUSE IT IS OUR INTENT TO REPORT CONSERVATIVELY AND THE PROXIMITY OF THE PALMAZ STENTS TO THE PROXIMAL RCA LESION AND STENT IS UNKNOWN, RESTENOSIS WILL BE CAPTURED ON THOSE STENTS ALSO. THE STERILE LOT NUMBERS FOR THE PALMAZ SCHATZ STENT IS UNKNOWN AT THIS TIME; THEREFORE, A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED ON THIS DEVICE. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND THE PROGRESSION OF CORONARY ARTERY DISEASE. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THE PATIENT'S EXTENSIVE HISTORY OF CORONARY ARTERY DISEASE IN CONJUNCTION WITH FAMILY HISTORY, HYPERTENSION AND DIABETES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN. THIS IS ONE OF FOUR PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2011-00210, 9616099-2011-00376, 9616099-2011-00377. CONCOMITANT MEDICAL PRODUCTS: HYOMAX 0.735MG, ASPIRIN 325MG ((B)(6) 2010), ENALAPRIL 40MG, ACTOS 30MG, METOPROLOL 100MG, ZETIA 10MG, LIPITOR 40MG, METFORMIN 1000MG, NORVASC 5MG, HYDROCHLORTHIAZIDE 25MG, PLAVIX 150MG ((B)(6) 2010) AND PLAVIX 75MG ((B)(6) 2010). THE DHR FOR THE CYPHER STENT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THIS IS ONE OF FOUR PRODUCTS USED IN THE SAME PATIENT AND REPORTED UNDER MANUFACTURING REPORT NUMBERS 3003742446-2011-00210, 9616099-2011-00376, 9616099-2011-00377 AND 1016427-2011-00044.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT APPROXIMATELY 12 YEARS PRIOR TO THE INDEX PROCEDURE, THE PATIENT HAD TWO PALMAZ SCHATZ STENTS IMPLANTED IN THE MID RIGHT CORONARY ARTERY (RCA). DURING INDEX PROCEDURE, THE PATIENT WAS TREATED WITH AN 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS DE NOVO, TYPE B1, 14MM LONG, WITH MILD CALCIFICATION AND NO VESSEL TORTUOSITY. THE LESION WAS PRE-DILATED WITH A 3.0 X 15MM BALLOON AT 20ATM WITH A NON-CORDIS BALLOON. A 3.5 X 18MM CYPHER STENT WAS DEPLOYED AT 20ATM SUCCESSFULLY. THERE WERE NO ANGIOGRAPHIC COMPLICATIONS OR PRODUCT MALFUNCTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ-SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM ENDOVASCULAR SDS/STENTS MAF CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R ASPIRIN 81MG