BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 4044483 · Received August 28, 2014

    Report

    Report Number
    9616099-2014-00548
    Event Type
    Injury
    Date Received
    August 28, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 6, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00548 AND 9616099-2014-00549. COMPLAINT CONCLUSION: AS RECEIVED FROM THE PUBLICATION BY MAMARY ET AL LATE STENT FRACTURE- A POTENTIAL ROLE OF LEFT VENTRICULAR DILATATION, J (B)(4) HEART ASSOCIATION 26(2014) 162-165, THIS CASE STUDY REPORTED ON A PATIENT WHO DEVELOPED A NEW LEFT BUNDLE BRANCH BLOCK (LBBB), ELEVATED TROPONINS AND LEFT VENTRICULAR (LV) DYSFUNCTION FIVE YEARS AFTER IMPLANTATION OF TWO CYPHER STENTS. ANGIOGRAPHY REVEALED TOTAL OCCLUSION OF THE STENTS AND MULTIPLE STENT FRACTURES. THE PATIENT REFUSED ANY FURTHER REVASCULARIZATION INTERVENTION AND WAS DISCHARGED HOME WITH MEDICAL THERAPY ALONE. THIS EVENT INVOLVED A (B)(6) MALE PATIENT WITH A PAST MEDICAL HISTORY OF ARTERIAL HYPERTENSION AND PREVIOUS ANGIOPLASTY AND STENTING WITH BARE METAL STENT OF HIS RAMUS WHO INITIALLY PRESENTED WITH UNSTABLE ANGINA. ANGIOGRAPHY REVEALED DIFFUSE DISEASE WITH MULTIPLE LESIONS IN THE PATIENT¿S PROXIMAL AND MID LEFT ANTERIOR DESCENDING (LAD). THE PATIENT WAS TREATED WITH THE IMPLANTATION OF THREE OVERLAPPING STENTS (A 2.75 X 33MM CYPHER STENT, A 2.75 X 33MM CYPHER STENT AND ONE 2.5 X 16MM TAXUS STENT). SUBSEQUENT YEARLY FOLLOW-UPS WERE UNEVENTFUL UNTIL FOUR YEARS AFTER THE IMPLANTATIONS. THIS OUTPATIENT EVALUATION NOTED THAT THE PATIENT HAD DEVELOPED A NEW LBBB, A MILD ELEVATION IN HIS TROPONIN-I LEVELS AND SEVERE LV DYSFUNCTION WITH AN EJECTION FRACTION OF 25%. THE PATIENT WAS ASYMPTOMATIC AT THIS TIME. ANGIOGRAPHY REVEALED TOTAL OCCLUSION OF THE PROXIMAL LAD WITH MULTIPLE STENT FRACTURES (TYPE V). THE FRACTURE WAS BEST VISUALIZED ON FLUOROSCOPY WITHOUT CONTRAST INJECTION. THESE VIEWS ARE REPORTED TO HAVE CLEARLY SHOWED AN ACQUIRED TRANSACTION AND A DISCRETE GAP IN THE STENT BODY. THE PATIENT REFUSED ANY FURTHER PERCUTANEOUS INTERVENTIONS OR ANY OTHER EVALUATIONS (SUCH AS IMPLANTABLE CARDIAC DEFIBRILLATOR/PACEMAKER). HE WAS DISCHARGED HOME ON MEDICAL THERAPY ALONE. THE TWO CYPHER STENTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR RETURN. REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED SINCE THE LOT NUMBERS WERE NOT PROVIDED. THE PRODUCT IFU INDICATES THAT THE CYPHER STENT IS INDICATED FOR USE IN DISCRETE, DE NOVO AND IN-STENT RESTENOTIC LESIONS OF = 30MM IN LENGTH. THE IFU FURTHER CAUTIONS THAT THE USE OF STENTS WITH DIFFERENT MATERIALS IN TANDEM WHERE OVERLAP OR CONTACT IS POSSIBLE SHOULD BE AVOIDED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THERE ARE VESSEL CHARACTERISTICS (LONG LESION WITH DIFFUSE DISEASE) AND PROCEDURAL FACTORS (IMPLANT OF MULTIPLE OVERLAPPING STENTS OF DIFFERENT MATERIALS) THAT MAY HAVE CONTRIBUTED TO THE REPORTED STENT FRACTURES, VESSEL OCCLUSION, LBBB AND ELEVATED TROPONIN LEVELS. WITHOUT THE RETURN OF THE DEVICES, THE REPORTED EVENTS COULD NOT BE CONFIRMED. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENTS COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE OR PREVENTATIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT; THEREFORE, IS IT NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: MAMARY ET AL (2014). LATE STENT FRACTURE- A POTENTIAL ROLE OF LEFT VENTRICULAR DILATATION. J SAUDI HEART ASSOCIATION 26, 162-165. THE CATALOG CODE PROVIDED (CYPHEROUS), REPRESENTS AN UNKNOWN OUS CYPHER STENT. THE CATALOG AND LOT NUMBERS FOR THE ACTUAL PRODUCT USED IN THE PROCEDURE ARE UNKNOWN. CONCOMITANT DEVICES: CYPHER 2.75X23 MM, CORDIS (B)(4) AND TAXUS 2.5X16 MM, TAXUS BOSTON SCIENTIFIC CORP.(B)(4). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED ADVERSE EVENT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2014-00548 AND 9616099-2014-00549.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY MAMARY ET AL LATE STENT FRACTURE- A POTENTIAL ROLE OF LEFT VENTRICULAR DILATATION, J SAUDI HEART ASSOCIATION 26(2014) 162-165; A (B)(6) MALE WITH HISTORY OF ARTERIAL HYPERTENSION AND PREVIOUS PERCUTANEOUS CORONARY INTERVENTION (PCI) ON RAMUS WITH BARE MEDICAL STENT IMPLANTATION PRESENTED TO OUR DEPARTMENT DUE TO UNSTABLE ANGINA. CORONARY ANGIOGRAPHY REVEALED DIFFUSE DISEASE WITH MULTIPLE LESIONS IN PROXIMAL AND MIDDLE SEGMENTS OF LEFT ANTERIOR DESCENDING ARTERY (LAD). PCI WAS PERFORMED WITH IMPLANTATION OF THREE OVERLAPPING DRUG-ELUTING STENTS (DES) ON PROXIMAL-TO-MIDDLE LAD, TWO CYPHER STENTS (2.75X33 MM & 2.75X23 MM AND A NON-CORDIS STENT). SUBSEQUENT, YEARLY FOLLOW-UP WAS UNEVENTFUL UNTIL THE FOURTH YEAR. AN OUTPATIENT EVALUATION AT THE FIFTH YEAR REVEALED NEW LEFT BUNDLE BRANCH BLOCK ASSOCIATED WITH MILD ELEVATION IN TROPONIN-I VALUE (TNI 0.053 UG/L) AND SEVERE LEFT VENTRICULAR DYSFUNCTION (EF 25%). AT THAT TIME, THE PATIENT WAS FREE OF SYMPTOMS. A NEW CORONARY ANGIOGRAPHY SHOWED TOTAL OCCLUSION OF PROXIMAL LAD WITH MULTIPLE STENT FRACTURE (TYPE V). THE FRACTURE WAS BEST VISIBLE IN FLUOROSCOPY WITHOUT CONTRAST INJECTION, CLEARLY SHOWING ACQUIRED TRANSECTION AND DISCRETE GAP IN THE STENT BODY (TYPE V). UNFORTUNATELY, THE PATIENT REFUSED ANY FURTHER INTERVENTION FOR REVASCULARIZATION OR ANY OTHER EVALUATION SUCH AS IMPLANTABLE CARDIOVERTER/ DEFIBRILLATOR. HE WAS THUS DISCHARGED ON MEDICAL THERAPY ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524599 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R