BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2140225 · Received June 25, 2011

    Report

    Report Number
    3003742446-2011-00332
    Event Type
    Injury
    Date Received
    June 25, 2011
    Date of Event
    May 14, 2010
    Report Date
    May 30, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE IT WAS CONFIRMED NO DISSECTION OCCURRED, THE EVENT DISSECTION WILL BE UNREPORTED AS THIS EVENT WILL NO LONGER BE DEEMED MDR REPORTABLE. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00331, 3003742446-2011-00332, AND 3003742446-2011-00333. 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 15104819 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00331, 3003742446-2011-00332, AND 3003742446-2011-00333. INFORMATION RECEIVED FROM (B)(4) STUDY INDICATED THAT PLAQUE SHIFT OCCURRED WHILE IMPLANTING A CORONARY ARTERY STENT AND THE PATIENT HAD ELEVATED CARDIAC ENZYMES POST-PROCEDURE. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR A POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA, HYPERLIPIDEMIA, HYPERTENSION, TYPE 2 DIABETES MELLITUS, SKIN RASH, AND ALLERGIES TO SULFA, CORTISONE, LIPITOR, WELLCHOL, AND CYMBALTA. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE TARGET LESIONS WERE LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND PROXIMAL CIRCUMFLEX (CX). THE LESION IN THE PROXIMAL LAD WAS DESCRIBED AS DE NOVO, 90% STENOSED, NON-THROMBOSED, 18MM IN LENGTH, TYPE B1, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON CATHETER AND A 3.0X23MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 9ATMS. POST-DILATION WAS DONE WITH AN UNKNOWN BALLOON CATHETER AT 14ATMS. RESIDUAL STENOSIS WAS 0%. THE LESION IN THE PROXIMAL CX WAS DESCRIBED AS DE NOVO, 90% STENOSED, 10MM IN LENGTH, TYPE B2, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON, FOLLOWED BY THE IMPLANT OF A 2.5X13MM CYPHER RX STENT AT 10ATMS. A PROXIMAL EDGE MISMATCH AND RUPTURED PLAQUE OCCURRED AFTER IMPLANTATION. THE SUB-INVESTIGATOR CONFIRMED THERE WAS PLAQUE SHIFT. A 2.5X8MM CYPHER RX STENT WAS THEN IMPLANTED. THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS RELATED TO CORDIS PRODUCT. THE STUDY COORDINATOR CONFIRMED THERE WAS NO DISSECTION AND THE PATIENT DID NOT EXPERIENCE ANY CHEST PAIN. THERE WERE NO POST-PROCEDURAL ECG CHANGES. TEN HOURS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ELEVATED CK =227 (ULN 173), CK-MB = 35.9 (ULN 3.6), AND TROPONIN I = 3.05 (ULN 0.09). PRE-PROCEDURE CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. THE PATIENT DID NOT HAVE A MYOCARDIAL INFARCTION EVEN THOUGH THE CARDIAC MARKERS WERE ELEVATED. PER THE SUB-INVESTIGATOR, RUPTURED PLAQUE OCCURRED AND THERE WAS A PLAQUE SHIFT. THE PATIENT HAD NOT BEEN RE-HOSPITALIZED SINCE HER ENROLLMENT AND WAS STABLE AT HER LAST VISIT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THESE LOTS PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. PLAQUE SHIFT AND ELEVATED CARDIAC BIOMARKERS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS. THE ACT OF ANGIOPLASTY INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, WHICH LEADS TO DAMAGED HEART CELLS AND THE RELEASE OF CARDIAC BIOMARKER ENZYMES INTO THE SYSTEMIC BLOODSTREAM AS WELL AS PLAQUE MOVEMENT WITHIN THE VESSEL. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00331, 3003742446-2011-00332, AND 3003742446-2011-00333. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED BY (B)(4) STUDY, THE PATIENT EXPERIENCED DISSECTION DESCRIBED AS DISTAL EDGE MISMATCH AND RUPTURED PLAQUE AFTER CYPHER RX STENT IMPLANTATION. TEN HOURS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED AN ELEVATED CK =227 (ULN 173), CK-MB = 35.9 (ULN 3.6), AND TROPONIN I = 3.05 (ULN 0.09). PRE-PROCEDURE CARDIAC ENZYMES WERE WITHIN NORMAL LIMITS. THE INDICATION FOR THE PROCEDURE WAS UNSTABLE ANGINA. THE TARGET LESIONS WERE LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY AND PROXIMAL CIRCUMFLEX (CX). THE LESION IN THE PROXIMAL LAD WAS DESCRIBED AS DE NOVO, 90% STENOSED, NON-THROMBOSED, 18MM IN LENGTH, TYPE B1, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON CATHETER AND A 3.0X23MM CYPHER RX STENT WAS SUCCESSFULLY IMPLANTED AT 9ATMS. POST-DILATION WAS DONE WITH AN UNKNOWN BALLOON CATHETER AT 14ATMS. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED. THE LESION IN THE PROXIMAL CX WAS DESCRIBED AS DE NOVO, 90% STENOSED, 10MM IN LENGTH, TYPE B2, NON-THROMBOSED, WITH NO CALCIFICATION. THE REFERENCE VESSEL WAS 2.5MM IN DIAMETER AND NON-TORTUOUS. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON CATHETER AT UNKNOWN ATMS AND A 2.5X13MM CYPHER RX STENT WAS IMPLANTED AT 10ATMS. A DISSECTION DESCRIBED AS DISTAL EDGE MISMATCH AND RUPTURED PLAQUE OCCURRED AFTER IMPLANTATION. A 2.5X8MM CYPHER RX STENT WAS IMPLANTED AT 11ATMS TO TREAT THE DISSECTION. THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS RELATED TO CORDIS PRODUCT.

    Description of Event or Problem · 1

    THE STUDY COORDINATOR REPORTED THERE WAS NO DISSECTION AND THE PATIENT DID NOT EXPERIENCE ANY CHEST PAIN. THERE WERE NO POST-PROCEDURAL ECG CHANGES. THE PATIENT DID NOT HAVE A MYOCARDIAL INFARCTION EVEN THOUGH THE CARDIAC MARKERS WERE ELEVATED. THERE WAS NOT A DISTAL EDGE MISMATCH BUT THERE WAS A PROXIMAL EDGE MISMATCH. PER THE SUB-INVESTIGATOR, RUPTURED PLAQUE OCCURRED AND THERE WAS A PLAQUE SHIFT. THE PATIENT HAD NOT BEEN RE-HOSPITALIZED SINCE HER ENROLLMENT AND WAS STABLE AT HER LAST VISIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA 15104819

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention