BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2060835 · Received April 18, 2011

    Report

    Report Number
    3003742446-2011-00187
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 4, 2011
    Report Date
    February 5, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT EXPERIENCED ANGINA, AND AN ANGIOGRAM PERFORMED APPROXIMATELY SEVEN WEEKS AFTER THE INDEX PROCEDURE RESULTED IN REVASCULARIZATION OF THE LEFT MAIN CORONARY ARTERY TO PROXIMAL LAD WITH THE IMPLANTATION OF A 3.0 X 28MM CYPHER RX STENT. IT WAS REPORTED THAT THE LM STENOSIS WAS NOT RELATED TO THE PREVIOUSLY IMPLANTED CYPHER STENT AND THE PREVIOUS STENT WAS PATENT. APPROXIMATELY SEVEN AND A HALF MONTHS AFTER THE INDEX PROCEDURE, ANGIOGRAPHY WAS PERFORMED DUE TO CONTINUING ANGINA AND THE PATIENT UNDERWENT BALLOON ANGIOPLASTY OF THE PROXIMAL CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE STENOSIS IN THE CIRCUMFLEX ARTERY WAS WITHIN 5MM OF THE STENT THAT HAD BEEN IMPLANTED IN THE LEFT MAIN ARTERY AND THE INVESTIGATOR REPORTED THAT IVUS OF THE OSTIUM OF THE CIRCUMFLEX DOCUMENTED A VERY TIGHT 95% OSTIAL STENOSIS THROUGH THE PREVIOUSLY DEPLOYED STENT. IT WAS REPORTED VIA THE CRF THAT THE PATIENT EXPERIENCED ELEVATED TROPONIN OF 0.2 (ULN 0.09) AND THE PHYSICIAN FELT THAT THE PATIENT HAD AN MI THE FOLLOWING DAY AFTER ANGIOPLASTY. THERE WAS NO MENTION OF MI IN THE RECORDS. STUDY STENT WAS PATENT. APPROXIMATELY FOUR AND A HALF MONTHS LATER, THE PATIENT EXPERIENCED CONTINUED ANGINA. ANGIOGRAPHY REVEALED 80 TO 90% STENOSIS IN THE OSTIAL CIRCUMFLEX THAT WAS TREATED WITH A 2.75 X 8MM XIENCE V DRUG-ELUTING STENT AND THE STENT AND PROXIMAL LAD STENT WERE POST-DILATED IN KISSING BALLOON FASHION. THERE WERE EXCELLENT ANGIOGRAPHIC RESULTS AND THE PATIENT'S CHEST PAIN RESOLVED. THE MDR REPORTABLE RESTENOSIS OF THE LM STENT WAS REPORTED ON (B)(4) 2011. CONCOMITANT MEDICATIONS INCLUDED NEXIUM 40MG BID, NITROSTAT 0.4MG SINCE (B)(6) 2010, METOPROLOL 25MG SINCE (B)(6) 2010, ASPIRIN 81MG SINCE (B)(6) 2010, PAXIL 20MG DAILY SINCE (B)(6) 2007, CLOPIDOGREL 65MG SINCE (B)(6) 2010. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00186 AND 3003742446-2011-00187.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED TREATMENT OF A NEW LESION, RESTENOSIS, MYOCARDIAL INFARCTION AND HYPOPERFUSION AFTER HAVING CORONARY ARTERY STENTS IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, CORONARY ARTERY BYPASS GRAFT SURGERY, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, CERVICAL CANCER, AND LVEF > 50%. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA WITH POSITIVE FUNCTIONAL TEST FOR ANEMIA. THE LESION WAS A SAPHENOUS VEIN GRAFT (SVG) TO THE FIRST DIAGONAL (DX), THERE WAS ALSO DISEASE IDENTIFIED IN THE LEFT MAIN THROUGH TO THE LEFT ANTERIOR DESCENDING ARTERY (LAD) IDENTIFIED. THE SVG WAS DIRECT STENTED WITH A 3.0MM X 28MM CYPHER STENT AT 15ATMS. NO REFLOW WAS OBSERVED AFTER STENT DEPLOYMENT SO NITROPRUSSIDE WAS ADMINISTERED INTRA-CORONARY, AND THERE WERE NO ADVERSE EVENTS ASSOCIATED WITH THE HYPO-PERFUSION. THE STENT WAS POST-DILATED FOR OPTIMAL EXPANSION AND THE REPORTED RESIDUAL STENOSIS WAS 0%. POST-PROCEDURE THE PATIENT EXPERIENCED ELEVATED TROPONIN OF 0.2 (ULN 0.09) AND THE PHYSICIAN FELT THAT THE PATIENT HAD AN MI THE DAY FOLLOWING ANGIOPLASTY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL. APPROXIMATELY SEVEN WEEKS LATER, THE PATIENT EXPERIENCED ANGINA, AND ANGIOPLASTY WAS PERFORMED ON THE LEFT MAIN TO THE LAD WITH A 3.0MM X 28MM CYPHER STENTS. APPROXIMATELY SEVEN AND A HALF MONTHS AFTER THE INDEX PROCEDURE, ANGIOGRAPHY WAS PERFORMED DUE TO CONTINUING ANGINA AND THE PATIENT UNDERWENT BALLOON ANGIOPLASTY OF THE PROXIMAL CIRCUMFLEX ARTERY. IT WAS REPORTED THAT THE STENOSIS IN THE CIRCUMFLEX ARTERY WAS WITHIN 5MM OF THE STENT THAT HAD BEEN IMPLANTED IN THE LEFT MAIN ARTERY AND THE INVESTIGATOR REPORTED THAT IVUS OF THE OSTIUM OF THE CIRCUMFLEX DOCUMENTED A VERY TIGHT 95% OSTIAL STENOSIS THROUGH THE PREVIOUSLY DEPLOYED STENT; THE EVENT WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY. APPROXIMATELY FOUR AND A HALF MONTHS LATER, THE PATIENT EXPERIENCED CONTINUED ANGINA. ANGIOGRAPHY REVEALED 80 TO 90% STENOSIS IN THE OSTIAL CIRCUMFLEX THAT WAS TREATED WITH A 2.75 X 8MM XIENCE V DRUG-ELUTING STENT AND THE STENT AND PROXIMAL LAD STENT WERE POST-DILATED IN KISSING BALLOON FASHION. THERE WERE EXCELLENT ANGIOGRAPHIC RESULTS AND THE PATIENT'S CHEST PAIN RESOLVED. THE EVENT OF HYPO-PERFUSION WAS PREVIOUSLY REPORTED. 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. RESTENOSIS, MYOCARDIAL INFARCTION AND HYPOPERFUSION 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. THIS ACTION (INHERENT RISK OF THE PROCEDURE) MAY HAVE CONTRIBUTED TO THE EVENT OF MI. HYPO-PERFUSION IS USUALLY RELATED TO ARTERIAL VESSEL SPASM AND RECOIL AFTER DEPLOYING A STENT AND IS USUALLY RELIEVED BY VASO-DILATING AGENTS, THIS EVENT MAY ALSO HAVE CONTRIBUTED TO THE REPORTED MI. THE ACT OF CORONARY STENTING IN AN OSTIAL LESION IS ASSOCIATED WITH A LOW SUCCESS RATE, HIGH RATE OF COMPLICATIONS AND A HIGH INCIDENCE OF TARGET VESSEL REVASCULARIZATION. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT ASIDE FROM THE INHERENT RISK OF THE PROCEDURE THAT, VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NOTHING TO INDICATE THAT THESE EVENTS ARE RELATED TO THE DESIGN OR MANUFACTURING PROCESS THEREFORE NO ACTION IS REQUIRED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00186 AND 3003742446-2011-00187.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) STUDY, A PATIENT UNDERWENT REVASCULARIZATION WITH A CYPHER STENT TO A NON-TARGET VESSEL IN THE LEFT MAIN (LM) TO PROXIMAL LAD AND LATER HAD PERI-STENT RESTENOSIS OF THAT STENT WITH MYOCARDIAL INFARCTION AND A SECOND RESTENOSIS FOUR AND A HALF MONTHS LATER. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 90% RESTENOSIS OF THE PROXIMAL SAPHENOUS VEIN GRAFT (SVG TO IR) AND KNOWN DISEASE OF THE LM TO LEFT ANTERIOR DESCENDING (LAD). THE SVG LESION WAS CLASS B1 AND 24MM IN LENGTH AND THE REFERENCE VESSEL WAS 3.0MM IN DIAMETER. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA AND A POSITIVE FUNCTIONAL TEST FOR ISCHEMIA. A 3.0 X 28MM CYPHER RX WAS IMPLANTED BY DIRECT STENTING AT 15ATM. THE PATIENT RECEIVED NITROPRUSSIDE DUE TO NO EVIDENCE OF REFLOW, BUT THERE WERE NO REPORTED ADVERSE EVENTS REPORTED FOR THIS INCIDENT. THE STENT WAS POST-DILATED WITH A 3.5 X 28MM BALLOON AT 10ATM TO FULLY EXPAND THE STENT. THERE WAS NO RESIDUAL STENOSIS AND THERE WAS TIMI 3 FLOW PRE AND POST-PROCEDURE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL.

    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 15105348

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening| R