BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3123990 · Received May 22, 2013

    Report

    Report Number
    3003742446-2013-00068
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    October 1, 2003
    Report Date
    April 29, 2013
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, HYZAAR, IMDUR, AND PLAVIX. THE ACTUAL IMPLANT DATE OF THE CYPHER STENTS AND EVENT DATES ARE UNKNOWN. COMPLAINT CONCLUSION: AS REPORTED FROM THE MEDICAL AFFAIRS, THE PATIENT WITH A MEDICAL HISTORY OF LATEX AND SEAFOOD ALLERGIES, IV DYE, "STATIN" MEDICATIONS, NO ALCOHOL OR SMOKING, AND OPEN HEART SURGERY UNDERWENT CYPHER STENT PLACEMENT IN THE LEFT MAIN AND A ¿GUARDIAN STENT¿ PLACEMENT IN AN UNKNOWN VESSEL FOLLOWING BLOCKAGES ON 10/2003. DURING PLACEMENT OF STENTS, PATIENT EXPERIENCED A TEAR IN A GROIN VESSEL AND A BLOOD CLOT IN LEFT LEG. TREATMENT INCLUDED MESH PLACED IN RIGHT GROIN, AND A FEM POP IN 2003 OR 2005. ON AN UNKNOWN DATE POST STENT PLACEMENT IN 2003, PATIENT EXPERIENCED CHEST PAIN, PAIN IN LEGS, COULDN'T WALK AND HEART RATE KEPT GOING UP. TREATMENT INCLUDED HYZAAR AND IMDUR. DIAGNOSTICS INCLUDED "BLOOD PRESSURE ON LEGS", SONOGRAMS, ANGIOPLASTIES, NUCLEAR STRESS TESTS ON SEVERAL OCCASIONS, AND THIRTY DAY HEART MONITORS. AFTER UNKNOWN DURATION OF TIME, ANOTHER CYPHER STENT WAS PLACED IN 2005 IN AN UNKNOWN VESSEL. TREATMENT ALSO INCLUDED ABLATION IN 2006. IN 2009, PATIENT EXPERIENCED ¿TIA". PATIENT REPORTED TO HAVE UNDERGONE ADDITIONAL 21 UNSPECIFIED CORONARY STENTS WHICH WERE PLACED IN UNKNOWN VESSELS, ON UNKNOWN DATES. PATIENT HAD ONE OR MORE SURGERIES THAT INVOLVED THE SAME TARGET VESSELS WHERE CYPHER STENTS WERE INITIALLY PLACED. PATIENT ALSO ADDED TO HAVE ¿TORE IN A GROIN VESSEL THAT REQUIRED ADDITIONAL CORONARY OR PERIPHERAL INTERVENTIONS¿ AND HAS BEEN IN PAIN SINCE AFTER PLACEMENT OF FIRST CYPHER STENT DUE TO TORE IN THE GROIN SITE. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS. THE LAST PLACEMENT WAS CONDUCTED ON (B)(4) 2013, WHEN AN UNSPECIFIED STENT WAS PLACED IN THE RCA FOLLOWING BLOCKAGE AND RE-OPENING OF UNSPECIFIED STENT. ON UNSPECIFIED DATES, 4 TO 5 UNSPECIFIED STENTS WERE PLACED IN UNKNOWN VESSELS OF THE LEGS AND ABDOMEN RELATED TO BLOCKAGES. IN (B)(4) 2013, PLAVIX WAS DISCONTINUED AND BRILINTA WAS PRESCRIBED, IMDUR WAS DISCONTINUED AND RANEXA WAS PRESCRIBED, HYZAAR WAS DISCONTINUED AND DIOVAN WAS PRESCRIBED. MEDICATION CHANGES WERE MADE FOR UNKNOWN REASONS. THERE IS NO LOT NUMBER INFORMATION AVAILABLE AND THUS NO DHR COULD BE PERFORMED. CHEST PAIN IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE CYPHER IFU AS SUCH. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. THE NATURAL PROGRESSION OF CORONARY DISEASE AS WELL AS TARGET LESION ISSUES MAY CONTRIBUTE TO THE EXPERIENCE OF CHEST PAIN / ANGINA. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE IFU. IN THE LITERATURE, IN-STENT STENOSIS RATES RANGE FROM 11% TO 39% FROM 6 TO 12 MONTHS AFTER STENT PLACEMENT. RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. IN-STENT STENOSIS WAS MORE PREVALENT IN OSTIAL STENT PLACEMENT PROCEDURES. STENOSES IN STENTS ARE USUALLY TREATED WITH INTRASTENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TREATMENT OF THE DISEASE PROCESS AND IT NOT A PREVENTIVE OR CURE FOR THE PROGRESSION OF SYMPTOMS OF ATHEROSCLEROTIC ARTERY DISEASE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2013-00068 AND 3003742446-2013-00069.

    Description of Event or Problem · 1

    AS REPORTED FROM THE MEDICAL AFFAIRS, THE PATIENT HAD A CYPHER STENT PLACED IN THE LEFT MAIN AND A GUARDIAN STENT PLACED IN AN UNKNOWN VESSEL FOLLOWING BLOCKAGES ON (B)(6) 2003. DURING PLACEMENT OF STENTS, PATIENT EXPERIENCED A TEAR IN A GROIN VESSEL AND A BLOOD CLOT IN LEFT LEG. TREATMENT INCLUDED MESH PLACED IN RIGHT GROIN, AND A FEM POP IN 2003 OR 2005. ON AN UNKNOWN DATE POST STENT PLACEMENT IN 2003, PATIENT EXPERIENCED CHEST PAIN, PAIN IN LEGS, COULDN'T WALK AND HEART RATE KEPT GOING UP. TREATMENT INCLUDED HYZAAR AND IMDUR. DIAGNOSTICS INCLUDED "BLOOD PRESSURE ON LEGS", SONOGRAMS, ANGIOPLASTIES, NUCLEAR STRESS TESTS ON SEVERAL OCCASIONS, AND THIRTY DAY HEART MONITORS. AFTER UNKNOWN DURATION OF TIME, ANOTHER CYPHER STENT WAS PLACED IN 2005 IN AN UNKNOWN VESSEL. TREATMENT ALSO INCLUDED ABLATION IN 2006. IN 2009, PATIENT EXPERIENCED ¿TIA". PATIENT REPORTED TO HAVE UNDERGONE ADDITIONAL 21 UNSPECIFIED CORONARY STENTS WHICH WERE PLACED IN UNKNOWN VESSELS, ON UNKNOWN DATES. PATIENT HAD ONE OR MORE SURGERIES THAT INVOLVED THE SAME TARGET VESSELS WHERE CYPHER STENTS WERE INITIALLY PLACED. PATIENT ALSO ADDED TO HAVE ¿TORE IN A GROIN VESSEL THAT REQUIRED ADDITIONAL CORONARY OR PERIPHERAL INTERVENTIONS¿ AND HAS BEEN IN PAIN SINCE AFTER PLACEMENT OF FIRST CYPHER STENT DUE TO TORE IN THE GROIN SITE. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS. THE LAST PLACEMENT WAS CONDUCTED ON (B)(6) 2013, WHEN AN UNSPECIFIED STENT WAS PLACED IN THE RCA FOLLOWING BLOCKAGE AND RE-OPENING OF UNSPECIFIED STENT. ON UNSPECIFIED DATES, 4 TO 5 UNSPECIFIED STENTS WERE PLACED IN UNKNOWN VESSELS OF THE LEGS AND ABDOMEN RELATED TO BLOCKAGES. IN (B)(6) 2013, PLAVIX WAS DISCONTINUED AND BRILINTA WAS PRESCRIBED, IMDUR WAS DISCONTINUED AND RANEXA WAS PRESCRIBED, HYZAAR WAS DISCONTINUED AND DIOVAN WAS PRESCRIBED. MEDICATION CHANGES WERE MADE FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225908 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS LLC (PR) NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R