BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1877242 · Received October 20, 2010

    Report

    Report Number
    3003742446-2010-00370
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    May 1, 2007
    Report Date
    September 23, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE FROM TEX HEART INST J. 2010; 37(4): 449-454. "IN (B)(6) 2006, A (B)(6) MAN WITH A HISTORY OF HYPERTENSION, DYSLIPIDEMIA, SMOKING, AND A FAMILY HISTORY POSITIVE FOR CORONARY ARTERY DISEASE WAS REFERRED TO OUR INSTITUTION FOR EMERGENT CARDIAC CATHETERIZATION DUE TO A DIAGNOSIS OF ST-ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION REVEALED 90% STENOSIS OF THE POSTERIOR DESCENDING CORONARY ARTERY. THE LESION WAS TREATED SUCCESSFULLY WITH A SIROLIMUS-ELUTING STENT. AFTER 1 YEAR, THE PATIENT PRESENTED AGAIN AT THE HOSPITAL WITH EXERTIONAL CHEST TIGHTNESS OF 1 MONTH'S DURATION, WHICH HAD GOTTEN WORSE OVER THAT TIME. AN ELECTROCARDIOGRAM SHOWED SINUS RHYTHM WITH NO ST-T CHANGES AND WITH Q WAVES IN LEADS III AND AVF. CARDIAC CATHETERIZATION REVEALED 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND A LARGE PDCA ANEURYSM AT THE PREVIOUS STENT SITE, WITH 70% TO 80% STENOSIS DISTAL TO THE STENT. IN CONSIDERATION OF THE ANEURYSM'S SIZE, WE DECIDED TO REPAIR IT WITH A COVERED STENT. EPTIFIBATIDE WAS GIVEN DURING THE PROCEDURE. AN 8F JR4 GUIDING CATHETER WAS USED. A 0.014-IN HI-TORQUE BALANCE MIDDLE WEIGHT GUIDEWIRE (ABBOTT VASCULAR) WAS ADVANCED ACROSS THE LESIONS IN THE RCA AND THE PDCA. A 2.5 × 15-MM VOYAGER BALLOON (ABBOTT VASCULAR) WAS USED TO DILATE THE PDCA LESION AT 6 ATM. A 3 × 19-MM PTFE-COVERED STENT, THE JOSTENT GRAFTMASTER (ABBOTT VASCULAR), WAS DEPLOYED AT 12 ATM ACROSS THE MID-PDCA LESION. THE POST-STENT ANGIOGRAM REVEALED A WELL-DEPLOYED STENT IN THE PDCA WITH NO RESIDUAL STENOSIS, NO RESIDUAL ANEURYSM, AND GOOD DISTAL FLOW (FIG. 2B). A 4 × 15-MM VISION STENT (ABBOTT VASCULAR) WAS DEPLOYED AT 14 ATM ACROSS THE PROXIMAL RCA LESION. THE POSTOPERATIVE PERIOD WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN, CLOPIDOGREL, METOPROLOL, ATORVASTATIN, AND ENALAPRIL. AFTER 2 YEARS OF FOLLOW-UP, THE PATIENT UNDERWENT AN EXERCISE CARDIOLITE STRESS TEST WHICH REVEALED AN EJECTION FRACTION OF GREATER THAN 0.70 AND NO EVIDENCE OF REVERSIBLE ISCHEMIA. THE PATIENT HAS BEEN REGULARLY MONITORED IN THE CARDIOLOGY CLINIC AND HAS BEEN DOING WELL." ADDITIONAL INFORMATION FROM THE AUTHOR INDICATES THAT THE CYPHER WAS ORIGINALLY IMPLANTED AT 16 ATMOSPHERES IN THE MID PDA ON (B)(6) 2006. THE MID PDA WAS 85-90% STENOSED. THE ANEURYSM WAS DETECTED ON (B)(6) 2007, AND TREATED WITH THE PTFE-COVERED JOSTENT 2 DAYS LATER. THE NEW STENOSIS SEEN DISTAL TO THE ANEURYSM/STENT WAS WITHIN 5MM OF THE CYPHER STENT IN THE PDA. THE PATIENT IS SAID TO STILL BE DOING WELL AT THIS TIME, WITH NO FURTHER EVENTS NOTED. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF CARDIOVASCULAR DISEASE. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE INSTENT RESTENOSIS AND DOES NOT INDICATE A DEVICE FAILURE. INTRA-ARTERIAL STENT PLACEMENT IS A TYPE OF TREATMENT OF THE DISEASE PROCESS AND IT IS NOT A PREVENTION OR CURE OF THE PROGRESSION OF ATHEROSCLEROTIC ARTERY DISEASE. THEREFORE, THERE ARE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE EXACT MECHANISM OF ANEURYSM FORMATION AFTER DES IMPLANTATION IS STILL UNKNOWN. HOWEVER, OTHER REPORTS SUGGEST SEVERAL POTENTIAL CAUSES, INCLUDING REACTION TO STENT MATERIAL (STAINLESS STEEL COMPOSED OF IRON, NICKEL AND CHROMIUM), DRUG EFFECTS AND HYPERSENSITIVITY TO THE DRUG ELUTING POLYMERS. NEITHER THE DHR NOR THE INFORMATION AVAILABLE FOR REVIEW INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    AFTER 2 YEARS OF FOLLOW-UP, THE PATIENT UNDERWENT AN EXERCISE CARDIOLITE STRESS TEST WHICH REVEALED AN EJECTION FRACTION OF GREATER THAN 0.70 AND NO EVIDENCE OF REVERSIBLE ISCHEMIA. THE PATIENT HAS BEEN REGULARLY MONITORED IN THE CARDIOLOGY CLINIC AND HAS BEEN DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE AUTHOR, AND IS SAID TO BE FORTHCOMING PER THE AUTHOR OF THE ARTICLE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. (B)(4).

    Description of Event or Problem · 1

    JOURNAL ARTICLE FROM TEX HEART INST J. 2010; 37(4): 449-454. "IN (B)(6) 2006, A (B)(6) MAN WITH A HISTORY OF HYPERTENSION, DYSLIPIDEMIA, AND SMOKING AND A FAMILY HISTORY POSITIVE FOR CORONARY ARTERY DISEASE WAS REFERRED TO OUR INSTITUTION FOR EMERGENT CARDIAC CATHETERIZATION DUE TO A DIAGNOSIS OF ST-ELEVATION MYOCARDIAL INFARCTION. CARDIAC CATHETERIZATION REVEALED 90% STENOSIS OF THE POSTERIOR DESCENDING CORONARY ARTERY. THE LESION WAS TREATED SUCCESSFULLY WITH A SIROLIMUS-ELUTING STENT. AFTER 1 YEAR, THE PATIENT PRESENTED AGAIN AT THE HOSPITAL WITH EXERTIONAL CHEST TIGHTNESS OF 1 MONTH'S DURATION, WHICH HAD GOTTEN WORSE OVER THAT TIME. AN ELECTROCARDIOGRAM SHOWED SINUS RHYTHM WITH NO ST-T CHANGES AND WITH Q WAVES IN LEADS III AND AVF. CARDIAC CATHETERIZATION REVEALED 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND A LARGE PDCA ANEURYSM AT THE PREVIOUS STENT SITE, WITH 70% TO 80% STENOSIS DISTAL TO THE STENT. IN CONSIDERATION OF THE ANEURYSM'S SIZE, WE DECIDED TO REPAIR IT WITH A COVERED STENT. EPTIFIBATIDE WAS GIVEN DURING THE PROCEDURE. AN 8F JR4 GUIDING CATHETER WAS USED. A 0.014-IN HI-TORQUE BALANCE MIDDLE WEIGHT GUIDEWIRE (ABBOTT VASCULAR) WAS ADVANCED ACROSS THE LESIONS IN THE RCA AND THE PDCA. A 2.5 × 15-MM VOYAGER BALLOON (ABBOTT VASCULAR) WAS USED TO DILATE THE PDCA LESION AT 6 ATM. A 3 × 19-MM PTFE-COVERED STENT, THE JOSTENT GRAFTMASTER (ABBOTT VASCULAR), WAS DEPLOYED AT 12 ATM ACROSS THE MID-PDCA LESION. THE POST-STENT ANGIOGRAM REVEALED A WELL-DEPLOYED STENT IN THE PDCA WITH NO RESIDUAL STENOSIS, NO RESIDUAL ANEURYSM, AND GOOD DISTAL FLOW (FIG. 2B). A 4 × 15-MM VISION STENT (ABBOTT VASCULAR) WAS DEPLOYED AT 14 ATM ACROSS THE PROXIMAL RCA LESION. THE POSTOPERATIVE PERIOD WAS UNEVENTFUL, AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON ASPIRIN, CLOPIDOGREL, METOPROLOL, ATORVASTATIN, AND ENALAPRIL.

    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) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R