BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2225708 · Received August 29, 2011

    Report

    Report Number
    9616099-2011-00685
    Event Type
    Injury
    Date Received
    August 29, 2011
    Date of Event
    October 8, 2010
    Report Date
    August 9, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED FROM THE JOURNAL ARTICLE "VERY LATE SIROLIMUS-ELUTING STENT THROMBOSIS DUE TO STENT FRACTURE AND LATE-ACQUIRED INCOMPLETE STENT APPOSITION DETECTED ON MULTISLICE COMPUTED TOMOGRAPHY"; TSUYOSHI ITO, MD, MITSUYASU TERASHIMA, MD, HIDEAKI KANEDA, MD, KENYA NASU, MD, YOSHIHISA KINOSHITA, MD, MAOTO HABARA, MD, ETSUO TSUCHIKANE, MD, TAKAHIKO SUZUKI, MD. A (B)(6) MAN WITH HYPERTENSION, HYPERLIPIDEMIA AND DIABETES MELLITUS WAS REFERRED FOR CORONARY ANGIOGRAPHY (CAG) FOLLOWING AN EPISODE OF CHEST PAIN ON EXERTION. CAG SHOWED A SIGNIFICANT STENOSIS IN THE MIDDLE SEGMENT OF HIS LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY, WHICH WAS TREATED WITH 2 OVERLAPPED SIROLIMUS-ELUTING STENTS (SESS; 3.5X23 MM AND 3.0X18 MM) ON (B)(6) 2005. INTRAVASCULAR ULTRASOUND (IVUS) IMMEDIATELY AFTER SES IMPLANTATION CONFIRMED A WELL-EXPANDED STENT THAT WAS NOT IN INCOMPLETE APPOSITION. AT 5 YEARS AFTER STENTING, THE PATIENT WAS ADMITTED FOR SURGERY OF AN UNRUPTURED ABDOMINAL AORTIC ANEURYSM. ALTHOUGH 64-SLICE MULTISLICE COMPUTED TOMOGRAPHY (MSCT) BEFORE THE OPERATION (ON (B)(6) 2010) SHOWED NO SIGNIFICANT STENOSIS IN THE CORONARY ARTERIES, CONTRAST ENHANCEMENT OUTSIDE THE STENT INDICATED LATE-ACQUIRED INCOMPLETE STENT APPOSITION (ISA; FIGURES D,E, ARROW HEADS). IN ADDITION, COMPLETE SEPARATION OF STENT STRUTS WAS SEEN ON 3-D IMAGING, AND ABSENCE OF STENT STRUTS DUE TO STENT FRACTURE WAS SEEN ON THE CROSS-SECTIONAL IMAGE. BOTH ASPIRIN AND TICLOPIDINE WERE DISCONTINUED FOR 7 DAYS BEFORE THE OPERATION, AND THEN REINSTITUTED 2 DAYS AFTER SURGERY. AT 5 DAYS AFTER SURGERY (ON (B)(6) 2010), THE PATIENT DEVELOPED ACUTE CHEST PAIN AND ELECTROCARDIOGRAM SHOWED AN ACUTE ANTERIOR-WALL ST ELEVATION MYOCARDIAL INFARCTION. EMERGENT CAG SHOWED IN-STENT OCCLUSION IN THE PROXIMAL LAD, FOLLOWED BY REVASCULARIZATION THERAPY. IVUS AND OPTICAL COHERENCE TOMOGRAPHY (OCT) WERE PERFORMED FOLLOWING REVASCULARIZATION WITH BALLOON DILATATION. IVUS DEMONSTRATED ABSENCE OF STENT STRUTS, INDICATING STENT FRACTURE, AND A LOW-INTENSITY MASS IN THE LUMEN, SUGGESTING THROMBUS (FIGURE I). IN ADDITION, OCT ALSO DEMONSTRATED A HIGH-BACKSCATTERING MASS WITH SIGNAL ATTENUATION PROTRUDING INTO THE LUMEN IMPLYING RED THROMBUS, COMPARABLE TO FINDINGS OF LATE STENT THROMBOSIS (LST). LST AFTER DES IMPLANTATION IS ONE OF THE PROBLEMS OF THE DRUG-ELUTING STENT ERA 1 WHILE THE MECHANISM OF LST IS YET TO BE COMPLETELY UNDERSTOOD, SEVERAL FACTORS HAVE BEEN SUGGESTED AS CONTRIBUTORS TO LST. IN A STUDY WITH IVUS, LATE-ACQUIRED ISA WAS HIGHLY PREVALENT IN PATIENTS WITH LST AFTER DES IMPLANTATION. PREVIOUS PATHOLOGICAL ANALYSIS REPORTED THAT STENT FRACTURE HAD A SIGNIFICANT IMPACT ON THE OCCURRENCE OF STENT THROMBOSIS. AN IVUS STUDY HAS PROPOSED A RELATIONSHIP BETWEEN LATE-ACQUIRED ISA AND STENT FRACTURE. SOME TYPES OF LATE-ACQUIRED ISA ARE CAUSED BY POSITIVE VESSEL REMODELING DUE TO BIOLOGICAL REACTIONS TO THE DES, WHICH MAY ALLOW MOTION AND/OR KINKING OF THE STENT, LEADING TO STENT FRACTURE. ALTERNATIVELY, STENT FRACTURE CAN LEAD TO LOCAL MECHANICAL IRRITATION OF THE VESSEL, WHICH MAY LEAD TO ISA. THEREFORE, LATE ACQUIRED ISA AND/OR STENT FRACTURE COULD SET THE STAGE FOR LST. LST MIGHT ARISE BY COMBINATION OF SUCH STRUCTURAL CHANGES OF THE VESSEL AND DISCONTINUATION OF ANTI-PLATELET THERAPY. INTRAVASCULAR IMAGING MODALITIES SUCH AS IVUS AND OCT ARE USEFUL FOR ASSESSMENT OF CORONARY ARTERIES WITH IMPLANTED STENTS, BUT THESE MODALITIES, AS A DIAGNOSTIC PROCEDURE, ARE INVASIVE. CURRENTLY, MSCT IS WIDELY USED FOR THE EVALUATION OF CORONARY ARTERY DISEASE AS A LESS INVASIVE IMAGING TECHNIQUE. IN THE PRESENT CASE, MSCT JUST BEFORE THE ONSET OF LST WAS ABLE TO VISUALIZE NOT ONLY LATE-ACQUIRED ISA BUT ALSO STENT FRACTURE. WE SHOULD CONSIDER ALTERNATIVE ANTICOAGULANT THERAPY SUCH AS HEPARIN IN CASES INVOLVING THESE MSCT FINDINGS REQUIRING DISCONTINUATION OF ANTI-PLATELET THERAPY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE FRACTURE OCCURRED ONLY ON THE STENT IN THE PROXIMAL LAD AND NOT IN THE MID LAD STENT. THE LARGER DIAMETER OF THE TWO STENTS WILL BE PRESUMED TO BE IMPLANTED IN THE PROXIMAL SEGMENT OF THE LAD. 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 I0605091 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. A DHR REVIEW WAS REQUESTED TO NORMAN NOBLE INC. AND THE RESULTS INDICATE THAT ALL STENTS SHIPPED MEETS SPECIFIED RELEASE REQUIREMENTS. THROMBOSIS AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STENT IMPLANTATION PROCEDURES. THERE IS A THEORETICAL CONCERN THAT INCOMPLETE STENT APPOSITION IN THE MIDDLE OF THE STENT CAN RESULT IN AREAS OF "CUL-DE-SAC" FORMATION WITH BLOOD-FLOW STAGNATION THAT CAN PREDISPOSE THE PATIENT TO STENT THROMBOSIS. AN ENLARGEMENT IN THE EXTERNAL ELASTIC MEMBRANE (EEM) OF THE VESSEL, INCREASING THE VESSEL VOLUME AND THE PLAQUE VOLUME FOUND BEHIND THE STENT INDICATES POSITIVE VESSEL REMODELING. SIROLIMUS HAS POTENT ANTI-INFLAMMATORY, IMMUNOSUPPRESSIVE, AND ANTIPROLIFERATIVE EFFECTS. THESE POTENT BIOLOGIC EFFECTS RAISE THEORETIC CONCERNS ABOUT POTENTIAL SIDE EFFECTS, SUCH AS INCOMPLETE HEALING, INCREASED THROMBOGENICITY, NECROSIS, APOPTOSIS, AND POSITIVE REMODELING. CONTINUED SURVEILLANCE AFTER DES IMPLANTATION IS REQUIRED TO DETERMINE THE LONG-TERM SAFETY. WHILE NOT OBSERVED IN THE (B)(4) CLINICAL TRIALS THAT SUPPORTED THE CYPHER STENT PMA, STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. IN THE CYPHER STENT, THEY HAVE BEEN REPORTED MOST OFTEN IN CERTAIN LESION SUBGROUPS IN WHICH SAFETY AND EFFECTIVENESS HAVE NOT BEEN ESTABLISHED. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME BECAUSE THERE HAS BEEN NO SPECIFIC ROOT CAUSE IDENTIFIED THAT CAN BE ATTRIBUTED TO EITHER THE PRODUCT DESIGN, RAW MATERIALS USED OR THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    TEN DAYS LATER, THE PATIENT UNDERWENT SURGERY OF AN UNRUPTURED ABDOMINAL AORTIC ANEURYSM. SEVEN DAYS LATER, THE PATIENT DEVELOPED CHEST PAIN DURING HOSPITALIZATION. ABNORMAL EGC WAS OBSERVED AND THE PATIENT WAS DIAGNOSED WITH ACUTE MYOCARDIAL INFARCTION (AMI). CORONARY ANGIOGRAPHY (CAG) WAS CONDUCTED AND THROMBUS WAS OBSERVED FROM THE PROXIMAL EDGE TO INSIDE OF THE CYPHER BX STENTS IMPLANTED AT THE PROXIMAL TO MID LAD. TO TREAT THE THROMBUS, PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS CONDUCTED. DURING THE TREATMENT, IVUS WAS CONDUCTED AND POSITIVE REMODELING WAS CONFIRMED AT THE VESSEL AROUND THE CYPHER BX IMPLANTED AT THE PROXIMAL LAD. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THIS EVENT. THE PHYSICIAN INDICATED THAT THE POSSIBLE CAUSE OF THE THROMBOSIS WAS THE EFFECT OF THE STENT FRACTURE AND STENT MALAPPOSITION DUE TO POSITIVE REMODELING. THE CAUSE OF THE POSITIVE REMODELING AND FRACTURE WAS UNKNOWN. THE PATIENT WAS DISCHARGED AND DOING WELL. DURING THE INDEX PROCEDURE, THE TARGET LESION TREATED WAS THE PROXIMAL TO MID LAD. THE LESION WAS DE-NOVO. OTHER LESION INFORMATION WAS UNKNOWN. TWO CYPHER BX STENTS (3.0 X 18MM AND 3.5 X 23MM) WERE IMPLANTED OVERLAPPING EACH OTHER. IVUS WAS CONDUCTED AND SUFFICIENT STENT APPOSITION WAS CONFIRMED. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THIS IMPLANT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE JOURNAL ARTICLE "VERY LATE SIROLIMUS-ELUTING STENT THROMBOSIS DUE TO STENT FRACTURE AND LATE-ACQUIRED INCOMPLETE STENT APPOSITION DETECTED ON MULTISLICE COMPUTED TOMOGRAPHY"; TSUYOSHI ITO, MD, MITSUYASU TERASHIMA, MD, HIDEAKI KANEDA, MD, KENYA NASU, MD, YOSHIHISA KINOSHITA, MD, MAOTO HABARA, MD, ETSUO TSUCHIKANE, MD, TAKAHIKO SUZUKI, MD; CIRCULATION JOURNAL INDICATED THAT APPROXIMATELY FIVE YEARS AND TWO MONTHS AFTER THE INDEX PROCEDURE, MULTISLICE COMPUTED TOMOGRAPHY (MSCT) WAS CONDUCTED FOR SURGERY OF AN UNRUPTURED ABDOMINAL AORTIC ANEURYSM (ASPIRIN AND TICLOPIDINE WERE DISCONTINUED 7 DAYS BEFORE THE SURGERY AND REINSTITUTED 2 DAYS LATER) AND THERE WAS NO STENOSIS OBSERVED IN THE CYPHER BX STENTS IMPLANTED AT THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT LATE-ACQUIRED INCOMPLETE STENT APPOSITION WAS CONFIRMED. IN ADDITION, A CONCENTRIC STENT FRACTURE WAS OBSERVED ON THE STENT STRUT PROXIMAL TO THE OVERLAPPED PORTION OF THE CYPHER BX IMPLANTED AT THE PROXIMAL LAD UNDER 3D CUT-AWAY IMAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA I0605091

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R TICLOPIDINE AND ASPIRIN.