BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 3851162 · Received June 5, 2014

    Report

    Report Number
    9616099-2014-00366
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 16, 2014
    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

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00365 & 9616099-2014-00366. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION ¿A CASE REPORT OF VERY LATE STENT THROMBOSIS OBSERVED SIMULTANEOUSLY IN ALL THREE VESSELS 5 YEARS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION¿, CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 29 2 (2014), 151-156; A (B)(6) MALE PATIENT WITH A MEDICAL HISTORY OF RECENT MYOCARDIAL INFARCTION UNDERWENT A TOTAL OF 5 SES IMPLANTATION (CYPHER BX OR CYPHER SELECT) IN THREE DIFFERENT VESSELS, CONSISTING OF TWO STENTS IN THE RIGHT CORONARY ARTERY (RCA). (3.5 X 33 MM AND 2.5 X 28 MM), NEXT MONTH, TWO IN THE CIRCUMFLEX CORONARY ARTERY (LCX) (3.0 X 33 MM AND 2.5 X 28 MM), AND 2 MONTHS LATER, ONE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) (2.5 X 28 MM), RESPECTIVELY. NO OTHER LESION CHARACTERISTIC INFORMATION IS AVAILABLE. IT IS UNKNOWN WHETHER THE LESIONS WERE DE-NOVO. AHA/ACC CLASSIFICATIONS OF THE VESSELS ARE UNKNOWN. DETAILS OF STENT IMPLANTATION ARE UNKNOWN. AFTER THE FIRST PROCEDURE, CILOSTAZOL, A PHOSPHODIESTERASE III INHIBITOR, WAS ADDED TO ASPIRIN WHEN TICLOPIDINE, A THIENOPYRIDINE, WAS DISCONTINUED OWING TO MODEST HEPATIC DYSFUNCTION. A FOLLOW-UP CORONARY ANGIOGRAPHY (CAG) AT 9 MONTHS AFTER THE LAST PROCEDURE SHOWED NO SIGNIFICANT RESTENOSIS BUT WITH MODEST FINDINGS SUCH AS PERI-STENT CONTRAST STAINING (PSS) IN THE RCA AND STENT FRACTURE IN THE LCX, EXCEPT ONE STENT PLACED IN THE POSTERIOR DESCENDING CORONARY ARTERY, WHICH SHOWED TOTAL OCCLUSION WITH COLLATERAL CIRCULATION SUPPLIED FROM LAD. THEREAFTER, THE PATIENT HAD CONTINUED TAKING BOTH ASPIRIN AND CILOSTAZOL, AND REMAINED ASYMPTOMATIC AND FREE FROM CARDIOVASCULAR EVENTS ON FOLLOW-UP. AT 66 MONTHS AFTER THE INITIAL PROCEDURE, HE HAD AN ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK. EMERGENT CAG REVEALED TOTAL OCCLUSION OF ALL THREE VESSELS AT THE SITE OF THE PROXIMAL SEGMENT OF THE STENT IN THE RCA, IN THE RCA, OF THE PROXIMAL SEGMENT OF THE STENT IN THE LAD, AND OF THE MID SEGMENT OF THE STENT IN THE LCX, RESPECTIVELY. IMMEDIATELY, WITH SUPPORT OF INTRAAORTIC BALLOON PUMPING, ASPIRATION THROMBECTOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) USING 3.5-MM BALLOON WERE PERFORMED, FIRST, FOR THE RCA. SECOND, ASPIRATION THROMBECTOMY AND POBA USING 2.5-MM BALLOON FOLLOWED BY AN EVEROLIMUS-ELUTING STENT (EES) IMPLANTATION (3.0 9 15 MM) FOR THE RESIDUAL STENOSIS AT THE PROXIMAL EDGE OF THE PREVIOUSLY PLACED SES WERE PERFORMED FOR THE LAD. FINALLY, ASPIRATION THROMBECTOMY AND POBA USING 3.0-MM BALLOON WERE SIMILARLY PERFORMED FOR THE LCX, AND TIMI 3 FLOW WAS OBTAINED IN ALL THREE VESSELS. INTRAVASCULAR ULTRASOUND EXAMINATION (IVUS) SHOWED THAT THERE WERE LARGE GAPS BETWEEN STENT STRUTS AND ENLARGED VESSEL WALL, INDICATING SIGNIFICANT LATE ACQUIRED INCOMPLETE STENT APPOSITION (ISA) WITH POSITIVE VESSEL REMODELING, CONSISTENT WITH ANGIOGRAPHIC FINDINGS SUCH AS PSS. ALTHOUGH THE PATIENT SUFFERED FROM REFRACTORY HEART FAILURE, HE WAS RECOVERED BECAUSE OF INTENSIVE TREATMENT. NINETEEN DAYS AFTER VLST EPISODE, A CAG REVEALED NO SIGNIFICANT RESTENOSIS BUT SERIOUS PSS ALONG WITH POSITIVE VESSEL REMODELING ESPECIALLY IN THE RCA AND LAD, AND GRADE V STENT FRACTURE IN THE LCX. THE EXTENT OF THESE ANGIOGRAPHIC FINDINGS WAS INCOMPARABLE TO THAT IN THE PREVIOUS CAG PERFORMED 4 YEARS AGO (AT 9 MONTHS AFTER THE LAST SES IMPLANTATION). HE WAS DISCHARGED FROM OUR HOSPITAL ON ANTICOAGULATION THERAPY IN ADDITION TO DUAL ANTIPLATELET THERAPY (DAPT) (ASPIRIN AT A DOSE OF 100 MG AND CLOPIDOGREL AT A DOSE OF 75 MG). THIS IS A RARE CASE SUFFERING FROM LIFE-THREATENING VLST OBSERVED SIMULTANEOUSLY IN ALL THREE VESSELS AT 5 YEARS AFTER SES IMPLANTATION, ASSOCIATING WITH MULTIPLE LATE ADVERSE FINDINGS RELATED TO SES, UNDER CONTINUATION OF ASPIRIN AND CILOSTAZOL. THE LOT NUMBERS OF THE CYPHERS ARE UNKNOWN BECAUSE IMPLANT DATES ARE UNKNOWN. REGARDING THE FRACTURED STENT, IT COULD NOT BE IDENTIFIED WHICH STENT HAD THE FRACTURE. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. MYOCARDIAL INFARCTION AND THROMBOTIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION. THESE EVENTS MAY RESULT IN CARDIOGENIC SHOCK IN SOME PATIENTS. WHILE NOT OBSERVED IN THE PIVOTAL 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. INCOMPLETE STENT APPOSITION, OR SEPARATION OF STENT STRUTS FROM THE INTIMAL SURFACE OF THE ARTERIAL WALL OVER TIME ALSO KNOWN AS LATE STENT MALPOSITION. 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. BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE PATIENT¿S EXTENSIVE HEART DISEASE (3 VESSEL DISEASE), DEPLOYMENT OF MULTIPLE STENTS, AND THE STENT FRACTURE MAY HAVE CONTRIBUTED TO THE EVENTS REPORTED. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED EVENTS COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    EMERGENT CAG REVEALED TOTAL OCCLUSION OF ALL THREE VESSELS AT THE SITE OF THE PROXIMAL SEGMENT OF THE STENT IN THE RCA, IN THE RCA, OF THE PROXIMAL SEGMENT OF THE STENT IN THE LAD, AND OF THE MID SEGMENT OF THE STENT IN THE LCX, RESPECTIVELY. IMMEDIATELY, WITH SUPPORT OF INTRAAORTIC BALLOON PUMPING, ASPIRATION THROMBECTOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA) USING 3.5-MM BALLOON WERE PERFORMED, FIRST, FOR THE RCA. SECOND, ASPIRATION THROMBECTOMY AND POBA USING 2.5-MM BALLOON FOLLOWED BY AN EVEROLIMUS-ELUTING STENT (EES) IMPLANTATION (3.0 9 15 MM) FOR THE RESIDUAL STENOSIS AT THE PROXIMAL EDGE OF THE PREVIOUSLY PLACED SES WERE PERFORMED FOR THE LAD. FINALLY, ASPIRATION THROMBECTOMY AND POBA USING 3.0-MM BALLOON WERE SIMILARLY PERFORMED FOR THE LCX, AND TIMI 3 FLOW WAS OBTAINED IN ALL THREE VESSELS. INTRAVASCULAR ULTRASOUND EXAMINATION (IVUS) SHOWED THAT THERE WERE LARGE GAPS BETWEEN STENT STRUTS AND ENLARGED VESSEL WALL, INDICATING SIGNIFICANT LATE ACQUIRED INCOMPLETE STENT APPOSITION (ISA) WITH POSITIVE VESSEL REMODELING, CONSISTENT WITH ANGIOGRAPHIC FINDINGS SUCH AS PSS. ALTHOUGH THE PATIENT SUFFERED FROM REFRACTORY HEART FAILURE, HE WAS RECOVERED BECAUSE OF INTENSIVE TREATMENT. NINETEEN DAYS AFTER VLST EPISODE, A CAG REVEALED NO SIGNIFICANT RESTENOSIS BUT SERIOUS PSS ALONG WITH POSITIVE VESSEL REMODELING ESPECIALLY IN THE RCA AND LAD, AND GRADE V STENT FRACTURE IN THE LCX. THE EXTENT OF THESE ANGIOGRAPHIC FINDINGS WAS INCOMPARABLE TO THAT IN THE PREVIOUS CAG PERFORMED 4 YEARS AGO (AT 9 MONTHS AFTER THE LAST SES IMPLANTATION). HE WAS DISCHARGED FROM OUR HOSPITAL ON ANTICOAGULATION THERAPY IN ADDITION TO DUAL ANTIPLATELET THERAPY (DAPT) (ASPIRIN AT A DOSE OF 100 MG AND CLOPIDOGREL AT A DOSE OF 75 MG). THIS IS A RARE CASE SUFFERING FROM LIFE-THREATENING VLST OBSERVED SIMULTANEOUSLY IN ALL THREE VESSELS AT 5 YEARS AFTER SES IMPLANTATION, ASSOCIATING WITH MULTIPLE LATE ADVERSE FINDINGS RELATED TO SES, UNDER CONTINUATION OF ASPIRIN AND CILOSTAZOL. THE LOT NUMBERS OF THE CYPHERS ARE UNKNOWN BECAUSE IMPLANT DATES ARE UNKNOWN. REGARDING THE FRACTURED STENT, IT COULD NOT BE IDENTIFIED WHICH STENT HAD THE FRACTURE. THE EXACT DATE OF PUBLICATION IS UNKNOWN; THEREFORE, THE EVENT DATE WAS PROVIDED AS (B)(6) 2014. CONCOMITANT MEDICATIONS: PRE-AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND TICLOPIDINE. POST-PROCEDURE MEDICATIONS INCLUDED CILOSTAZOL. THIS ARTICLE WAS FOUND DURING A RECENT LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: FUKUI, S ET AL (2014, APRIL). A CASE REPORT OF VERY LATE STENT THROMBOSIS OBSERVED SIMULTANEOUSLY IN ALL THREE VESSELS 5 YEARS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION. CARDIOVASCULAR INTERVENTION AND THERAPEUTICS, 29, 151-156. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENTS AND ARE ASSOCIATED MANUFACTURER REPORT NUMBERS 9616099-2014-00365 & 9616099-2014-00366.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION ¿A CASE REPORT OF VERY LATE STENT THROMBOSIS OBSERVED SIMULTANEOUSLY IN ALL THREE VESSELS 5 YEARS AFTER SIROLIMUS-ELUTING STENT IMPLANTATION¿, CARDIOVASCULAR INTERVENTION AND THERAPEUTICS 29 2 (2014), 151-156; A 67-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF RECENT MYOCARDIAL INFARCTION UNDERWENT A TOTAL OF 5 SES IMPLANTATION (CYPHER BX OR CYPHER SELECT) IN THREE DIFFERENT VESSELS, CONSISTING OF TWO STENTS IN THE RIGHT CORONARY ARTERY (RCA). (3.5 X 33 MM AND 2.5 X 28 MM), NEXT MONTH, TWO IN THE CIRCUMFLEX CORONARY ARTERY (LCX) (3.0 X 33 MM AND 2.5 X 28 MM), AND 2 MONTHS LATER, ONE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) (2.5 X 28 MM), RESPECTIVELY. NO OTHER LESION CHARACTERISTIC INFORMATION IS AVAILABLE. IT IS UNKNOWN WHETHER THE LESIONS WERE DE-NOVO. AHA/ACC CLASSIFICATIONS OF THE VESSELS ARE UNKNOWN. DETAILS OF STENT IMPLANTATION ARE UNKNOWN. AFTER THE FIRST PROCEDURE, CILOSTAZOL, A PHOSPHODIESTERASE III INHIBITOR, WAS ADDED TO ASPIRIN WHEN TICLOPIDINE, A THIENOPYRIDINE, WAS DISCONTINUED OWING TO MODEST HEPATIC DYSFUNCTION. A FOLLOW-UP CORONARY ANGIOGRAPHY (CAG) AT 9 MONTHS AFTER THE LAST PROCEDURE SHOWED NO SIGNIFICANT RESTENOSIS BUT WITH MODEST FINDINGS SUCH AS PERI-STENT CONTRAST STAINING (PSS) IN THE RCA AND STENT FRACTURE IN THE LCX, EXCEPT ONE STENT PLACED IN THE POSTERIOR DESCENDING CORONARY ARTERY, WHICH SHOWED TOTAL OCCLUSION WITH COLLATERAL CIRCULATION SUPPLIED FROM LAD. THEREAFTER, THE PATIENT HAD CONTINUED TAKING BOTH ASPIRIN AND CILOSTAZOL, AND REMAINED ASYMPTOMATIC AND FREE FROM CARDIOVASCULAR EVENTS ON FOLLOW-UP. AT 66 MONTHS AFTER THE INITIAL PROCEDURE, HE HAD AN ACUTE MYOCARDIAL INFARCTION WITH CARDIOGENIC SHOCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330124 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R| S