BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1962090 · Received January 17, 2011

    Report

    Report Number
    3003742446-2011-00035
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    March 9, 2010
    Report Date
    December 22, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING THE INDEX PROCEDURE, A CORONARY ARTERIOSPASM AND EITHER PLAQUE SHIFT OR A CORONARY ARTERY DISSECTION OCCURRED AFTER IMPLANTATION OF TWO CYPHER STENTS AND APPROXIMATELY POST INDEX PROCEDURE THE PATIENT SUFFERED RESTENOSIS. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF OBESITY, ANGINA, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, PREVIOUS PCI AND SMOKING. THE TARGET LESION WAS THE MID TO PROXIMAL RCA. THE VESSEL DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 38MM. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. LESION CLASSIFICATION WAS B1. THE LESION WAS DE NOVO AND 90% STENOSED. PRE-DILATION WAS CONDUCTED BEFORE A 3.5X18MM CYPHER STENT WAS DEPLOYED AT 14ATM IN THE MID RCA. A 3.5X23MM CYPHER WAS DEPLOYED AT 14ATM, PROXIMAL AND OVERLAPPING THE FIRST STENT IN THE PROXIMAL RCA. FOLLOWING THE IMPLANT OF THE 2ND STENT, NARROWING OF THE PROXIMAL MARGIN OF STENTED SEGMENT WAS NOTED WHICH RESOLVED WITH INTRA-CORONARY (IC) NITROGLYCERIN. HOWEVER, THE DISTAL MARGIN OF THE STENTED SEGMENT WAS STILL NARROWED WHICH DID NOT RESOLVE WITH IC NITROGLYCERIN "SUGGESTING PLAQUE SHIFT OR EDGE DISSECTION". THE REPORTER INDICATED THAT A DISTINCTION TO CONFIRM ONE OF THE TWO COULD NOT BE MADE WITH ANGIOGRAPHY, HENCE THE MOST SEVERE EVENT WILL BE REPORTED. A 3RD CYPHER, 3.5X18MM CYPHER STENT WAS DEPLOYED AT 14ATM, DISTAL AND OVERLAPPING THE FIRST STENT IN THE MID RCA, TO TREAT THE DISSECTION OR PLAQUE SHIFT. POST-PROCEDURE STENOSIS WAS 0%. APPROXIMATELY A YEAR AND EIGHT MONTHS POST INDEX PROCEDURE THE PATIENT EXPERIENCE EXERTION CHEST TIGHTNESS AND HAD A REVASCULARIZATION OF THE PROXIMAL RIGHT CORONARY ARTERY. THERE WAS RESTENOSIS NOTED IN THE STENT THAT WAS INITIALLY IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT WAS TREATED WITH A 3.5 X 18, NON CORDIS, STENT. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. VESSEL SPASMS AND DISSECTIONS ARE KNOWN POTENTIAL COMPLICATIONS DESCRIBED IN THE IFU. A SPASM IS A CONTRACTION OF SMOOTH MUSCLES IN A VESSEL WALL REDUCING THE VESSEL DIAMETER AND REDUCING BLOOD FLOW. THE CORONARY ARTERIES HAVE A RELATIVELY HIGH TENDENCY TO DEVELOP SPASM. VESSEL SPASMS RESULT FROM VARIOUS LOCAL EFFECTS LIKE DAMAGES TO THE VESSEL WALL (PTCA) OR INJECTION OF COLD FLUIDS. COMMON TREATMENTS OF VESSEL SPASMS INCLUDE THE ADMINISTRATION OF VASODILATORS SUCH AS NITROGLYCERIN. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. BASED ON THE INFORMATION PROVIDED, THERE ARE INHERENT PROCEDURAL RISK FACTORS AND VESSEL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. 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. 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. THERE ARE PATIENT AND LESION CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, SPECIFICALLY THE RISK FACTORS FOR ATHEROSCLEROTIC DISEASE; I.E. HYPERTENSION AND SMOKING. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00035 AND 3003742446-2011-00036.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: APPROXIMATELY A YEAR AND EIGHT MONTHS POST INDEX PROCEDURE, THE PATIENT EXPERIENCE EXERTION CHEST TIGHTNESS AND HAD A REVASCULARIZATION OF THE PROXIMAL RIGHT CORONARY ARTERY. THERE WAS RESTENOSIS NOTED IN THE STENT THAT WAS INITIALLY IMPLANTED IN THE PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT WAS TREATED WITH A 3.5 X 18, NON CORDIS, STENT. (B)(4). THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3003742446-2011-00035 AND 3003742446-2011-00036. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBER IS 3003742446-2011-00036.

    Additional Manufacturer Narrative · 1

    A REPORT FROM THE (B)(4) STUDY INDICATED THAT DURING THE INDEX PROCEDURE, A CORONARY ARTERIOSPASM AND EITHER PLAQUE SHIFT OR A CORONARY ARTERY DISSECTION OCCURRED AFTER IMPLANTATION OF TWO CYPHER STENTS. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF OBESITY, ANGINA, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION, PREVIOUS PCI AND SMOKING. THE TARGET LESION WAS THE MID TO PROXIMAL RCA. THE VESSEL DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 38MM. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. LESION CLASSIFICATION WAS B1. THE LESION WAS DE NOVO AND 90% STENOSED. PRE-DILATION WAS CONDUCTED BEFORE A 3.5X18MM CYPHER STENT WAS DEPLOYED AT 14ATM IN THE MID RCA. A 3.5X23MM CYPHER WAS DEPLOYED AT 14ATM, PROXIMAL AND OVERLAPPING THE FIRST STENT IN THE PROXIMAL RCA. FOLLOWING THE IMPLANT OF THE 2ND STENT, NARROWING OF THE PROXIMAL MARGIN OF STENTED SEGMENT WAS NOTED WHICH RESOLVED WITH INTRA-CORONARY (IC) NITROGLYCERIN. HOWEVER, THE DISTAL MARGIN OF THE STENTED SEGMENT WAS STILL NARROWED WHICH DID NOT RESOLVE WITH IC NITROGLYCERIN "SUGGESTING PLAQUE SHIFT OR EDGE DISSECTION." THE REPORTER INDICATED THAT A DISTINCTION TO CONFIRM ONE OF THE TWO COULD NOT BE MADE WITH ANGIOGRAPHY, HENCE THE MOST SEVERE EVENT WILL BE REPORTED. A 3RD CYPHER, 3.5X18MM CYPHER STENT WAS DEPLOYED AT 14ATM, DISTAL AND OVERLAPPING THE FIRST STENT IN THE MID RCA, TO TREAT THE DISSECTION OR PLAQUE SHIFT. POST-PROCEDURE STENOSIS WAS 0%. THE PRODUCTS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. VESSEL SPASMS AND DISSECTIONS ARE KNOWN POTENTIAL COMPLICATIONS DESCRIBED IN THE IFU. A SPASM IS A CONTRACTION OF SMOOTH MUSCLES IN A VESSEL WALL REDUCING THE VESSEL DIAMETER AND REDUCING BLOOD FLOW. THE CORONARY ARTERIES HAVE A RELATIVELY HIGH TENDENCY TO DEVELOP SPASM. VESSEL SPASMS RESULT FROM VARIOUS LOCAL EFFECTS LIKE DAMAGES TO THE VESSEL WALL (PTCA) OR INJECTION OF COLD FLUIDS. COMMON TREATMENTS OF VESSEL SPASMS INCLUDE THE ADMINISTRATION OF VASODILATORS SUCH AS NITROGLYCERIN. IN THE PRECAUTIONS SECTION OF THE IFU IT INDICATES THAT IMPLANTING A STENT MAY LEAD TO A DISSECTION OF THE VESSEL DISTAL AND/OR PROXIMAL TO THE STENTED PORTION AND MAY CAUSE ACUTE CLOSURE OF THE VESSEL REQUIRING ADDITIONAL INTERVENTION, I.E. PLACEMENT OF ADDITIONAL STENTS. THIS IS AN INHERENT RISK OF THE PROCEDURE. BASED ON THE INFORMATION PROVIDED, THERE ARE INHERENT PROCEDURAL RISK FACTORS AND VESSEL FACTORS THAT MAY HAVE CONTRIBUTED TO THESE EVENTS. 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.

    Description of Event or Problem · 1

    THE REPORT IS FROM THE (B)(6) STUDY. THE PATIENT WAS A (B)(6) MALE WITH A HISTORY OF OBESITY, ANGINA, HYPERLIPIDEMIA, HYPERTENSION, MYOCARDIAL INFARCTION (WITH PCI IN (B)(6) 2006), AND SMOKING. THE TARGET LESION WAS THE MID TO PROXIMAL RCA. VESSEL DIAMETER WAS 3.5MM AND THE LESION LENGTH WAS 38MM. LESION CLASSIFICATION WAS B1. THE LESION WAS DE NOVO AND 90% STENOSED. PRE-DILATION WAS CONDUCTED WITH A 3 X 15MM BALLOON AT 6ATM. A (B)(4) WAS DEPLOYED AT 14ATM IN THE MID RCA. A (B)(4) WAS DEPLOYED AT 14ATM, PROXIMAL AND OVERLAPPING THE FIRST STENT. FOLLOWING THE IMPLANT OF THE 2ND STENT, NARROWING OF THE PROXIMAL MARGIN OF STENTED SEGMENT WAS NOTED, RESOLVED WITH IC NITROGLYCERIN. HOWEVER, THE DISTAL MARGIN STILL WAS NARROWED WHICH DID NOT RESOLVE (WITH IC NITRO), SUGGESTING PLAQUE SHIFT OR EDGE DISSECTION. A 3RD CYPHER, (B)(4) WAS DEPLOYED AT 14ATM, DISTAL AND OVERLAPPING THE FIRST STENT, TO TREAT THE DISSECTION. POST-PROCEDURE STENOSIS WAS 0%.

    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 15075561

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention