BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2024090 · Received March 18, 2011

    Report

    Report Number
    3003742446-2011-00130
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    January 28, 2011
    Report Date
    February 19, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MID LAD TARGET LESION (TL#1) WAS REPORTED TO BE: DE NOVO, 2.75 MM VESSEL DIAMETER, 12 MM LENGTH, A 90% STENOSIS, NOT HEAVILY CALCIFIED, NOT TORTUOUS, NO THROMBUS PRESENT, AND TYPE B2. THE STENT WAS PRE-DILATED WITH A 2.5 X 12 MM BALLOON CATHETER AT 4 ATM. A CYPHER 2.75 X 18 MM STENT (STENT #1) WAS IMPLANTED AT 11 ATM. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE PROXIMAL LAD LESION (TL#2) WAS REPORTED TO BE: DE NOVO, 15 MM LENGTH, A 95% STENOSIS, NOT HEAVILY CALCIFIED, NOT TORTUOUS, NO THROMBUS PRESENT, AND TYPE B2. THE STENT WAS PRE-DILATED WITH A 2.5 X 12 MM BALLOON CATHETER AT 4 ATM. A CYPHER 2.75 X 23 MM STENT (STENT #2) WAS IMPLANTED AT 11 ATM. THE STENT WAS NOT POST-DILATED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. THIS IS ONE OF THREE PRODUCTS USED FOR THE SAME PATIENT. PLEASE REFERENCE MFR REPORT #3003742446-2011-00087, # 3003742446-2010-00168, AND # 3003742446-2011-00130.

    Additional Manufacturer Narrative · 1

    A PATIENT FROM THE (B)(4) STUDY EXPERIENCED RESTENOSIS OF A CYPHER STENT APPROXIMATELY 9 MONTHS AFTER IMPLANTATION. PAST MEDICAL HISTORY THAT MAY HAVE INCREASED THIS PATIENT'S RISK FOR MACE INCLUDES HYPERTENSION, SMOKING, HISTORY OF ALLERGY TO PENICILLIN AND CODEINE, TUBAL LIGATION, HEADACHES, CHRONIC BACK AND NECK PAIN. DURING THE INDEX PROCEDURE, TWO LESIONS IN THE LAD WERE TREATED. THE LESION IN THE MID LAD WAS DESCRIBED AS DE NOVO, TYPE B2, 12MM IN LENGTH IN A 2.75MM VESSEL DIAMETER WITH 90% STENOSIS. A 2.75 X 18 MM CYPHER STENT WAS IMPLANTED IN THE MID LAD. THE LESION IN THE PROXIMAL LAD WAS DESCRIBED AS DE NOVO, TYPE B2, 15MM IN LENGTH IN A 2.75MM VESSEL DIAMETER WITH 95% STENOSIS. THE LESION WAS PRE-DILATED BEFORE A 2.75X23MM CYPHER WAS IMPLANTED. THE STENTS WERE NOT OVERLAPPING. POST-DILATION WAS NOT CONDUCTED. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. MEDICATIONS PRESCRIBED AT DISCHARGE INCLUDED ASPIRIN AND PLAVIX. THREE DAYS LATER, THE PATIENT HAD AN MI AND CORONARY ANGIOGRAPHY REVEALED A THROMBUS INSIDE THE 2.75X23MM CYPHER IN THE PROXIMAL LAD. THERE WAS NO PROBLEM REPORTED WITH THE CYPHER 2.75 X 18 MM STENT IMPLANTED IN THE MID LAD. THESE EVENTS WERE PREVIOUSLY REPORTED. TO TREAT THE THROMBUS, A 3.0X13MM CYPHER STENT WAS IMPLANTED BETWEEN AND OVERLAPPING THE TWO PREVIOUSLY IMPLANTED STENTS. THE PATIENT DID WELL AFTER THE RE-INTERVENTION AND WAS DISCHARGED SIX DAYS AFTER THE INDEX PROCEDURE. DURING THE ONE-MONTH FOLLOW-UP, THE PATIENT REPORTED ANGINA. ADDITIONAL INFORMATION RECEIVED INDICATED THAT APPROXIMATELY NINE MONTHS AFTER THE INDEX PROCEDURE, THERE WAS RESTENOSIS OBSERVED IN THE CYPHER STENT IMPLANTED IN THE MID LAD. THE IN-STENT RESTENOSIS WAS NOTED WITHIN THE 3.0 X 13MM CYPHER STENT (LOT 15111511, (B)(4)) IMPLANTED ON (B)(6) 2010 BETWEEN THE (2) PREVIOUSLY PLACED STENTS. THERE WERE NO PROBLEMS IDENTIFIED REGARDING THE (2) PREVIOUSLY PLACED STUDY STENTS. RE-PCI WAS CONDUCTED WITH THE IMPLANTATION OF A DES STENT. THE DEVICES REMAIN IMPLANTED IN THE PATIENT AND ARE NOT AVAILABLE FOR INSPECTION. MANUFACTURING RECORD (DHR) REVIEW WAS CONDUCTED FOR THE AFFECTED LOT NUMBERS AND THE PRODUCTS MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE 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. PATIENTS WHO ARE KNOWN TO BE AT HIGH-RISK FOR RESTENOSIS INCLUDE THOSE WITH DIABETES, LONG LESIONS, SMALL VESSELS, BIFURCATIONS, AND RESTENOTIC LESIONS. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS AND VESSEL/LESION FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. 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. THIS IS ONE OF THREE PRODUCTS USED FOR THE SAME PATIENT. PLEASE REFERENCE MFR. REPORT #3003742446-2011-00087, # 3003742446-2010-00168, AND # 3003742446-2011-00130.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND WAS FOUND TO HAVE ONE-VESSEL DISEASE AND HAD TWO LESIONS TREATED DURING THE INDEX PROCEDURE. THE PATIENT HAD TWO CYPHER STENTS IMPLANTED IN TWO DIFFERENT LESIONS DURING THE STUDY INDEX PROCEDURE: 2.75 X 18 MM IN THE MID LEFT ANTERIOR DESCENDING (LAD), AND A 2.75 X 23 MM STENT IN THE PROXIMAL LAD. THE TWO STENTS IMPLANTED DURING THE INDEX PROCEDURE WERE NOT OVERLAPPING AND WERE PLACED IN TWO SEPARATE LESIONS. THE INDICATION FOR THE INDEX PROCEDURE WAS UNSTABLE ANGINA/ACUTE CORONARY SYNDROME (ACS). THERE WERE NO ADVERSE EVENTS, PRODUCT DEVIATIONS, OR PROCEDURAL COMPLICATIONS REPORTED DURING THE INDEX PROCEDURE. THREE DAYS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED A MYOCARDIAL INFARCTION (MI). CORONARY ANGIOGRAPHY WAS DONE AND THE CYPHER 2.75 X 23 MM STENT IMPLANTED IN THE PROXIMAL LAD WAS NOTED HAVE IN-STENT-THROMBOSIS AND WAS NOTED TO BE TOTALLY OCCLUDED (100% STENOSIS). THERE WAS NO PROBLEM REPORTED WITH THE CYPHER 2.75 X 18 MM STENT IMPLANTED IN THE MID LAD. THE SUB-ACUTE THROMBOSIS WAS TREATED BY PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). THE EVENT WAS A SERIOUS ADVERSE EVENT (SAE) AND WAS REPORTED TO BE UNRELATED TO THE STUDY PROCEDURE/DRUG, AND WAS PROBABLY RELATED TO THE STUDY DEVICE. THE EVENT OUTCOME WAS REPORTED TO BE RESOLVED WITHOUT SEQUEL. THE PATIENT DID WELL AFTER THE RE-INTERVENTION AND WAS DISCHARGED SIX DAYS AFTER THE INDEX PROCEDURE. ADDITIONAL INFORMATION OBTAINED INDICATED THE PATIENT HAD A CYPHER 3.0 X 13 MM STENT IMPLANTED AFTER THE STUDY INDEX PROCEDURE TO TREAT THE PREVIOUSLY REPORTED THROMBOTIC EVENT/MI AND THAT APPROXIMATELY NINE MONTHS LATER THE CYPHER 3.0 X 13 MM STENT HAD AN IN-STENT-RESTENOSIS (ISR).

    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 15111511

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R