BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1994005 · Received February 16, 2011

    Report

    Report Number
    3003742446-2011-00079
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    October 4, 2010
    Report Date
    January 20, 2011
    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: THE CORE LAB IDENTIFIED STENT FRACTURE FOR BOTH DEVICES. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #3003742446-2011-00078 AND #3003742446-2011-00079.

    Additional Manufacturer Narrative · 1

    AMENDED CC TO INCLUDE STENT FRACTURE IN INTRODUCTION SENTENCE. THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT A (B)(6) FEMALE EXPERIENCED RESTENOSIS AND STENT FRACTURE APPROXIMATELY EIGHT MONTHS POST IMPLANTATION OF TWO CYPHER STENTS. THE PATIENT'S MEDICAL HISTORY INCLUDES: HYPERTENSION, HYPERLIPIDEMIA, HISTORY OF MYOCARDIAL INFARCTION ((B)(6) 2009), OBESITY, ASTHMA, DEGENERATIVE JOINT DISEASE (LUMBARSACRAL), HISTORY OF GASTRO ESOPHAGEAL REFLUX DISEASE, HISTORY OF ANXIETY, HISTORY OF DEPRESSION AND CURRENT SMOKING. THE PATIENT WAS ENROLLED IN THE STUDY AND HAD TWO CYPHER STENTS IMPLANTED IN OVERLAPPING FASHION: A 3.0 X 33 MM WAS IMPLANTED IN THE MID RCA AND A 3.5 X 28 MM WAS IMPLANTED IN THE PROXIMAL RCA. ACCORDING TO THE IFU, THIS PRODUCT IS INDICATED FOR USE IN DISCRETE LESIONS EQUAL TO OR LESS THAN 30MM IN LENGTH. THE PROXIMAL RCA LESION WAS DESCRIBED AS 80% STENOSED, DE NOVO, TYPE B1, 20MM IN LENGTH IN A 3.7MM VESSEL REFERENCE DIAMETER. THE MID RCA LESION WAS DESCRIBED AS 60% STENOSED, DE NOVO, TYPE B1, ANATOMICALLY COMPLEX, 30MM IN LENGTH IN A 3.3MM VESSEL REFERENCE DIAMETER. THE LESIONS WERE NOT PRE-DILATED BEFORE DEPLOYMENT OF BOTH CYPHER STENTS. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. POST-DILATION WAS CONDUCTED AND TIMI III FLOW WAS MAINTAINED. APPROXIMATELY EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS NOTED TO HAVE AN 80% IN-STENT-RESTENOSIS (ISR) OF THE PROXIMAL RCA AND STENT FRACTURE PROXIMAL TO THE OVERLAP. THERE WAS COMPLETE TRANSVERSE STENT FRACTURE WITH ABUNDANT MOVEMENT AND DISPLACEMENT OF FRACTURED FRAGMENTS OF MORE THAN 1 MM DURING THE CARDIAC CYCLE AND 62.1% IN-STENT STENOSIS. RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) WAS PERFORMED. THE ISR LESION WAS TREATED BY BALLOON ANGIOPLASTY (PTCA).THE OUTCOME WAS REPORTED TO BE RESOLVED WITHOUT SEQUELAE. 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. 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. 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. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. POSSIBLE DISPOSING FACTORS OF STENT FRACTURE ARE OVERLAPPING STENTS, CARDIAC MOTION AND VESSEL ANGULATIONS/TORTUOSITY FOR THE NATIVE CORONARY ARTERY. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT THERE ARE PATIENT FACTORS, VESSEL/LESION AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. THE CAUSE OF COMPLETE SES FRACTURE IN THE PRESENT CASE WAS MOST LIKELY RELATED TO MECHANICAL STRESSES RESULTING FROM CARDIAC CONTRACTIONS IN A LONG STENTED SEGMENT OF THE RCA. 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 TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR REPORT #3003742446-2011-00078 AND #3003742446-2011-00079.

    Additional Manufacturer Narrative · 1

    CORRECTION: PLEASE NOTE THAT THE STENT FRACTURE WAS NOTED TO BE IN THE PROXIMAL ZONE 3.5X28MM CYPHER STENT. THUS THE CODE FOR FRACTURE HAS BEEN REMOVED FROM THIS 3.0X33MM CYPHER STENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S LEFT VENTRICULAR EJECTION FRACTION WAS FORTY-FIFTY PERCENT (LVEF 40-50%). THE PATIENT WAS REPORTED TO HAVE ONE-VESSEL DISEASE AND HAD TWO LESIONS TREATED DURING THE STUDY INDEX PROCEDURE. THE MID RCA TARGET LESION WAS REPORTED TO BE: A 60% STENOSIS, DE NOVO, 3.3 MM VESSEL DIAMETER, 30 MM LENGTH, NOT CALCIFIED/TORTUOUS, AND TYPE B1. THE LESION WAS NOT PRE-DILATED. A CYPHER 3.0 X 33 MM STENT (STENT #1) WAS IMPLANTED AT 14 ATM. VIA DIRECT STENTING. THE STENT WAS POST-DILATED WITH A 3.75 X 15 MM BALLOON CATHETER AT 22 ATM. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE PROXIMAL RCA TARGET LESION WAS REPORTED TO BE: DE NOVO, AN 80% STENOSIS, 3.7 MM VESSEL DIAMETER, NOT CALCIFIED/TORTUOUS, AND TYPE B1. THE LESION WAS NOT PRE-DILATED. A CYPHER 3.5 X 28 MM STENT (STENT #2) WAS IMPLANTED AT 16 ATM. IN OVERLAPPING FASHION VIA DIRECT STENTING. THE STENT WAS POST-DILATED WITH A 3.75 X 15 MM BALLOON CATHETER AT 16 ATM. THE RESIDUAL STENOSIS WAS 0%. THE FLOW PRE AND POST-PROCEDURE WAS TIMI 3. THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #3003742446-2011-00078 AND #3003742446-2011-00079.

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM (B)(4) STUDY INDICATED THAT A (B)(6) FEMALE EXPERIENCED RESTENOSIS APPROXIMATELY EIGHT MONTHS POST IMPLANTATION OF TWO CYPHER STENTS. THE PATIENT'S MEDICAL HISTORY INCLUDES: HYPERTENSION, HYPERLIPIDEMIA, HISTORY OF MYOCARDIAL INFARCTION ((B)(6) 2009), OBESITY, ASTHMA, DEGENERATIVE JOINT DISEASE (LUMBARSACRAL), HISTORY OF GASTRO ESOPHAGEAL REFLUX DISEASE, HISTORY OF ANXIETY, HISTORY OF DEPRESSION AND CURRENT SMOKING. THE PATIENT WAS ENROLLED IN THE STUDY AND HAD TWO CYPHER STENTS IMPLANTED IN OVERLAPPING FASHION: A 3.0 X 33 MM WAS IMPLANTED IN THE MID RCA AND A 3.5 X 28 MM WAS IMPLANTED IN THE PROXIMAL RCA. THE PROXIMAL RCA LESION WAS DESCRIBED AS 80% STENOSED, DE NOVO, TYPE B1, 20MM IN LENGTH IN A 3.7MM VESSEL REFERENCE DIAMETER. THE MID RCA LESION WAS DESCRIBED AS 60% STENOSED, DE NOVO, TYPE B1, ANATOMICALLY COMPLEX, 30MM IN LENGTH IN A 3.3MM VESSEL REFERENCE DIAMETER. THE LESIONS WERE NOT PRE-DILATED BEFORE DEPLOYMENT OF BOTH CYPHER STENTS. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. POST-DILATION WAS CONDUCTED AND TIMI III FLOW WAS MAINTAINED. APPROXIMATELY EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS NOTED TO HAVE AN 80% IN-STENT-RESTENOSIS (ISR) OF THE PROXIMAL RCA AND A RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) WAS PERFORMED. THE ISR LESION WAS TREATED BY BALLOON ANGIOPLASTY (PTCA).THE OUTCOME WAS REPORTED TO BE RESOLVED WITHOUT SEQUELAE. 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, VESSEL/LESION AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS PATIENT'S RESTENOTIC EVENT. THE INFORMATION AVAILABLE FOR REVIEW DOES NOT INDICATE THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE NO CORRECTIVE ACTION IS REQUIRED. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT #3003742446-2011-00078 AND #3003742446-2011-00079.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE (B)(4) STUDY INDICATED THAT THE PATIENT WAS ENROLLED IN THE STUDY AND HAD TWO CYPHER STENTS IMPLANTED IN THE PROXIMAL/MID RIGHT CORONARY ARTERY (RCA) TARGET LESIONS IN OVERLAPPING FASHION: A 3.0 X 33 MM AND A 3.5 X 28 MM. APPROXIMATELY EIGHT MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS NOTED TO HAVE AN 80% IN-STENT-RESTENOSIS (ISR) OF THE PROXIMAL RCA AND A RE-PERCUTANEOUS CORONARY INTERVENTION (RE-PCI) WAS PERFORMED. THE ISR LESION WAS TREATED BY BALLOON ANGIOPLASTY (PTCA). THE EVENT WAS REPORTED TO BE RELATED TO HAVE A PROBABLE RELATIONSHIP TO THE PREVIOUSLY IMPLANTED DEVICES/PROCEDURE, AND WAS NOT RELATED TO THE STUDY DRUG. THE OUTCOME WAS REPORTED TO BE RESOLVED WITHOUT SEQUELAE.

    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 15050751

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 3.75 X 15 MM BALLOON CATHETER