BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2240736 · Received September 9, 2011

    Report

    Report Number
    3003742446-2011-00408
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    May 5, 2010
    Report Date
    August 16, 2011
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. DISSECTIONS ARE KNOWN POTENTIAL ADVERSE EVENTS DURING PCI. 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. THE CHEST PAIN AND ELEVATED ENZYMES EXPERIENCED BY THE PATIENT POST PROCEDURE ARE LIKELY TO BE RELATED TO THE DISSECTION. 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 DURING THE SAME PROCEDURAL SETTING. PLEASE REFERENCE MFR REPORT #S 3003742446-2011-00407, 00408, AND 00409.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ADDENDUM: BASED ON THE CEC ADJUDICATION MINUTES RECEIVED ON (B)(4) 2012, THE COMMITTEE DETERMINED THAT THE PATIENT EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCT BASED ON THE POST PROCEDURE ELEVATED CARDIAC ENZYMES. MYOCARDIAL INFARCT HAS BEEN ADDED TO THIS REPORT. COMPLAINT CONCLUSION: THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT SUFFERED A PERI-PROCEDURAL MI AND CORONARY ARTERY DISSECTION DURING THE INDEX PROCEDURE. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING MI IN (B)(6) 1990, CABG IN (B)(6) 2009, DYSLIPIDEMIA, HYPERTENSION, ATRIAL FIBRILLATION AND FORMER SMOKER. THE INDICATION FOR THE INDEX PROCEDURE WAS A POSITIVE FUNCTIONAL STUDY WITH ANGINA. ANGIOGRAPHY REVEALED A 60% STENOSIS IN THE PROXIMAL RCA AND A 70% STENOSIS IN THE MID RCA. IN (B)(6) 2010, THE INDEX PROCEDURE WAS PERFORMED FOR TREATMENT OF TWO TARGET LESIONS. THE SITE REPORTED THE FIRST TARGET LESION IN THE PROXIMAL RCA WAS TREATED WITH ONE STUDY STENT AND POST-DILATION. THE CORE LAB REPORTED AN 11% RESIDUAL STENOSIS, NO DISSECTION AND TIMI 3 FLOW WITH THE FOLLOWING COMMENT: "ADDITIONAL STENT DEPLOYED TO COVER DISSECTION IN PROXIMAL MARGIN OF FIRST STENT". THE SITE REPORTED THE SECOND TARGET LESION TREATED WAS THE MID RCA. TWO STUDY STENTS WERE IMPLANTED AND POST-DILATED. THE SECOND STUDY STENT WAS DEPLOYED OVERLAPPING AND PROXIMAL TO THE INITIAL STUDY STENT TO TREAT THE PROXIMAL EDGE DISSECTION. THE SITE REPORTED A 0% RESIDUAL STENOSIS WITH A GRADE B DISSECTION AND TIMI 3 FLOW. THE CORE LAB REPORTED A 3% RESIDUAL STENOSIS, NO DISSECTION AND TIMI 3 FLOW. PRE-PROCEDURE AT 10:35, THE CK WAS 45, THE CKMB WAS 1.9 AND TROPONIN WAS <0.10. IMMEDIATELY PRE-PROCEDURE AT 11:23, THE CK WAS 114, THE CKMB 0.8 AND THE TROPONIN WAS <0.012. POST PROCEDURE THE CK WAS 147, THE CKMB WAS 4.1 AND THE TROPONIN WAS NOT PERFORMED. THE NEXT DAY THE CK WAS 186, THE CKMB WAS 9.4 AND THE TROPONIN WAS 1.72. THE CEC COMMITTEE HAS DEEMED THIS ENZYME ELEVATION AS AN ARC PERI-PROCEDURAL PCI THUS THE FILE HAS BEEN CODED FOR MI. THE ECG CORE LAB REPORT WAS NOT AVAILABLE. THE ECG CORE LAB REPORTED NEW INTERMITTENT PR PROLONGATION (206 MSEC), NO NEW MAJOR ST-T ABNORMALITIES AND NO Q WAVES. THE POST PROCEDURE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED THE DAY AFTER THE PROCEDURE ON DUAL ANTI-PLATELET THERAPY. THE STUDY STENT REMAINS IMPLANTED THUS UNAVAILABLE FOR ANALYSIS. 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. MYOCARDIAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. THE ACT OF ANGIOPLASTY/STENT IMPLANTATION INHERENTLY PRODUCES A LOCALIZED VESSEL INJURY, INCLUDING PLAQUE COMPRESSION AND SPLITTING, POTENTIALLY LEADING TO RELEASE OF ATHEROMATOUS MATERIAL (LESION CONTENTS) INTO THE DOWNSTREAM FLOW AND POTENTIALLY SLOWING OR COMPLETELY OCCLUDING THE BLOOD FLOW. THE INFLATION OF CORONARY DEVICES ALSO INHERENTLY OCCLUDES THE DISTAL BLOOD FLOW, POSSIBLY CREATING ISCHEMIC AREAS (CAUSING CARDIAC ENZYME CHANGES) DISTAL TO THE TARGET LESION. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO RELEASE FOR MARKETING. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS ACTION (INHERENT RISK OF THE PROCEDURE) COMBINED WITH THE PATIENT'S COMPLEX MEDICAL STATUS, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THIS (B)(6) MALE WITH A HISTORY OF PREVIOUS CABG AND MI UNDERWENT STENTING OF THE PROXIMAL AND MID RCA. ONE STENT WAS FIRST IMPLANTED IN THE PROXIMAL RCA. DURING IMPLANT OF THE FIRST STENT IN THE MID RCA, A TYPE B DISSECTION OCCURRED, AND A SECOND STENT WAS THEN DEPLOYED TO COVER THE DISSECTION, WHICH WAS IN THE PROXIMAL MARGIN OF THE 1ST STENT IN THAT LESION. CARDIAC ENZYMES WERE NOTED TO BE ELEVATED BEGINNING 6-12 HOURS POST PROCEDURE, AND AT 16-24 HOURS POST, THE CKMB WAS OVER 3 TIMES THE UPPER LIMIT OF NORMAL. THE PATIENT WAS DISCHARGED HOME THE DAY AFTER THE INDEX PROCEDURE.

    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 15112638

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR