BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1902614 · Received November 18, 2010

    Report

    Report Number
    3003742446-2010-00415
    Event Type
    Injury
    Date Received
    November 18, 2010
    Date of Event
    April 17, 2010
    Report Date
    April 19, 2010
    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

    THIS (B)(4) STUDY PATIENT UNDERWENT STENT IMPLANTATION OF THE DISTAL LCX (CIRCUMFLEX) ARTERY AND EXPERIENCED CHEST PAIN ONE DAY POST INDEX PROCEDURE AND APPROXIMATELY (B)(6) MONTHS POST INDEX PROCEDURE SUFFERED INSTENT RESTENOSIS. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY ANGINA, PREVIOUS PERCUTANEOUS CORONARY INTERVENTION, HYPERLIPIDEMIA, HYPERTENSION, POST TRAUMATIC STRESS DISORDER, DEPRESSION, THYROID DISORDER, URTICARA, AND LIPITOR AND NAPROXEN ALLERGY. THE INDEX TARGET LESION WAS LOCATED IN THE DISTAL CIRCUMFLEX. THE LESION WAS DESCRIBED AS DE NOVO, 18 MM IN LENGTH, NON-THROMBOSED, 90% STENOTIC, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 2.75 MM IN DIAMETER AND MILDLY TORTUOUS. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON AT 8 ATMS. A 2.50X23 MM CYPHER RX WAS SUCCESSFULLY IMPLANTED AT 14 ATMS. THE CYPHER RX STENT WAS NOT POST-DILATED. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED DURING THE PROCEDURE. ONE DAY AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA THAT WAS MEDICALLY MANAGED. THE EVENT RESOLVED AFTER TWO DAYS WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO CORDIS PRODUCT AND POSSIBLY RELATED TO THE INDEX PROCEDURE. IT WAS CONFIRMED THE PATIENT EXPERIENCED CHEST PAIN. THE PATIENT DID NOT HAVE A MYOCARDIAL INFARCTION. TREATMENT INCLUDED THREE BABY ASPIRIN. SERIAL TROPONIN AND SERIAL ELECTROCARDIOGRAM WERE NEGATIVE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL UNDER SELF CARE AND PAIN FREE. APPROXIMATELY FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT AGAIN PRESENTED WITH ANGINA. ON FLUOROSCOPIC EXAMINATION, THERE WAS 75 - 80% RESTENOSIS OF THE DISTAL LCX CYPHER INDEX STENT. A NON-CORDIS STENT WAS USED TO TREAT THE RESTENOSIS. THE INDEX 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. REVIEW OF LOT 15096569 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. IN-STENT RESTENOSIS IS A WELL-KNOWN POTENTIAL COMPLICATION FOR THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU). IN THE LITERATURE, (B)(4). RATES WERE HIGHER IN OLDER PATIENTS WITH MORE SEVERE ATHEROSCLEROSIS AND DEPENDED ON THE TYPE OF STENOSIS TREATED. RESTENOSES IN STENTS ARE USUALLY TREATED WITH INTRA-STENT PTA OR PLACEMENT OF A SECOND STENT. PROGRESSION OF ATHEROSCLEROTIC DISEASE IS KNOWN TO CAUSE IN-STENT 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 HYPERLIPIDEMIA.

    Additional Manufacturer Narrative · 1

    THE STUDY COORDINATOR CONFIRMED THE PATIENT HAD 75-80% IN-STENT RESTENOSIS OF CYPHER STENT IMPLANTED IN THE DISTAL CIRCUMFLEX. SHE STATED A NON-CORDIS STENT WAS IMPLANTED AS TREATMENT FOR THE RESTENOSIS. SHE CONFIRMED THE PATIENT DID NOT HAVE CORONARY ARTERY BYPASS GRAFT SURGERY. SHE STATED THAT "CABG" BOX WAS CHECKED IN ERROR ON THE CASE REPORT FORM. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS NOT AVAILABLE FOR EVALUATION. CONCOMITANT DEVICES INCLUDE A 2.5X18MM VOYAGER BALLOON CATHETER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT. 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. REVIEW OF LOT 15096569 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED VIA THE CEC ADJUDICATION MINUTES THAT STATED THE ANGIOGRAPHIC CORE LAB, ON (B)(6), 2010 REPORTED A 24% FINAL RESIDUAL IN-LESION STENOSIS IN THE L-PDA (LEFT POSTERIOR DESCENDING ARTERY) WITH NO DISSECTION AND TIMI 3 FLOW. THE ANGIOGRAPHIC CORE LAB PROVIDED COMMENTS: PATENT STUDY STENT; REMOTE TARGET VESSEL REVASCULARIZATION (TVR) PERFORMED TO IN-STENT RESTENOSIS (ISR) AT DISTAL EDGE OF PREVIOUSLY DEPLOYED STENT IN MARGINAL BRANCH. ON (B)(6) , THE PATIENT UNDERWENT REVASCULARIZATION WITH STENT PLACEMENT IN THE MID CIRCUMFLEX PER A PROVIDED CATHETERIZATION NOTE. THE PATIENT WAS DISCHARGED ON (B)(6) 2010.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6) STUDY, THE PATIENT EXPERIENCED ANGINA APPROXIMATELY ONE DAY AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE DISTAL CIRCUMFLEX. THE LESION WAS DESCRIBED AS DE NOVO, 18MM IN LENGTH, NON-THROMBOSED, 90% STENOSED, WITH MILD CALCIFICATION. THE REFERENCE VESSEL WAS 2.75MM IN DIAMETER AND MILDLY TORTUOUS. THE LESION WAS PRE-DILATED WITH A NON-CORDIS BALLOON AT 8ATMS. A 2.50X23MM CYPHER RX WAS SUCCESSFULLY IMPLANTED AT 14ATMS. THE CYPHER RX STENT WAS NOT POST-DILATED. RESIDUAL STENOSIS WAS 0%. PRE AND POST-PROCEDURE TIMI FLOW WAS 3. NO DISSECTION OCCURRED DURING THE PROCEDURE. ONE DAY AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA THAT WAS MEDICALLY MANAGED. THE EVENT RESOLVED AFTER TWO DAYS WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS POSSIBLY RELATED TO CORDIS PRODUCT AND POSSIBLY RELATED TO THE INDEX PROCEDURE. IT WAS CONFIRMED THE PATIENT EXPERIENCED CHEST PAIN. THE PATIENT DID NOT HAVE A MYOCARDIAL INFARCTION. THE PATIENT WAS SEEN IN THE EMERGENCY ROOM. TREATMENT INCLUDED THREE BABY ASPIRIN. SERIAL TROPONIN AND SERIAL ELECTROCARDIOGRAM WERE NEGATIVE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL UNDER SELF CARE. THE PATIENT REMAINS COMPLETELY PAIN FREE SINCE HOSPITAL DISCHARGE. ADDITIONAL INFORMATION WAS RECEIVED THAT STATED APPROXIMATELY FIVE MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT EXPERIENCED ANGINA AND UNDERWENT CORONARY ARTERY BYPASS SURGERY OF THE DISTAL CIRCUMFLEX. THE EVENT RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR 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) 15096569

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R