BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2627900 · Received June 25, 2012

    Report

    Report Number
    3003742446-2012-00433
    Event Type
    Injury
    Date Received
    June 25, 2012
    Date of Event
    April 1, 2010
    Report Date
    May 30, 2012
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS INCLUDED ASPIRIN, PLAVIX, AND HEPARIN. COMPLAINT CONCLUSION: AS REPORTED VIA THE CYPRESS STUDY, AN (B)(6) FEMALE PATIENT WITH A HISTORY OF ANGINA, STABLE ANGINA PECTORIS, HYPERLIPIDEMIA, AND HYPERTENSION EXPERIENCED A VESSEL DISSECTION DURING WIRING OF THE LESION (PRIOR TO THE STENT BEING ENTERED INTO THE PATIENT), EXCESSIVE BLEEDING DURING THE PROCEDURE, AND PERI-PROCEDURAL MI DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS 14 MM IN LENGTH, SEVERELY CALCIFIED, CLASS C AND DE NOVO. THE REFERENCE VESSEL WAS 3.5 MM IN DIAMETER AND SEVERELY TORTUOUS. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA. A 3.0 X 18 MM CYPHER RX WAS IMPLANTED AT 14 ATM BY DIRECT STENTING AND THE LESION WAS POST-DILATED WITH A MAVERICK 3.5 X 12 BALLOON PER STANDARD PROCEDURE AT 16 ATM. THE PATIENT EXPERIENCED A GRADE A DISSECTION DURING THE PROCEDURE PRIOR TO THE CYPHER BEING IN THE PATIENT, WHICH THE INVESTIGATOR FELT WAS DUE TO THE STIFF WIRE (HI-TORQUE EXTRA S'PORT, 300 CM 0.014"). THERE WAS NO TREATMENT FOR THE DISSECTION. PRE- PROCEDURE HEMOGLOBIN WAS 12.3 (LLN 12.3), HEMATOCRIT 35.5 (LLN 35.9), AND TROPONIN I 0.09 (ULN 0.09). THE FOLLOWING DAY HER HEMOGLOBIN WAS 9.8, HEMATOCRIT 28.3 AND TROPONIN I 1.65 (16 TO 24 HOURS POST-PROCEDURE). IT WAS REPORTED THAT THERE WAS EXCESSIVE BLEEDING DURING THE PROCEDURE DUE TO THE COMPLEXITY OF THE PROCEDURE, BUT THERE WAS NO TREATMENT OR BLOOD TRANSFUSION FOR THE BLEEDING. (B)(6) 2010 (PRE-PROCEDURE): CK 91 (ULN 215) AND TROPONIN I = 0.09 (ULN 0.09). (B)(6) 2010: CK = 103 AND TROPONIN I = 1.65 THIS ENZYME ELEVATION EVENT HAS BEEN DEEMED BY THE CEC COMMITTEE TO BE AN ARC (PERI-PROCEDURAL PCI) THUS THE FILE WAS CODED FOR MI. PRE-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL 75 MG AND ASPIRIN 81 MG. INTRA-PROCEDURE MEDICATIONS INCLUDED INTEGRILIN AND HEPARIN. ACT WAS 237. THERE WERE NO CARDIAC EVENTS DURING OR AFTER THE PROCEDURE AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. 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 15087076 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. BLOOD LOSS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL INVASIVE PROCEDURES AND IS INCLUDED IN THE INFORMED CONSENT PROCESS THAT ALL PATIENTS RECEIVE PRIOR TO SURGERY OR PROCEDURE. THIS POSSIBILITY IS USUALLY DISCUSSED AT LENGTH WITH THE PATIENT'S PERFORMING PRACTITIONER. IT IS PARTICULARLY STRESSED WHEN THE PROCEDURE IS ENDOVASCULAR IN NATURE AND THE ARTERIAL SYSTEM IS BEING ACCESSED FOR INTERVENTIONAL TREATMENT. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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.

    Description of Event or Problem · 1

    AS REPORTED VIA THE (B)(4) STUDY, A PATIENT EXPERIENCED A VESSEL DISSECTION DURING WIRING OF THE LESION (PRIOR TO THE STENT BEING ENTERED INTO THE PATIENT), EXCESSIVE BLEEDING DURING THE PROCEDURE, AND PERI-PROCEDURAL MI DURING THE INDEX PROCEDURE. AT THE TIME OF THE INDEX PROCEDURE, ANGIOGRAPHY REVEALED 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE LESION WAS 14 MM IN LENGTH, SEVERELY CALCIFIED, CLASS C AND DE NOVO. THE REFERENCE VESSEL WAS 3.5 MM IN DIAMETER AND SEVERELY TORTUOUS. THE INDICATION FOR THE PROCEDURE WAS STABLE ANGINA. A 3.0 X 18 MM CYPHER RX WAS IMPLANTED AT 14 ATM BY DIRECT STENTING AND THE LESION WAS POST-DILATED WITH A MAVERICK 3.5 X 12 BALLOON PER STANDARD PROCEDURE AT 16 ATM. THE PATIENT EXPERIENCED A GRADE A DISSECTION DURING THE PROCEDURE PRIOR TO THE CYPHER BEING IN THE PATIENT, WHICH THE INVESTIGATOR FELT WAS DUE TO THE STIFF WIRE (HI-TORQUE EXTRA S'PORT, 300 CM 0.014"). THERE WAS NO TREATMENT FOR THE DISSECTION. PRE- PROCEDURE HEMOGLOBIN WAS 12.3 (LLN 12.3), HEMATOCRIT 35.5 (LLN 35.9), AND TROPONIN I 0.09 (ULN 0.09). THE FOLLOWING DAY HER HEMOGLOBIN WAS 9.8, HEMATOCRIT 28.3 AND TROPONIN I 1.65 (16 TO 24 HOURS POST-PROCEDURE). IT WAS REPORTED THAT THERE WAS EXCESSIVE BLEEDING DURING THE PROCEDURE DUE TO THE COMPLEXITY OF THE PROCEDURE, BUT THERE WAS NO TREATMENT OR BLOOD TRANSFUSION FOR THE BLEEDING. (B)(6) 2010 (PRE-PROCEDURE): CK 91 (ULN 215) AND TROPONIN I = 0.09 (ULN 0.09). (B)(6) 2010: CK = 103 AND TROPONIN I = 1.65 THIS ENZYME ELEVATION EVENT HAS BEEN DEEMED BY THE CEC COMMITTEE TO BE AN ARC (PERI-PROCEDURAL PCI) THUS THE FILE WAS CODED FOR MI. PRE-PROCEDURE MEDICATIONS INCLUDED CLOPIDOGREL 75 MG AND ASPIRIN 81 MG. INTRA-PROCEDURE MEDICATIONS INCLUDED INTEGRILIN AND HEPARIN. ACT WAS 237. THERE WERE NO CARDIAC EVENTS DURING OR AFTER THE PROCEDURE AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY.

    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 15087076

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening