BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 2070948 · Received April 27, 2011

    Report

    Report Number
    3003742446-2011-00209
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    April 19, 2010
    Report Date
    May 13, 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

    CONCOMITANT MEDICAL PRODUCTS: PRE-PROCEDURE: ASPIRIN 325MG, CLOPIDOGREL 75MG, BETA-BLOCKERS AND ACE INHIBITORS. POST-PROCEDURE: ASPIRIN 325MG AND CLOPIDOGREL 754MG. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    ADJUDICATION STATUS-FINAL REPORT. THE REPORT INDICATES THAT THE PATIENT EXPERIENCED A PERI-PROCEDURAL MYOCARDIAL INFARCTION. THIS EVENT WAS PREVIOUSLY REPORTED AS ELEVATED TROPONINS. TARGET LESION: MID LEFT ANTERIOR DESCENDING (LAD) ARTERY: THE LESION WAS 14MM LONG, DE NOVO, HAD 70% STENOSIS AND WAS PRE-DILATED. A 2.5 X 18MM CYPHER STENT WAS DEPLOYED AT 14 ATM. THE STENT WAS POST-DILATED. 1ST DIAGONAL ARTERY: A TYPE C DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY. KISSING BALLOON TECHNIQUE WAS USED AFTER STENTING THE LAD. THERE WAS 80% OSTIAL NARROWING IN THE 1ST DIAGONAL POST STENTING THE LAD. A VERY SMALL DISSECTION OCCURRED AFTER BALLOONING THE DIAGONAL. CONCOMITANT MEDICATIONS WERE ADDED: ASPIRIN 325MG (UNKNOWN START DATE, STOP DATE (B)(6) 2010), METOPROLOL 100MG (UNKNOWN START DATE, STOP DATE (B)(6) 2010), NITROGLYCERIN 0.4MG, RAMITIDINE 300MG, LISINOPRIL 5MG, ATORVASTATIN 40MG, LOPRESSOR 75MG, START DATE: (B)(6) 2010, ASPIRIN 81MG (START DATE: (B)(6) 2010), LOPRESSOR 50 MG (START DATE: (B)(6) 2010). INFORMATION RECEIVED FROM (B)(4) STUDY INDICATED THAT A PATIENT EXPERIENCED A DISSECTION AND A PERI-PROCEDURAL MYOCARDIAL INFARCTION AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS SIGNIFICANT FOR ANGINA, POSITIVE FUNCTIONAL STUDY FOR ISCHEMIA, PREVIOUS PCI 1999, FAMILY HISTORY OF CORONARY ARTERY DISEASE, HYPERLIPIDEMIA, HYPERTENSION, DIABETES, HISTORY OF AN UNKNOWN ALLERGY AND HYPOTHYROIDISM. THE TARGET LESION WAS THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE LESION WAS DESCRIBED AS 75% STENOSED, DE NOVO AND 14MM LONG AND IN THE AREA OF A BIFURCATION. THE LESION WAS PRE-DILATED WITH A 2.5 X 12MM NON-CORDIS BALLOON AT 10ATM. A 2.5 X 18MM CYPHER STENT WAS THEN DEPLOYED AT 14 ATM AND POST-DILATED WITH A 2.5 X 12MM BALLOON AT 14 ATM. THERE WERE NO ANGIOGRAPHIC COMPLICATIONS OR MALFUNCTION. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. A 5MM OSTIAL LESION IN THE 1ST DIAGONAL WAS ALSO TREATED WITH A NON-CORDIS BALLOON. THE OSTIAL 1ST DIAGONAL, A NON-TARGET LESION, WAS TREATED WITH BALLOON ANGIOPLASTY. THE REASON FOR TREATMENT WAS REPORTED BY THE SITE AS "PCI/DISSECTION DID NOT NEED TREATMENT". THE SITE REPORTED A 30% FINAL RESIDUAL IN-LESION STENOSIS WITH A GRADE C DISSECTION AND TIMI 3 FLOW. ADDITIONAL INFORMATION INDICATED THAT THE OSTIUM OF THE DIAGONAL BRANCH HAD BECOME "PINCHED" BY THE STENT IN THE LAD; THE EVENT WAS TREATED WITH KISSING BALLOON TECHNIQUE WITH SATISFACTORY RESULTS. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. DISSECTION AND MYOCARDIAL INFARCTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH IMPLANTING CORONARY ARTERY STENTS AND ARE LISTED AS SUCH IN THE IFU. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT LESION CHARACTERISTICS (AREA OF BIFURCATION) AND THE INHERENT RISK OF THE PROCEDURE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION IN THE INFORMATION PROVIDED THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    THE ADJUDICATION MINUTES WERE RECEIVED AND INDICATE "THE TARGET LESION IN THE MID LAD WAS TREATED WITH PRE-STENT BALLOON ANGIOPLASTY, PLACEMENT OF ONE STUDY STENT AND POST-STENT BALLOON ANGIOPLASTY. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE OSTIAL 1ST DIAGONAL, A NON-TARGET LESION, WAS TREATED WITH BALLOON ANGIOPLASTY. THE REASON FOR TREATMENT WAS REPORTED BY THE SITE AS "PCI/DISSECTION DID NOT NEED TREATMENT". THE SITE REPORTED A 30% FINAL RESIDUAL IN-LESION STENOSIS WITH A GRADE C DISSECTION AND TIMI 3 FLOW." ADDITIONALLY IT IS NOTED IN (B)(6) MINUTES AN ELEVATION OF TROPONIN I IS REPORTED POST PROCEDURE [POST-PROCEDURE ON (B)(6) 2010 AT 13:22, THE CK WAS 82 (RATIO <1), THE CKMB WAS 3.2 (RATIO <1) AND THE TROPONIN I WAS 0.68 (RATIO 3.4)].

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE (B)(4) STUDY INDICATED THAT DURING THE INDEX PROCEDURE, THE PATIENT HAD A 75% STENOSIS IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE LESION WAS DE NOVO, TYPE C AND 14MM LONG. THE LESION WAS PRE-DILATED WITH A 2.5 X 12MM BALLOON AT 10ATM WITH A NON-CORDIS BALLOON. A 2.5 X 18MM CYPHER STENT WAS DEPLOYED AT 14 ATM SUCCESSFULLY. THE STENT WAS POST-DILATED WITH A 2.5 X 12MM BALLOON AT 14 ATM. THERE WERE NO ANGIOGRAPHIC COMPLICATIONS OR MALFUNCTION. THE SITE REPORTED A 0% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. A 5MM OSTIAL LESION IN THE 1ST DIAGONAL WAS ALSO TREATED WITH A NON-CORDIS BALLOON. THE REASON FOR TREATMENT WAS REPORTED BY THE SITE AS "PCI/DISSECTION DID NOT NEED TREATMENT." THE SITE REPORTED A 30% FINAL RESIDUAL IN-LESION STENOSIS WITH A GRADE C DISSECTION AND TIMI 3 FLOW.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening BIVALIRUDIN