BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1004013 · Received February 26, 2008

    Report

    Report Number
    9616099-2008-00464
    Event Type
    Injury
    Date Received
    February 26, 2008
    Date of Event
    November 3, 2007
    Report Date
    January 31, 2008
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIRST TARGET LESION WAS AT THE MID-RCA. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 3.0MM, AND LESION LENGTH WAS 16MM. PRE-PROCEDURE AND POST-PROCEDURE STENOSIS WAS 95% AND ZERO PERCENT, RESPECTIVELY. TIMI PRE AND POS PROCEDURE WAS I AND III. THE LESION WAS DENOVO, SMOOTH AND READILY ACCESSIBLE AT PROXIMAL SEGMENT. ANGULATION WAS <45 DEGREES, CONCENTRIC WITH LITTLE TO NO CALCIFICATION AND WITHOUT THROMBUS. LESION CLASSIFICATION WAS TYPE B2. A 6F-GUIDING CATHETER WAS USED. THE LESION WAS PREDILATED WITH A 2.5X9MM BALLOON AT 16 ATMS. A DEVICE WAS DEPLOYED AT 16 ATMS WITH SUBOPTIMAL CAUSING INSUFFICIENT FLOW AND REQUIRING POST DILATATION WITH A 3.5X15MM BALLOON AT 10 ATMS. IVUS WAS NOT PERFORMED. THE SECOND LESION WAS AT THE PROXIMAL RCA. THE VESSEL WAS A NATIVE CORONARY ARTERY. REFERENCE VESSEL DIAMETER WAS 3.5MM, AND LESION LENGTH WAS 6MM. PRE-PROCEDURE AND POST-PROCEDURE STENOSIS WAS 95% AND ZERO PERCENT, RESPECTIVELY. TIMI PRE AND POS PROCEDURE WAS I AND III. THE LESION WAS DENOVO, SMOOTH AND READILY ACCESSIBLE AT PROXIMAL SEGMENT. ANGULATION WAS <45 DEGREES, CONCENTRIC WITH LITTLE TO NO CALCIFICATION AND WITHOUT THROMBUS. LESION CLASSIFICATION WAS TYPE B1. A 6F-GUIDING CATHETER WAS USED. THE LESION WAS NOT PREDILATED. A DEVICWE WAS DEPLOYED AT 10 ATMS WITH SUBOPTIMAL CAUSING INSUFFICIENT FLOW AND REQUIRING POST DILATATION WITH A 3.5X9MM BALLOON AT 12 ATMS. IVUS WAS NOT PERFORMED. MEDICATIONS AT DISCHARGE INCLUDED ASPIRIN 100MG, STATINS, ACE-INHIBITORS, BETA-BLOCKERS AND 75MG CLOPIDOGREL. THIS PRODUCT REMAINS IMPLANTED IN THE PATIENT THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. THIS IS ONE OF TWO PRODS BEING REPORTED FOR THE SAME EVENT. PLEASE REFERENCE MFG REPORTS #: 9616099-2008-00464 AND 9616099-2008-00465. PLEASE NOTE: DEVICE IS DISTRIBUTED OUTSIDE THE US. HOWEVER, IT IS SIMILAR TO THE US PRODUCT. ANY ADD'L INFO WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    A REVIEW OF THE INFO RECEIVED INDICATES THAT REDUCED FLOW/HYPO PERFUSION WAS REPORTED DURING THE INDEX PROCEDURE FOLLOWING DEPLOYMENT OF BOTH CYPHER STENTS REQUIRING POST DILATATION OF BOTH STENTS. A REPORT WAS RECEIVED INDICATING THAT AT ONE-MONTH FOLLOW-UP (2007), THE PT WAS ADMITTED TO A HOSP IN A FOREIGN COUNTRY FOR ANGINA PECTORIS. DURING THE ADMISSION, HE HAD NO PAIN, AND WAS DISCHARGED AFTER ONE-DAY HOSPITALIZATION WITH NO CHANGE OF MEDICATION. THIS EVENT WAS REPORTED AS POSSIBLE RELATED TO THE TARGET LESIONS. TWENTY DAYS LATER, THE PT STILL HAD ANGINA PECTORIS. A STRESS TEST WAS PERFORMED WITH POSITIVE RESULTS. AN ANGIOGRAM FOLLOWED, WHICH REVEALED CYPHER STENT PATENCY AND NO EVIDENCE OF MYOCARDIAL INFARCTION. AT THE TARGET LESIONS TIMI WAS III, DIAMETER STENOSIS WAS ZERO PERCENT, WITH NO PERI-STENT RESTENOSIS OF IN STENT RESTENOSIS PATTERN. HOWEVER, THERE WERE OTHER CORONARY PROBLEMS (2 NON-TARGET VESSEL OCCLUSIONS) REQUIRING A CORONARY ARTERY BYPASS GRAFT SURGERY (CABG) PROCEDURE. THE CABG WAS REPORTED AS UNRELATED TO THE INDEX PROCEDURE AND DEVICES. IN 2008, THE PT EXPERIENCED ANOTHER EVENT OF ANGINA PECTORIS. ANOTHER ANGIOGRAPHY WAS PERFORMED DURING ADMISSION TO THE HOSPITAL (FOUR DAYS IN THE). THE STENTS IN THE RCA REMAINED PATENT (INDICATED AS OPEN). HOWEVER, THE RESULTS OF THE CABG PROCEDURE WERE NOT OPTIMAL. THE ONLY POSSIBLE TREATMENT GOING FORWARD IS MEDICATION. THIS EVENT WAS REPORTED AS UNRELATED TO THE INDEX PROCEDURE AND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYPHER SIROLIMUS-ELUTING CORONARY STENT DRUG-ELUTING STENT (NIQ) NIQ CORDIS DE MEXICO NA 13268182

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening| R GUIDING CATHETER SIZE (FR) 6