BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    MDR report key: 1952395 · Received January 7, 2011

    Report

    Report Number
    3003742446-2011-00022
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    September 28, 2010
    Report Date
    November 5, 2010
    Manufacturer
    CORDIS LLC (PR)
    Product Code
    NIQ
    PMA / PMN Number
    P020026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOR THE INDEX PROCEDURE, THE LESION IN THE MID LAD WAS DESCRIBED AS 70% STENOSED, BIFURCATED, ECCENTRIC, WITH CALCIFICATION. THE LESION WAS PRE-DILATED WITH A NON-CORDIS PRODUCT. THE REFERENCE VESSEL WAS TORTUOUS. THE LESION WAS NOT A CHRONIC TOTAL OCCLUSION. THERE WAS GOOD WALL APPOSITION OF THE CYPHER STENTS IMPLANTED IN THE MID LAD. THE LESION WAS NOT PRE OR POST-DILATED WITH CORDIS PRODUCT. THERE WAS NO DIFFICULTY TRACKING THE STENT DELIVERY SYSTEM TO THE LESION. THE CAUSE OF THE DISSECTION WAS DEPLOYMENT OF THE STENT. THE DISSECTION WAS TYPE B. THE DISSECTION WAS NOT FLOW LIMITING. THE INVESTIGATOR FELT THE DISSECTION WAS NOT RELATED TO CORDIS PRODUCT. THE PATIENT WAS 100% COMPLIANT WITH (B)(4). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED BY THE (B)(4) STUDY, A CORONARY ARTERY DISSECTION OCCURRED AFTER IMPLANTATION OF A CYPHER STENT. THE DISSECTION WAS SUCCESSFULLY TREATED WITH THE IMPLANTATION OF ANOTHER CYPHER STENT. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. THE LESION WAS DESCRIBED AS ECCENTRIC, 70% STENOSED, BIFURCATED, CALCIFIED AND TORTUOUS. PRE-DILATION WAS NOT CONDUCTED BEFORE A 2.5X18 MM CYPHER STENT WAS IMPLANTED IN THE LAD. THIS WAS COMPLICATED BY A DISTAL MARGINAL, TYPE B DISSECTION THAT WAS NOT FLOW LIMITING. CYPHER IS INDICATED FOR USE IN LESIONS JUDGED TO BE AMENABLE TO COMPLETE INFLATION OF AN ANGIOPLASTY BALLOON. THE DISSECTION WAS SUCCESSFULLY TREATED WITH THE IMPLANTATION OF ANOTHER 2.5X18 MM CYPHER STENT. RESIDUAL STENOSIS 0% AND TIMI FLOW WAS 3. IT WAS OBSERVED DURING THIS PERCUTANEOUS CORONARY INTERVENTION (PCI) THAT THE RCA WAS TOTALLY OCCLUDED AND THERE WAS A 30% STENOSIS IN THE CIRCUMFLEX THAT WAS NOT TREATED. (B)(6) MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH RECURRENT EPISODES OF SHORTNESS OF BREATH AND CHEST TIGHTNESS. CORONARY ANGIOGRAPHY REVEALED PATENT CYPHER STENTS IN THE MID LAD, HOWEVER THERE WAS NEW STENOSIS IN THE FOLLOWING NON-TARGET VESSELS: 50% STENOSIS OF THE MID CIRCUMFLEX, 70% STENOSIS OF THE FIRST OBTUSE MARGINAL, AND 95% STENOSIS OF THE PROXIMAL RIGHT CORONARY ARTERY. THE PATIENT WAS MEDICALLY MANAGED. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT 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 INSTRUCTIONS FOR USE (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 IFU ALSO WARNS THAT THE BALLOON PRESSURE SHOULD NOT EXCEED THE RATED BURST PRESSURE. USE OF PRESSURES HIGHER THAN SPECIFIED ON PRODUCT LABEL MAY RESULT IN RUPTURED BALLOON WITH POSSIBLE INTIMAL DAMAGE AND DISSECTION. BASED ON THE INFORMATION AVAILABLE, THERE ARE POSSIBLE VESSEL CHARACTERISTICS (CALCIFICATION) AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(4) STUDY, THE PATIENT EXPERIENCED UNSTABLE ANGINA SIX MONTHS AFTER THE INDEX PROCEDURE. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY. TWO UNKNOWN CYPHER STENTS WERE IMPLANTED. RESIDUAL STENOSIS 0% AND TIMI FLOW WAS 3. SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH UNSTABLE ANGINA. REPEAT ANGIOGRAPHY WAS PERFORMED AND A CATHETERIZATION REPORT WAS REQUESTED. THE SITE INQUIRED ON WHETHER THERE WAS REVASCULARIZATION AND IF CARDIAC ENZYMES WERE DRAWN. THE UNSTABLE ANGINA RESOLVED AFTER ONE DAY. THE PATIENT RECOVERED AND WAS DISCHARGED. ACCORDING TO THE INVESTIGATOR, THE EVENT WAS NOT RELATED TO CORDIS PRODUCT OR THE INDEX PROCEDURE. MEDICAL RECORDS REVEALED THE DURING THE INDEX PROCEDURE, THE PATIENT UNDERWENT IMPLANTATION OF A 2.5X18MM CYPHER STENT IN THE LAD. THIS WAS COMPLICATED BY A DISTAL MARGINAL DISSECTION AND WAS TREATED WITH ANOTHER 2.5X18MM CYPHER STENT. SIX MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH RECURRENT EPISODES OF SHORTNESS OF BREATH AND CHEST TIGHTNESS. THE SYMPTOMS HAD BEEN GOING ON A FEW DAYS AND THE PATIENT HAD WORSENING SHORTNESS OF BREATH AND TIGHTNESS IN HIS CHEST WITH A DULL ACHE OVER THE LEFT SIDE OF HIS CHEST THAT OCCURRED WITH PHYSICAL ACTIVITY AND EXERTION. THIS WAS RELIEVED WITH SUBLINGUAL NITROGLYCERIN. PATIENT ADMITTED TO TELEMETRY TO RULE OUT MYOCARDIAL INFARCTION. HE WAS STARTED ON HEPARIN, ASPIRIN, PLAVIX, TOPROL, LISINOPRIL, AND CONTINUED NITROGLYCERIN. THERE WAS NO EVIDENCE OF ISCHEMIA ON HIS EKG AND CARDIAC ENZYMES WERE NEGATIVE ON ADMISSION. CORONARY ANGIOGRAPHY REVEALED PATENT CYPHER STENTS IN THE MID LAD. CARDIAC CATHETERIZATION REPORT REVEALED 50% STENOSIS OF THE MID CIRCUMFLEX, 70% STENOSIS OF THE FIRST OSTIAL MARGINAL, AND 95% STENOSIS OF THE PROXIMAL RIGHT CORONARY ARTERY.

    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 15076318

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention UNKNOWN BALLOON CATHETER.