BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2001236 · Received February 24, 2011

    Report

    Report Number
    2024168-2011-01174
    Event Type
    Injury
    Date Received
    February 24, 2011
    Date of Event
    November 4, 2010
    Report Date
    January 31, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANGINA AND MYOCARDIAL INFARCTION ARE KNOWN ADVERSE EVENTS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE RX PROMUS (PART 1009541-18B, LOT 8100161) IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. OCCLUSION IS A KNOWN ADVERSE EVENT AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE OR DESIGN.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL REPORTED INFORMATION INDICATES THAT ON (B)(6) 2010, 442 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED DUE TO CHEST PAIN AND SHORTNESS OF BREATH. TROPONIN ELEVATION WAS CONSISTENT WITH ARC DEFINITION MI. THE PATIENT WAS TREATED MEDICALLY. THE GRADIENT ACROSS THE SUBJECT'S BIOPROSTHETIC AORTIC VALVE WAS IN THE MID 50'S AND AORTIC VALVE STENOSIS WAS SUSPECTED. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. THE SUBJECT IS RECOVERING AND THE EVENT IS RESOLVING. RELATIONSHIP TO INDEX PROCEDURE PER INVESTIGATOR: UNRELATED. ON (B)(6) 2011, THE PATIENT WAS ADMITTED, 548 DAYS POST INDEX PROCEDURE, DUE TO 3 DAYS OF SHORTNESS OF BREATH AND LEFT-SIDED CHEST HEAVINESS. THE PATIENT WAS TREATED MEDICALLY. DISCHARGE ASSESSMENT NOTES (B)(6) AORTIC VALVE STENOSIS AND SEVERE MITRAL REGURGITATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2011 ON ASPIRIN AND CLOPIDOGREL. RELATIONSHIP TO INDEX PROCEDURE PER INVESTIGATOR: UNRELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2009. THE TARGET LESION WAS LOCATED IN THE RIGHT POSTEROLATERAL AND THE RIGHT POSTERIOR DESCENDING ARTERY. AFTER PRE-DILATATION, A 3.0 X 18 PROMUS STENT WAS DEPLOYED WITH 5% RESIDUAL STENOSIS. A NON-TARGET LESION IN THE OSTIAL LEFT CIRCUMFLEX ARTERY WAS TREATED WITH ANGIOPLASTY AND A 3.0 X 18 PROMUS STENT. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY WITH ASPIRIN AND CLOPIDOGREL PRESCRIBED. ON (B)(6) 2010, CONGESTIVE HEART FAILURE WAS DIAGNOSED AND THE PATIENT WAS HOSPITALIZED. TREATMENT IF ANY WAS NOT REPORTED. THE PATIENT WAS DISCHARGED (B)(6) 2010. PER PHYSICIAN, THE RELATIONSHIP OF THE CONGESTIVE HEART FAILURE AND HOSPITALIZATION IS UNRELATED TO THE INDEX PROCEDURE. ON (B)(6) 2010, OBSTRUCTIVE CORONARY ARTERY DISEASE WAS DIAGNOSED. THE PATIENT WAS HOSPITALIZED AND UNDERWENT TARGET VESSEL REVASCULARIZATION. THE OUTCOME IS REPORTED AS RESOLVING AND THE PATIENT IS RECOVERING. THE PATIENT WAS DISCHARGED ON (B)(6) 2010. PER THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE INDEX PROCEDURE IS PROBABLE. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9021961

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R RX PROMUS (PART 1009541-18B, LOT 8100161)