BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3332228 · Received September 9, 2013

    Report

    Report Number
    2024168-2013-05727
    Event Type
    Death
    Date Received
    September 9, 2013
    Date of Event
    December 31, 2011
    Report Date
    August 12, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. AFTER PROPENSITY SCORE-BASED PATIENT MATCHING, 647 PATIENTS IN EACH GROUP WERE ASSESSED FOR ANALYSIS. THE OVERALL INCIDENCE OF MACCES WAS 7.6% IN THE PCI GROUP (49 PATIENTS) AND 3.2% IN THE OPCAB GROUP (21 PATIENTS, P=0.001). MATCHING POPULATION PCI GROUP (N=647): DEATH (20, 3.1%), NONFATAL MI (13, 2.0%), STROKE (8, 1.2%), TVR (20, 3.1%). IN PATIENTS WITH TRIPLE-VESSEL DISEASE AND LEFT MAIN CORONARY ARTERY DISEASE, THE UNADJUSTED 3-YEAR FREEDOM FROM MACCE WAS 88.5 +/- 1.6% IN THE PCI GROUP (N=847) AND 94.8 +/- 1.1% IN THE OPCAB GROUP (N=799)(P=0.0003). PCI DEATH (95.4 +/- 1.6%), NONFATAL MI (96.5, +/- 1.1%), STROKE (98.4 +/- 0.6%), TVR (95.1 +/- 1.1%) IN THE SUBGROUP ANALYSIS OF LEFT MAIN DISEASE, FREEDOM FROM A MACCE WAS 84.6 +/- 3.0% IN THE PCI GROUP (N=236) AND 96.4 +/- 1.3% IN THE OPCAB GROUP (N=251)(P=0.0001). PCI DEATH (93.3 +/- 2.0%), NONFATAL MI (97.3 +/- 1.4%), STROKE (96.7 +/- 1.6%), TVR (92.6 +/- 2.3%). NO ADDITIONAL INFORMATION WAS PROVIDED. DATE OF EVENT ESTIMATED BASED ON DATE OF PUBLICATION. DATE OF IMPLANT ESTIMATE BASED ON DATE OF PUBLICATION. THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH IS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN PATIENT EFFECT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE RX XIENCE REFERENCED IS BEING FILED UNDER A SEPARATE MANUFACTURING REPORT NUMBER.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE ARTICLE: IT WAS REPORTED THAT THE STUDY ENROLLED 1,821 PATIENTS WITH TRIPLE VESSEL OR LEFT MAIN CORONARY DISEASE, OR BOTH, WHO UNDERWENT OFF PUMP CORONARY ARTERY BYPASS GRAFTING (OPCAB) (N=843) OR PERCUTANEOUS CORONARY INTERVENTION (PCI, N=978) WITH SECOND-GENERATION DRUG ELUTING STENT (DES) FROM JANUARY 2008 TO DECEMBER 2011. THE REAL WORLD POPULATION OF 1,821 PATIENTS AND IN A PROPENSITY SCORE-BASED MATCHED POPULATION OF 1,294 PATIENTS. THE NUMBER OF PATIENTS IN THE DES GROUP WHO RECEIVED AT LEAST 1 SECOND-GENERATION DES STENT OF PROMUS OR XIENCE V WERE 425 PATIENTS (43.5%) AND THE NUMBER OF NON-ABBOTT STENTS USED WERE IN 553 PATIENTS (56.5%). MAJOR ADVERSE CARDIAC AND CEREBROVASCULAR EVENTS (MACCES), INCLUDING DEATH, MYOCARDIAL INFARCTION, STROKE, AND TARGET VESSEL REVASCULARIZATION, WERE RETROSPECTIVELY COMPARED BETWEEN THE TWO GROUPS IN A REALWORLD AND IN A MATCHED POPULATION (N=1,294). FOLLOWUP DURATION WAS 23.0 +/- 13.0 MONTHS (RANGE, 0 TO 56 MONTHS). THERE WERE 5 IN-HOSPITAL DEATHS (0.5%) IN THE PCI GROUP AND 7 IN THE OPCAB GROUP (0.8%, P=0.384). IN THE PCI GROUP, 4 PATIENTS REQUIRED SURGICAL REPAIR FOR PUNCTURE SITE COMPLICATIONS. THE OVERALL INCIDENCE OF MACCES WAS 7.3% (71 PATIENTS) IN THE PCI GROUP AND 3.8% (32 PATIENTS) IN THE OPCAB GROUP (P=0.0001): REAL WORLD PCI GROUP (N=978): DEATH (28, 2.9%), NONFATAL MYOCARDIAL INFARCTION (MI) 17, 1.7%), STROKE (11, 1.1%), TARGET VESSEL REVASCULARIZATION (TVR) (31, 3.2%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448627 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death