BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2233449 · Received September 2, 2011

    Report

    Report Number
    2024168-2011-06133
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    August 4, 2011
    Report Date
    August 12, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. THE 3.0 X 18 MM PROMUS WAS FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THERE WAS NO REPORT OF ANY DAMAGE OBSERVED TO THE STENT DELIVERY SYSTEM (SDS) OR THE STENT IMPLANT DURING THE INDEX PROCEDURE, WHICH MAY SUGGEST THAT A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE DIFFICULTIES EXPERIENCED. THERE WAS NO REPORTED INFORMATION ON THE PATIENT ANATOMICAL MORPHOLOGY (TORTUOSITY OR CALCIFICATION), WHICH MAY HAVE AIDED THE INVESTIGATION. AS THE DEVICE WAS DISCARDED BY THE ACCOUNT, THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND MAY HAVE FURTHER ASSISTED IN THE INVESTIGATION. FACTORS THAT CAN CONTRIBUTE TO DIFFICULTY DEPLOYING THE STENT/STENT MALAPPOSITION MAY INCLUDE, BUT ARE NOT LIMITED TO, IMPROPER OR INADEQUATE CRIMPING AT THE TIME OF MANUFACTURE, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, INFLATION TECHNIQUE, AN INTERACTION WITH THE PATIENT ANATOMY AND/OR PREVIOUSLY IMPLANTED STENTS, POST DILATATION TECHNIQUE, OR UNDER SIZING OF THE VESSEL. TO ASSURE THAT ALL PRODUCTS PERFORM ACCORDING TO SPECIFICATION, THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE AT ABBOTT VASCULAR. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY PRODUCT QUALITY, INCLUDING FUNCTIONAL TESTING FOR DEPLOYED STENT OUTER DIAMETERS AND PROPER STENT DEPLOYMENT/UNIFORMITY OF EXPANSION. THE REPORTED PATIENT EFFECT OF ARRHYTHMIAS, INCLUDING BRADYCARDIA, AS LISTED IN THE VISION INSTRUCTIONS FOR USE, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING PROCEDURES. REPORTEDLY, PRIOR TO IMPLANTING THE VISION STENT, THE PATIENT WAS DIAGNOSED WITH A MYOCARDIAL INFARCTION (MI) AND CARDIAC CATHETERIZATION REVEALED AN OCCLUSION WITH STENOSIS AND RUPTURED PLAQUE/PROLAPSE IN A PREVIOUSLY IMPLANTED PROMUS STENT. THE LOT HISTORY RECORD REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED AND THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE REPORTED MALAPPOSITION OF THE STENT, WHICH REQUIRED ADDITIONAL TREATMENT WITH A BALLOON CATHETER. IT IS POSSIBLE THAT THE REPORTED INADEQUATE WALL APPOSITION OF THE STENTS MAY HAVE BEEN RELATED TO CHARACTERISTICS OF THE LESION; HOWEVER, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE MALAPPOSITION OF THE STENTS IN ADDITION TO THE PATIENTS ANTIPLATELET MEDICATIONS BEING STOPPED FOR APPROXIMATELY 4-6 WEEKS CONTRIBUTED TO THE REPORTED OCCLUSION, ALTHOUGH THIS COULD NOT BE CONFIRMED. BASED ON THE INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. IT IS POSSIBLE THAT THE REPORTED PATIENT EFFECTS OF ANGINA, NAUSEA, DYSPNEA, DIAPHORESIS AND BRADYCARDIA WERE CASCADING EFFECTS OF THE MI, AS NOTED IN THE PATIENT EFFECTS. ADDITIONALLY, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED WITH A 40% OSTIAL STENOSIS OF THE 1ST SEPTAL PERFORATOR (1SP) AND AN 80% STENOSIS OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (PLAD). A 3.0X18/20MM PROMUS STENT WAS IMPLANTED IN THE P(LAD), JAILING THE 1SP ARTERY. THE STENOSIS AT THE OSTIAL 1SP INCREASED TO 70-80% WITH A TIMI FLOW OF 3. ON (B)(6) 2009, THE PATIENT REPORTED CHEST PAIN. CORONARY ANGIOGRAM CONFIRMED A WIDELY PATENT STENT WITH SIGNIFICANT OSTIAL SEPTAL PERFORATOR DISEASE. THE PATIENT WAS TREATED WITH MEDICATION AND DISCHARGED ON (B)(6) 2009. ON (B)(6) 2011, THE PATIENT WAS RE-HOSPITALIZED WITH SUDDEN ONSET OF SEVERE CHEST PAIN AND VENTRICULAR FIBRILLATION WHICH WAS TREATED WITH DEFIBRILLATION AND WAS DIAGNOSED AS A MYOCARDIAL INFARCTION. ANTIPLATELET MEDICATIONS HAD BEEN STOPPED FOR 4-6 WEEKS. CARDIAC CATHETERIZATION REVEALED AN OCCLUDED OSTIAL LAD WITH STENOSIS AND RUPTURED PLAQUE TO THE MID LAD. THE OSTIAL LAD WAS TREATED WITH THROMBECTOMY AND A 3.0X28MM VISION STENT OVERLAPPING THE PROMUS STENT. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED WITH ORDERS TO TAKE ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2011, THE PATIENT WAS RE-ADMITTED WITH CHEST PAIN, SHORTNESS OF BREATH, DIAPHORESIS AND NAUSEA. TROPONIN WAS ELEVATED. ON (B)(6) 2011, ANGIOGRAM REVEALED WIDELY PATENT STENTS IN THE LAD, BUT THERE WERE A FEW AREAS WHERE THE STENTS WERE NOT FULLY APPOSED TO THE VESSEL WALL. BALLOON ANGIOPLASTY WAS DONE RESULTING IN GOOD WALL APPOSITION. POST-PROCEDURE, THE PATIENT EXPERIENCED SOME BRADYCARDIA WHICH WAS TREATED MEDICALLY. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM CORONARY STENT SYSTEM MAF AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention STENT: PROMUS 3.0 X 18 MM