BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 2003972 · Received March 1, 2011

    Report

    Report Number
    2024168-2011-01270
    Event Type
    Death
    Date Received
    March 1, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 4, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MAF
    PMA / PMN Number
    P020047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) EVALUATION SUMMARY: EVALUATION OF THE RETURNED DEVICE NOTED BLOOD AND CONTRAST VISIBLE IN THE LOOSELY FOLDED BALLOON, INFLATION LUMEN, AND GUIDE WIRE LUMEN, CONSISTENT WITH A RUPTURE WHILE IN THE PATIENT ANATOMY. THERE WERE MULTIPLE KINKS IN THE HYPOTUBE. THERE WAS A KINK IN THE DISTAL SHAFT 13 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE SOFT TIP WAS BUNCHED AT THE PROXIMAL END FOR A LENGTH OF 1 MM. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINKS AND BUNCHED TIP MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THERE WAS A KINK AND A TEAR IN THE INNER AND OUTER MEMBER 8.8 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE TEAR WAS RADIAL AND LONGITUDINAL, ABOUT 1 MM IN LENGTH. A NEW INDEFLATOR, FILLED WITH WATER, WAS USED TO PRESSURIZE THE STENT DELIVERY SYSTEM (SDS) WHEN WATER LEAKED OUT OF THE TEAR 8.8 CM DISTAL TO THE GUIDE WIRE EXIT NOTCH. THE DISTAL SHAFT WAS CUT 5 CM PROXIMAL TO THE PROXIMAL BALLOON SEAL AND THE BALLOON WAS PRESSURIZED BY ATTACHING A LUER. THERE WAS A LONGITUDINAL RUPTURE IN THE BALLOON AT THE DISTAL END OF THE DISTAL TAPER FOR A LENGTH OF 1 CM. THERE WERE NO SCRATCHES NOTED. SCANNING ELECTRON MICROSCOPY (SEM) ANALYSIS DETERMINED THE RUPTURE MAY POSSIBLY BE RELATED TO EXPOSURE CONDITIONS OR A MATERIAL/PROCESSING DISCREPANCY. THE BALLOON FAILURE INITIATED ALONG THE INNER SURFACE. LONGITUDINAL PARTIAL TEARS WERE OBSERVED ALONG THE INNER SURFACE ADJACENT THE FRACTURE. THE ANALYSIS ALSO CONFIRMED THE SHAFT LEAK MAY BE ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, OR THE LESION/ANATOMY. A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. THE REVIEWER NOTED A STENT IS POSITIONED OVER A LESION IN THE PROXIMAL/MID REGION OF A HIGHLY CALCIFIED AND TORTUOUS LEFT ANTERIOR DESCENDING (LAD). THERE WAS A DEPLOYED STENT SHADOW WITH A BULBOUS, ANEURYSMIC-APPEARING AREA OF THE VESSEL ADJACENT TO THE DISTAL STENT EDGE. THE VESSEL IS OCCLUDED BEYOND THIS AREA. THE REVIEWER CONCLUDED THAT THERE ARE NO IMAGES OF THE BALLOON INFLATION/RUPTURE, OR OF THE PERFORATION AND VESSEL EXTRAVASATION. HOWEVER, IT IS CLEAR THAT THERE WAS SIGNIFICANT VESSEL INJURY AFTER STENT IMPLANT. THIS ANEURYSMIC INJURY WOULD BE THE MOST LIKELY AREA OF RUPTURE OR PERFORATION WHICH COULD LEAD TO CARDIAC TAMPONADE. FACTORS THAT CAN CONTRIBUTE TO MATERIAL RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES AND/OR STENTS, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. RUPTURES THAT INITIATE ALONG THE INNER SURFACE OF THE BALLOON ARE CONSISTENT WITH MULTIPLE/HIGH PRESSURE INFLATIONS; HOWEVER, IT IS UNKNOWN AT WHAT PRESSURE THE BALLOON RUPTURED. IT WAS REPORTED NO PRE-DILATATION WAS PERFORMED PRIOR TO IMPLANTATION OF THE VISION STENT. IT SHOULD BE NOTED THE VISION INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER. ADDITIONALLY, IT SHOULD BE NOTED OCCLUSIONS, PERFORATIONS, VENTRICULAR FIBRILLATION, VENTRICULAR TACHYCARDIA (A TYPE OF ARRHYTHMIA), AND DEATH ARE KNOWN ADVERSE EVENTS LISTED IN THE VISION IFU. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO SIMILAR INCIDENTS REPORTED FOR MATERIAL RUPTURES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. A CONCLUSIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Additional Manufacturer Narrative · 1

    (B)(4) - NO PRE-DILATATION. THE STENT REMAINS IN THE PATIENTS BODY. THE STENT DELIVERY SYSTEM IS EXPECTED TO BE RETURNED. THE LOT NUMBER WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ANGIOPLASTY IN THE MIDDLE THIRD OF THE LEFT ANTERIOR DESCENDING ARTERY, A 3.5 X 18 MM VISION STENT WAS DEPLOYED VIA DIRECT STENTING. DURING INFLATION OF THE STENT DELIVERY SYSTEM BALLOON, WHEN PRESSURE WAS APPLIED TO THE NON-ABBOTT INDEFLATOR, THE GAUGE FAILED TO SHOW PRESSURE INCREASING AND ON ANGIOGRAPHY, THE VISION STENT DELIVERY SYSTEM BALLOON WAS NOTED TO BE RUPTURED, ALONG WITH A DISTAL OPACIFICATION (OCCLUSION) OF THE ARTERY. A NON-ABBOTT BALLOON WAS USED FOR POSTDILATATION OF THE STENT, AT WHICH TIME, THE DISTAL OCCLUSION AND A PERFORATION OF THE ARTERY WAS CONFIRMED. THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND CARDIOGENIC SHOCK. ADENOSIN WAS ADMINISTERED, ALONG WITH DOPAMINE, AND NORADRENALINE. VENTILATORY SUPPORT FOLLOWED BY OROTRACHEAL INTUBATION WAS PERFORMED, KEEPING PROPER LEVELS OF SATURATION. THE PATIENT EXPERIENCED EPISODES OF VENTRICULAR TACHYCARDIA AND VENTRICULAR FIBRILLATION, WHICH REQUIRED ELECTRIC CARDIOVERSION. PERICARDIOCENTISIS WAS PERFORMED UNDER ECHOCARDIOGRAPHIC VISION. A BLOOD TRANSFUSION WAS PERFORMED AND HEMODYNAMIC STABILIZATION OF THE PATIENT WAS ACHIEVED. THE PATIENT SITUATION WAS EVALUATED BY THE CARDIOLOGY MEDICAL BOARD CONSIDERING THE FIRST OPTION, TRANSFER OF THE PATIENT TO THE UNIT WITH EXPECTANT MANAGEMENT, WITH THE POSSIBILITY TO PRESENT ANTERO APICAL INFARCTION. THE NEXT DAY, THE PATIENT EXPIRED. NO ADDITIONAL INFORMATION WAS 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 0081041

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death GUIDE WIRE:CHOICE FLOPPY, INFLATION:BSC INDEFLATOR