BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI-LINK RX VISION CORONARY STENT SYSTEM

    MDR report key: 1151432 · Received September 5, 2008

    Report

    Report Number
    2024168-2008-00776
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 6, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A CONCLUSIVE ROOT CAUSE COULD NOT BE DETERMINED FOR THE INABILITY TO DEFLATE THE BALLOON. EVAL SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT SDS WAS RETURNED WITH BLOOD VISIBLE ON THE BALLOON AND IN THE GUIDE WIRE LUMEN. THERE WAS CRYSTALLIZED CONTRAST VISIBLE IN THE BALLOON AND IN THE INFLATION LUMEN. THE STENT IMPLANT WAS NOT RETURNED. THE BALLOON WAS LOOSELY FOLDED. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE TOTAL LENGTH OF THE SDS WAS MEASURED AND MET MANUFACTURING CRITERIA. A NEW INDEFLATOR WAS USED TO PRESSURIZE THE BALLOON. THE BALLOON WOULD NOT INFLATE DUE TO CONTRAST IN THE INFLATION LUMEN. THE SDS WAS PRESSURIZED OVERNIGHT; HOWEVER, THE BALLOON DID NOT INFLATE AND CRYSTALLIZED CONTRAST WAS STILL IN THE INFLATION LUMEN. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND THE RETURNED SDS ANALYSIS. THE ANALYSIS IS CONSISTENT WITH THE REPORTED USE OF THE SDS. FACTORS THAT CAN CONTRIBUTE TO THE INABILITY TO DEFLATE INCLUDE, BUT ARE NOT LIMITED TO, OBSTRUCTIONS IN THE INFLATION LUMEN, CONTRAST CONCENTRATION, KINKS, BENDS, OR TORTUOUS ANATOMY. SUBSEQUENTLY, THE UNSUCCESSFUL DEFLATION LED TO DIFFICULTIES REMOVING THE SDS FROM THE PT ANATOMY. REPORTEDLY, THIS WAS AN AMI CASE AND THE LESION WAS MILDLY TORTUOUS AND CALCIFIED WITH 90% STENOSIS, WHICH MAY HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED. UNFORTUNATELY, DUE TO THE CONDITION OF THE RETURNED DEVICE, A CONCLUSIVE ROOT CAUSE FOR THE INABILITY TO DEFLATE THE BALLOON CANNOT BE DETERMINED. ALSO NOTED DURING THE ANALYSIS WERE BENDS IN THE HYPOTUBE, IT IS POSSIBLE FOR BENDS TO AFFECT THE INABILITY TO DEFLATE, ALTHOUGH, NO DAMAGE WAS OBSERVED DURING PRODUCT INSPECTION PRIOR TO USE AND NO ANOMALIES WERE NOTED AS THE DEVICE WAS PREPPED AND INFLATED. THEREFORE, THEY MAY HAVE OCCURRED DURING REMOVAL OF THE SDS ONCE RESISTANCE WAS ENCOUNTERED OR POSSIBLY DUE TO HANDLING AFTER THE PROCEDURE. IT SHOULD BE NOTED THAT THE CONTRAINDICATION SECTION OF THE VISION IFU STATES NOT TO USE IN, "PATIENTS WHO HAVE EXPERIENCED A RECENT (LESS THAN 1 WEEK) AMI." IN ADDITION, THE IFU ALSO WARNS "SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION, THE ENTIRE SYSTEM SHOULD BE REMOVED AS A SINGLE UNIT." A REVIEW OF THE FINISHED DEVICE LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NON-CONFORMING MATERIAL REPORTS ASSOCIATED WITH THIS LOT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBUS REQUIRING MEDICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. DEVICE ISSUE: FAILURE TO DEFLATE. IT WAS REPORTED THE PROCEDURE WAS AN ACUTE MYOCARDIAL INFARCTION (AMI) CASE WITH MILD TORTUOSITY AND CALCIFICATION. AFTER THE RX VISION STENT DELIVERY SYSTEM (SDS) WAS PRESSURIZED TO 14MM FOR 30 SECONDS TO DEPLOY THE STENT, THE DEVICE FAILED TO DEFLATE COMPLETELY. SUBSEQUENTLY, THERE WAS DIFFICULTY REMOVING THE SDS AND FORCE WAS APPLIED IN ORDER TO RETRACT THE SDS. THE PT THEN EXPERIENCED ST ELEVATION AND THERE WAS THROMBUS OBSERVED AT THE LESION, WHICH WAS TREATED WITH AN ESPRIT BALLOON CATHETER AND INTRA-AORTIC BALLOON PUMP ASSIST DEVICE (IABP). THERE WAS PROLONGED HOSPITALIZATION AND THE PT RECOVERED. NO ADDITIONAL EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK RX VISION CORONARY STENT SYSTEM 74 MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 6101031

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R DIL CATH: LACROSS 2.5X20| GUIDE WIRE: NEO'S ROUTE| RUNTHROUGH| GUIDE CATH: HEARTRAIL 7F JR4.0 SH| 7F GC| OTHER: ATLANTIS PRO| SUOU| THROMBUSTER 7F| ESPRIT 3.5X20