BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1211076 · Received October 24, 2008

    Report

    Report Number
    2953200-2008-00965
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 26, 2008
    Report Date
    September 26, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (SECONDARY INTERVENTION) - EVAL SUMMARY: MEDTRONIC HAS RECEIVED THE DEVICE AND ITS ANALYSIS HAS BEEN COMPLETED. THE BALLOON FOLDS AND PROXIMAL AND DISTAL PILLOWS WERE STILL INTACT. THE STENT WAS NOT RETURNED WITH THE DEVICE. A SECTION OF THE HYPOTUBE ALONG WITH LUER AND THE STRAIN RELIEF HAD DETACHED AND WERE NOT RETURNED WITH THE DEVICE. CLARIFICATION HAS BEEN SOUGHT FROM THE ACCOUNT REGARDING THE HYPOTUBE DETACHMENT. THERE WERE CRIMP BAKE IMPRESSIONS EVIDENT ON THE BALLOON INDICATING THAT THE STENT WAS CORRECTLY CRIMPED ONTO THE BALLOON DURING MANUFACTURE. THE PROXIMAL AND DISTAL PILLOWS WERE INTACT AND SHOWED NO EVIDENCE OF INFLATION. INFO RECEIVED FROM THE ACCOUNT CONFIRMED THAT THERE WERE NO ISSUES NOTED WHEN REMOVING THE PROTECTIVE SHEATH. THE STENT WAS INSPECTED PRIOR TO USE WITH NO ISSUES NOTED. THERE WAS NO RESISTANCE NOTED DELIVERING THE STENT TO THE TARGET LESION SITE. CD PROCEDURAL IMAGES SHOW A GAP BETWEEN THE PROXIMAL BALLOON MARKER BAND AND THE MOST PROXIMAL STENT SEGMENTS. THE DISTAL STENT SEGMENTS ARE POSITIONED IMMEDIATELY DISTAL TO THE DISTAL BALLOON MARKER BAND AS PER SPECIFICATION. THE MOST PROXIMAL STENT SEGMENTS APPEAR TO BE FLARED AND BUNCHED. THE POSSIBILITY EXISTS THAT DURING ADVANCEMENT, THE DEVICE MAY HAVE BEEN PULLED TOWARD AND HIT OFF THE GUIDE CATHETER TIP CAUSING THE PROXIMAL STENT SEGMENTS TO FLARE AND BUNCH. IT IS ALSO POSSIBLE THAT DURING ADVANCEMENT THE GUIDE CATHETER POSITION WAS LOST AND THAT THE CATHETER TIP MOVED DISTALLY HITTING OFF THE PROXIMAL STENT SEGMENTS.

    Description of Event or Problem · 1

    COMPLAINT CONCLUSION SUMMARY: A 2.75 MM DIAMETER X 30 MM LENGTH ENDEAVOR RX DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A MID LAD LESION. LESION MORPHOLOGY WAS REPORTED AS NOT TORTUOUS WITH NO CALCIFICATION AND 75% STENOSIS. THE LESION WAS PRE-DILATED. THE PHYSICIAN INSERTED THE ENDEAVOR DRUG-ELUTING STENT USING A TRANSRADIAL APPROACH THROUGH THE RIGHT RADIAL ARTERY. WHEN THE STENT WAS ALMOST TO THE LESION SITE, THE PHYSICIAN NOTED THAT THE PROXIMAL END OF THE STENT HAD BEEN PARTIALLY INFLATED; THOUGH HE HAD NOT INFLATED THE STENT. THE PHYSICIAN TRIED TO PULL BACK THE DELIVERY SYSTEM; HOWEVER WHEN REACHING THE GUIDE CATHETER, THE STENT COULD NOT PULL INWARD INTO THE GUIDE CATHETER. THE PHYSICIAN DECIDED TO USE A SNAP TO ELONGATE THE STENT FOR REMOVAL; THIS WAS SUCCESSFUL AND THE STENT WAS REMOVED. IT IS UNK HOW THE LESION WAS TREATED. THE PT IS REPORTED TO BE GOOD. PLEASE NOTE THAT THIS DEVICE IS DISTRIBUTED OUTSIDE THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000729438

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention