BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER

    MDR report key: 11170885 · Received January 14, 2021

    Report

    Report Number
    1721279-2021-00009
    Event Type
    Injury
    Date Received
    January 14, 2021
    Date of Event
    December 17, 2020
    Report Date
    December 17, 2020
    Manufacturer
    THE SPECTRANETICS CORPORATION
    Product Code
    LPC
    UDI-DI
    00813132025459
    PMA / PMN Number
    P910001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE DEVICE WAS NOT RETURNED FOR EVALUATION, FROM THE INFORMATION PROVIDED INITIALLY AND IN FURTHER DISCUSSIONS WITH PHILIPS PHYSICIAN (ASSOCIATE DIRECTOR OF MEDICAL AFFAIRS), PHILIPS R&D ENGINEER AND PHILIPS REPRESENTATIVE WHO WAS PRESENT IN THE PROCEDURE, A USE RELATED FAILURE WAS CONCLUDED. IN THE SPECTRANETICS ELCA INSTRUCTIONS FOR USE (IFU), DIRECTIONS FOR USE, CLINICAL TECHNIQUE, , IT STATES: "INTRODUCE A 0.014" (OR SMALLER) GUIDEWIRE TO THE CORONARY ARTERIES VIA THE GUIDING CATHETER. CROSS THE TARGET LESION WITH THE GUIDEWIRE". IT STATES, IN PART: "...UNDER FLUOROSCOPIC CONTROL, GUIDE THE LASER CATHETER TO THE LESION. THE LASER CATHETER'S RADIOPAQUE BAND MARKER INDICATES ITS POSITION RELATIVE TO THE LESION. NOTE: DURING USE WITHIN THE BODY, SIMILAR TO ANY DEVICE USED FOR VASCULAR INTERVENTION, ALWAYS MONITOR LASER CATHETER MOVEMENT AND THE RADIOPAQUE TIP MARKER POSITION WITH FLUOROSCOPY. THE MOVEMENT AND RATE OF ADVANCEMENT OF THE CATHETER DISTAL TIP SHOULD CORRESPOND DIRECTLY WITH THE RATE OF ADVANCEMENT BEING APPLIED TO THE PROXIMAL SHAFT OF THE CATHETER. IF CORRESPONDING MOVEMENT IS NOT APPARENT, REASSESS THE LESION MORPHOLOGY, THE LASER ENERGY BEING APPLIED AND THE STATUS OF SUPPORT EQUIPMENT PRIOR TO CONTINUED TREATMENT..." AND IT STATES: "ADVANCE THE LASER CATHETER TO THE LESION SITE WHILE MAINTAINING THE GUIDEWIRE POSITION IN THE PATIENT'S CIRCLATORY SYSTEM. INJECT CONTRAST MEDIUM SOLUTION THROUGH THE GUIDING CATHETER TO VERIFY THE POSITIONING OF THE LASER CATHETER UNDER FLUOROSCOPY" AND IT STATES, IN PART: DEPRESS THE FOOTSWITCH, ACTIVATING THE CVX-300 EXCIMER LASER SYSTEM, AND SLOWLY, LESS THAN 1MM PER SECOND, ADVANCE THE LASER CATHETER ALLOWING THE LASER ENERGY TO REMOVE THE DESIRED MATERIAL...". IT WAS REPORTED IN THE COMPLAINT THAT THERE WAS RESISTANCE ENCOUNTERED IN THE DISTAL PORTION OF THE EXISTING STENT. DIFFERENT SETTINGS WERE TRIED, BUT THE CATHETER WOULD NOT ADVANCE. THE RADIOPAQUE MARKER SEEMED TO BE WEDGED BETWEEN THE PRE-EXISTING STRUTS OF THE STENT. IT WAS SUSPECTED BY THE TEAM THAT THE GUIDEWIRE WENT THROUGH THE STENT STRUT INSTEAD OF THROUGH THE LESION, AND WHEN THE ELCA DEVICE FOLLOWED THE PATH OF THE GUIDEWIRE IN ATTEMPTS TO ADVANCE THE DEVICE, THE DEVICE'S MARKER BAND BECAME WEDGED BETWEEN THE STENT'S STRUTS AND DETACHED WHEN THE DEVICE WAS REMOVED FROM THE PATIENT.

    Description of Event or Problem · 1

    A PERIPHERAL CORONARY ATHERECTOMY PROCEDURE COMMENCED TO TREAT AN IN-STENT RESTENOSIS (ISR) IN THE DISTAL PORTION OF THE PATIENT'S RIGHT CORONARY ARTERY (RCA). THE PHYSICIAN CHOSE TO USE A SPECTRANETICS ELCA LASER CORONARY LASER ATHERECTOMY CATHETER TO TREAT THE PATIENT. FOLLOWING FLUSHING PROCEDURES LISTED IN THE INSTRUCTIONS FOR USE (IFU), LASING WAS PERFORMED. IT WAS REPORTED THAT THE PHYSICIAN ENCOUNTERED RESISTANCE IN THE DISTAL PORTION OF THE EXISTING STENT, AND THE ELCA DEVICE WOULD NOT ADVANCE DESPITE ATTEMPTING DIFFERENT SETTINGS. THE ELCA DEVICE WAS REMOVED FROM THE PATIENT; HOWEVER THE RADIOPAQUE MARKER BAND THAT IS PRESENT AT THE DISTAL TIP OF THE DEVICE HAD DETACHED AND REMAINED IN THE PATIENT. THE MARKER BAND APPEARED TO BE WEDGED BETWEEN THE PRE-EXISTING STRUTS OF THE STENT. REMOVAL OF THE MARKER BAND FROM THE PATIENT WAS ATTEMPTED BUT UNSUCCESSFUL. A BALLOON AND A STENT WERE USED TO TRAP THE MARKER BAND IN PLACE BETWEEN THE PRE-EXISTING STENT AND THE NEW STENT TO PREVENT INJURY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THE PATIENT SURVIVED WITH NO REPORTED INJURIES, AND WAS REPORTEDLY HOME THE NEXT DAY. ON 13 JAN 2021, ADDITIONAL CASE DETAIL WAS OBTAINED FROM THE PHILIPS REPRESENTATIVE WHO WAS PRESENT IN THE CASE. THERE WAS NO MALFUNCTION NOR DAMAGE TO THE GUIDEWIRE BEING USED DURING THE PROCEDURE. AT NO TIME DID THE GUIDEWIRE'S DISTAL TIP SLIP BACK INTO THE ELCA DEVICE; IT WAS ALWAYS IN FRONT OF THE DEVICE'S DISTAL TIP, PROVIDING A TRACK FOR THE ELCA DEVICE TO FOLLOW. IT WAS SUSPECTED BY THE TEAM THAT THE GUIDEWIRE WENT THROUGH THE STENT STRUT INSTEAD OF THROUGH THE LESION, AND WHEN THE ELCA DEVICE FOLLOWED THE PATH OF THE GUIDEWIRE IN ATTEMPTS TO ADVANCE THE DEVICE, THE DEVICE'S MARKER BAND BECAME WEDGED BETWEEN THE STENT'S STRUTS, LEADING TO THE DEVICE'S MARKER BAND DETACHMENT WHEN THE ELCA DEVICE WAS REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68886 SPECTRANETICS ELCA CORONARY LASER ATHERECTOMY CATHETER DEVICE, ANGIOPLASTY, LASER, CORONARY LPC THE SPECTRANETICS CORPORATION 110-004 FG020C09A 00813132025459

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention