BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT 2 (TM)

    MDR report key: 1884292 · Received October 27, 2010

    Report

    Report Number
    2134265-2010-04783
    Event Type
    Injury
    Date Received
    October 27, 2010
    Date of Event
    August 31, 2010
    Report Date
    October 3, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A DRUG ELUTING STENTING TREATMENT AND PERCUTANEOUS CORONARY INTERVENTIONAL (PCI) PROCEDURE, A GUIDE WIRE FRACTURE OCCURRED. PATIENT STATUS WAS "URGENT". RETROGRADE VASCULAR ACCESS WAS OBTAINED THROUGH THE RIGHT FEMORAL ARTERY WITH A NON-BSC 5FR SHEATH. THE 70% STENOSED, 5MM LESION WITH TIMI III FLOW WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). DURING THE TREATMENT WITH ANOTHER MANUFACTURER'S 3.0 X 18MM DES STENT, THE PT2 LIGHT SUPPORT 300CM J-TIP GUIDE WIRE SEPARATED AND 6CM OF THE GUIDE WIRE WAS RETAINED IN THE STENT. THE PHYSICIAN WAS UNABLE TO REWIRE THE LAD IN ORDER TO SNARE OR CRUSH THE GUIDE WIRE AGAINST THE VESSEL WALL. THE LAD STENOSIS WAS REDUCED TO 0% AND TIMI III FLOW WAS PRESENT POST PROCEDURE. A SECOND LESION, 100% STENOSED, TIMI 0 FLOW WITH POOR RUN OFF WAS LOCATED IN THE PROXIMAL 1ST DIAGONAL OF THE LAD ARTERY AND WAS TREATED WITH ANOTHER MANUFACTURER'S 2.5MM X 15MM DES STENT. THE STENOSIS WAS REDUCED TO 0% AND TIMI III WAS PRESENT POST PROCEDURE. THE PATIENT REMAINED HOSPITALIZED OVERNIGHT FOR OBSERVATION. NO FURTHER COMPLICATION WAS REPORTED AND THE PATIENT'S STATUS IS DISCHARGED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS INDICATED DUE TO NON-ST ELEVATION MYOCARDIAL INFARCTION. THE PATIENT PRESENTED TO ANOTHER FACILITY REPORTING VERY HEAVY CHEST PRESSURE AND MILD DYSPNEA. THE PATIENT WAS ADMITTED AND SERIAL ENZYMES ROSE FROM .2 TO 2.4. THE FOLLOWING MORNING, CATHETERIZATION REVEALED SIGNIFICANT STENOSIS IN THE LEFT ANTERIOR DESCENDING ARTERY AND THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR THE PREVIOUSLY REPORTED INTERVENTION. THE PROXIMAL LAD WAS PREDILATED WITH A 2.5X15 NON - BSC BALLOON CATHETER THAT WAS INFLATED ONCE TO 6 ATMS FOR 20 SECS. A 2.5X18 NON-BSC DRUG ELUTING STENT (DES)WAS DEPLOYED IN THE PROXIMAL LAD AT 12 ATMS FOR 15 SECS. THE PREVIOUSLY REPORTED 3X18 NON-BSC DES WAS IMPLANTED IN THE 1ST DIAGONAL, NOT THE LAD AS PREVIOUSLY REPORTED, AT 16 ATMS FOR 20 SECS. THE GUIDEWIRE TIP WAS NOTED TO HAVE FORMED A "BALL-LIKE OBSTRUCTION" IN THE PROXIMAL PORTION OF THE STENT. THE PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT RETURNED TO THE CATH LAB THE FOLLOWING DAY. THE PREVIOUSLY INSERTED FEMORAL SHEATH REMAINED SECURED IN PLACE IN THE RIGHT GROIN WITH A 6 INCH HEMATOMA NOTED AROUND THE SHEATH THAT WAS TENDER TO THE TOUCH. FEMORAL AND DORSALIS PEDAL PULSES WERE PRESENT. THE PREVIOUSLY NOTED GUIDE WIRE TIP REMAINED VISIBLE IN THE LAD. A2.0X20 NON-BSC BALLOON CATHETER WAS UNABLE TO CROSS THE LESION. THE BALLOON WAS EXCHANGED FOR A 15X1.5 NON-BSC BALLOON; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS THE LESION. THE PROCEDURE WAS ABORTED. THE PATIENT RETURNED TO THE ICU IN GUARDED CONDITION. AS PREVIOUS ATTEMPTS TO REMOVE OR CRUST THE WIRE TIP AGAINST WERE UNSUCCESSFUL AND THE PATIENT CONTINUED TO DEVELOP INTERMITTENT CHEST PAIN, THE PATIENT WAS SENT TO SURGERY THE FOLLOWING DAY. URGENT OFF-PUMP CORONARY ARTERY BYPASS WAS PERFORMED USING REVERSE AUTOGENOUS SAPHENOUS VEIN GRAFT TO THE LEFT ANTERIOR DESCENDING ARTERY. ON POSTOPERATIVE DAY #2, THE PATIENT DEVELOPED ATRIAL FIBRILLATION. AN AMIODARONE DRIP WITH METOPROLOL CONTROLLED THE PATIENT'S RATE. THE PATIENT DID HAVE SOME LOW BLOOD PRESSURES AND WAS ON NEO-SYNEPHRINE FOR A SHORT TIME. THE PATIENT CONVERTED TO SINUS RHYTHM ON POSTOPERATIVE DAY #3. ON POSTOPERATIVE DAY #5, THE PATIENT HAD RECEIVED MAXIMUM HOSPITAL BENEFIT AND WAS READY FOR DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PT 2 (TM) WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA H7493893102J0

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 2.5 X 15MM XIENCE STENT| VOYAGER BC MR 2.5X15| 3.0 X 18MM XIENCE STENT| 2.5X15 VOYAGER BALLOON CATHETER| DIAGNOSTIC CATHETER: CORDIS 5FR JL4| 2.5X18MM XIENCE STENT