BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPO GUIDE CATHETER

    MDR report key: 6089676 · Received November 9, 2016

    Report

    Report Number
    2134265-2016-09966
    Event Type
    Injury
    Date Received
    November 9, 2016
    Date of Event
    October 11, 2016
    Report Date
    October 13, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQO
    PMA / PMN Number
    K992142
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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

    SAME CASE AS MDR ID 2134265-2016-09965. (B)(6). IT WAS REPORTED THAT SPIRAL DISSECTION OCCURRED. IN (B)(6) 2016, CLINICAL ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS LOCATED IN THE RIGHT POSTERIOR DISTAL ARTERY (R-PDA) WITH 90% STENOSIS AND WAS 9MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF 3.00 X 16MM STUDY STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0%. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2016, DURING 6 MONTH FOLLOW UP, THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST PRESSURE OVER A WEEK TO AN OUTLYING HOSPITAL. ECG REVEALED MINOR NON-SPECIFIC ST-T WAVE CHANGES. TROPONIN LEVEL WAS NOT ELEVATED. SYSTOLIC BLOOD PRESSURE WAS 230. THE PATIENT WAS TRANSFERRED TO THE STUDY HOSPITAL FOR FURTHER EVALUATION. WHILE BEING TRANSFERRED TO THE STUDY HOSPITAL, THE PATIENT HAD 7 OUT OF 10 CHEST PAIN ON TRIDIL WITH MINIMAL RELIEF. THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED 40% PROXIMAL STENOSIS, 30% DISTAL STENOSIS, PATENT STENTS IN DISTAL PORTION OF THE RIGHT CORONARY ARTERY (RCA). A SMALL ANEURYSM WAS NOTED WHICH WAS LOCATED OUTSIDE OF THE LUMEN IN THE DISTAL STENT; HOWEVER, THERE WAS NO OBSTRUCTION IN THE FLOW. SUBSEQUENTLY, DURING THE INJECTION OF CONTRAST, IN THE RIGHT ANTERIOR OBLIQUE (RAO) PROJECTION, IT WAS NOTED THAT PATIENT HAD A SPIRAL DISSECTION IN RCA. IT WAS NOTED THAT THE DISSECTION WAS MOST LIKELY CAUSED BY A BSC 5 FRENCH JR4 DIAGNOSTIC CATHETER. THIS SPIRAL DISSECTION RESULTED IN 100% OCCLUSION OF THE RCA. THE OCCLUDED RCA WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A DISTAL 3.00 X 38MM SYNERGY STENT OVERLAPPING WITH THE INITIALLY PLACED STENTS IN DISTAL RCA AND R-PDA FROM THE PAST PROCEDURE (INDEX AND PRIOR TO INDEX), FOLLOWED BY MORE PROXIMAL OVERLAPPING 3.5 X 38MM SYNERGY STENT, FOLLOWED BY ANOTHER MORE PROXIMAL OVERLAPPING OSTIAL 3.5 X 28MM SYNERGY STENT. FOLLOWING POST DILATATION OF THE THREE STENTS, TIMI 3 FLOW WAS NOTED. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740822 EXPO GUIDE CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO BOSTON SCIENTIFIC - MAPLE GROVE UNK130

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention