BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2003001 · Received February 28, 2011

    Report

    Report Number
    2024168-2011-01242
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 2, 2011
    Report Date
    February 3, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REPEAT ANGIOGRAM, DONE ON (B)(6) 2011, REVEALED THE DISSECTION IN THE PROXIMAL CX WAS UNCHANGED WITH TIMI 3 FLOW; HOWEVER A 50% OCCLUDED FLAP DISSECTION WAS SEEN IN THE LEFT MAIN (LM) ARTERY. INSTENT RESTENOSIS WAS SEEN IN THE PREVIOUSLY IMPLANTED STENT IN THE LAD. FRACTIONAL FLOW RESERVE (FFR) TO THE LAD WAS 0.69, INDICATING FLOW LIMITATION. THE PATIENT WAS HEMODYNAMICALLY STABLE AND HAD NO RECURRENCE OF CHEST PAIN OR ARRHYTHMIA. EJECTION FRACTION WAS 55%. CORONARY ARTERY BYPASS GRAFT TO THE LAD AND LCX WAS PERFORMED ON (B)(6) 2011. THE PATIENT DID WELL POST-OPERATIVELY AND WAS SCHEDULED FOR DISCHARGE TO HOME ON (B)(6) 2011. THE TREATING PHYSICIAN STATED HE THOUGHT THE GUIDE CATHETER CAUSED THE LM FLAP/DISSECTION AS HE HAD TO DEEP SEAT THE GUIDE FOR IMPROVED SUPPORT TO IMPROVE HIS ABILITY TO DELIVER XIENCE IN MID VESSEL. THE PHYSICIAN ALSO STATED THE LM DISSECTION ALONE WOULD NOT ROUTINELY REQUIRE BYPASS SURGERY AS IT WOULD HEAL; FOR THIS PATIENT WITH THE LM DISSECTION, INSTENT RESTENOSIS IN LAD, AND LCX TIGHT LESION, BYPASS IS BEST TREATMENT. ALTHOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED. GUIDE WIRE: ASAHI PROWATER, BALANCE MIDDLE WEIGHT; GUIDE CATH: VASCULAR SOLUTIONS GUIDELINER, MEDTRONIC GUIDE CATHETER; SHEATH: UNK NON-ABBOTT 6FR; STENT: XIENCE V 2.5X12, XIENCE V 2.5X15, XIENCE V 3.0X18, XIENCE V 2.5X23; OTHER: PLAVIX, ASPIRIN, INTEGRILLIN. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED DISSECTION, ANGINA, AND ARRHYTHMIAS ARE KNOWN ADVERSE EVENTS LISTED IN THE TREK INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2011, DIAGNOSTIC ANGIOGRAPHY SHOWED A TOTAL OCCLUSION IN RIGHT CORONARY ARTERY (RCA), MODERATE DISEASE IN LEFT MAIN (LM), DISTAL LEFT CIRCUMFLEX (LCX), DIAGONAL, AND MILD DISEASE IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH RESTENOSIS OF AN UNKNOWN STENT PREVIOUSLY IMPLANTED IN THE LAD. THEREFORE TREATMENT OF THE DISTAL CX WAS ATTEMPTED WITH 2 PLANNED STENTS. VIA RIGHT RADIAL APPROACH, USING A NON-ABBOTT SHEATH AND NON-ABBOTT GUIDING CATHETER FOR SUPPORT, THE DISTAL CX LESION WAS PREDILATATED USING A TREK BALLOON AND A XIENCE V 2.5 X 18 STENT WAS IMPLANTED WITHOUT DIFFICULTY. AN ATTEMPT WAS THEN MADE TO STENT THE REMAINDER OF THE LESION PROXIMAL TO THE FIRST STENT. A XIENCE V 2.5 X 12 STENT DELIVERY SYSTEM (SDS) DID NOT CROSS THE LESION AND WAS REMOVED. THE PROXIMAL CX WAS DILATATED USING ANOTHER TREK BALLOON, HOWEVER, THE SAME XIENCE V SDS DID NOT CROSS A SECOND TIME AND WAS REMOVED. A XIENCE V 2.5 X 15 DID NOT CROSS THE LESION AND WAS REMOVED. A DISSECTION WAS THEN SEEN IN THE PROXIMAL CX. ATTEMPTS TO TREAT THE DISSECTION WERE UNSUCCESSFUL AS A XIENCE V 3.0 X 18 AND A XIENCE V 2.5 X 23 DID NOT CROSS. THE PROCEDURE ENDED LEAVING THE DISSECTION UNTREATED. THAT EVENING THE PATIENT EXPERIENCED CHEST PAIN AND PREMATURE VENTRICULAR CONTRACTIONS REQUIRING NO TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization| R| S