BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATW STEERABLE GUIDEWIRE

    MDR report key: 2222080 · Received August 24, 2011

    Report

    Report Number
    1016427-2011-00082
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    November 1, 2009
    Report Date
    August 5, 2011
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K994358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION RECEIVED FROM (B)(4) INDICATED THAT THE LEFT SUBCLAVIAN ARTERY WAS CANNULATED WITH A JUDKINS RIGHT 3.5, 7F CORONARY GUIDE CATHETER, AND THE TOTALLY OCCLUDED AXILLARY-BRACHIAL SEGMENT WAS CROSSED WITH A 0.014 INCH ALL TRACK CORONARY GUIDE WIRE (CORDIS) WITH A 2.5 MM × 20 MM BALLOON SUPPORT. AFTER SUCCESSFUL CROSSING OF THE LESION WITH THE GUIDE WIRE, IT WAS DILATED WITH A 2.5 MM × 20 MM FOLLOWED BY A 3.5 MM × 28 MM BALLOON. THERE WAS A LONG SEGMENT DISSECTION ACROSS THE OCCLUDED AXILLARY-BRACHIAL ARTERY, WHICH WAS STENTED WITH TWO 8 MM × 80 MM AND 8 MM × 60 MM SMART CONTROL SELF EXPANDING NITINOL STENTS. FOR THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH LEFT UPPER LIMB CLAUDICATION ON DOING MINIMAL MANUAL WORK DURING THE LAST 3 MO. HE ALSO COMPLAINED OF CLASS DYSPNEA ON EXERTION OF THE SAME DURATION. THERE WAS NO HISTORY OF CHEST PAIN, SYNCOPE, LEFT UPPER LIMB NUMBNESS OR DISCOLORATION. THERE WAS NO HISTORY OF RADIATION THERAPY IN THE NECK OR CHEST REGION FOR ANY MALIGNANCY. ON GENERAL PHYSICAL EXAMINATION, HIS LEFT BRACHIAL AND RADIAL PULSES WERE NOT PALPABLE AND BLOOD PRESSURE IN LEFT UPPER LIMB WAS NOT RECORDABLE. THE LEFT UPPER LIMB WAS WARM AND VIABLE WITH NO DISCOLORATION, EPILATION, BRITTLE NAILS OR GANGRENOUS CHANGES. OTHER ARTERIAL PULSES WERE WELL PALPABLE. SYSTEMIC EXAMINATION WAS UNREMARKABLE. HE WAS SUBJECTED TO CARDIAC CATHETERIZATION AND A PERIPHERAL ANGIOGRAM. CORONARY ANGIOGRAPHY PERFORMED VIA THE RIGHT TRANS-FEMORAL ROUTE, REVEALED 50% DIFFUSE STENOSIS OF MAJOR OBTUSE MARGINAL 1, 70% DIFFUSE STENOSIS OF THE PROXIMAL-DISTAL LAD, DOMINANT RCA HAVING MID CUTOFF WITH GRADE ANTEGRADE FILLING OF THE DISTAL RCA. A PERIPHERAL ANGIOGRAM REVEALED TOTAL CUTOFF OF THE LEFT AXILLARY ARTERY AT THE LEVEL OF THE HEAD OF THE HUMERUS. BILATERAL CAROTID, SUBCLAVIAN AND RENAL ARTERIES WERE NORMAL. FOLLOWING A WRITTEN INFORMED CONSENT, HE WAS TAKEN UP FOR CORONARY AND PERIPHERAL INTERVENTIONS. THE LEFT CORONARY ARTERY WAS CANNULATED WITH AN EXTRA BACK-UP 3.5, 6F (MEDTRONIC) GUIDE CATHETER VIA RIGHT TRANS-FEMORAL APPROACH. THE LAD LESION WAS CROSSED WITH A 0.014 INCH ATW CORONARY GUIDE WIRE (CORDIS), PRE- DILATED WITH A 2 MM × 20 MM SPRINTER (MEDTRONIC) BALLOON, AND STENTED WITH 3.5 MM × 28 MM AND 3.5 MM × 18 MM MULTI-LINK VISION (ABBOTT VASCULAR,(B)(4)) STENTS AT 14 ATMS. THE WHOLE STENTED LAD SEGMENT WAS POST-DILATED WITH A 3.5 MM × 15 MM NON-COMPLIANT SPRINTER (MEDTRONIC) BALLOON AT 18 ATMS. TIMI-3 FLOW WAS ACHIEVED IN LAD. THE COMPLAINT PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. DISSECTION IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF THIS TYPE OF PROCEDURE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THE PHYSICAL MANIPULATION INHERENT IN THE STENT IMPLANTATION PROCEDURE INTENTIONALLY DISRUPTS THE VESSEL PLAQUE AND INTIMA IN AN EFFORT TO RECONSTRUCT VIABLE PATENT VASCULATURE AND TREAT THE ATHEROSCLEROTIC DISEASE PROCESS. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. INSPECTIONS ARE IN PLACE TO ENSURE THAT NO DAMAGED PRODUCTS LEAVE THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    ON GENERAL PHYSICAL EXAMINATION, HIS LEFT BRACHIAL AND RADIAL PULSES WERE NOT PALPABLE AND BLOOD PRESSURE IN LEFT UPPER LIMB WAS NOT RECORDABLE. THE LEFT UPPER LIMB WAS WARM AND VIABLE WITH NO DISCOLORATION, EPILATION, BRITTLE NAILS OR GANGRENOUS CHANGES. OTHER ARTERIAL PULSES WERE WELL PALPABLE. SYSTEMIC EXAMINATION WAS UNREMARKABLE. HE WAS SUBJECTED TO CARDIAC CATHETERIZATION AND A PERIPHERAL ANGIOGRAM. CORONARY ANGIOGRAPHY PERFORMED VIA THE RIGHT TRANS-FEMORAL ROUTE, REVEALED 50% DIFFUSE STENOSIS OF MAJOR OBTUSE MARGINAL 1, 70% DIFFUSE STENOSIS OF THE PROXIMAL-DISTAL LAD, DOMINANT RCA HAVING MID CUTOFF WITH GRADE ANTEGRADE FILLING OF THE DISTAL RCA. A PERIPHERAL ANGIOGRAM REVEALED TOTAL CUTOFF OF THE LEFT AXILLARY ARTERY AT THE LEVEL OF THE HEAD OF THE HUMERUS. BILATERAL CAROTID, SUBCLAVIAN AND RENAL ARTERIES WERE NORMAL. FOLLOWING A WRITTEN INFORMED CONSENT, HE WAS TAKEN UP FOR CORONARY AND PERIPHERAL INTERVENTIONS. THE LEFT CORONARY ARTERY WAS CANNULATED WITH AN EXTRA BACK-UP 3.5, 6F (MEDTRONIC) GUIDE CATHETER VIA RIGHT TRANS-FEMORAL APPROACH. THE LAD LESION WAS CROSSED WITH A 0.014 INCH ATW CORONARY GUIDE WIRE (CORDIS), PRE- DILATED WITH A 2 MM X 20 MM SPRINTER (MEDTRONIC) BALLOON, AND STENTED WITH 3.5 MM X 28 MM AND 3.5 MM X 18 MM MULTI-LINK VISION (ABBOTT VASCULAR, (B)(4)) STENTS AT 14 ATMS. THE WHOLE STENTED LAD SEGMENT WAS POST-DILATED WITH A 3.5 MM X 15 MM NON-COMPLIANT SPRINTER (MEDTRONIC) BALLOON AT 18 ATMS. TIMI-3 FLOW WAS ACHIEVED IN LAD. PLEASE NOTE THE CATALOG NUMBER IS UNKNOWN. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS FROM RECEIPT.

    Description of Event or Problem · 1

    THE INFORMATION RECEIVED FROM THE JOURNAL ARTICLE BY VIJAYVERGIYA ET AL IN "PERCUTANEOUS ENDOVASCULAR MANAGEMENT OF ATHEROSCLEROTIC AXILLARY STENOSIS: REPORT OF 2 CASES AND REVIEW OF LITERATURE"; WORLD J CARDIOL, DOI:10.4330/WJC.V3.I5.65 INDICATED THAT THE LEFT SUBCLAVIAN ARTERY WAS CANNULATED WITH A JUDKINS RIGHT 3.5, 7F CORONARY GUIDE CATHETER, AND THE TOTALLY OCCLUDED AXILLARY-BRACHIAL SEGMENT WAS CROSSED WITH A 0.014 INCH ALL TRACK CORONARY GUIDE WIRE (CORDIS) WITH A 2.5 MM X 20 MM BALLOON SUPPORT. AFTER SUCCESSFUL CROSSING OF THE LESION WITH THE GUIDE WIRE, IT WAS DILATED WITH A 2.5 MM X 20 MM FOLLOWED BY A 3.5 MM X 28 MM BALLOON. THERE WAS A LONG SEGMENT DISSECTION ACROSS THE OCCLUDED AXILLARY-BRACHIAL ARTERY, WHICH WAS STENTED WITH TWO 8 MM X 80 MM AND 8 MM X 60 MM SMART CONTROL SELF EXPANDING NITINOL STENTS. FOR THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH LEFT UPPER LIMB CLAUDICATION ON DOING MINIMAL MANUAL WORK DURING THE LAST 3 MO. HE ALSO COMPLAINED OF CLASS DYSPNEA ON EXERTION OF THE SAME DURATION. THERE WAS NO HISTORY OF CHEST PAIN, SYNCOPE, LEFT UPPER LIMB NUMBNESS OR DISCOLORATION. THERE WAS NO HISTORY OF RADIATION THERAPY IN THE NECK OR CHEST REGION FOR ANY MALIGNANCY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATW STEERABLE GUIDEWIRE CARDIOLOGY WIRES & METALS (DQX) DQX CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention 2.5 X 20MM AND 3.5 X 28MM BALLOON.