BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AVIATOR PLUS PTA DILATATION CATHETER

    MDR report key: 1923938 · Received December 14, 2010

    Report

    Report Number
    9610978-2010-00257
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 14, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    LIT
    PMA / PMN Number
    K071189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE INITIAL 3500A REPORT SHOULD HAVE INDICATED THE FOLLOWING: THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 1016427-2010-00148 AND 9610978-2010-00257. THEREFORE, THIS REPORT IS SUBMITTED TO CORRECT THE OMISSION. ADDITIONAL INFORMATION REMAINS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICATIONS: INTRA-PROCEDURE MEDICATION WAS BIVALIRUDIN. PRE AND POST-PROCEDURE MEDICATIONS INCLUDED ASPIRIN AND CLOPIDOGREL. CONCOMITANT DEVICES: 6MM EXTRA SUPPORT ANGIOGUARD EMBOLIC PROTECTION DEVICE, 2 8X20MM PRECISE PRO RX STENTS AND A 9X20MM PRECISE PRO RX STENT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT THIS (B)(4) STUDY PATIENT UNDERWENT CAROTID ARTERY INTERVENTION AND DURING THE PROCEDURE SUFFERED AN ARTERIAL DISSECTION. THIS IS A (B)(6) MALE WITH MEDICAL HISTORY INCLUDING HYPERLIPIDEMIA, CARDIAC ARRHYTHMIA, ABNORMAL STRESS TEST, CABG, DIABETES MELLITUS, CORONARY ARTERY DISEASE, AND HYPERTENSION (SYSTOLIC>140, OR DIASTOLIC>90, OR REQUIRING MEDICATION). THE INDEX LESION WAS PROXIMAL LEFT INTERNAL CAROTID ARTERY DESCRIBED AS MODERATELY TORTUOUS AND 90% STENOTIC. A CORDIS AVIATOR PLUS 5X20 BALLOON WAS USED TO PREDILATE THE TARGET LESION PRIOR TO ANGIOGUARD INSERTION. HOWEVER, DURING ADVANCEMENT OF THE ANGIOGUARD IT WAS NOTED THAT A DISSECTION HAD OCCURRED WITH THE BALLOON PREDILATATION. THE DISSECTION WAS DESCRIBED AS TYPE B. TWO PRECISE PRO RX STENTS, 8X20MM PRECISE PRO RX AND A 9X20MM PRECISE PRO RX, WERE IMPLANTED TO TREAT BOTH THE TARGET LESION AND THE DISSECTION. THE FINAL DISSECTION GRADE WAS 0. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THE PATIENT HAD NO NEUROLOGICAL DEFICITS UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED ON THE SAME DAY WITHOUT ANY FURTHER ADVERSE EVENTS. NEITHER OF THE COMPLAINT PRODUCTS IS AVAILABLE FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. 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. THERE IS NO EVIDENCE TO SUGGEST THERE WERE ANY MANUFACTURING ISSUES THAT CONTRIBUTED TO THE REPORTED EVENT. THE PHYSICAL MANIPULATION INHERENT DURING 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. REVIEW OF THE INFORMATION SUGGESTS THAT VESSEL AND PROCEDURAL ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 1016427-2010-00148 AND 9610978-2010-00257.

    Description of Event or Problem · 1

    THE NOTIFICATION RECEIVED FOR THE (B)(4) STUDY INDICATED THAT DURING ANGIOPLASTY WITH A CORDIS AVIATOR PLUS 5X20 BALLOON. LOT 15185827 PART#: 424-5020W, A TYPE B DISSECTION OCCURRED. A 6MM EXTRA SUPPORT BASKET ANGIOGUARD EMBOLIC PROTECTION DEVICE WAS ALREADY IN PLACE WHEN THE DISSECTION OCCURRED. IT WAS TREATED WITH AN 8X20MM PRECISE PRO RX. TWO ADDITIONAL STENTS WERE ALSO DEPLOYED TO TREAT THE DISSECTION, ANOTHER 8X20MM PRECISE PRO RX AND A 9X20MM PRECISE PRO RX. THE FINAL DISSECTION GRADE WAS 0. PTA WAS BEING PERFORMED ON A 90% OCCLUDED LESION IN THE PROXIMAL LEFT INTERNAL CAROTID ARTERY OF 13MM IN LENGTH IN A 5.5MM VESSEL DIAMETER WITH MODERATE VESSEL TORTUOUSITY. THE ARCH TYPE WAS I. THE LESION WAS PRE-DILATED AND THE DISSECTION OCCURRED AFTER THE PRE-DILATATION. THE RESIDUAL DIAMETER STENOSIS MEASURED 0%. THE PATIENT HAD NO NEUROLOGICAL DEFICITS UPON LEAVING THE ANGIO SUITE AND WAS DISCHARGED ON THE SAME DAY WITHOUT ANY FURTHER ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVIATOR PLUS PTA DILATATION CATHETER PTA CATHETERS (LIT) LIT CORDIS EUROPA, N.V. NA 15185827

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R