BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 3250648 · Received July 26, 2013

    Report

    Report Number
    2024168-2013-04712
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 2, 2013
    Report Date
    July 2, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K111899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT PRODUCTS: GUIDE WIRE: STORQ 180CM; SHEATH: 5F CORDIS BRITE TIP. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BALLOON RUPTURE WAS ABLE TO BE CONFIRMED. BASED ON A VISUAL INSPECTION AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. A CINE OF THE PROCEDURE WAS RECEIVED AND REVIEWED BY AN ABBOTT CLINICAL SPECIALIST. A BALLOON INFLATION IS PERFORMED AT THE LESION SITE. A DISSECTION IS VISIBLE AT THE LESION SITE. A STENT IS DEPLOYED THAT OVERLAPS THE EDGES OF THE PREVIOUSLY IMPLANTED STENTS, COVERING THE DISSECTION. THE REVIEWER CONCLUDED THAT THE IMAGES CANNOT CONFIRM BALLOON RUPTURE; HOWEVER, THE SEQUENCE OF EVENTS ARE CONSISTENT WITH THE DESCRIPTION. THE REPORTED PATIENT EFFECT OF DISSECTION IS A KNOWN OBSERVED AND POTENTIAL ADVERSE EVENT AS LISTED IN THE ARMADA 35 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER INSTRUCTIONS FOR USE (IFU). A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET AREA WAS AN IN-STENT RESTENOSIS OF PREVIOUSLY PLACED BARE METAL STENTS (UNSPECIFIED) IN BOTH THE LEFT COMMON ILIAC ARTERY (CIA) AND THE LEFT EXTERNAL ILIAC ARTERY (EIA). IN THE AREA BETWEEN THE PROXIMAL END OF THE STENT IN THE CIA AND THE DISTAL END OF THE STENT IN THE EIA, A MASSIVE STENOSIS WAS NOTED, WHICH ALSO WAS PLANNED TO BE TREATED WITH THE ARMADA 35 BALLOON. THE ARMADA 35 BALLOON WAS ADVANCED OVER THE GUIDE WIRE THROUGH THE STENT IN THE EIA, WITHOUT ANY RESISTANCE, AND IT WAS POSITIONED IN THE AREA BETWEEN THE TWO PREVIOUSLY PLACED STENTS. DURING FIRST INFLATION, THE ARMADA 35 BALLOON RUPTURED AT APPROXIMATELY 8 ATMOSPHERES (ATM). THE PHYSICIAN USED A SYRINGE AND NOT AN INFLATION DEVICE, THEREFORE THE EXACT PRESSURE CANNOT BE VERIFIED. THE RUPTURED BALLOON WAS RETRACTED WITHOUT RESISTANCE. OUTSIDE THE ANATOMY, THE PHYSICIAN CHECKED THE RUPTURED BALLOON, AND IT APPEARED INTACT WITH NO PIECES MISSING. ANGIOGRAPHY REVEALED A DISSECTION AT THE AREA WHERE THE INTERNAL ILIAC ARTERY TAKES OFF FROM THE CIA. A 6.0 X 60 MM FOX PLUS BALLOON WAS USED TO TREAT THE DISSECTION AND TO TREAT THE TARGET IN-STENT RESTENOSIS SECTIONS. HOWEVER, THE RESULT IN THE TREATMENT OF THE DISSECTION WAS NOT SATISFACTORY; THEREFORE THE PHYSICIAN DECIDED TO PLACE A NON-ABBOTT STENT IN THE DISSECTED AREA. THE STENT WAS POST-DILATED WITH A NON-ABBOTT BALLOON AND WAS CONSIDERED TO BE SUCCESSFULLY TREATED. PLAVIX WAS PRESCRIBED FOR THE NEXT 6 MONTHS, DUE TO THE IMPLANTED STENT. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349981 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 798669

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention