BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATRIUM ICAST COVERED STENT

    MDR report key: 6041671 · Received October 19, 2016

    Report

    Report Number
    1219977-2016-00219
    Event Type
    Injury
    Date Received
    October 19, 2016
    Date of Event
    October 3, 2016
    Report Date
    October 12, 2016
    Manufacturer
    ATRIUM MEDICAL CORPORATION
    Product Code
    JCT
    UDI-DI
    00650862854190
    PMA / PMN Number
    K050814
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED. ASSOCIATED FILE: 1219977-2016-00220.

    Additional Manufacturer Narrative · 1

    ENGINEERING INVESTIGATION: UPON OPENING THE RETURNED DEVICE PACKAGING IT WAS NOTICED THAT ONLY ONE OF THE TWO DEVICES DETAILED IN THE COMPLAINT WAS RETURNED. THERE WERE TWO ICAST BOXES RETURNED AND WERE BOTH 9MM X 59MM X120CM PRODUCTS HOWEVER BOTH DEVICES WERE PRODUCED FROM THE SAME PRODUCTION LOT OF CATHETERS. THE STENT, WHEN EVALUATED, HAD A SIGNIFICANT BEND TO IT PRESUMABLY FROM TRACKING UP AND OVER THE ILIAC ARCH. THE CATHETER SHAFT HAD BEEN ACCORDIANED AT THE PROXIMAL END AS DESCRIBED IN THE COMPLAINT DETAILS. THE CRIMPED STENT DIAMETER WAS MEASURED AND WAS 2.5MM AND IS INDICATIVE OF A PROPERLY CRIMPED STENT. THE STENT WAS IN ITS ORIGINAL CRIMPED POSITION. TO DETERMINE IF THE DEVICE WAS STILL FUNCTIONAL AN 0.035 WIRE WAS PLACED UP THROUGH THE DISTAL END OF THE CATHETER GUIDEWIRE LUMEN. THE WIRE COULD NOT PASS THROUGH THE DAMAGED SECTION OF THE SHAFT. THE DEVICE WAS THEN PREPARED PER THE INSTRUCTIONS FOR USE SUPPLIED WITH THE PRODUCT. THE STENT WAS THEN DEPLOYED TO 8ATM AS SPECIFIED ON THE PRODUCT LABEL. THE BALLOON WAS THEN PRESSURIZED WITH THE STENT STILL IN POSITION TO THE RATED BURST PRESSURE OF 12ATM ALSO SPECIFIED ON THE PRODUCT LABEL. THE ICAST STENT AND DELIVERY SYSTEM PERFORMED PROPERLY WITHOUT ANY ABNORMALITIES NOTED. THE PRODUCT PERFORMED AS EXPECTED EVEN WITH THE DAMAGE TO THE SHAFT AS DESCRIBED ABOVE IN THE COMPLAINT DETAILS. THE DAMAGE OF THE SHAFT DESCRIBED AS ACCORDIANED WAS CAUSED BY EXCESSIVE FORCE BEING APPLIED TO THE CATHETER SHAFT DURING ATTEMPTED ADVANCEMENT. THE INSTRUCTIONS FOR USE SPECIFY THE FOLLOWING CAUTION: "IF RESISTANCE IS ENCOUNTERED DO NOT FORCE PASSAGE". THE DOCTOR WAS INSTRUCTED TO USE THE PROPERLY SIZED SHEATH DURING THE PROCEDURE ON MORE THAN ONE OCCASION BUT DID NOT FOLLOW THE ADVICE OF THE SALES REPRESENTATIVES THAT THE SHEATH WAS TOO LARGE. THE LABEL OF THE ICAST STENT DELIVERY SYSTEM CLEARLY STATES TO USE A 7FR INTRODUCER SHEATH WITH THIS PRODUCT. ENGINEERING SUMMARY: A FULL REVIEW OF BOTH THE DEVICES USED CASE CATHETER LOT HISTORY RECORDS FOR THE DEVICES IN QUESTION WAS PERFORMED. THE RECORDS INDICATE THAT BOTH LOTS OF CATHETERS PASSED ATRIUMS FINAL LOT QUALIFICATION TESTING. THIS INSPECTION REQUIRES THAT THE CATHETER LOT MUST PASS THE FOLLOWING: ABILITY OF THE STENT AND DELIVERY SYSTEM TO BE PASSED THROUGH THE LABELED INTRODUCER SHEATH. ABILITY TO DEPLOY THE STENT AT NOMINAL PRESSURE (8ATM). ABILITY TO WITHDRAW THE DEFLATED BALLOON CATHETER BACK THROUGH THE LABELED INTRODUCER SHEATH ABILITY OF THE DELIVERY SYSTEM TO WITHSTAND 5 INFLATE/DEFLATE CYCLES AT THE RATED BURST PRESSURE (12ATM) WITHOUT LEAKS OR FAILURES. BALLOON BURST TESTING. THE BALLOON MUST BURST OVER THE RATED BURST PRESSURE SPECIFIED ON THE LABEL (12ATM) RESULT: ALL QUALITY INSPECTION SAMPLES PASSED THIS FINAL INSPECTION WITHOUT ANY NON-CONFORMANCES NOTED DURING THE FINAL LOT QUALIFICATION TESTING. CONCLUSION: BASED ON THE DETAILS OF THE EVENT AND THE SUCCESSFUL LOT QUALIFICATION TEST DATA, ATRIUM CAN FIND NO FAULT WITH THE LOT OF STENT DELIVERY SYSTEMS IN QUESTION. CLINICAL EVALUATION: ARTERIAL DISEASE IS USUALLY CAUSED BY A BUILD-UP OF FATTY DEPOSITS ON THE WALLS OF THE ARTERIES. ISCHEMIA IS A RESTRICTION IN BLOOD SUPPLY TO TISSUES CAUSED BY AN OCCLUSION AND RESULTING IN A SHORTAGE OF OXYGEN NEEDED AT THE CELLULAR LEVEL. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND STENTING ARE FREQUENTLY DONE TO TREAT VASCULAR OCCLUSIONS WITH THE INTENTION OF RESTORING BLOOD FLOW THROUGH THE OCCLUDED ARTERIES. A DELAY IN TREATMENT WOULD AFFECT THE SUCCESS OF REPERFUSION OF THAT TISSUE. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE DELIVERY CATHETER TO THE TARGET LESION. THE INSTRUCTIONS FOR USE STATE, "DO NOT FORCE PASSAGE OR WITHDRAWAL OF THE GUIDE WIRE OR DELIVERY SYSTEM IF RESISTANCE IS ENCOUNTERED." THE INSTRUCTIONS FOR USE ALSO RECOMMEND THAT SPECIAL CARE SHOULD BE TAKEN TO ENSURE THAT THE APPROPRIATE SIZE DEVICE, GUIDE WIRE AND SHEATH ARE SELECTED PRIOR TO INTRODUCTION. NATIVE LUMEN DIMENSIONS MUST BE ACCURATELY MEASURED NOT ESTIMATED. ASSOCIATED FILE: (B)(4).

    Description of Event or Problem · 1

    RESISTANCE WAS FELT WHILE ATTEMPTING TO GO FROM THE GUIDE. THE PHYSICIAN PUSHED VERY HARD SEVERAL TIMES. HE THEN PULLED BACK AND THE CATHETER ACCORDIONED TOWARDS THE PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691489 ATRIUM ICAST COVERED STENT PTFE COVERED STENT JCT ATRIUM MEDICAL CORPORATION 85419 241949 00650862854190

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention