BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION¿

    MDR report key: 2221307 · Received August 24, 2011

    Report

    Report Number
    2134265-2011-03512
    Event Type
    Injury
    Date Received
    August 24, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 27, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE AVAIL. FOR EVAL, RETURNED TO MFR. ON, DEVICE RETURNED TO MFR, DEVICE EVALUATED BY MFR, EVAL SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES: UPDATED. DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A (B)(4) STENT DELIVERY SYSTEM (SDS), STENT, AND A NON-BSC GUIDE CATHETER. THE SDS WAS RECEIVED IN THE LUMEN OF THE GUIDE CATHETER. THERE WAS BLOOD AND CONTRAST ON THE OUTER SURFACES OF THE SDS. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE STENT STRUT IMPRESSIONS ON THE SURFACE OF THE BALLOON BETWEEN THE MARKERBANDS, WHICH INDICATES THE STENT WAS APPROPRIATELY POSITIONED AND SECURED TO THE BALLOON IN MANUFACTURING. THE PROXIMAL END OF THE STENT WAS 5 MM DISTAL TO THE PROXIMAL MARKERBAND. THERE WERE FLARED AND LIFTED STRUTS ON SEVERAL ROWS OF THE PROXIMAL END OF THE STENT. THERE WAS NO DAMAGE TO THE SDS AND GUIDE CATHETER. THERE WAS NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFICIENCIES THAT COULD HAVE CONTRIBUTED TO THE DAMAGE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS COMBINATION PRODUCT. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-03546. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.5X15MM NON BSC BALLOON. THREE ION STENTS WERE THEN SUCCESSFULLY DEPLOYED IN THE PROXIMAL, MID AND DISTAL RCA WITH NO ISSUES. THE PHYSICIAN ATTEMPTED TO PLACE A 3.50X16MM ION STENT BETWEEN THE MID AND DISTAL PREVIOUSLY PLACED ION STENTS; HOWEVER, THE 3.50X16MM ION STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE PREVIOUSLY PLACED 4.0X20MM ION STENT LOCATED IN THE PROXIMAL RCA. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. THE PHYSICIAN THEN ADVANCED A 4.0X16MM ION SDS TO THE LESION; HOWEVER THIS DEVICE WAS ALSO UNABLE TO CROSS THE PREVIOUSLY PLACED STENT IN THE PROXIMAL RCA. THE PHYSICIAN ATTEMPTED TO REMOVE THE SDS FROM THE LESION; HOWEVER, THE DEVICE GOT HUNG UP ON THE PROXIMAL STENT AND BECAME DISLODGED. A NON BSC BALLOON WAS ADVANCED THROUGH THE DISLODGED STENT AND WAS INFLATED, DEPLOYING THE STENT IN THE RCA. IT WAS NOTED THAT THE PATIENT EXPERIENCED NO REFLOW IN THE RCA, A BLOOD PRESSURE DROP AND BRADYCARDIA DUE TO AN AIR BUBBLE AFTER THE STENTS WERE IMPLANTED. THE PATIENT WAS GIVEN ATROPINE AND THE SYMPTOMS WERE SUCCESSFULLY RESOLVED. THE PROCEDURE WAS ENDED AT THIS POINT WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS OKAY.

    Description of Event or Problem · 1

    SAME CASE AS MFR# 2134265-2011-03546. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, STENT DAMAGE OCCURRED. THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PREDILATED WITH A 2.5X15MM NON BSC BALLOON. THREE ION STENTS WERE THEN SUCCESSFULLY DEPLOYED IN THE PROXIMAL, MID AND DISTAL RCA WITH NO ISSUES. THE PHYSICIAN ATTEMPTED TO PLACE A 3.50X16MM ION STENT BETWEEN THE MID AND DISTAL PREVIOUSLY PLACED ION STENTS; HOWEVER, THE 3.50X16MM ION STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE PREVIOUSLY PLACED 4.0X20MM ION STENT LOCATED IN THE PROXIMAL RCA. THE DEVICE WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THE PROXIMAL EDGE OF THE STENT WAS DAMAGED. THE PHYSICIAN THEN ADVANCED A 4.0X16MM ION SDS TO THE LESION; HOWEVER, THIS DEVICE WAS ALSO UNABLE TO CROSS THE PREVIOUSLY PLACED STENT IN THE PROXIMAL RCA. THE PHYSICIAN ATTEMPTED TO REMOVE THE SDS FROM THE LESION; HOWEVER, THE DEVICE GOT HUNG UP ON THE PROXIMAL STENT AND BECAME DISLODGED. A NON BSC BALLOON WAS ADVANCED THROUGH THE DISLODGED STENT AND WAS INFLATED, DEPLOYING THE STENT IN THE RCA. IT WAS NOTED THAT THE PATIENT EXPERIENCED NO REFLOW IN THE RCA, A BLOOD PRESSURE DROP AND BRADYCARDIA DUE TO AN AIR BUBBLE AFTER THE STENTS WERE IMPLANTED. THE PATIENT WAS GIVEN ATROPINE AND THE SYMPTOMS WERE SUCCESSFULLY RESOLVED. THE PROCEDURE WAS ENDED AT THIS POINT WITH NO ADDITIONAL PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CURRENT CONDITION IS OKAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ION¿ CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902416350 14366660

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention 2.5X15MM TREK BALLOON CATHETER| (3) ION STENTS