BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BX SONIC STENT DELIVERY SYSTEM (OUS RX)

    MDR report key: 1843571 · Received September 24, 2010

    Report

    Report Number
    9616099-2010-00716
    Event Type
    Injury
    Date Received
    September 24, 2010
    Date of Event
    August 1, 2010
    Report Date
    October 18, 2010
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    MAF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    INFORMATION PROVIDED BY A SALES REPRESENTATIVE INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AND STENT FRACTURE AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THE PATIENT RECEIVED A 3.5 MM X 13 MM BX SONIC STENT IN THE MID RIGHT CORONARY ARTERY IN 2004 FOR UNKNOWN REASONS. THE LESION HAD SOME PLAQUE AND WAS LOCATED IN AN ACTIVELY MOVING SEGMENT OF THE ARTERY. THE STENT WAS NOT POST-DILATED. APPROXIMATELY SIX YEARS LATER THE PATIENT EXPERIENCED CHEST PAIN AND WENT TO THE HOSPITAL. ANGIOGRAPHY AND IVUS WAS PERFORMED REVEALING STENT FRACTURE AND RESTENOSIS. THE PHYSICIAN IMPLANTED ANOTHER STENT TO COVER THE LESION. THREE CDS WITH FILMS WERE RECEIVED AND EVALUATED BY AN INDEPENDENT CARDIOLOGIST WHO INDICATED THE FOLLOWING: "THE FINDINGS WERE THAT OF AN INDIVIDUAL WHO UNDERWENT DIAGNOSTIC CATHETERIZATION IN THE YEAR 2004 FOR MODERATE DISEASE OF THE MID RIGHT CORONARY ARTERY. THE STENT WAS PLACED AND SIX YEARS LATER THE PATIENT DEVELOPED CHEST PAIN, WAS FOUND TO HAVE A STENT FRACTURE WITH AN ECCENTRIC RE-STENOTIC LESION. THE PATIENT HAD ANOTHER STENT TO COVER THE LESION AND THERE WS EVIDENCE OF PROGRESSION OF DISEASE DISTALLY WHERE STENTING WS PERFORMED IN THE DISTAL SEGMENT. THE EVENTUAL ANGIOGRAPHIC RESULT WAS GOOD AFTER THE LONG STENT WAS PLACED IN THE MID RCA IN THE PRE-EXISTING FRACTURED STENT WHICH WAS A BARE METAL STENT 3.5X13 MM DX SONIC. THE ANGIOGRAPHIC FINDINGS OF SIGNIFICANCE ARE THAT THE VESSEL WAS HYPERMOBILE AND THERE WAS NO SIGNIFICANT CALCIFICATION OR ANGULATION NOTED. IT SEEMS UNUSUAL THAT THIS SHORT LENGTH STENT FRACTURED, HOWEVER THE STUDIES INCLUDED INTRAVASCULAR ULTRASOUND CONFIRMED THERE WAS A STENT FRACTURE AND RE-STENOSIS". THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. THE STENT FRACTURE WAS CONFIRMED. STENT FRACTURES ARE UNCOMMON EVENTS, BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. RECENTLY, SES FRACTURE HAS BEEN RECOGNIZED AS A NEW POTENTIAL MECHANISM OF RESTENOSIS. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT VESSEL/LESION CHARACTERISTICS (VESSEL HYPERMOBILITY) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    INFORMATION PROVIDED BY A SALES REPRESENTATIVE INDICATED THAT A PATIENT EXPERIENCED RESTENOSIS AND STENT FRACTURE AFTER HAVING A CORONARY ARTERY STENT IMPLANTED. THE PATIENT'S MEDICAL HISTORY IS UNKNOWN. THE PATIENT RECEIVED A 3.5MM X 13MM BX SONIC STENT IN THE MID RIGHT CORONARY ARTERY IN 2004 FOR UNKNOWN REASONS. THE LESION HAD SOME PLAQUE AND WAS LOCATED IN AN ACTIVELY MOVING SEGMENT OF THE ARTERY. THE STENT WAS NOT POST-DILATED. APPROXIMATELY SIX YEARS LATER, THE PATIENT EXPERIENCED CHEST PAIN AND WENT TO THE HOSPITAL. ANGIOGRAPHY AND IVUS WAS PERFORMED REVEALING STENT FRACTURE AND RESTENOSIS. THE PHYSICIAN IMPLANTED ANOTHER STENT TO COVER THE LESION. THE STERILE LOT NUMBER FOR THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE PERFORMED. WITHOUT THE PROCEDURAL CD'S THE REPORTED STENT FRACTURE COULD NOT BE CONFIRMED. RESTENOSIS IS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. STENT FRACTURES ARE UNCOMMON EVENTS BUT HAVE BEEN OBSERVED IN LONG STENTED SEGMENTS INCLUDING THOSE IN WHICH OVERLAPPING STENTS HAVE BEEN USED. THEY HAVE BEEN OBSERVED IN CORONARY SEGMENTS THAT UNDERGO SIGNIFICANT MOTION, PARTICULARLY IN AREAS WITH SEVERE ANGULATION, TORTUOSITY AND CALCIFICATION. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT VESSEL/LESION CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO INDICATION THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IN 2004, THE PATIENT RECEIVED A BX SONIC STENT IN THE MID RCA. THE LESION HAD SOME PLAQUE. IN 2010, THE PATIENT CAME TO THE HOSPITAL DUE TO CHEST PAIN. THE PHYSICIAN CONDUCTED IVUS AND FOUND THAT THE IMPLANTED STENT WAS FRACTURED WHICH LED TO RESTENOSIS. THE PHYSICIAN IMPLANTED ANOTHER STENT TO COVER THE LESION. THE PATIENT WAS FINE AND EVENTUALLY DISCHARGED. THE ORIGINAL IMPLANTED STENT HAD NOT BEEN POSTDILATED. THE STENT HAD BEEN IMPLANTED IN A ACTIVELY MOVING SEGMENT OF THE ARTERY. NO MYOCARDIAL BRIDGING WAS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BX SONIC STENT DELIVERY SYSTEM (OUS RX) CORONARY SDS/STENTS (MAF) MAF CORDIS DE MEXICO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R