BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS UNKNOWN

    MDR report key: 3619718 · Received February 10, 2014

    Report

    Report Number
    9616099-2014-00090
    Event Type
    Injury
    Date Received
    February 10, 2014
    Date of Event
    July 8, 2007
    Report Date
    January 17, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    FGE
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LITERATURE ARTICLE IS ATTACHED. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING A LITERATURE REVIEW, AN ARTICLE WAS NOTED IN THE PUBLICATION BY WROBEL ET AL, FRACTURE OF A CAROTID STENT AND RESTENOSIS OF COMMON CAROTID ARTERY, ARCHIVES OF MEDICAL SCIENCE 5 (2013) 953-956. THE ARTICLE STATED THAT APPROXIMATELY FOUR MONTHS AFTER A FEMALE PATIENT WITH A HISTORY OF HYPERTENSION HAD AN 8 MM X 24 MM GENESIS BALLOON-EXPANDABLE STENT IMPLANTED AT THE OSTIUM OF THE LEFT COMMON CAROTID ARTERY (LCCA). THE STENT WAS IMPLANTED AT TEN ATMOSPHERES FOR THIRTY SECONDS. A SECOND STENOSIS IN THE LEFT INTERNAL CAROTID ARTERY WAS ALSO NOTED BUT WAS NOT TREATED AT THAT TIME. APPROXIMATELY THREE MONTHS LATER THE PATIENT RETURNED FOR TREATMENT OF THE ADDITIONAL LESION. SELECTIVE LEFT CAROTID ANGIOGRAPHY REVEALED AN IN-STENT RESTENOSIS WITHIN THE PREVIOUSLY IMPLANTED STENT AT THE OSTIUM OF THE LCCA. FURTHERMORE, A FRACTURE IN THE MID PART OF THE STENT WAS DIAGNOSED WITH COMPLETE SEPARATION OF THE STENT FRAGMENTS. THE FRACTURE CORRELATED WITH THE AREA OF RESTENOSIS. TWO LESIONS: PROXIMAL AND DISTAL IN THE LCCA WERE TREATED USING BALLOON ANGIOPLASTY AND IMPLANTATION OF AN ADDITIONAL NON-CORDIS STENT. AN OPTIMAL ANGIOGRAPHIC RESULT WAS OBTAINED WITH A RESIDUAL STENOSIS OF 20% NOTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DHR COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED. THE REPORTED FRACTURE/SEPARATION OF THE STENT AND ARTERIAL RESTENOSIS COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED (REMAINED IMPLANTED IN THE PATIENT). BASED ON THE INFORMATION AVAILABLE FOR REVIEW, THE STENT WAS IMPLANTED IN THE INTERNAL CAROTID ARTERY. PALMAZ GENESIS STENTS ARE INDICATED FOR USE BELOW THE AORTIC ARCH. STENT FRACTURES ARE WELL-KNOWN POTENTIAL COMPLICATIONS OF THIS TYPE OF PROCEDURE AND ARE LISTED IN THE IFU AS SUCH. THE CAROTID VESSELS ARE PRONE TO AND UNDERGO BIOMECHANICAL FORCES SUCH AS FLEXION DURING MOVEMENT. ALSO, THE VESSELS MAY BE COMPRESSED BY EXTERNAL STRUCTURES. IN THIS CASE, VESSEL/LESION CHARACTERISTICS AND BIOMECHANICAL FORCES LIKELY CONTRIBUTED TO THE REPORTED EVENT. RESTENOSIS IS ASSOCIATED WITH THE PROGRESSION OF ATHEROSCLEROTIC DISEASE AND IS A KNOWN POTENTIAL ADVERSE EVENT FOLLOWING STENT IMPLANTATION AND DOES NOT REPRESENT A DEVICE FAILURE. WITHOUT RETURN OF THE DEVICE OR A STERILE LOT NUMBER TO CONDUCT A DRH IT IS NOT POSSIBLE TO DETERMINE IF THIS ISSUE COULD BE RELATED TO THE DESIGN AND MANUFACTURING PROCESS OF THE DEVICE; THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING A LITERATURE REVIEW, AN ARTICLE WAS NOTED IN THE PUBLICATION BY WROBEL ET AL, FRACTURE OF A CAROTID STENT AND RESTENOSIS OF COMMON CAROTID ARTERY, ARCHIVES OF MEDICAL SCIENCE 5 (2013) 953-956. THE ARTICLE STATED THAT APPROXIMATELY FOUR MONTHS AFTER A FEMALE PATIENT WITH A HISTORY OF HYPERTENSION HAD AN 8MM X 24MM GENESIS BALLOON-EXPANDABLE STENT IMPLANTED AT THE OSTIUM OF THE LEFT COMMON CAROTID ARTERY (LCCA). THE STENT WAS IMPLANTED AT TEN ATMOSPHERES FOR THIRTY SECONDS. A SECOND STENOSIS IN THE LEFT INTERNAL CAROTID ARTERY WAS ALSO NOTED BUT WAS NOT TREATED AT THAT TIME. APPROXIMATELY THREE MONTHS LATER THE PATIENT RETURNED FOR TREATMENT OF THE ADDITIONAL LESION. SELECTIVE LEFT CAROTID ANGIOGRAPHY REVEALED AN IN-STENT RESTENOSIS WITHIN THE PREVIOUSLY IMPLANTED STENT AT THE OSTIUM OF THE LCCA. FURTHERMORE, A FRACTURE IN THE MID PART OF THE STENT WAS DIAGNOSED WITH COMPLETE SEPARATION OF THE STENT FRAGMENTS. THE FRACTURE CORRELATED WITH THE AREA OF RESTENOSIS. TWO LESIONS: PROXIMAL AND DISTAL IN THE LCCA WERE TREATED USING BALLOON ANGIOPLASTY AND IMPLANTATION OF AN ADDITIONAL NON-CORDIS STENT. AN OPTIMAL ANGIOGRAPHIC RESULT WAS OBTAINED WITH A RESIDUAL STENOSIS OF 20% NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86938 PALMAZ GENESIS UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Life Threatening| R