BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ STENT UNKNOWN

    MDR report key: 1954510 · Received January 10, 2011

    Report

    Report Number
    9610978-2011-00010
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 15, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT IS FROM A LITERATURE ARTICLE/LITERATURE SEARCH AND THE EXACT EVENT DATE IS UNKNOWN. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    LITERATURE REVIEW: PIROTTE ET AL REPORT "UNSUCCESSFUL TREATMENT OF A COLLAPSED THORACIC STENT GRAFT BY PALMAZ STENT", ANNALS OF VASCULAR SURGERY 24 (2010), PAGES 1137.E13-1137.E19, REPORT THAT A GORE TAG EXCLUDER STENT GRAFT WAS DEPLOYED IN A (B)(6) WOMAN FOR AN ISTHMIC SACCULAR ANEURYSM. AT 12-HOUR FOLLOW-UP, WE DIAGNOSED A PROXIMAL COLLAPSE OF THE GORE EXCLUDER. A PALMAZ STENT WAS USED TO REOPEN THE PROXIMAL SEGMENT OF THE STENT GRAFT. TWO MONTHS LATER, THE PATIENT PRESENTED WITH A TRANSIENT ISCHEMIC ATTACK (EMBOLIC PROCESS) RELATED TO A SUBOPTIMAL APPOSITION OF THE PALMAZ STENT IN THE DISTAL AORTIC ARCH. THIS LED TO OPEN SURGICAL REPLACEMENT OF THE ASCENDING AORTA AND AORTIC ARCH WITH REIMPLANTATION OF THE SUPRAAORTIC BRANCHES. THE CONCLUSION DRAWN WAS THAT REOPENING OF A STENT GRAFT COLLAPSE WITH A PALMAZ STENT MIGHT BE A SHORT-TERM SOLUTION; HOWEVER, ITS PRESENCE CAN LEAD TO EMBOLIC COMPLICATIONS. THE STENT IS UNAVAILABLE FOR ANALYSIS. THE PRODUCT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR INSPECTION. THERE IS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. APHASIA, AS A SYMPTOM OF TIA, IS A WELL-KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE STENT GRAFT IMPLANTATION PROCEDURES. TIA IS OFTEN ASSOCIATED WITH A TEMPORARY STOPPAGE OR SLOWING OF BLOOD FLOW TO THE CEREBRAL ARTERIES. THE PLACEMENT OF STENT GRAFT AND STENT DEVICES WITHIN THE AORTA CREATES AREAS OF POTENTIAL BLOOD FLOW DISTURBANCES, POSSIBLY CONTRIBUTING THE FORMATION OF THROMBUS. THESE THROMBI COULD LEAD TO TIA EVENTS. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT, PROCEDURE AND VESSEL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    THE REPORT RECEIVED THROUGH A LITERATURE SEARCH YIELDED THE FOLLOWING ARTICLE: PIROTTE ET AL REPORT UNSUCCESSFUL TREATMENT OF A COLLAPSED THORACIC STENT GRAFT BY PALMAZ STENT, ANNALS OF VASCULAR SURGERY 24 (2010), PAGES 1137.E13-1137.E19. THE ARTICLE INDICATED THAT A GORE TAG EXCLUDER STENT GRAFT WAS DEPLOYED IN A (B)(6) YEAR-OLD WOMAN FOR AN ISTHMIC SACCULAR ANEURYSM. AT 12-HOUR FOLLOW-UP, WE DIAGNOSED A PROXIMAL COLLAPSE. A PALMAZ STENT WAS USED TO REOPEN THE PROXIMAL SEGMENT. TWO MONTHS LATER, SHE PRESENTED WITH A TRANSIENT ISCHEMIC ATTACK (EMBOLIC PROCESS) RELATED TO A SUBOPTIMAL APPOSITION OF THE PALMAZ STENT IN THE DISTAL AORTIC ARCH. THIS LED TO OPEN SURGICAL REPLACEMENT OF THE ASCENDING AORTA AND AORTIC ARCH WITH REIMPLANTATION OF THE SUPRAAORTIC BRANCHES. REOPENING OF A STENT GRAFT COLLAPSE WITH A PALMAZ STENT MIGHT BE A SHORT-TERM SOLUTION; HOWEVER, ITS PRESENCE CAN LEAD TO EMBOLIC COMPLICATIONS. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ STENT UNKNOWN ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L GORE TAG EXCLUDER STENT GRAFT