BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AAA

    MDR report key: 12924730 · Received December 3, 2021

    Report

    Report Number
    9616099-2021-05091
    Event Type
    Injury
    Date Received
    December 3, 2021
    Date of Event
    October 8, 2021
    Report Date
    December 3, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE REPORT ALSO REPRESENTS NOTIFICATION OF TWO EVENTS FOR THROMBOSIS. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICES ARE INCRAFT AORTIC ANEURYSM STENT GRAFT, BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS (LONG-TERM RESULTS OF LOW-PROFILE STENT GRAFTS FOR TREATMENT OF INFRARENAL AORTIC ANEURYSMS: RESULTS FROM A RETROSPECTIVE MULTICENTER REGISTRY. JOURNAL OF VASCULAR SURGERY). A COPY OF THE PUBLICATION IS ATTACHED TO THIS REPORT. (B)(6). AS REPORTED IN THE LITERATURE ARTICLE BY DE DONATO, G., PASQUI, E., NANO, G., LENTI, M., MANGIALARDI, N., SPEZIALE, F., FERRARI, M., MICHELAGNOLI, S., TOZZI, M., PALASCIANO, G., LOLOPRO REGISTRY COLLABORATORS., RIGHINI, P., FINO, G., ORRICO, M., RONCHEY, S., SIRIGNANO, P., BERCHIOLLI, R., CHISCI, E., TADIELLO, M., GALZERANO, G., ¿ FERRARO, G. (2021). LONG-TERM RESULTS OF LOW-PROFILE STENT GRAFTS FOR TREATMENT OF INFRARENAL AORTIC ANEURYSMS: RESULTS FROM A RETROSPECTIVE MULTICENTER REGISTRY. JOURNAL OF VASCULAR SURGERY, S0741-5214(21)02196-0. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.JVS.2021.09.036, AFTER IMPLANTATION OF AN UNKNOWN INCRAFT AAA STENT GRAFT SYSTEM, TWO PATIENTS DEVELOPED ILIAC THROMBOSIS THAT WAS TREATED WITH SURGICAL RECANALIZATION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿THROMBOSIS¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿POTENTIAL ADVERSE EVENTS AND POTENTIAL DEVICE RISKS INCLUDE, BUT ARE NOT LIMITED TO: ARTERIAL OR VENOUS THROMBOSIS. IT IS RECOMMENDED THAT PHYSICIANS CONDUCT REGULAR EXAMINATIONS AND IMAGING FOR THE PATIENT¿S LIFETIME. FOLLOW-UP IMAGING SHOULD BE DECIDED BASED UPON THE PHYSICIAN¿S CLINICAL ASSESSMENT OF THE PATIENT PRE- AND POST-IMPLANTATION OF THE STENT GRAFT. AFTER ENDOVASCULAR GRAFT PLACEMENT, PATIENTS SHOULD BE REGULARLY MONITORED FOR PERIGRAFT FLOW, ANEURYSM GROWTH OR CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT. ANNUAL IMAGING IS RECOMMENDED, INCLUDING ABDOMINAL RADIOGRAPHS TO EXAMINE DEVICE INTEGRITY (STENT FRACTURE, SEPARATION BETWEEN BIFURCATED DEVICE AND PROXIMAL CUFFS OR LIMB EXTENSIONS, IF APPLICABLE); AND CONTRAST AND NON-CONTRAST CT TO EXAMINE ANEURYSM CHANGES, PERIGRAFT FLOW, PATENCY, TORTUOSITY AND PROGRESSIVE DISEASE. IF RENAL COMPLICATIONS OR OTHER FACTORS PRECLUDE THE USE OF IMAGE CONTRAST MEDIA, ABDOMINAL RADIOGRAPHS AND DUPLEX ULTRASOUND MAY PROVIDE SIMILAR INFORMATION.¿ THE VERY LIMITED INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED IN THE LITERATURE ARTICLE BY DE DONATO, G., PASQUI, E., NANO, G., LENTI, M., MANGIALARDI, N., SPEZIALE, F., FERRARI, M., MICHELAGNOLI, S., TOZZI, M., PALASCIANO, G., LOLOPRO REGISTRY COLLABORATORS., RIGHINI, P., FINO, G., ORRICO, M., RONCHEY, S., SIRIGNANO, P., BERCHIOLLI, R., CHISCI, E., TADIELLO, M., GALZERANO, G., ¿ FERRARO, G. (2021). LONG-TERM RESULTS OF LOW-PROFILE STENT GRAFTS FOR TREATMENT OF INFRARENAL AORTIC ANEURYSMS: RESULTS FROM A RETROSPECTIVE MULTICENTER REGISTRY. JOURNAL OF VASCULAR SURGERY, S0741-5214(21)02196-0. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.JVS.2021.09.036, AFTER IMPLANTATION OF AN UNKNOWN INCRAFT AAA STENT GRAFT SYSTEM, TWO PATIENTS DEVELOPED ILIAC THROMBOSIS THAT WAS TREATED WITH SURGICAL RECANALIZATION. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826361 UNKNOWN AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CORDIS CORPORATION AAAXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown