BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-AAA

    MDR report key: 11051323 · Received December 21, 2020

    Report

    Report Number
    9616099-2020-04138
    Event Type
    Injury
    Date Received
    December 21, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 30, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: G3, G6, H1, H2, H3, H6, AND H10. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE ARTICLE, ZAVATTA, M., SQUIZZATO, F., BALESTRIERO, G., BONVINI, S., PERKMANN, R., MILITE, D., GREGO, F., ANTONELLO, M., & TRIVENETO INCRAFT REGISTRY COLLABORATORS (2020). EARLY AND MID-TERM OUTCOMES OF EVAR WITH AN ULTRA LOW-PROFILE ENDOGRAFT FROM THE TRIVENETO INCRAFT REGISTRY. JOURNAL OF VASCULAR SURGERY, S0741-5214(20)32469-1. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.JVS.2020.09.044, ONE PATIENT, WHO WAS TREATED WITH AN INCRAFT AAA DELIVERY SYSTEM, HAD THE OCCLUSION OF AN ILIAC BRANCH THEREFORE A FEMORO-FEMORAL CROSSOVER BY-PASS GRAFT WAS PERFORMED. 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 ¿ILIAC ARTERY OCCLUSION¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN, NOR WAS OTHER RELEVANT CLINICAL INFORMATION PROVIDED. IT IS UNKNOWN WHETHER THIS WAS RELATED TO THE PROSTHESIS OR ONGOING AND WORSENING INTRINSIC DISEASE PROCESSES, AS THE CULPRIT VESSEL IS NOTED TO BE AN ILIAC ARTERY BRANCH, OR PERHAPS A RESULT OF MALPOSITIONING. 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 ¿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. POTENTIAL ADVERSE EVENTS AND POTENTIAL DEVICE RISKS INCLUDE, BUT ARE NOT LIMITED TO PROSTHESIS OCCLUSION/STENOSIS; STENOSIS OF NATIVE VESSEL; SURGICAL CONVERSION TO OPEN SURGERY.¿ 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.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER, DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED IN THE LITERATURE ARTICLE, ZAVATTA, M., SQUIZZATO, F., BALESTRIERO, G., BONVINI, S., PERKMANN, R., MILITE, D., GREGO, F., ANTONELLO, M., & TRIVENETO INCRAFT REGISTRY COLLABORATORS (2020). EARLY AND MID-TERM OUTCOMES OF EVAR WITH AN ULTRA LOW-PROFILE ENDOGRAFT FROM THE TRIVENETO INCRAFT REGISTRY. JOURNAL OF VASCULAR SURGERY, S0741-5214(20)32469-1. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.JVS.2020.09.044, ONE PATIENT, WHO WAS TREATED WITH AN INCRAFT AAA DELIVERY SYSTEM, HAD THE OCCLUSION OF AN ILIAC BRANCH THEREFORE A FEMORO-FEMORAL CROSSOVER BY-PASS GRAFT WAS PERFORMED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1512247 UNK-AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CORDIS CORPORATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNK.