BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AAA

    MDR report key: 11090962 · Received December 29, 2020

    Report

    Report Number
    9616099-2020-04162
    Event Type
    Injury
    Date Received
    December 29, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 29, 2020
    Manufacturer
    CARDINAL HEALTH MEXICO
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE REPORT ALSO REPRESENTS NOTIFICATION OF 1 EVENT FOR A TYPE III ENDOLEAK. PLEASE NOTE THAT PATIENT SPECIFIC DETAILS (DEMOGRAPHICS, MEDICAL HISTORY AND REASON FOR INTERVENTION) ARE NOT AVAILABLE. THE DEVICE IS THE INCRAFT STENT GRAFT BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS (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). 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 IMPLANTED, NEEDED OPEN CONVERSION, DUE TO AN ENDOLEAK (EL) TYPE 3. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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 ¿STENT-GRAFT ENDOLEAK TYPE III¿ 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. PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. TYPE III ENDOLEAKS HAVE COMMONLY BEEN REPORTED AS A RESULT OF MODULAR COMPONENT SEPARATION. THESE ENDOLEAKS ARE DUE TO LEAKAGE THROUGH A DEFECT IN THE GRAFT FABRIC OR BETWEEN THE SEGMENTS OF A MODULAR, MULTI-SEGMENTAL GRAFT. THIS SUBGROUP IS DUE TO MECHANICAL FAILURE OF THE GRAFT. WHEN THERE IS LEAKAGE OF BLOOD THROUGH THE BODY OF A STENT-GRAFT, A TYPE III ENDOLEAK RESULTS. THIS ENDOLEAK IS RELATED TO POOR APPOSITION OR SEPARATION OF THE COMPONENTS OF THE STENT-GRAFT, OR IT CAN BE DUE TO RUPTURE OR TEAR OF THE GRAFT MATERIAL. LIKE TYPE I ENDOLEAKS, TYPE III ENDOLEAKS ARE CONSIDERED HIGH-PRESSURE, HIGH-RISK LEAKS AND REQUIRE URGENT MANAGEMENT. TYPE III ENDOLEAKS ALSO ARE OFTEN ASSOCIATED WITH MEASURABLE INCREASES IN ANEURYSM SAC SIZE. TYPE III ENDOLEAK ACCOUNTS FOR 20% OF ALL ENDOLEAKS, THE VAST MAJORITY OF WHICH ARE CAUSED BY MODULAR DISCONNECTION. REPORTED INCIDENCES OF THIS TYPE OF COMPLICATION ARE AS HIGH AS 4.8%. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿CAREFULLY OBSERVE ALL WARNINGS AND CAUTIONS NOTED THROUGHOUT THESE INSTRUCTIONS AS FAILURE TO DO SO MAY RESULT IN INJURY TO THE PATIENT. A VASCULAR SURGICAL TEAM SHOULD BE AVAILABLE WHILE THE IMPLANT PROCEDURE IS IN PROGRESS IN CASE A CONVERSION TO AN OPEN SURGICAL REPAIR IS REQUIRED. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK MAY LEAD TO ANEURYSM RUPTURE.¿ ¿EXPECTED CLINICAL ADVERSE EVENTS. AORTIC DAMAGE (PERFORATION, DISSECTION, BLEEDING, RUPTURE) ¿DEATH ¿ENDOLEAK.¿ ¿EXPECTED POTENTIAL RISKS ASSOCIATED WITH THE STENT GRAFT SYSTEM ¿IMPROPER COMPONENT PLACEMENT ¿INCOMPLETE COMPONENT DEPLOYMENT ¿PERIGRAFT FLOW.¿ ¿INTRODUCE APPROPRIATELY SIZED AND COMPATIBLE MOLDING BALLOON AND TACK THE OVERLAP AND SEAL AREAS OF THE ILIAC LIMB EXTENSION. CAUTION: BE CAREFUL NOT TO DISPLACE THE PROSTHESIS UPON INTRODUCING AND RETRACTING THE BALLOON CATHETER. NOTE: CARE SHOULD BE TAKEN WHEN INFLATING THE BALLOON, ESPECIALLY WITH CALCIFIED, TORTUOUS, STENOTIC, OR OTHERWISE DISEASED VESSELS. INFLATE SLOWLY. ENSURE TO NOT INFLATE THE BALLOON OUTSIDE THE GRAFT MATERIAL. IT IS RECOMMENDED THAT A BACKUP BALLOON BE AVAILABLE. WARNINGS: ¿OVER INFLATION OF BALLOON CAN CAUSE GRAFT TEARS AND/OR VESSEL DISSECTION OR RUPTURE. ¿WHEN EXPANDING THE PROSTHESIS, THERE IS AN INCREASED RISK OF VESSEL INJURY AND/OR RUPTURE, AND POSSIBLE PATIENT DEATH, IF THE BALLOON¿S PROXIMAL AND DISTAL RADIOPAQUE MARKERS ARE NOT COMPLETELY WITHIN THE COVERED (GRAFT FABRIC) PORTION OF THE PROSTHESIS.¿ 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 · 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 IMPLANTED, NEEDED OPEN CONVERSION, DUE TO AN ENDOLEAK (EL) TYPE 3. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1554441 UNKNOWN AAA SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CARDINAL HEALTH MEXICO AAAXXXX UNK

    Patients

    Seq Age Sex Outcome Treatment
    1