BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILIAC LIMB

    MDR report key: 17435201 · Received August 1, 2023

    Report

    Report Number
    9616099-2023-06565
    Event Type
    Death
    Date Received
    August 1, 2023
    Date of Event
    July 7, 2023
    Report Date
    October 6, 2023
    Manufacturer
    CORDIS US. CORP
    Product Code
    MIH
    UDI-DI
    20705032067208
    PMA / PMN Number
    P150002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REPORTED AS A DEATH; HOWEVER, THE DATE OF THE DEATH WAS NOT PROVIDED. COMPLAINT CONCLUSION: A 10MM INCRAFT ABDOMINAL AORTIC ANEURYSM (AAA) ILIAC LIMB EXTENSION WAS ¿RAISED¿ CONTRALATERALLY WITH THE INTRODUCER DUE TO A SEVERELY CALCIFIED AND 55% STENOSED ILIAC ARTERY. THE 10MM ILIAC EXTENSION WAS SUCCESSFULLY IMPLANTED IN THE ILIAC ARTERY WITHOUT ISSUE; HOWEVER, WHEN REMOVING THE DELIVERY SYSTEM, THE NOSE OF THE DEVICE WAS ANCHORED IN THE CURVATURE OF THE PROSTHESIS AND BECAME FRACTURED DURING ATTEMPTS TO DISLODGE THE NOSE OF THE DELIVERY SYSTEM. MANY ATTEMPTS TO SNARE THE NOSE SEGMENT WERE MADE FROM BOTH BRACHIAL AND FEMORAL APPROACHES; HOWEVER, IT WAS NOT POSSIBLE TO RETRIEVE THE NOSE SEGMENT. IT WAS DECIDED TO LEAVE THE SEPARATED DELIVERY SYSTEM SEGMENT WITHIN THE ENDOPROSTHESIS AS THERE WERE NO OTHER OPTIONS. THERE WAS REPORTEDLY A DEATH TO THE PATIENT. THE DEPLOYER WAS INCRAFT CERTIFIED, AND CORDIS CLINICAL PERSONNEL WERE PRESENT DURING THE PROCEDURE. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 18061900 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿LEG PROSTHESIS DELIVERY SYSTEM WITHDRAWAL DIFFICULTY¿ AND ¿LEG PROSTHESIS DELIVERY SYSTEM SEPARATED¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. PROCEDURAL OR HANDLING FACTORS OR VESSEL CHARACTERISTICS (SEVERE CALCIFICATION AND A RATE OF STENOSIS OF 55%) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿THE INCRAFT® STENT-GRAFT SYSTEM IS INTENDED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH INFRARENAL ABDOMINAL AORTIC ANEURYSMS WITH THE FOLLOWING CHARACTERISTICS: MORPHOLOGY SUITABLE FOR ANEURYSM REPAIR. IRREGULAR CALCIFICATION AND/OR PLAQUE MAY COMPROMISE THE FIXATION AND SEALING OF THE IMPLANT, ESPECIALLY AT THE CRANIAL AND CAUDAL SEALING ZONES. POTENTIAL ADVERSE EVENTS AND POTENTIAL DEVICE RISKS INCLUDE, BUT ARE NOT LIMITED TO: DEATH. INSERTION AND REMOVAL DIFFICULTIES. EXERCISE PARTICULAR CARE IN AREAS THAT ARE DIFFICULT TO NAVIGATE, SUCH AS AREAS OF STENOSIS, INTRAVASCULAR THROMBUS, CALCIFICATION OR TORTUOSITY, OR WHERE EXCESSIVE RESISTANCE IS EXPERIENCED, AS VESSEL OR CATHETER DAMAGE COULD OCCUR. CONSIDER PERFORMING BALLOON ANGIOPLASTY AT THE SITE OF A NARROWED OR STENOTIC VESSEL, AND THEN ATTEMPT TO GENTLY REINTRODUCE THE CATHETER DELIVERY SYSTEM. ALSO EXERCISE CARE WITH DEVICE SELECTION AND CORRECT PLACEMENT/POSITIONING OF THE DEVICE IN THE PRESENCE OF ANATOMICALLY CHALLENGING SITUATIONS SUCH AS AREAS OF SIGNIFICANT STENOSIS, INTRAVASCULAR THROMBUS, CALCIFICATION, TORTUOSITY AND/OR ANGULATION WHICH CAN AFFECT SUCCESSFUL INITIAL TREATMENT OF THE ANEURYSM.¿ NEITHER THE PHR REVIEW NOR THE INFORMATION PROVIDED SUGGESTS THAT THE EVENT EXPERIENCED BY THE CUSTOMER COULD BE RELATED TO THE MANUFACTURING PROCESS; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS REPORTED AS A DEATH; HOWEVER, THE DATE OF THE DEATH WAS NOT PROVIDED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 18061900 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, A 10MM INCRAFT ABDOMINAL AORTIC ANEURYSM (AAA) ILIAC LIMB EXTENSION WAS ¿RAISED¿ CONTRALATERALLY WITH THE INTRODUCER DUE TO A SEVERELY CALCIFIED AND 55% STENOSED ILIAC ARTERY. THE 10MM ILIAC EXTENSION WAS SUCCESSFULLY IMPLANTED IN THE ILIAC ARTERY WITHOUT ISSUE; HOWEVER, WHEN REMOVING THE DELIVERY SYSTEM, THE NOSE OF THE DEVICE WAS ANCHORED IN THE CURVATURE OF THE PROSTHESIS AND BECAME FRACTURED DURING ATTEMPTS TO DISLODGE THE NOSE OF THE DELIVERY SYSTEM. MANY ATTEMPTS TO SNARE THE NOSE SEGMENT WERE MADE FROM BOTH BRACHIAL AND FEMORAL APPROACHES; HOWEVER, IT WAS NOT POSSIBLE TO RETRIEVE THE NOSE SEGMENT. IT WAS DECIDED TO LEAVE THE SEPARATED DELIVERY SYSTEM SEGMENT WITHIN THE ENDOPROSTHESIS AS THERE WERE NO OTHER OPTIONS. THERE WAS REPORTEDLY A DEATH TO THE PATIENT. THE DEPLOYER WAS INCRAFT CERTIFIED, AND CORDIS CLINICAL PERSONNEL WERE PRESENT DURING THE PROCEDURE. THE DEVICE WAS DISCARDED AND WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337919 ILIAC LIMB SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CORDIS US. CORP 18061900 20705032067208

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention| D