BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILIAC LIMB 20MM X 12CM

    MDR report key: 12934937 · Received December 6, 2021

    Report

    Report Number
    9616099-2021-05108
    Event Type
    Death
    Date Received
    December 6, 2021
    Date of Event
    November 1, 2018
    Report Date
    December 22, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    MIH
    PMA / PMN Number
    P150002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #: 9616099-2021-05106, 9616099-2021-05107. THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: STOMP, W., DIERIKX, J. E., WEVER, J. J., VAN DIJK, L. C., VAN EPS, R., VEGER, H., & VAN OVERHAGEN, H. (2021). PERCUTANEOUS EVAR FOR RUPTURED ABDOMINAL AORTIC ANEURYSMS USING THE CORDIS INCRAFT ENDOGRAFT. ANNALS OF VASCULAR SURGERY, S0890-5096(21)00664-6. COMPLAINT CONCLUSION: AS REPORTED IN THE LITERATURE ARTICLE BY STOMP, W., DIERIKX, J. E., WEVER, J. J., VAN DIJK, L. C., VAN EPS, R., VEGER, H., & VAN OVERHAGEN, H. (2021). PERCUTANEOUS EVAR FOR RUPTURED ABDOMINAL AORTIC ANEURYSMS USING THE CORDIS INCRAFT ENDOGRAFT. ANNALS OF VASCULAR SURGERY, S0890-5096(21)00664-6. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.AVSG.2021.07.018, AFTER IMPLANTATION OF AN AORTIC BIFURCATE 26MM INCRAFT AAA DEVICE, ONE PATIENT EXPIRED OF HEMORRHAGIC SHOCK SHORTLY AFTER HIS RUPTURED ANEURYSM HAD BEEN TECHNICALLY SUCCESSFULLY TREATED WITH THE UNKNOWN INCRAFT AAA STENT GRAFT SYSTEM. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 17740482 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿HEMORRHAGIC SHOCK¿ AND ¿AORTIC ANEURYSM RUPTURE¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS OR PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. ACCORDING TO THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿POTENTIAL ADVERSE EVENTS AND POTENTIAL DEVICE RISKS INCLUDE, BUT ARE NOT LIMITED TO: ANEURYSM SAC RUPTURE. 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.¿ NEITHER THE PHR NOR THE LIMITED INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF THREE REPORTS SUBMITTED FOR THE SAME EVENT. PLEASE REFERENCE MFR REPORT #: 9616099-2021-05106 AND 9616099-2021-05107. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS COMPLAINT WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE CITATION IS AS FOLLOWS: STOMP, W., DIERIKX, J. E., WEVER, J. J., VAN DIJK, L. C., VAN EPS, R., VEGER, H., & VAN OVERHAGEN, H. (2021). PERCUTANEOUS EVAR FOR RUPTURED ABDOMINAL AORTIC ANEURYSMS USING THE CORDIS INCRAFT ENDOGRAFT. ANNALS OF VASCULAR SURGERY, S0890-5096(21)00664-6.

    Description of Event or Problem · 0

    AS REPORTED IN THE LITERATURE ARTICLE BY STOMP, W., DIERIKX, J. E., WEVER, J. J., VAN DIJK, L. C., VAN EPS, R., VEGER, H., & VAN OVERHAGEN, H. (2021). PERCUTANEOUS EVAR FOR RUPTURED ABDOMINAL AORTIC ANEURYSMS USING THE CORDIS INCRAFT ENDOGRAFT. ANNALS OF VASCULAR SURGERY, S0890-5096(21)00664-6. ADVANCE ONLINE PUBLICATION. HTTPS://DOI.ORG/10.1016/J.AVSG.2021.07.018, AFTER IMPLANTATION OF AN AORTIC BIFURCATE 26MM INCRAFT AAA DEVICE, ONE PATIENT EXPIRED OF HEMORRHAGIC SHOCK SHORTLY AFTER HIS RUPTURED ANEURYSM HAD BEEN TECHNICALLY SUCCESSFULLY TREATED WITH THE UNKNOWN INCRAFT AAA STENT GRAFT SYSTEM. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832189 ILIAC LIMB 20MM X 12CM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH CORDIS CORPORATION IL2012 17740482

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death UNK.