BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6348610 · Received February 22, 2017

    Report

    Report Number
    3002808486-2017-00363
    Event Type
    Injury
    Date Received
    February 22, 2017
    Date of Event
    June 11, 2013
    Report Date
    June 16, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002236117
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K): P070016. SUMMARY OF INVESTIGATIONAL FINDINGS: BASED ON THE PROVIDED INFORMATION, IT WAS NOT POSSIBLE TO DETERMINE THE CAUSE OF THIS EVENT. THE REPORTED INFORMATION STATES A TYPE I ENDOLEAK HOWEVER WITHOUT SPECIFYING THE LOCATION. ENDOLEAK IS ONE OF THE ADDRESSED ADVERSE EVENTS IN THE IFU. NO EVIDENCE WAS FOUND SUGGESTING THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: (B)(6), PROXIMAL TYPE I ENDOLEAK AT CONCLUSION OF IMPLANT PROCEDURE . ON (B)(6) 2013, THE PATIENT RECEIVED THE FOLLOWING DEVICES: ZTEG-2PT-40-30-165-PF (LOT #E2985727); T-BRANCH-34-18-202 (LOT #A910061); UNIBODY-22-98 (LOT #A905898); ZSLE-16-56-ZT (LOT # 4025391) RIGHT ILIAC LEG; ZSLE-16-74-ZT (LOT #4006882) LEFT ILIAC LEG. THE RIGHT RENAL ARTERY WAS STENTED WITH A FLUENCY COVERED STENT, A CORDIS GENESIS UNCOVERED STENT, AND A PROTÉGÉ EVERFLEX UNCOVERED STENT. THE LEFT RENAL ARTERY WAS STENTED WITH A FLUENCY COVERED STENT, A CORDIS GENESIS UNCOVERED STENT, AND A PROTÉGÉ EVERFLEX UNCOVERED STENT. THERE WERE NO DIFFICULTIES DEPLOYING THE DEVICES. THE COMPLETION ANGIOGRAM SHOWED PATENT DEVICES WITH A PROXIMAL TYPE I ENDOLEAK. A POST-PROCEDURE CT SCAN WAS DONE ON (B)(6) 2013. IT SHOWED PATENT DEVICES WITH A TYPE I ENDOLEAK (PROXIMAL OR DISTAL WAS NOT SPECIFIED). THERE WERE NO COMPONENT SEPARATION, MIGRATION, OR DEVICE INTEGRITY ISSUES. THE PATIENT WAS DISCHARGED ON (B)(6) 2013. ON (B)(6) 2013, THE SIX-MONTH FOLLOW-UP CT SCAN SHOWED PATENT DEVICES WITH A TYPE II ENDOLEAK (PROXIMAL OR DISTAL WAS NOT SPECIFIED). THERE WERE NO COMPONENT SEPARATION, MIGRATION, OR DEVICE INTEGRITY ISSUES. PATIENT OUTCOME: THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132463 ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002236117

    Patients

    Seq Age Sex Outcome Treatment
    1 67 Life Threatening