BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FENESTRATED GRAFT

    MDR report key: 15875449 · Received November 29, 2022

    Report

    Report Number
    9680654-2022-00030
    Event Type
    Injury
    Date Received
    November 29, 2022
    Report Date
    January 26, 2023
    Manufacturer
    WILLIAM A. COOK AUSTRALIA, PTY LTD
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PART OF THE DEVICE WAS RETURNED FOR EVALUATION. NO IMAGING WAS SUPPLIED TO ASSIST THE INVESTIGATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT NOT RECEIVED. MEDICAL DIRECTOR REVIEWED THE INFORMATION AVAILABLE AND STATED THE FOLLOWING: "THEY WERE ACTUALLY IMPRESSIVE IN BOTH THE EXTREMELY LOW NUMBER OF ENDOLEAKS AND VERY LOW INCIDENCE OF OVERALL ADVERSE EVENTS. THEY ACTUALLY SHOWED THAT ZFEN CAN BE USED EVEN THOUGH THE NECK DIAMETER IS LARGER THAN THE RECOMMENDED RANGE, AND ALSO IF THE PATIENT FALLS OUTSIDE THE IFU PARAMETERS IN MORE THAN ONE CATEGORY. THE DIFFERENCES BETWEEN THE LARGE DIAMETER GROUP AND THE ¿NORMAL¿ DIAMETER GROUP OF AORTIC NECKS WAS NOT STATISTICALLY SIGNIFICANT IN TERMS OF TYPE 1A ENDOLEAKS. SAME IN THE IFU VS NON-IFU PAPER - ONLY MINOR DIFFERENCES IN OUTCOMES". WORK ORDER REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THE COMPLAINT DEVICE STATES: WARNINGS AND PRECAUTIONS GENERAL USE INFORMATION THE LONG-TERM PERFORMANCE OF FENESTRATED ENDOVASCULAR GRAFTS, INCLUDING THE STENTS PLACED IN FENESTRATIONS/SCALLOPS, HAS NOT YET BEEN ESTABLISHED. ALL PATIENTS SHOULD BE ADVISED THAT ENDOVASCULAR TREATMENT REQUIRES LIFE-LONG, REGULAR FOLLOW-UP TO ASSESS THEIR HEALTH AND THE PERFORMANCE OF THEIR ENDOVASCULAR GRAFT. PATIENTS WITH SPECIFIC CLINICAL FINDINGS (E.G., ENDOLEAKS, ENLARGING ANEURYSMS, CHANGES IN THE STRUCTURE OR POSITION OF THE ENDOVASCULAR GRAFT, OR STENOSIS/OCCLUSION OF VESSELS ACCOMMODATED BY FENESTRATIONS) SHOULD RECEIVE ENHANCED FOLLOW-UP. INTERVENTION OR CONVERSION TO STANDARD OPEN SURGICAL REPAIR FOLLOWING INITIAL ENDOVASCULAR REPAIR SHOULD BE CONSIDERED FOR PATIENTS EXPERIENCING ENLARGING ANEURYSMS, UNACCEPTABLE DECREASE IN FIXATION LENGTH (VESSEL AND COMPONENT OVERLAP) AND/OR ENDOLEAK. AN INCREASE IN ANEURYSM SIZE AND/OR PERSISTENT ENDOLEAK MAY LEAD TO ANEURYSM RUPTURE. IMPLANT PROCEDURE INACCURATE PLACEMENT AND/OR INCOMPLETE SEALING OF THE ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT WITHIN THE VESSEL MAY RESULT IN INCREASED RISK OF ENDOLEAK, MIGRATION OR INADVERTENT OCCLUSION OF THE RENAL OR INTERNAL ILIAC ARTERIES. RENAL ARTERY PATENCY MUST BE MAINTAINED TO PREVENT/REDUCE THE RISK OF RENAL FAILURE AND SUBSEQUENT COMPLICATIONS. IT IS RECOMMENDED THAT ALL VESSELS ACCOMMODATED BY A SMALL FENESTRATION BE STENTED IN ORDER TO SECURE POSITIVE ALIGNMENT OF THE GRAFT FENESTRATION WITH THE VESSEL ORIGIN. ADVERSE EVENTS ENDOLEAK THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THIS IS A KNOWN POTENTIAL ADVERSE EVENT AS DESCRIBED IN THE INSTRUCTIONS FOR USE. BASED ON THE INFORMATION PROVIDED A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, POSSIBLE ROOT CAUSE(S) ARE: - INCOMPLETE EXPANSION OF IMPLANT - MISMATCH OF IMPLANT DIMENSIONS TO PATIENT ANATOMY - INSUFFICIENT SEAL DUE TO INADEQUATE RADIAL FORCE - PATIENT-RELATED FACTORS.

    Description of Event or Problem · 0

    FROM A JOURNAL ARTICLE COVERING A TYPE 1A ENDOLEAK FOLLOWING ZFEN IMPLANT IN 1 PATIENT: PATIENTS WERE DIVIDED INTO LARGE DIAMETER (LD) GROUP AND NORMAL DIAMETER (ND) GROUP. PATIENTS IN THE LD GROUP WERE TREATED WITH LARGER DIAMETER ZFEN DEVICES (EITHER 34 MM OR 36 MM). PATIENTS IN THE ND GROUP WERE TREATED WITH LESS THAN/EQUAL TO 32 MM ZFEN DEVICES. PATIENTS WERE FOLLOWED POSTOPERATIVELY BY CTA AND/OR DUPLEX ULTRASOUND. MEAN FOLLOW-UP TIME WAS 22 MONTHS. ONE HUNDRED (100) PATIENTS WERE TREATED FROM 2012-2017 WITH THE ZFEN DEVICE. IN ADDITION TO LARGER NECKS, PATIENTS IN THE LD GROUP HAD SHORTER, AND LESS ANGULATED INFRARENAL NECKS. PERCENT OVERSIZING WAS SIGNIFICANTLY LESS IN THE LD GROUP. LD GROUP 19.05% +/- 18.25%. ND GROUP 24.27% +/- 12.01%. AAA DIAMETER FOR PATIENTS IN THE ND GROUP: 58.5 MM +/- 9.6 MM. AAA DIAMETER FOR PATIENTS IN THE LD GROUP: 61.0 MM +/- 17.4 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE ND GROUP: 23.4 MM +/- 3.2 MM. INFRARENAL NECK DIAMETER FOR PATIENTS IN THE LD GROUP: 30.1 MM +/- 5.3 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE ND GROUP: 4.7 MM +/- 3.44 MM. INFRARENAL NECK LENGTH FOR PATIENTS IN THE LD GROUP: 2.6 MM +/- 2.9 MM. INFRARENAL ANGULATION FOR PATIENTS IN THE ND GROUP: 31.7 DEGREES +/- 19.4 DEGREES. INFRARENAL ANGULATION FOR PATIENTS IN THE LD GROUP: 21.5 DEGREES +/- 12.1 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE ND GROUP: 24.8 DEGREES +/- 18.9 DEGREES. SUPRARENAL ANGULATION FOR PATIENTS IN THE LD GROUP: 16.5 DEGREES +/-15.8 DEGREES. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE ND GROUP: 18. RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE LD GROUP: 8. 1 PATIENT (LD GROUP) HAD TYPE 1A ENDOLEAK THAT REQUIRED REINTERVENTION.

    Description of Event or Problem · 0

    FROM A JOURNAL ARTICLE COVERING A TYPE 1A ENDOLEAK FOLLOWING ZFEN IMPLANT IN 1 PATIENT: PATIENTS WERE DIVIDED INTO LARGE DIAMETER (LD) GROUP AND NORMAL DIAMETER (ND) GROUP. PATIENTS IN THE LD GROUP WERE TREATED WITH LARGER DIAMETER ZFEN DEVICES (EITHER 34 MM OR 36 MM). PATIENTS IN THE ND GROUP WERE TREATED WITH LESS THAN/EQUAL TO 32 MM ZFEN DEVICES. PATIENTS WERE FOLLOWED POSTOPERATIVELY BY CTA AND/OR DUPLEX ULTRASOUND. MEAN FOLLOW-UP TIME WAS 22 MONTHS. ONE HUNDRED (100) PATIENTS WERE TREATED FROM 2012-2017 WITH THE ZFEN DEVICE. IN ADDITION TO LARGER NECKS, PATIENTS IN THE LD GROUP HAD SHORTER, AND LESS ANGULATED INFRARENAL NECKS. PERCENT OVERSIZING WAS SIGNIFICANTLY LESS IN THE LD GROUP. LD GROUP 19.05% +/- 18.25%. ND GROUP 24.27% +/- 12.01%. AAA DIAMETER FOR PATIENTS IN THE ND GROUP: 58.5 MM +/- 9.6 MM AAA DIAMETER FOR PATIENTS IN THE LD GROUP: 61.0 MM +/- 17.4 MM INFRARENAL NECK DIAMETER FOR PATIENTS IN THE ND GROUP: 23.4 MM +/- 3.2 MM INFRARENAL NECK DIAMETER FOR PATIENTS IN THE LD GROUP: 30.1 MM +/- 5.3 MM INFRARENAL NECK LENGTH FOR PATIENTS IN THE ND GROUP: 4.7 MM +/- 3.44 MM INFRARENAL NECK LENGTH FOR PATIENTS IN THE LD GROUP: 2.6 MM +/- 2.9 MM INFRARENAL ANGULATION FOR PATIENTS IN THE ND GROUP: 31.7 DEGREES +/- 19.4 DEGREES INFRARENAL ANGULATION FOR PATIENTS IN THE LD GROUP: 21.5 DEGREES +/- 12.1 DEGREES SUPRARENAL ANGULATION FOR PATIENTS IN THE ND GROUP: 24.8 DEGREES +/- 18.9 DEGREES SUPRARENAL ANGULATION FOR PATIENTS IN THE LD GROUP: 16.5 DEGREES +/-15.8 DEGREES RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE ND GROUP: 18 RENAL OCCLUSIVE DISEASE FOR PATIENTS IN THE LD GROUP: 8 1 PATIENT (LD GROUP) HAD TYPE 1A ENDOLEAK THAT REQUIRED REINTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2112853 ZENITH FENESTRATED GRAFT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM A. COOK AUSTRALIA, PTY LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention