BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 5243685 · Received November 23, 2015

    Report

    Report Number
    1820334-2015-00831
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    August 19, 2014
    Report Date
    October 29, 2015
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, TRENDS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE DEVICE IS SHIPPED WITH AN INSTRUCTION FOR USE (IFU) THAT DESCRIBES THE INTENDED USE, SPECIFIC ITEMS ARE ADDRESSED SUCH AS: "VESSELS THAT ARE SIGNIFICANTLY CALCIFIED, OCCLUSIVE, TORTUOUS OR THROMBUS-LINED MAY PRECLUDE PLACEMENT OF THE ENDOVASCULAR GRAFT AND/OR MAY INCREASE THE RISK OF EMBOLIZATION. PRE-EXISTING REGIONS OF STENOSIS/NARROWING HAVE BEEN SHOWN TO INCREASE THE RISK OF A THROMBOEMBOLIC EVENT. FOLLOW-UP IMAGING SHOULD BE CAREFULLY REVIEWED FOR NARROWING WITHIN THE GRAFT LEG. PATIENTS WITH A GRAFT LEG LUMEN OF LESS THAN APPROXIMATELY 5MM ID MAY BE AT INCREASED RISK OF A THROMBOEMBOLIC EVENT. PATIENTS WITH POOR OUTFLOW OR A HYPERCOAGULABLE STATE MAY BE AT AN INCREASED RISK OF A THROMBOEMBOLIC EVENT. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO: ARTERIAL OR VENOUS THROMBOSIS." "PATIENTS EXPERIENCING REDUCED BLOOD FLOW THROUGH THE GRAFT LIMB AND/OR LEAKS MAY BE REQUIRED TO UNDERGO SECONDARY INTERVENTIONS OF SURGICAL PROCEDURES." A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED DUE TO NO LOT INFORMATION. DUE TO THIS PRODUCT ONLY BEING ONE PER LOT NUMBER NO OTHER COMPLAINTS WOULD BE ASSOCIATED WITH THIS COMPLAINT IF LOT INFORMATION WAS AVAILABLE. THROMBOSIS CAN OCCUR FOR A VARIETY OF REASONS, LIKE: GENETIC PREDISPOSITION, ILIAC TORTUOSITY, EXTERNAL COMPRESSION, PULSATION / REPETITIVE STENOSIS, NARROW INNER ILIAC LUMEN, VESSEL DAMAGE, AND ROUGH SURFACES. TORTUOSITY, COMPRESSION, AND PULSATION CAN CREATE SHEAR FORCES WITHIN THE LEG THAT STIMULATE THROMBUS GROWTH. WHERE A SMALL THROMBUS HAS FORMED, THE CLOT CAN ENLARGE BECAUSE THE BLOOD FLOW SLOWS AROUND THE CLOT, ALLOWING CLOT-FORMING ELEMENTS TO BE DEPOSITED. PULSATION AND A SMALL INNER LUMEN CAN OCCUR THROUGH GRAFT OVERSIZING OR UNDERSIZING. THE COMPLAINT REPORT STATES THAT THE PROXIMAL NECK HAD AN IRREGULAR SHAPE WITH PARTIAL PLAQUE/THROMBUS, AND THE BILATERAL ILIAC ARTERIES HAD MILD TORTUOSITY, BUT THIS DOES NOT PROVIDE ENOUGH INFORMATION TO DETERMINE IF THE ANATOMY COULD HAVE HAD AN EFFECT. BASED ON THE IFU, TORTUOSITY AND THROMBUS CAN LEAD TO FURTHER ISSUES (EMBOLIZATION AND THROMBOSIS), BUT IT IS UNKNOWN THE DEGREE OF SEVERITY AT THE DATE OF IMPLANTATION. THE ROOT CAUSE COULD NOT BE DETERMINED. THERE WAS NOT ENOUGH INFORMATION PROVIDED TO DETERMINED IF THE PATIENT HAD ANY CONDITIONS THAT WOULD/WOULD NOT PREDISPOSE THEM TO AN THROMBOEMBOLIC EVENT. IN ADDITION, THERE WAS NOT ENOUGH DETAILS PROVIDED RELATED TO THE IMPLANT PROCEDURE TO DETERMINE IF CERTAIN TECHNIQUES (I.E. EXCESSIVE OVERLAP) WERE USED BY THE PHYSICIAN THAT COULD HAVE INCREASED THE RISK OF LIMB THROMBOSIS. THEREFORE, THE ROOT CAUSE IS INCONCLUSIVE - CANNOT BE DETERMINED. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT IN THE SPIRAL-Z POST-MARKET REGISTRY (11-015) EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK) ON 08/19/2014 (103 DAYS POST PROCEDURE) AND LOWER EXTREMITY ISCHEMIA (413 DAYS POST PROCEDURE). THE PATIENT WAS TREATED ON (B)(6) 2014 FOR AN AORTIC ANEURYSM. THE MAXIMUM AORTIC DIAMETER WAS 58 MM. THE PROXIMAL NECK HAD AN IRREGULAR SHAPE WITH PARTIAL PLAQUE/THROMBUS. THE BILATERAL ILIAC ARTERIES HAD MILD TORTUOSITY, NO OCCLUSIVE DISEASE, AND MILD CALCIFICATION. THE PATIENT RECEIVED A 22MM X 98MM MAIN-BODY DEVICE(ANOTHER MANUFACTURER), A 16MM X 74MM LEFT ILIAC LEG, AND A 16MM X 56MM RIGHT ILIAC LEG. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER PROCEDURES WERE PERFORMED AND NO ADDITIONAL DEVICES WERE USED. A MOLDING BALLOON WAS USED BUT NO DETAILS WERE PROVIDED REGARDING ITS USE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, OR THROMBUS. A TYPE II ENDOLEAK WAS NOTED. ON (B)(6) 2014 (71 DAYS POST-PROCEDURE), THE PATIENT WAS SEEN IN FOLLOW-UP. THE STATUS OF THE ANEURYSM WAS NOT SPECIFIED. DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, MIGRATION OR ENDOLEAKS. THERE WAS EVIDENCE OF THROMBUS IN THE RIGHT ILIAC LEG. ON (B)(6) 2014 (103 DAYS POST PROCEDURE), THE PATIENT EXPERIENCED CLAUDICATION (LOWER LIMB OR BUTTOCK). ON THE SAME DAY, A SECONDARY INTERVENTION WAS PERFORMED TO TREAT THROMBOSIS IN THE RIGHT ILIAC LEG. THE SECONDARY INTERVENTION INCLUDED FEMOROFEMORAL BYPASS. ON (B)(6) 2015 (413 DAYS POST-PROCEDURE), THE PATIENT WAS SEEN IN FOLLOW-UP. THERE WAS NO CHANGE IN THE SIZE OF THE ANEURYSM. THE DEVICES WERE OCCLUDED IN THE MAIN BODY, RIGHT ILIAC LEG AND LEFT ILIAC LEG. THERE WAS EVIDENCE OF EXTERNAL COMPRESSION IN THE RIGHT ILIAC LEG. THERE WAS EVIDENCE OF THROMBUS IN THE MAIN BODY, RIGHT ILIAC LEG (1820334-2015-00781) AND LEFT ILIAC LEG (1820334-2015-00831). THERE WAS NO EVIDENCE OF FLOW-LIMITING KINKS, MIGRATION OR ENDOLEAKS. ON THE SAME DAY, THE PATIENT EXPERIENCED CLINICAL SIGNS INDICATIVE OF LOWER EXTREMITY ISCHEMIA AND UNDERWENT A SECONDARY INTERVENTION TO TREAT THROMBOSIS IN BOTH THE RIGHT AND LEFT ILIAC LEGS. THE INTERVENTION INCLUDED THROMBECTOMY AND COVERED STENT PLACEMENT. NO FURTHER FOLLOW-UP INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774029 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention