BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS

    MDR report key: 19403471 · Received May 28, 2024

    Report

    Report Number
    3002808486-2024-00081
    Event Type
    Malfunction
    Date Received
    May 28, 2024
    Date of Event
    October 17, 2019
    Report Date
    November 12, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) PMA/510(K): P140016 INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF#(B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: DURING A POST MARKET CLINICAL FOLLOW-UP (PMCF) STUDY COOK BECAME AWARE OF THIS EVENT. THE SUBJECT OF THIS COMPLAINT IS A 78-YEAR-OLD FEMALE PATIENT. PRIMARY INDICATION FOR THORACIC ENDOVASCULAR AORTIC REPAIR WAS INTRAMURAL HEMATOMA. THE PATIENT WAS TREATED WITH TWO NON-COOK STENT GRAFTS AND ZTA-DE-38-91 (THE MOST DISTAL DEVICE). PROXIMAL NECK WAS REPORTED WITHOUT THROMBUS, WITH INVERTED FUNNEL NECK SHAPE, MODERATE TORTUOSITY AND MILD CALCIFICATION. DISTAL NECK WAS REPORTED WITHOUT THROMBUS, WITH PARALLEL NECK SHAPE, WITHOUT TORTUOSITY, OCCLUSIVE DISEASE AND CALCIFICATION. LOCALIZED ANGLE IN SEGMENT OF AORTA INTO WHICH DEPLOYMENT OF THE DEVICE WAS INTENDED WAS REPORTED TO BE MORE THAN 45 DEGREES. RADIUS OF CURVATURE OF AORTA INTO WHICH DEPLOYMENT OF THE DEVICE WAS INTENDED WAS REPORTED TO BE LESS THAN 20 MM. PROXIMAL NECK DIAMETER WAS 28 (MINIMUM) ¿ 32MM (MAXIMUM). DISTAL NECK DIAMETER WAS 26MM. PATIENT PRESCRIBED ANTI-PLATELETS MEDICATION AT TIME OF DISCHARGE. LEFT SUBCLAVIAN TO LEFT COMMON CAROTID BYPASS, LEFT SUBCLAVIAN EMBOLIZATION, LEFT ILIAC ARTERY STENT (COVERED) AND FEMORAL ARTERY RECONSTRUCTION WAS PERFORMED. 6 MONTH FOLLOW CT (COMPUTER TOMOGRAPHY) REVEALED A THROMBUS IN THE ZTA-DE-38-91. NO DEVICE ISSUE WAS REPORTED. THROMBUS WAS ALSO OBSERVED ON 2, 3, 4 AND 5 YEAR FOLLOW UPS. THE PATIENT WAS ON THE ANTI-PLATELET MEDICATION THROUGHOUT THE FIVE YEARS OF FOLLOW-UP. NO REINTERVENTION WAS PERFORMED, NOR IS IT PLANNED. THROMBUS LINING IS STABLE. NO IMAGING WAS PROVIDED FOR THE INVESTIGATION. BASED ON THE PROVIDED INFORMATION IT IS LIKELY THAT INCORRECT PLANNING AND SIZING IN RELATION TO PATIENT ANATOMY SUCH AS MORE THAN 45-DEGREE ANGULATION, LESS THAN 20MM RADIUS OF CURVATURE, INVERTED FUNNEL NECK SHAPE AND OVERSIZING OF STENT COULD POSSIBLY HAVE CONTRIBUTED TO THE THROMBUS FORMATION. IT IS STATED IN THE IFU THAT NO LOCALIZED ANGULATION SHOULD BE LARGER THAN 45 DEGREES AND THAT AORTIC ARCH RADIUS OF CURVATURE SHOULD BE = 20MM. IFU RECOMMEND LANDING THE PROXIMAL AND THE DISTAL ENDS OF THE DEVICE IN PARALLEL AORTIC NECK IN SEGMENTS WITHOUT ACUTE ANGULATION. FURTHERMORE, THE USE OF ZTA-DE-38-91 IN RELATION TO REPORTED PROXIMAL NECK DIAMETER BETWEEN 28 AND 32MM, AND DISTAL NECK DIAMETER OF 26MM, IT IS STATED IN THE IFU THAT OVERSIZING OF THE STENT GRAFTS DIAMETER MAY RESULT IN INCOMPLETE SEALING OR COMPROMISED FLOW. IT IS NOTED THAT ZTA DEVICE IS USED FOR TREATMENT OF INTRAMURAL HEMATOMA AND IN COMBINATION WITH NON-COOK DEVICE WHICH IS OUTSIDE OF INTENDED USE FOR THIS TYPE OF DEVICE. ZTA IS INDICATED FOR TREATMENT OF ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA. DISTAL EXTENSIONS CAN BE USED TO PROVIDE ADDITIONAL LENGTH TO THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTALLY OR TO INCREASE THE LENGTH OF OVERLAP BETWEEN COMPONENTS. COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). INVESTIGATION IS STILL IN PROGRESS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY: 6 MONTH FOLLOW UP: FROM FOLLOW-UP CT/MRI, PATENCY: IS THERE ANY EVIDENCE OF THROMBUS? = YES IS THERE EVIDENCE OF DEVICE ISSUE(S)? = NO DISTAL EXTENSION (ZTA-DE-) = YES 2 YEAR FOLLOW UP: FROM FOLLOW-UP CT/MRI, PATENCY: IS THERE ANY EVIDENCE OF THROMBUS? = YES IS THERE EVIDENCE OF DEVICE ISSUE(S)? = NO DISTAL EXTENSION (ZTA-DE-) = YES 3 YEAR FOLLOW UP: FROM FOLLOW-UP CT/MRI, PATENCY: IS THERE ANY EVIDENCE OF THROMBUS? = YES IS THERE EVIDENCE OF DEVICE ISSUE(S)? = NO DISTAL EXTENSION (ZTA-DE-) = YES 4 YEAR FOLLOW UP: FROM FOLLOW-UP CT/MRI, PATENCY: IS THERE ANY EVIDENCE OF THROMBUS? = YES IS THERE EVIDENCE OF DEVICE ISSUE(S)? = NO DISTAL EXTENSION (ZTA-DE-) = YES 5 YEAR FOLLOW UP: FROM FOLLOW-UP CT/MRI, PATENCY: IS THERE ANY EVIDENCE OF THROMBUS? = YES IS THERE EVIDENCE OF DEVICE ISSUE(S)? = NO DISTAL EXTENSION (ZTA-DE-) = YES INFORMATION FROM CASE STUDY 23MAY2024 PRIMARY INDICATION FOR THORACIC ENDOVASCULAR AORTIC REPAIR INTRAMURAL HEMATOMA EMERGENT (AS SOON AS POSSIBLE) SYMPTOMATIC: PAIN IN BACK AND ABDOMINAL ANTI-PLATELETS (OTHER THAN ASPIRIN): YES ASA KLASSE 4 ONE DAY PRIOR TO PROCEDURE AORTIC ARCH TYPE: TYPE II RADIUS IF CURVATURE <20 MM IN ANY SEGMENT OF AORTA INTO WHICH DEPLOYMENT OF THE DEVICE IS INTENDED: YES LOCALIZED ANGLE >45 DEGREES IN ANY SEGMENT OF AORTA INTO WHICH DEPLOYMENT OF THE DEVICE IS INTENDED: YES LENGTH OF PROXIMAL SEALING ZONE : 25 LENGTH OF DISTAL SEALING ZONE: 48 DURING PROCEDURE A LEFT SUBCLAVIAN TO LEFT COMMON CAROTID BYPASS AND A LEFT SUBCLAVIAN EMBOLIZATION WAS PERFORMED. AN ILIAC ARTERY STENT (COVERED), LEFT AND FEMORAL ARTERY RECONSTRUCTION WAS PERFORMED DEVICE IMPLANTED DURING PROCEDURE: ZTA-DE AND TWO NON-COOK STENT GRAFTS. ADDITIONAL INFORMATION RECEIVED 23MAY2024: ASIDE FROM THE ANTI-PLATELET MEDICATION THAT THE PATIENT WAS ON THROUGHOUT THE FIVE YEARS OF FOLLOW-UP, I CANNOT CONFIRM ANY OTHER TREATMENT AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED 23MAY2024: ASIDE FROM THE ANTI-PLATELET MEDICATION THAT THE PATIENT WAS ON THROUGHOUT THE FIVE YEARS OF FOLLOW-UP, ANY OTHER TREATMENT CANNOT BE CONFIRMED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676657 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT DISTAL EXTENSIONS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE G34616 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female