BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 12210257 · Received July 22, 2021

    Report

    Report Number
    3002808486-2021-01649
    Event Type
    Death
    Date Received
    July 22, 2021
    Date of Event
    July 8, 2021
    Report Date
    April 4, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002449609
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: PER REPORTED INFORMATION AN 83 YEAR OLD MALE PATIENT UNDERWENT ELECTIVE SURGERY FOR THORACIC AORTIC ANEURYSM (TAA) WITH A ZTA-P-38-167-W1 (COMPLAINT DEVICE ONE) ON (B)(6) 2021. THE PATIENT WAS SUFFERING FROM HYPERTENSION, DIABETES MELLITUS, DYSLIPIDEMIA, CHRONIC KIDNEY DISEASE, CHRONIC HEART FAILURE, ANGINA PECTORIS, PROSTATE CANCER, DEMENTIA AND FRACTURE OF THE RIBS BEFORE UNDERGOING SURGERY. THE PHYSICIAN WAS AWARE THAT PATIENT ANATOMY WAS OUTSIDE INSTRUCTIONS FOR USE (IFU) DUE TO SEVERE TORTUOSITY AND SHORTAGE OF NECK LENGTH BUT THE ZTA-P-38-167-W1 WAS IMPLANTED FROM ZONE 1 ANYWAY, AS THE PHYSICIAN ASSESSED THE PATIENT UNABLE TO UNDERGO OPEN SURGERY DUE TO MULTIMORBIDITY. THE ZTA-P-38-167-W1 COVERED THE LEFT SUBCLAVIAN ARTERY AND A LEFT COMMON CAROTID ARTERY TO THE LEFT SUBCLAVIAN ARTERY BYPASS WAS PERFORMED. POST IMPLANTATION A TYPE 1A ENDOLEAK (B)(4) WAS CONFIRMED AND BALLOONING WAS PERFORMED. HOWEVER, SINCE THE TYPE 1A ENDOLEAK PERSISTED A ZTA -P-38-117 -W1 (COMPLAINT DEVICE TWO) WAS DEPLOYED SLIGHTLY PROTRUDING (5MM) TO BACK THE ZTA-P-38-167-W1. NO ENDOLEAK WAS PRESENT AFTER A SECOND PROXIMAL BALLOONING PROCEDURE. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT AND WAS STABLE UNTIL THE SUDDEN ONSET OF AN IMPORTANT CLINICAL DETERIORATION IN THE MIDDLE OF THE NIGHT ON (B)(6) 2021. THE DEVELOPMENT OF A TYPE A DISSECTION WAS ESTABLISHED, AND THE PATIENT DIED SHORTLY HEREAFTER. PER MEDICAL ADVISOR´S CLINICAL ASSESSMENT IT IS MOST LIKELY THAT THE CAUSE OF DEATH WAS THE TYPE-A DISSECTION. HOWEVER, THE PATIENT¿S EXTENSIVE AND SEVERE CO-MORBIDITY, ESPECIALLY CHRONIC KIDNEY DISEASE AND CHRONIC HEART FAILURE AND THUS PRESUMABLY SIGNIFICANTLY REDUCED PHYSIOLOGICAL HEMODYNAMIC COMPENSATORY CAPABILITY MAY ALSO HAVE CONTRIBUTED TO THE DEADLY OUTCOME. NO IMAGES, AUTOPSY REPORT OR POSTMORTEM INFORMATION IS AVAILABLE. REVIEW OF THE DEVICE HISTORY RECORD GAVE NO INDICATION OF THE DEVICE BEING PRODUCED OUT OF SPECIFICATION. THE INSTRUCTIONS FOR USE (IFU) FOR THIS TYPE OF DEVICE STATES THAT THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS OR ULCERS OF THE DESCENDING THORACIC AORTA HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR. THE ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT IS DESIGNED TO TREAT PROXIMAL AORTIC NECKS (DISTAL TO EITHER THE LEFT SUBCLAVIAN OR LEFT COMMON CAROTID ARTERY) OF AT LEAST 20 MM IN LENGTH. THE IFU ALSO STATES AORTIC DAMAGE AND DEATH AS A POTENTIAL SERIOUS ADVERSE EVENT. BASED ON THE LIMITED INFORMATION AVAILABLE IT HAS NOT BEEN POSSIBLE TO ESTABLISH AN EXACT CAUSE FOR THIS EVENT. THE PHYSICIAN WAS AWARE THAT A PROXIMAL LANDING ZONE 1AND VASCULAR MORPHOLOGY IN THIS PATIENT WAS OUTSIDE INTENDED USE. IT HAS NOT BEEN POSSIBLE TO ESTABLISH IF THIS HAS CONTRIBUTED TO THE RETROGRADE TYPE A DISSECTION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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

    MANUFACTURER REF (B)(4). INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR 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

    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 ON 28JUL2021: BYPASS WAS PERFORMED BETWEEN THE LEFT COMMON CAROTID ARTERY AND THE LEFT AXILLARY ARTERY. THE DOCTOR SAID THAT HE COULD NOT DETERMINE WHETHER THE DEATH WAS CAUSED BY THE WIRE MANIPULATION OF THE PROCEDURE, BALLOONING, OR THE PATIENT'S (MEDICAL HISTORY AND CHRONIC DISEASE) CONDITION. ALSO, THE INFLUENCE OF THE HEART BEAT AFTER DEVICE IMPLANTATION WAS ALSO CONSIDERED AS A CAUSE. PATIENT OUTCOME: PROCEDURE WAS PREFORMED (B)(6) 2021 AND THE PATIENT DIED ON (B)(6) 2021.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF# (B)(4). SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): P140016. INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER: ON (B)(6) 2021 TEVAR WAS PERFORMED WITH A PLAN TO IMPLANT ZTA-P-38-167-W1(E4098972) FROM BOVINE ARCH 1DEB (ZONE 1). THE ACCESS WAS GAINED FROM THE RIGHT EIA. AFTER IMPLANTATION, TYPE 1A ENDOLEAK WAS CONFIRMED AND BALLOONING WAS PERFORMED. HOWEVER, SINCE TYPE 1A ENDOLEAK REMAINED, ZTA-P-38-117-W1(E3779409) WAS PLACED WITH THE TIP SLIGHTLY PROTRUDING (PUTTING OUT) FOR BACKING ZTA-P-38-167-W1(E4098972) . THEN, BALLOONING WAS PERFORMED, AND THE ENDOLEAK DISAPPEARED, AND THE PROCEDURE WAS COMPLETED. POSTOPERATIVE CONDITION WAS GOOD IN THE ICU AFTER THE PROCEDURE, THEN IT SUDDENLY CHANGED IN THE MIDDLE OF THE NIGHT (DETAILED TIME IS UNKNOWN) AND THE PATIENT DEVELOPED TYPE A DISSECTION. ADDITIONAL INFORMATION RECEIVED ON 14JUL2021. THE TARGET OF TEVAR WAS ANEURYSM. THE FIRST BALLOONING WAS PERFORMED AT THE PROXIMAL SITE OF ZTA-P-38-167-W1. THE SECOND BALLOONING WAS PERFORMED AT THE PROXIMAL SITE OF ZTA-P-38-117-W1. THE INFLATION SIZE WAS SET TO EXPAND TO 38MM. ADDITIONAL INFORMATION RECEIVED ON 15JUL2021. ZTA-P-38-167-W1(E4098972) WAS ABLE TO LAND BOVINE ARCH 1DEB (ZONE 1) ACCURATELY. DUE TO ENDOLEAK TYPE 1A, ZTA-P-38-117-W1(E3779409) WAS PLACED WITH THE TIP SLIGHTLY PROTRUDING (PUTTING OUT) ABOUT 5MM FOR BACKING ZTA-P-38-167-W1(E4098972). BYPASS WAS PERFORMED BETWEEN THE LEFT COMMON CAROTID ARTERY AND THE LEFT SUBCLAVIAN ARTERY OR THE LEFT AXILLARY ARTERY. OTHER DEVICES WERE USED: GORE/TRI-LOBE BALLOON CATHETER, GORE/DRY SEAL 22FR. PATIENT OUTCOME: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108919 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3779409 10827002449609

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Death