BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 8140880 · Received December 7, 2018

    Report

    Report Number
    3002808486-2018-01412
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    September 7, 2017
    Report Date
    November 21, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002347042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). G1) NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI) 400 DANIELS WAY BLOOMINGTON, IN 47404 REGISTRATION NO.: 3005580113. G5) SIMILAR TO DEVICES UNDER PMA/510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AN 80-YEAR-OLD MALE PATIENT WITH A THORACIC AORTIC ANEURYSM WITH A MAXIMUM DIAMETER OF 66 MM UNDERWENT SURGERY ON (B)(6) 2016 AND HAD 3 PROXIMAL COMPONENTS IMPLANTED, ONE OF WHICH IS REPORTED TO BE A ZTA-P-38-167. DURING THE PROCEDURE A LSA REVASCULARIZATION WAS ALSO PERFORMED. FOLLOW-UP CT SCAN PERFORMED ON (B)(6) 2016 SHOWED A MAXIMUM ANEURYSM DIAMETER OF 66 MM AND A TOTAL LENGTH OF THE COVERED AORTA ON 160 MM. A TYPE 2 ENDOLEAK WAS OBSERVED COMING FROM THE BRONCHIAL ARTERY. ON A CT-SCAN PERFORMED ON (B)(6) 2017 THE MAXIMUM DIAMETER OF THE ANEURYSM HAD INCREASED TO 96 MM WITH A TOTAL LENGTH OF THE COVERED AORTA ON 167 MM. ON A CT SCAN ON (B)(6) 2017 THE LENGTH OF THE COVERED AORTA WAS 250 MM AND IT WAS DECIDED TO PERFORM A SECONDARY INTERVENTION WHERE A DISTAL EXTENSION WAS INSERTED. THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE, HYPERTENSION AND RENAL INSUFFICIENCY. NO PRODUCT WAS RETURNED, AND NO IMAGING PROVIDED. A CLINICAL ASSESSMENT WAS MADE, THIS STATED: ¿IT IS IMPOSSIBLE TO ASSESS IF THERE WAS A FAULT OR FAILURE OF THE ALPHA THORACIC DEVICE(S) DUE TO LACK OF INFORMATION AND IMAGING. NO MENTION IS MADE IN THE REPORT OF ENDOLEAKS APART FROM THE TYPE 2 BRONCHIAL ONE, BUT A TYPE 1A OR 1B ENDOLEAK COULD HAVE BEEN THE CAUSE OF THE PROBLEM, USUALLY DUE TO UNDERSIZING OF THE GRAFT. HOWEVER, THIS IS PURE SPECULATION, AND CONCLUSIVE ANALYSIS CAN¿T BE DONE.¿ INFORMATION WAS GIVEN ON ONLY 1 OUT OF 3 USED DEVICES. BASED ON THE PROVIDED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE WHETHER THE REPORTED DEVICE WAS PART OF THE INCIDENCE. HOWEVER, DEVICE HISTORY RECORD FOR THE REGISTERED DEVICE ZTA-P-38-167 WITH LOT NO. E3423842 WAS REVIEWED AND GAVE NO EVIDENCE OF NON-CONFORMANCES. SINCE NO INFORMATION ABOUT PLANNING, SIZING OR PLACEMENT OF THE STENT-GRAFTS AND NO IMAGING HAVE BEEN PROVIDED, NO CAUSE FOR THIS EVENT CAN BE ESTABLISHED. COOK WILL REOPEN THE COMPLAINT IF FURTHER INFORMATION IS "RECEIVED". 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

    EXEMPTION NUMBER E2016032. WILLIAM COOK EUROPE APS (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI) (IMPORTER). MANUFACTURERS REF# (B)(4). CORRECTION IN DESCRITION OF EVENT: LOT# ADDED. NAME AND ADDRESS FOR IMPORTER SITE: COOK MEDICAL INCORPORATED (CMI), 400 DANIELS WAY, BLOOMINGTON, IN 47404, REGISTRATION NO.: 3005580113. 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

    DESCRIPTION OF EVENT ACCORDING TO STUDY: AT TIME OF ENROLLMENT THE PATIENT PRESENTED WITH A THORACIC AORTIC ANEURYSM WITH TAA MAX DIAMETER >= 6 CM. ON (B)(6) 2015 (216 DAYS PRE-PROCEDURE), THE PRE-PROCEDURE IMAGING WAS PERFORMED. IT SHOWED NO CIRCUMFERENTIAL CALCIFICATIONS OF MAIN ACCESS VESSEL AND NO VESSEL WALL THROMBOSIS IN THE AORTIC NECKS >50% OF CIRCUMFERENCE WAS OBSERVED. THE MAXIMUM ANEURYSM DIAMETER WAS 66 MM. PROXIMAL NECK DIAMETER WAS 32 MM AND PROXIMAL NECK LENGTH WAS 10 MM. THE CHARACTERISTICS OF THE PROXIMAL NECK WAS TAPERED AND THE DISTAL NECK WAS STRAIGHT. THE PRIMARY INDICATION FOR TREATMENT WAS THORACIC AORTIC ANEURYSM. ON (B)(6) 2016 THE PATIENT UNDERWENT SURGERY DUE TO HIS THORACIC AORTIC ANEURYSM. FOLLOWING COMPONENTS WAS IMPLANTED SUCCESSFULLY DURING THE INDEX PROCEDURE: THREE PROXIMAL COMPONENTS. THE SITE HAS BEEN ASKED TO VERIFY THE LOT AND CATALOG NUMBERS FOR THE DEVICES IMPLANTED. NO REPORTABLE ADVERSE EVENTS WERE OBSERVED ON COMPLETION ANGIOGRAM. A LSA REVASCULARIZATION WAS PERFORMED DURING THE PROCEDURE. ON (B)(6) 2016 (66 DAYS POST-PROCEDURE) A FOLLOW-UP VISIT SHOWED A MAXIMUM ANEURYSM DIAMETER OF 66 MM. THE TOTAL LENGTH OF COVERED AORTA WAS 160 MM. A TYPE 2 ENDOLEAK WAS OBSERVED COMING FROM THE BRONCHIAL ARTERY. ON (B)(6) 2017 (399 DAYS POST-PROCEDURE) A FOLLOW-UP VISIT SHOWED A CT-SCAN WITH MAXIMUM ANEURYSM DIAMETER OF 96 MM AND A TOTAL LENGTH OF COVERED AORTA ON 167 MM. ON (B)(6) 2017 (465 DAYS POST-PROCEDURE), AN ANGIOGRAM SHOWED A MAXIMUM ANEURYSM DIAMETER OF 96 MM AND A TOTAL LENGTH OF COVERED AORTA ON 250 MM. BASED ON THIS INFORMATION, IT WAS DECIDED TO PERFORM A SECONDARY INTERVENTION ON (B)(6) 2017 (465 DAYS POST-PROCEDURE ) WHERE A DISTAL EXTENSION WAS INSERTED. THE PATIENT WAS DISCHARGED AGAIN ON (B)(6) 2017 (469 DAYS POST-PROCEDURE). PATIENT OUTCOME: THE PATIENT REMAINS IN THE STUDY.

    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

    CORRECTION IN DESCRIPTION OF EVENT: ON (B)(6) 2016 THE PATIENT UNDERWENT SURGERY DUE TO HIS THORACIC AORTIC ANEURYSM. FOLLOWING COMPONENTS WAS IMPLANTED SUCCESSFULLY DURING THE INDEX PROCEDURE: THREE PROXIMAL COMPONENTS (CATALOG # ZTA-P-38-167, LOT # E3423842).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980999 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3423842 10827002347042

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention