BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS

    MDR report key: 7446051 · Received April 20, 2018

    Report

    Report Number
    3002808486-2018-00487
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    July 3, 2017
    Report Date
    August 3, 2018
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002347141
    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 DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ANEURYSM EXPANSION WITH SECONDARY INTERVENTION. PRIMARY THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) INDICATION WAS A SYMPTOMATIC, PENETRATING AORTIC ULCER. THE PATIENT EXPERIENCED BACK/CHEST PAIN PRE-PROCEDURE. PRE-PROCEDURE MEASUREMENTS SHOWED NO VESSEL WALL THROMBOSIS IN AORTIC NECKS > 50% OF CIRCUMFERENCE. PROXIMAL NECK WAS STRAIGHT AND THE DIAMETER WAS 25 MM. THE DISTAL NECK WAS ALSO STRAIGHT. THE SITE HAS NOTED THAT THERE WAS MALPERFUSION IN THE RENALS. PROXIMAL START OF FALSE LUMEN WAS ZONE 2 USING ISHUMARUS CLASSIFICATION OF AORTIC ARCH. THE MOST DISTAL EXTENT OF FALSE LUMEN WAS THE THORACIC AORTA. NO RE-ENTRY TEARS WERE VISIBLE. THE FALSE LUMEN STATUS WAS PATENT. ON (B)(6) 2016, THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE ACCESS SITE WAS IN THE AORTA. THE LEFT SUBCLAVIAN ARTERY WAS NOT COVERED BY THE STENT GRAFT FABRIC. THE PROXIMAL IMPLANTATION ZONE WAS ZONE 3. FOLLOWING ADDITIONAL PROCEDURES WAS PERFORMED DURING STUDY PROCEDURE: BRACHIOCEPHALIC ARTERY REVASCULARIZATION, LCCA REVASCULARIZATION, SA REVASCULARIZATION. ON (B)(6) 2016 (DAY OF PROCEDURE), THE PATIENT HAD CARDIAC ARREST BUT WAS RESUSCITATED AND HAD AN EXTERNAL PACEMAKER INSERTED. THIS WAS CONSIDERED RELATED TO PROCEDURE BUT NOT RELATED TO DEVICE. ON (B)(6) 2016 (55 DAYS POST-PROCEDURE), A FOLLOW-UP VISIT SHOWED A TYPE 1A ENDOLEAK AND ANEURYSM EXPANSION IN THE ASCENDING AORTA. THERE WAS NO PROGRESSION OF DISSECTION. ON (B)(6) 2016 (61 DAYS POST-PROCEDURE), THE PATIENT HAD A SECONDARY INTERVENTION PERFORMED WITH REPLACEMENT OF THE AORTIC ARCH AND ASCENDING AORTA DUE TO THE ANEURYSM EXPANSION. THIS WAS CONSIDERED NOT RELATED TO DEVICE OR PROCEDURE. THEY HAVE GIVEN FOLLOWING COMMENTS: ¿A CT-SCAN ON (B)(6) 2016 SHOWED PLICATION OF THE STENT GRAFT OF THE ASCENDING AORTA, 3.6CM AFTER THE AORTIC ANNULUS.¿ AN ENDOLEAK TYPE 1A WAS SEEN AFTER THE SECONDARY INTERVENTION. ON (B)(6) 2016 (139 DAYS POST-PROCEDURE), A FOLLOW-UP VISIT SHOWED NO PROGRESSION OF DISSECTION AND THE PREVIOUSLY NOTED ENDOLEAK TYPE 1A WAS STILL PRESENT. ADDITIONAL INFORMATION RECEIVED (B)(6) 2018: ON (B)(6) 2017 (419 DAYS POST-PROCEDURE), A FOLLOW-UP VISIT SHOWED PATENT FALSE LUMEN AT STENTED SEGMENT OF AORTA AND AN ATEGRADE PROGRESSION OF DISSECTION. THE SITE NOTED "THE PLICATION OF THE STENT GRAFT OF THE ASCENDING AORTA IS STABLE". ON (B)(6) 2017 (514 DAYS POST-PROCEDURE), THE PATIENT WAS HOSPITALIZED DUE TO THORACIC PAIN. HE HAD AN INTERVENTION PERFORMED ON (B)(6) 2017 WITH PLACEMENT OF A PROXIMAL EXTENSION TO THE INITIAL THORACIC GRAFT. THE REASON FOR THE INTERVENTION WAS CT PROOF OF A TYPE 1A ENDOLEAK AND ANEURYSM EXPANSION. PATIENT OUTCOME: HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. THE PATIENT REMAINS IN THE STUDY.

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER E2016032. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE COMPLAINT STATES A PATIENT WHO UNDERGO A TEVAR PROCEDURE WHERE ZTA-P-42-225 (COMPLAINT DEVICE) AND ZTA-P-38-217 ARE IMPLANTED. THE PATIENT HAS A FALSE LUMEN FROM ZONE 2 TO THE THORACIC AORTA, AND A SYMPTOMATIC PENETRATING AORTIC ULCER. ON THE FOLLOW-UP VISIT, 55 DAYS POST-PROCEDURE, A TYPE IA ENDOLEAK IS OBSERVED. THE ENDOLEAK IS STILL PRESENT ON 61 DAYS AND 139 DAYS POST -PROCEDURE. ON 528 DAYS POST-PROCEDURE THE PATIENT UNDERGO A SECONDARY PROCEDURE, WITH PLACEMENT OF A PROXIMAL EXTENSION, DUE TO TYPE IA ENDOLEAK AND ANTEGRADE PROGRESSION OF DISSECTION. THE FOLLOW-UP VISIT, 560 DAYS POST-PROCEDURE, SHOWS NO ENDOLEAK. THIS COMPLAINT WAS RECEIVED WITH "ANEURYSM EXPANSION RELATED TO DEVICE". HOWEVER, PER THE EVENT DESCRIPTION, THE ANEURYSM IS DESCRIBED TO BE IN THE ASCENDING AORTA, WHEREAS THE COMPLAINT DEVICE WAS IMPLANTED IN ZONE 3, THE DESCENDING AORTA. TYPE IA ENDOLEAK WAS ALSO REPORTED AFTER THE TEVAR PROCEDURE. THE ENDOLEAK WAS STILL PRESENT ON THE FOLLOW-UP VISITS UNTIL THE SECONDARY PROCEDURE (PROXIMAL EXTENSION PLACEMENT) WAS PERFORMED 560 DAYS POST-PROCEDURE, WERE THE OUTCOME OF THE PROCEDURE REVEALED NO ENDOLEAK. THE CAUSE FOR THE ENDOLEAK IS UNKNOWN. HOWEVER, PER THE EVENT DESCRIPTION THE STENT GRAFT WAS PLACED IN ZONE 3, WHEREAS THE PROXIMAL START OF THE FALSE LUMEN WAS ZONE 2 AND THE MOST DISTAL EXTENT OF THE FALSE LUMEN WAS THE THORACIC AORTA. THIS INDICATES THAT THE LANDING ZONE WAS LIKELY DISEASED AND THAT THE STENT GRAFT WAS USED TO TREATMENT OF DISSECTION. IT IS NOT POSSIBLE TO DETERMINE IF THE USE OF THE DEVICE OUTSIDE OF INTENDED USE DID CONTRIBUTE TO THE OCCURRENCE OF THE REPORTED ENDOLEAK AS THE DEVICE HAS NOT BEEN FORMALLY TESTED IN PATIENTS HAVING DISSECTIONS. NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: PRIMARY THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) INDICATION WAS A SYMPTOMATIC, PENETRATING AORTIC ULCER. THE PATIENT EXPERIENCED BACK/CHEST PAIN PRE-PROCEDURE. PRE-PROCEDURE MEASUREMENTS SHOWED NO VESSEL WALL THROMBOSIS IN AORTIC NECKS > 50% OF CIRCUMFERENCE. PROXIMAL NECK WAS STRAIGHT AND THE DIAMETER WAS 25 MM. THE DISTAL NECK WAS ALSO STRAIGHT. THE SITE HAS NOTED THAT THERE WAS MALPERFUSION IN THE RENALS. PROXIMAL START OF FALSE LUMEN WAS ZONE 2 USING ISHUMARUS CLASSIFICATION OF AORTIC ARCH. THE MOST DISTAL EXTENT OF FALSE LUMEN WAS THE THORACIC AORTA. NO RE-ENTRY TEARS WERE VISIBLE. THE FALSE LUMEN STATUS WAS PATENT. ON (B)(6) 2016, THE PATIENT UNDERWENT A SURGICAL PROCEDURE WHERE ACCESS SITE WAS IN THE AORTA. THE LEFT SUBCLAVIAN ARTERY WAS NOT COVERED BY THE STENT GRAFT FABRIC. THE PROXIMAL IMPLANTATION ZONE WAS ZONE 3. FOLLOWING ADDITIONAL PROCEDURES WAS PERFORMED DURING STUDY PROCEDURE: BRACHIOCEPHALIC ARTERY REVASCULARIZATION. LCCA REVASCULARIZATION. LSA REVASCULARIZATION. ON (B)(6) 2016 (DAY OF PROCEDURE), THE PATIENT HAD CARDIAC ARREST BUT WAS RESUSCITATED AND HAD AN EXTERNAL PACEMAKER INSERTED. THIS WAS CONSIDERED RELATED TO PROCEDURE BUT NOT RELATED TO DEVICE. ON (B)(6) 2016 (55 DAYS POST-PROCEDURE), A FOLLOW-UP VISIT SHOWED A TYPE 1A ENDOLEAK AND ANEURYSM EXPANSION IN THE ASCENDING AORTA. THERE WAS NO PROGRESSION OF DISSECTION. ON (B)(6) 2016 (61 DAYS POST-PROCEDURE), THE PATIENT HAD A SECONDARY INTERVENTION PERFORMED WITH REPLACEMENT OF THE AORTIC ARCH AND ASCENDING AORTA DUE TO THE ANEURYSM EXPANSION. THIS WAS CONSIDERED NOT RELATED TO DEVICE OR PROCEDURE. THEY HAVE GIVEN FOLLOWING COMMENTS: ¿A CT-SCAN ON (B)(6) 2016 SHOWED PLICATION OF THE STENT GRAFT OF THE ASCENDING AORTA, 3.6CM AFTER THE AORTIC ANNULUS.¿ AN ENDOLEAK TYPE 1A WAS SEEN AFTER THE SECONDARY INTERVENTION. ON (B)(6) 2016 (139 DAYS POST-PROCEDURE), A FOLLOW-UP VISIT SHOWED NO PROGRESSION OF DISSECTION AND THE PREVIOUSLY NOTED ENDOLEAK TYPE 1A WAS STILL PRESENT. ADDITIONAL INFORMATION RECEIVED 11APR2018: ON (B)(6) 2017 (419 DAYS POST-PROCEDURE), A FOLLOW-UP VISIT SHOWED PATENT FALSE LUMEN AT STENTED SEGMENT OF AORTA AND AN ANTEGRADE PROGRESSION OF DISSECTION. THE SITE NOTED "THE PLICATION OF THE STENT GRAFT OF THE ASCENDING AORTA IS STABLE". ON (B)(6) 2017 (514 DAYS POST-PROCEDURE), THE PATIENT WAS HOSPITALIZED DUE TO THORACIC PAIN. HE HAD AN INTERVENTION PERFORMED ON (B)(6) 2017 WITH PLACEMENT OF A PROXIMAL EXTENSION TO THE INITIAL THORACIC GRAFT. THE REASON FOR THE INTERVENTION WAS CT PROOF OF A TYPE 1A ENDOLEAK AND ANEURYSM EXPANSION. PATIENT OUTCOME: HE WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2017. THE PATIENT REMAINS IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289178 ZENITH ALPHA¿ THORACIC ENDOVASCULAR GRAFT PROXIMAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE E3405448 10827002347141

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention