BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT

    MDR report key: 6371124 · Received March 2, 2017

    Report

    Report Number
    3002808486-2017-00690
    Event Type
    Death
    Date Received
    March 2, 2017
    Date of Event
    April 25, 2016
    Report Date
    May 11, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    UDI-DI
    10827002236148
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SIMILAR TO DEVICE UNDER 510(K) P070016. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THE REPORTED INFORMATION FOR THIS COMPLAINT SUGGESTED DEATH OF THE PATIENT DUE TO ANAPHYLACTIC SHOCK (TYPE 1 HYPERSENSITIVITY REACTION) RELATED TO THE DEVICE, ZTEG-, MANUFACTURED BY WCE. THE PATIENT EXPERIENCED A SUDDEN AND DRAMATIC CIRCULATORY COLLAPSE APPROXIMATELY TEN MINUTES AFTER PLACING THE FIRST DEVICE ACCOMPANIED BY LINGUAL AND LABIAL SWELLING OBSERVED DURING THE RECOVERY. THESE SYMPTOMS ARE CONSISTENT WITH HYPERSENSITIVITY REACTIONS INCLUDING ANAPHYLAXIS; NO FURTHER CLINICAL EXAMINATION OR DIAGNOSTIC TESTS WERE CONDUCTED TO CONFIRM THE SUSPECTED DIAGNOSIS OF TYPE 1 HYPERSENSITIVITY REACTION. MAINTAINING PHYSIOLOGIC BLOOD PRESSURE AT A LEVEL TO ENSURE SUFFICIENT TISSUE PERFUSION IS A CHALLENGE IN ALL PATIENTS UNDERGOING GENERAL ANESTHESIA, ESPECIALLY IN PATIENTS SUFFERING FROM SEVERE SYSTEMIC DISEASE. IN CASES OF PERSISTENT HYPOTENSION WITH NO OR LIMITED TREATMENT RESPONSE A TYPE 1 HYPERSENSITIVITY REACTION MUST BE SUSPECTED AS A POSSIBLE CAUSE. A TYPE 1 HYPERSENSITIVITY REACTION MAY OCCUR AS A SEVERE AND IMMEDIATE RESPONSE AFTER EXPOSURE TO A VAST NUMBER OF ALLERGENS. BASED ON THE CURRENT INFORMATION WE HAVE NOT BEEN ABLE TO DETERMINE IF THE IMPLANTED AORTIC GRAFT WAS RESPONSIBLE FOR THE REPORTED ANAPHYLACTIC SHOCK. BIOLOGICAL TESTING IN COMPLIANCE WITH EN/ISO 10993-1 (2009) HAS BEEN PERFORMED ON THE MATERIALS COMPRISING THE ZENITH TX2 ENDOVASCULAR GRAFT WITH PRO-FORM AND THE Z-TRAK PLUS INTRODUCTION SYSTEM. NO EVIDENCE TO SUGGEST THAT THIS 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 INITIAL REPORTER: THE PHYSICIAN MEANS THAT THERE WAS AN ANAPHYLACTIC SHOCK FROM THE GRAFTS. THE PATIENT DIED A FEW DAYS LATER. ADDITIONAL INFORMATION RECEIVED: A HEMODYNAMIC COLLAPSE OCCURED 10 MINUTES AFTER DEPLOYMENT OF THE FIRST STENT GRAFT. THE PATIENT WAS RESUSCITATED AND THE PROCEDURE WAS ENDED PROMPTLY AFTER DEPLOYMENT OF THE SECOND ENDOPROSTHESIS. POSTOPERATIVE CTA REVEALED NO ANATOMIC CORRELATE. ADDITIONAL INFORMATION RECEIVED 19MAY2016: ACCORDING TO PHYSICIAN THE PATIENT HAD A TYPE I THORACOABDOMINAL AORTIC ANEURYSM THAT THEY WERE PLANNING TO TREAT WITH A T-BRANCH DEVICE. HE WAS PREPARING THE ¿LANDING¿ ZONE BY FIRST PLACING A TX2 MAIN BODY. THERE WAS NOTHING UNUSUAL ABOUT THE DEPLOYMENT, BUT ABOUT TEN MINUTES AFTER IT WAS PLACED THE PATIENT EXPERIENCED A SUDDEN AND DRAMATIC CIRCULATORY COLLAPSE, CONSISTENT WITH AN ANAPHYLACTIC REACTION, AND WITH NO OTHER OBVIOUS CAUSE (FOR EXAMPLE, ULTRASOUND OF THE HEART DEMONSTRATED ADEQUATE FUNCTION; HIGH CARDIAC OUTPUT). IN THE RECOVERY ROOM THEY ALSO NOTED SWOLLEN TONGUE AND LIPS, WHICH ARE CONSISTENT WITH AN ANAPHYLACTIC RESPONSE. THEY ATTEMPTED TO ADDRESS THE CIRCULATORY COLLAPSE WITH THE USUAL COCKTAIL OF MEDICATIONS BUT WERE HAVING GREAT DIFFICULTY IN GETTING HER BLOOD PRESSURE BACK UP. THEY CONTINUED WITH PLACEMENT OF A PROXIMAL EXTENSION, BUT THEN ABORTED THE PROCEDURE BECAUSE OF THE ONGOING ANAPHYLACTIC RESPONSE. IN THE ICU AFTER THE PROCEDURE THE PATIENT HAD SIGNS OF BOWEL ISCHEMIA/INFARCTION SO THEY TOOK HER TO THE OPERATING ROOM WHERE THEY ORIGINALLY FOUND (APPARENTLY) HEALTHY SMALL INTESTINE BUT DEAD LARGE INTESTINE WHICH WAS RESECTED. A COUPLE DAYS LATER THEY TOOK A SECOND LOOK AND PORTIONS OF SMALL INTESTINE ALSO DEAD, AND RESECTED. THE PATIENT DIED ON POST-OP DAY 4. PATHOLOGY DID NOT SHOW ANY SIGNS OF THROMBOTIC MESENTERIC VESSELS SO PRESUMABLY THE DEAD GUT WAS NOT DUE TO VESSELS FEEDING THE GUT HAVING BEEN BLOCKED, BUT INSTEAD DUE TO PROLONGED HYPOTENSION/SHOCK. PATIENT DID NOT HAVE ANY KNOWN ALLERGIES AND HAD NOT HAD REACTIONS TO CONTRAST MEDIA IN THE PAST, SO THEY¿RE ASSUMING THE REACTION WAS AN ANAPHYLACTIC RESPONSE TO SOME MATERIAL IN OUR GRAFT. PATIENT OUTCOME: THE PATIENT DIED A FEW DAYS LATER. THE PATIENT DID EXPERIENCE ADVERSE EFFECTS DUE TO THIS OCCURRENCE: WE ASSUME A FULMINANT ANAPHYLACTIC REACTION TO THE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156823 ZENITH® TX2® TAA ENDOVASCULAR GRAFT PROXIMAL TAPERED COMPONENT MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE 10827002236148

    Patients

    Seq Age Sex Outcome Treatment
    1 77 Death