BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 6035880 · Received October 18, 2016

    Report

    Report Number
    3002808486-2016-01247
    Event Type
    Death
    Date Received
    October 18, 2016
    Report Date
    September 26, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Report Source
    Manufacturer report
    Reporter Location
    SG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: UNKNOWN BUT REFERRED TO AS A ZENITH ALPHA THORACIC STENT GRAFT. DEVICE SIMILAR TO DEVICE UNDER 510(K) P140016. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG #: UNKNOWN BUT REFERRED TO AS A ZENITH ALPHA THORACIC STENT GRAFT. EXPIRATION DATE: UNKNOWN AS LOT # IS UNKNOWN. DEVICE SIMILAR TO DEVICE UNDER 510(K) P140016. UNKNOWN AS LOT # IS UNKNOWN. SUMMARY OF INVESTIGATIONAL FINDINGS: THE PROVIDED INFORMATION IN THIS COMPLAINT CONCERNS THE PRODUCT ALPHA MANUFACTURED BY WCE. THIS PRODUCT IS INDICATED FOR THE ENDOVASCULAR TREATMENT OF PATIENTS WITH ANEURYSMS/ULCERS OF THE DESCENDING THORACIC AORTA; HOWEVER, THE PRODUCT WAS USED IN THIS CASE TO TREAT DISSECTION. COOK IS UNABLE TO DETERMINE THE EFFECTIVENESS OF USING ALPHA TO TREAT DISSECTION. ADDITIONALLY, THE COMPLAINT DOES NOT INCLUDE INFORMATION ABOUT NEITHER THE PATIENT NOR THE PRODUCT WHY ITS NOT POSSIBLE TO DETERMINE WHETHER THE PATIENT DEATH IS DEVICE OR PATIENT RELATED. THIS COMPLAINT CAN BE REOPENED AND INVESTIGATED IN CASE FURTHER INFORMATION IS RECEIVED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: THE DOCTOR TOLD THE COOK REPRESENTATIVE OF A PATIENT THAT HE HAD TREATED WITH A ALPHA THORACIC STENT GRAFT. THE PATIENT HAD COME FROM MALAYSIA FOR TREATMENT AND RETURNED HOME AFTER THE PROCEDURE. THE DOCTOR HAD THEN HEARD THAT THE PATIENT HAD DIED AFTER RETURNING HOME. IT IS UNSURE HOW THE PATIENT HAD DIED AND THE DOCTOR WAS UNABLE TO GET ACCESS TO ANY REPORTS ON THE PATIENT'S DEATH. AT NO TIME DID THE DOCTOR SAY OR INDICATE THAT HE BELIEVED THE ALPHA GRAFT HAD ANYTHING TO DO WITH THE DEATH OF THIS PATIENT. PATIENT OUTCOME: PATIENT DEATH WAS REPORTED AFTER HE RETURNED TO HIS HOME COUNTRY OF (B)(6). THE PHYSICIAN HAS NO INFORMATION ON PATIENT DEATH OR IF A COOK DEVICE MAY HAVE BEEN INVOLVED. THE DATE OF DEATH IS UNKNOWN.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO THE INITIAL REPORTER: THE DOCTOR TOLD THE COOK REPRESENTATIVE OF A PATIENT THAT HE HAD TREATED WITH A ALPHA THORACIC STENT GRAFT. THE PATIENT HAD COME FROM (B)(6) FOR TREATMENT AND RETURNED HOME AFTER THE PROCEDURE. THE DOCTOR HAD THEN HEARD THAT THE PATIENT HAD DIED AFTER RETURNING HOME. IT IS UNSURE HOW THE PATIENT HAD DIED AND THE DOCTOR WAS UNABLE TO GET ACCESS TO ANY REPORTS ON THE PATIENT'S DEATH. AT NO TIME DID THE DOCTOR SAY OR INDICATE THAT HE BELIEVED THE ALPHA GRAFT HAD ANYTHING TO DO WITH THE DEATH OF THIS PATIENT. PATIENT OUTCOME: PATIENT DEATH WAS REPORTED AFTER HE RETURNED TO HIS HOME COUNTRY OF (B)(6). THE PHYSICIAN HAS NO INFORMATION ON PATIENT DEATH OR IF A COOK DEVICE MAY HAVE BEEN INVOLVED. THE DATE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688316 UNKNOWN MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death