BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS

    MDR report key: 8481598 · Received April 4, 2019

    Report

    Report Number
    3002808486-2019-00373
    Event Type
    Death
    Date Received
    April 4, 2019
    Date of Event
    March 28, 2019
    Report Date
    November 15, 2019
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 DEVICE IS MARKETED UNDER PMA/510(K): P140016. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: AN 85-YEAR MALE PATIENT WITH TORTUOUS ANATOMY UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A RUPTURED THORACIC ANEURYSM BY IMPLANTING ZTA-D-44-211. THE PHYSICIAN TOOK A STENT GRAFT, WHICH WAS INTENDED TO BE IMPLANTED IN ANOTHER PATIENT THE FOLLOWING WEEK. AS PER THE REPORTED INFORMATION, PART OF THE DISTAL BARE STENT REMAINED BLOCKED IN THE INTRODUCTION SYSTEM. FURTHER COMMUNICATION WITH THE USER FACILITY REVEALED THAT THE PHYSICIAN WAS NOT TRAINED IN THE USE OF THIS PRODUCT. THE PATIENT OUTCOME IS REPORTED TO DEATH DURING THE PROCEDURE. AS PER THE REPORTED INFORMATION, ¿THE PATIENT WAS ALREADY FRAGILE AND MISSING BLOOD, HE DIED DURING THE PROCEDURE¿. IN RESPONSE TO THIS INCIDENT, COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. A SEARCH WAS PERFORMED TO IDENTIFY ALL ZTA-D THAT WERE SHIPPED TO THE CUSTOMER OF THIS COMPLAINT. THE SEARCH REVEALED ONE ZTA-D THAT MATCHES THE REPORTED RPN IN THIS COMPLAINT. THE LOT NUMBER OF THIS DEVICE IS E3745899. REVIEW OF DHR FOR E3745899 INCLUDING THE SUBASSEMBLY OF THE INNER SYSTEM (E3736740) IS THEREFORE PERFORMED. THE REVIEW REVEALED ZERO NON-CONFORMANCES. AS THIS IS A ONE-DEVICE LOT, THERE ARE NO OTHER POTENTIALLY NON-CONFORMING PRODUCTS IN DISTRIBUTION. CLINICAL ASSESSMENT OF THE REPORTED INFORMATION WAS PERFORMED. AS PER THIS ASSESSMENT, THE OVERALL MORTALITY FOR RUPTURED TAA IS HIGH REGARDLESS OF METHOD OF REPAIR. DEPLOYMENT OF THE DISTAL COMPONENT IS MORE COMPLEX AND REQUIRES ADDITIONAL STEPS COMPARED TO DEPLOYING THE PROXIMAL COMPONENT. NO INFORMATION ON WHICH MEASURES (TROUBLESHOOTING) WERE APPLIED IN THE ATTEMPT TO RELEASE THE DISTAL COMPONENT FROM THE INTRODUCTION SYSTEM. IN CONCLUSION, THE EVENT DOES NOT INCLUDE SUFFICIENT INFORMATION TO DETERMINE, IF THE EVENT CAUSED OR CONTRIBUTED TO THE DEATH OF THE PATIENT. FURTHERMORE, THE EVENT DOES NOT INCLUDE SUFFICIENT INFORMATION TO DETERMINE, IF THE REPORTED DIFFICULTIES RELEASING THE DISTAL BARE STENT WAS CAUSED BY A DEVICE-FAILURE, PHYSICIAN FACTORS (LEVEL OF EXPERIENCE/TRAINING), PATIENT FACTORS (ANATOMY) OR NON-ADHERENCE TO THE IFU (SIZING, DEPLOYMENT SEQUENCE AND TROUBLESHOOTING). THE CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED BASED ON THE PROVIDED INFORMATION. SEVERAL ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION AND REQUEST A PRODUCT RETURN; HOWEVER, WITHOUT ANY SUCCESS. IF THE INFORMATION AND/OR IMAGING REQUESTED BECOMES AVAILABLE, THE INVESTIGATION WILL BE UPDATED ACCORDINGLY. 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). G1) 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 INITIAL REPORTER: PATIENT ARRIVED IN THE HOSPITAL WITH A RUPTURED THORACIC ANEURYSM. THE PHYSICIAN TOOK A STENT GRAFT, EXPECTED FOR ANOTHER PATIENT NEXT WEEK. THE ANATOMY WAS TORTUOUS. THE PHYSICIAN TOLD ME THAN A PART OF THE DISTAL BARE STENT REMAINED BLOCKED IN THE INTRODUCER . PATIENT OUTCOME: THE PATIENT WAS ALREADY FRAGILE AND MISSING BLOOD, HE DIED DURING THE PROCEDURE.

    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 11APR2019 FROM AREA REP: THIS DEVICE WAS ORDERED FOR ANOTHER PATIENT. HE WAS SCHEDULED THE WEEK AFTER FOR ANOTHER PHYSICIAN. THE USER OF THE PRODUCT, ¿THE COMPLAINTER¿ IS NOT A COOK USER AND AS I KNOW WAS NOT TRAINED ON THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276144 ZENITH ALPHA THORACIC ENDOVASCULAR GRAFT DISTAL COMPONENTS MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death