BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM

    MDR report key: 10469203 · Received August 28, 2020

    Report

    Report Number
    2017233-2020-01194
    Event Type
    Malfunction
    Date Received
    August 28, 2020
    Date of Event
    August 1, 2020
    Report Date
    November 10, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. METHOD CODE 3: CODE 4112 - IMAGES WERE PROVIDED, AND AN IMAGING EVALUATION WAS PERFORMED. H.6. RESULTS CODE 3: CODE 213 - THE IMAGING EVALUATION FOUND THE FOLLOWING: IMAGES PROVIDED WERE POST-IMPLANT (NON-GORE DEVICE), PRE-RE-INTERVENTION (WITH GORE DEVICE) CTA DATED 7/29/2020, ARTERIAL PHASE ONLY. THERE APPEARS TO BE NON-NATIVE ASCENDING AORTA, DISTAL AORTA, AND COMMON ILIACS. ANATOMY DISTAL TO THE IMPLANTED DEVICES APPEARS TO BE SIGNIFICANTLY TORTUOUS. THERE APPEARS TO BE A LACK OF WALL APPOSITION AT THE PROXIMAL END OF THE NON-GORE IMPLANTED DEVICE. CONTRAST-LIKE DENSITY PRESENT OUTSIDE OF THE IMPLANTED DEVICE. THERE APPEARS TO BE A LACK OF WALL APPOSITION AT THE DISTAL END OF THE NON-GORE IMPLANTED DEVICE. H.6. CONCLUSIONS CODE 1 REMAINS UNCHANGED.

    Additional Manufacturer Narrative · 0

    B.4. EVENT DESCRIPTION - ADDITIONAL EVENT DESCRIPTION ADDED. H.6. METHOD CODE 1 (PHR REVIEW) REMAINS UNCHANGED. H.6. METHOD CODE 2 (DEVICE EVALUATION) REMAINS UNCHANGED. H.6. METHOD CODE 3 (IMAGING EVALUATION) REMAINS UNCHANGED. H.6. RESULTS CODE 1 (PHR REVIEW) REMAINS UNCHANGED. H.6. RESULTS CODE 2: CODE 213 - THE ENGINEERING EVALUATION STATED THE FOLLOWING: NO DEVICE EVALUATION COULD BE PERFORMED AS THE DELIVERY CATHETER AND HANDLES WERE NOT RETURNED FOR EVALUATION. THEREFORE, THE EVENT DESCRIPTION REPORT OF THE PRIMARY DEPLOYMENT LINE BREAKING COULD NOT BE CONFIRMED. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: IT WAS REPORTED THAT THERE WAS RESISTANCE FELT DURING THE PRIMARY DEPLOYMENT BECAUSE THE DEVICE WAS BENT. THE DEPLOYMENT LINE BROKE WHEN HALF THE LENGTH OF THE STENT GRAFT DEPLOYED TO 50% DIAMETER. THE DEPLOYMENT LINE ACCESS HATCH WAS NOT USED. SINCE THE LINE END REMAINED ON THE DISTAL SIDE OF THE SECONDARY DEPLOYMENT HANDLE, THE LINE WAS GRASPED WITH THE PEAN FORCEPS. AN ESTIMATED 2-3 CM OF THE DEPLOYMENT LINE REMAINED ATTACHED TO THE PRIMARY DEPLOYMENT HANDLE. NO IMAGES OF THE DEVICE HANDLE AFTER THE PROCEDURE WERE AVAILABLE. PER THE PRODUCT HISTORY REVIEW THE ASSOCIATED MANUFACTURING LOTS MET ALL PRE-RELEASE SPECIFICATIONS. A REASON FOR THE PRIMARY DEPLOYMENT LINE SEPARATING CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION. BASED ON THIS INVESTIGATION, THERE IS POTENTIAL FOR A MANUFACTURING DEFICIENCY. PER MD145952 (REV. 19), NO CAPA REQUEST IS REQUIRED. H.6. RESULTS CODE 3 (IMAGING EVALUATION) REMAINS UNCHANGED. H.6. CONCLUSIONS CODE 1 UPDATED. H.6. CONCLUSIONS CODE 2 ADDED. H.6. CONCLUSIONS CODE 2: CODE 22 - ACCORDING TO THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS OR COMPLICATIONS ASSOCIATED WITH THE USE OF THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO, INCOMPLETE DEPLOYMENT AND DEPLOYMENT DIFFICULTIES/FAILURES.

    Description of Event or Problem · 0

    FURTHER CLARIFICATION WAS OBTAINED. IT WAS REPORTED THAT THERE WAS RESISTANCE FELT DURING THE PRIMARY DEPLOYMENT BECAUSE THE DEVICE WAS BENT. THE DEPLOYMENT LINE BROKE WHEN HALF THE LENGTH OF THE STENT GRAFT DEPLOYED TO 50% DIAMETER. THE DEPLOYMENT LINE ACCESS HATCH WAS NOT USED. SINCE THE LINE END REMAINED ON THE DISTAL SIDE OF THE SECONDARY DEPLOYMENT HANDLE, THE LINE WAS GRASPED WITH THE PEAN FORCEPS. AN ESTIMATED 2-3 CM OF THE DEPLOYMENT LINE REMAINED ATTACHED TO THE PRIMARY DEPLOYMENT HANDLE. NO IMAGES OF THE DEVICE HANDLE AFTER THE PROCEDURE WERE AVAILABLE.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT: ASKED BUT UNAVAILABLE. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: ASKED BUT UNAVAILABLE. THE DEVICE REMAINS IMPLANTED, AND THE DELIVERY CATHETER WAS DISCARDED AT THE FACILITY. AN ANALYSIS OF RELEVANT DATA WILL BE PERFORMED IN VIEW OF SUPPORTING THE IDENTIFICATION OF POSSIBLE CAUSES FOR THE ADVERSE EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2020, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A PSEUDOANEURYSM DISTAL TO A NON-GORE THORACIC STENT GRAFT (TX2) USING GORE® TAG® CONFORMABLE THORACIC STENT GRAFTS WITH ACTIVE CONTROL SYSTEM. DURING PRIMARY DEPLOYMENT OF THE DEVICE AT THE TARGET LOCATION, THE DEPLOYMENT LINE BROKE. THE PHYSICIAN STATED THAT THE PATIENT'S AORTA HAD BEEN REPLACED WITH AN ARTIFICIAL BLOOD VESSEL, AND THAT THE AORTA WAS HIGHLY TORTUOUS. IT WAS EXPECTED THAT THESE PUT A BURDEN ON THE DEVICE. THE PHYSICIAN COMPLETED THE DEPLOYMENT BY GRASPING THE DEPLOYMENT LINE REMAINING ON THE CATHETER SHAFT USING PEAN FORCEPS. THE PROCEDURE WAS CONTINUED WITH NO FURTHER REPORTED ISSUES. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    932255 GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR