BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMMANDER DELIVERY SYSTEM

    MDR report key: 16962834 · Received May 19, 2023

    Report

    Report Number
    2015691-2023-13100
    Event Type
    Malfunction
    Date Received
    May 19, 2023
    Date of Event
    April 26, 2023
    Report Date
    July 21, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR EVALUATION AND AN ENGINEERING EVALUATION WAS PERFORMED. A REVIEW OF EDWARDS LIFESCIENCES RISK MANAGEMENT DOCUMENTATION WAS PERFORMED FOR THIS CASE. THE REPORTED EVENT IS AN ANTICIPATED RISK OF THE TRANSCATHETER HEART VALVE PROCEDURE, ADDITIONAL ASSESSMENT OF THE FAILURE MODE IS NOT REQUIRED AT THIS TIME. THE COMPLAINT OF DIFFICULTY TRACKING THE SYSTEM THROUGH ANATOMY WAS UNABLE TO BE CONFIRMED DUE TO NO APPLICABLE IMAGERY RETURNED. A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. A REVIEW OF THE DHR, LOT HISTORY AND COMPLAINT HISTORY DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. AS REPORTED, ''29MM SAPIEN 3 VALVE IN AORTIC POSITION BY TRANSAXILLARY/SUBCLAVIAN APPROACH. PATIENT PRESENTED A CALCIFIED SUBCLAVIAN ARTERY. DURING PROCEDURE, IT WAS DIFFICULT TO GET THE ESHEATH THROUGH THE VESSEL AND THEN THE COMMANDER DELIVERY SYSTEM. MUCH TENSION WAS FOUND ON THE SYSTEM WHEN ADVANCING THE COMMANDER DELIVERY SYSTEM THROUGH THE ESHEATH, SEVERAL ATTEMPTS WERE MADE TO GET THE VALVE IN THE ASCENDING AORTA, WHICH EVENTUALLY WORKED (2023-09616-01). AFTER PERFORMING THE VALVE ALIGNMENT, IT WAS VERY DIFFICULT POSITIONING THE VALVE IN THE LANDING ZONE, THE SYSTEM KEPT BENDING IN THE AORTA AND COULD NOT GET THE VALVE INTO THE AORTIC ROOT. EVENTUALLY, IT WAS POSSIBLE TO POSITION THE VALVE IN THE ANNULUS. PER ADDITIONAL CLARIFIED INFORMATION, PATIENT HAD MILD TORTUOSITY IN THE SUBCLAVIAN ARTERY IN ADDITION TO IT BEING CALCIFIED.'' OBSTRUCTIVE CALCIFICATION MAY HAVE RESTRICTED THE ADVANCEMENT OF DELIVERY SYSTEM AS THE VALVE COULD PHYSICALLY INTERACT WITH RIGID CALCIUM NODES ALONG THE ADVANCEMENT PATHWAY. ADDITIONALLY, TORTUOUS VASCULATURE COULD HAVE CREATED DIFFICULT BEND ANGLES FOR THE DEVICES TO OVERCOME, WHICH WOULD ALSO RESTRICT SYSTEM TRACKING THROUGH ANATOMY AND/OR SYSTEM MANOEUVRES DOWNSTREAM (DURING THV POSITIONING IN THE LANDING ZONE). WITHOUT APPLICABLE PATIENT OR PROCEDURAL IMAGERY, A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. HOWEVER, AVAILABLE INFORMATION SUGGESTS THAT PATIENT (TORTUOSITY, CALCIFICATION) MAY HAVE CONTRIBUTED TO THE COMPLAINT EVENT. NO DEVICE OR LABELING PROBLEM WAS IDENTIFIED DURING THE EVALUATION. THEREFORE, NO FURTHER ESCALATION (CAPA/SCAR/PRA) IS REQUIRED. THE COMPLAINT BALLOON TORN WAS CONFIRMED BASED ON EVALUATION OF THE RETURNED DEVICE. A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. DOUBLE-WALL THICKNESS MEASUREMENTS OF THE CRIMP BALLOON WERE TAKEN AND THE MEASURED COMPONENTS WERE WITHIN SPECIFICATIONS. A REVIEW OF THE DHR, LOT HISTORY, AND MANUFACTURING MITIGATIONS, AND COMPLAINT HISTORY DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. AS REPORTED, ''WHEN INFLATING THE COMMANDER DELIVERY SYSTEM BALLOON, BLOOD WAS ENTERING IN THE ATRION.'' PER PROVIDED MEDICAL OPINION, ''BALLOON LEAKAGE MAY BE RELATED TO THE CALCIFICATION AND TENSION ON SYSTEM.'' EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED AN I/C BOND SEPARATION. IN THIS CASE PATIENT HAD CALCIFIED AND TORTUOUS ACCESS VASCULATURE, WHICH COULD HAVE CAUSED THE USER TO APPLY EXCESSIVE MANIPULATION DURING SYSTEM TRACKING THROUGH ANATOMY AND/OR DURING VALVE POSITIONING. THIS IN TURN COULD HAVE CONTRIBUTED TO UNFAVOURABLE PHYSICAL INTERACTIONS BETWEEN THE CRIMP BALLOON AND THE THV/CALCIUM, CAUSING THE I/C BOND TO WEAKEN AND SEPARATE. A DEFINITIVE ROOT CAUSE IS UNABLE TO BE DETERMINED. HOWEVER, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (EXCESSIVE MANIPULATION) AND/OR PATIENT FACTORS (CALCIFICATION, TORTUOSITY) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. NO DEVICE OR LABELING PROBLEM WAS IDENTIFIED DURING THE EVALUATION. THEREFORE, NO FURTHER ESCALATION (CAPA/SCAR/PRA ) IS REQUIRED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS MONTHLY, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL REPORT SUBMITTED TO INCLUDE ADDITIONAL PRE-DECONTAMINATION FINDINGS. AS PER THE PRE-DECONTAMINATION EVALUATION, THE BALLOON OF COMMANDER DELIVERY SYSTEM WAS FOUND SEPARATED FROM I/C BOND. THIS IS ONE OF THREE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2023-14031 AND 2015691-2023-13101.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.

    Description of Event or Problem · 0

    EDWARDS RECEIVED NOTIFICATION FROM OUR AFFILIATE IN THE NETHERLANDS. AS REPORTED, THIS WAS AN IMPLANT CASE OF A 29MM SAPIEN 3 VALVE IN AORTIC POSITION BY TRANSAXILLARY/SUBCLAVIAN APPROACH. PATIENT PRESENTED A CALCIFIED SUBCLAVIAN ARTERY. DURING PROCEDURE, IT WAS DIFFICULT TO GET THE ESHEATH THROUGH THE VESSEL AND THEN THE COMMANDER DELIVERY SYSTEM. MUCH TENSION WAS FOUND ON THE SYSTEM WHEN ADVANCING THE COMMANDER DELIVERY SYSTEM THROUGH THE ESHEATH, SEVERAL ATTEMPTS WERE MADE TO GET THE VALVE IN THE ASCENDING AORTA, WHICH EVENTUALLY WORKED. AFTER PERFORMING THE VALVE ALIGNMENT, IT WAS VERY DIFFICULTY POSITIONING THE VALVE IN THE LANDING ZONE, THE SYSTEM KEPT BENDING IN THE AORTA AND COULD NOT GET THE VALVE INTO THE AORTIC ROOT. EVENTUALLY, IT WAS POSSIBLE TO POSITION THE VALVE IN THE ANNULUS, WHEN INFLATING THE COMMANDER DELIVERY SYSTEM BALLOON, BLOOD WAS ENTERING IN THE ATRION. THEN, THE VALVE WAS RETRIEVED INSIDE THE ESHEATH AND EVERYTHING WAS REMOVED TOGETHER FROM THE PATIENT. A SECOND ATTEMPT WAS PERFORMED WITH A 29MM SAPIEN 3 KIT. AS PER MEDICAL OPINION, THE ROOT CAUSE FOR THE DIFFICULTIES INTRODUCING THE DEVICES MAY BE RELATED TO THE PATIENT'S ANATOMY AND, FOR THE DIFFICULTIES POSITIONING THE VALVE AND BALLOON LEAKAGE MAY BE RELATED TO THE CALCIFICATION AND TENSION ON SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464047 COMMANDER DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610TF29 64824502

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male