BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U

    MDR report key: 10404859 · Received August 13, 2020

    Report

    Report Number
    2015691-2020-13080
    Event Type
    Injury
    Date Received
    August 13, 2020
    Date of Event
    July 20, 2020
    Report Date
    July 20, 2020
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P140031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 0

    ADDED ADDITIONAL INFORMATION TO B.5 AND F.10. IMAGERY WAS RETURNED FROM THE FIELD. THE DEVICE WAS OBSERVED POST PROCEDURE AND A RADIAL BALLOON BURST WAS CONFIRMED. THE BALLOON WAS OBSERVED PULLED OVER THE NOSE TIP. IMAGERY OF THE PATIENT¿S ANATOMY REVEALED A CALCIFIED ANNULS, LVOT, AND LEAFLETS. BASED ON THE PROVIDED IMAGERY THE BALLOON BURST, WITHDRAWAL DIFFICULTY THROUGH THE SHEATH, AND SEPARATION OF THE DISTAL TIP, NOSE TIP WERE CONFIRMED. A REVIEW OF LOT HISTORY REVEALED NO OTHER SIMILAR COMPLAINT RELATED TO THE EVENTS. A DHR REVIEW WAS PERFORMED AND DID NOT REVEAL ANY MANUFACTURING NON-CONFORMANCE THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT EVENT. A REVIEW OF COMPLAINT HISTORY ON CONFIRMED DEVICE COMPLAINTS FROM AUGUST 2019 THROUGH JULY 2020 FOR THE COMMANDER DELIVERY SYSTEM WAS PERFORMED. THE COMPLAINTS WERE REVIEWED BASED ON SIMILAR REPORTED EVENTS AND ASSOCIATED ROOT CAUSES AND EVALUATION CODES. OTHER COMPLAINTS WERE NOTED AND THE EVENTS WERE ATTRIBUTED TO PATIENT FACTORS: CALCIFICATION AND/OR PROCEDURAL FACTORS: WITHDRAWAL OF BURST BALLOON. THE IFU AND DEVICE PROCEDURAL TRAINING MANUAL WERE REVIEWED FOR INSTRUCTIONS INVOLVING DEVICE PREPARATION AND PROCEDURES RELATING TO THE COMPLAINT EVENT. AS NOTED, IF THE DELIVERY SYSTEM BALLOON BURSTS OR LEAKS DURING DEPLOYMENT WITH THV EMBOLIZATION, EXCESSIVE FORCE SHOULD BE AVOIDED. CARE IS TO BE TAKEN WHEN CROSSING THE THV, TRACKING BACK OVER THE ARCH AND REMOVING THE DELIVERY SYSTEM. GUIDEWIRE POSITION SHOULD BE MAINTAINED. FORCE SHOULD NOT BE USED IF RESISTANCE IS MET NEAR OR AT THE SHEATH TIP AS FORCE CAN RESULT IN ADDITIONAL TEARING OF THE BALLOON MATERIAL AND THE BALLOON MATERIAL OR TIP COMING OFF. DURING MANUFACTURING OF THE COMMANDER DELIVERY SYSTEM, THE DELIVERY SYSTEM AND COMPONENTS ARE INSPECTED SEVERAL TIMES THROUGHOUT THE MANUFACTURING PROCESS. IN ADDITION, PRODUCT VERIFICATION TESTING WAS PERFORMED ON A SAMPLING BASIS AND ALL TESTING MET SPECIFICATIONS. THESE INSPECTIONS PERFORMED DURING MANUFACTURING PROCESS AND TESTING PERFORMED DURING PRODUCT VERIFICATION SUPPORT THAT IT IS UNLIKELY THAT A MANUFACTURING NON-CONFORMANCE CONTRIBUTED TO THE REPORTED EVENTS. THE EVENTS WERE ABLE TO BE CONFIRMED BY THE PROVIDED IMAGERY. HOWEVER, NO MANUFACTURING NONCONFORMANCE WAS IDENTIFIED DURING THE EVALUATION. A REVIEW OF THE DHR, LOT HISTORY, COMPLAINT HISTORY AND MANUFACTURING MITIGATIONS DID NOT PROVIDE ANY INDICATION THAT A MANUFACTURING NON-CONFORMANCE WOULD HAVE CONTRIBUTED TO THE COMPLAINT. A REVIEW OF THE IFU AND TRAINING MANUALS REVEALED NO DEFICIENCIES. AS REPORTED, ¿THE DELIVERY SYSTEM BALLOON RUPTURED DURING DEPLOYMENT OF THE VALVE. THE PERCEIVED ROOT CAUSE OF THE RUPTURE WAS INTERACTION WITH THE PATIENT¿S SIGNIFICANT ANNULAR AND LVOT CALCIUM¿. THE PRESENCE OF CALCIFICATION CAN CREATE A CHALLENGING ANATOMY FOR BALLOON INFLATION. WHILE THE BALLOONS ARE SUFFICIENTLY DESIGNED AND TESTED FOR RATED BURST PRESSURES WELL ABOVE THEIR INFLATION PRESSURE, CALCIFIED NODULES CAN COMPROMISE THE STRUCTURE OF THE BALLOON WALL VIA FOLLOWING MECHANISMS SUCH AS PUNCTURE, LOCAL OVERSTRETCHING, OPEN CELL IMPINGEMENT, OR STRESS CONCENTRATION. PER THE COMPLAINT DESCRIPTION, ¿THE LARGER PROFILE OF THE RUPTURED BALLOON MADE IT DIFFICULT TO WITHDRAW THE DELIVERY SYSTEM BACK INTO THE SHEATH.¿ IT IS POSSIBLE THAT THE BALLOON BURST ALTERED THE BALLOON PROFILE, CONTRIBUTING TO THE WITHDRAWAL DIFFICULTY AS THE ALTERED BALLOON PROFILE WOULD HAVE LIKELY BECOME CAUGHT ON THE TIP OF THE SHEATH. AS THE TRAINING MANUAL STATES, ¿DO NOT USE EXCESSIVE FORCE. TAKE CARE WHEN REMOVING THE BALLOON THROUGH THE TIP OF THE SHEATH.¿ THE RECOMMENDATION TO CONVERT TO SURGERY IF UNABLE TO PULL THE ENTIRE BALLOON INTO THE SHEATH, IS ALSO DETAILED IN THE TRAINING MANUAL. TO OVERCOME WITHDRAWAL DIFFICULTY, IT IS POSSIBLE ADDITIONAL FORCE WAS APPLIED, RESULTING IN THE SEPARATION OF THE DISTAL TIP. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION) AND PROCEDURAL FACTORS (WITHDRAWAL OF A BURST BALLOON/EXCESSIVE DEVICE MANIPULATION) MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. 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. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED. ADDITIONALLY, SINCE NO PRODUCT NON-CONFORMANCES OR IFU/TRAINING MANUAL DEFICIENCIES WERE IDENTIFIED, NO ESCALATION TO A PRA WAS REQUIRED.

    Description of Event or Problem · 0

    DURING A REVIEW OF IMAGERY PROVIDED BY THE SITE IT WAS OBSERVED THAT THE DISTAL END APPEARED TO BE SEPARATED FROM THE REST OF THE SYSTEM.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS REPORTED, DURING A TF TAVR CASE THE DELIVERY SYSTEM BALLOON RUPTURED DURING DEPLOYMENT OF THE VALVE. THE VALVE WAS SUCCESSFULLY DEPLOYED AND NO POST-DILATION WAS REQUIRED. THE PERCEIVED ROOT CAUSE OF THE RUPTURE WAS INTERACTION WITH THE PATIENT¿S SIGNIFICANT ANNULAR AND LVOT CALCIUM. THE LARGER PROFILE OF THE RUPTURED BALLOON MADE IT DIFFICULT TO WITHDRAW THE DELIVERY SYSTEM BACK INTO THE ESHEATH SO THE DECISION WAS MADE TO WITHDRAW THE TWO DEVICES TOGETHER. THE BALLOON MATERIAL FOLDED BACK DURING WITHDRAWAL AND A MINI CUTDOWN WAS NEEDED TO SUCCESSFULLY REMOVE IT FROM THE PATIENT¿S FEMORAL ARTERY TO ENSURE THERE WAS NO INJURY TO THE PATIENT. INSPECTION OF THE SHEATH AFTER THE CASE DID NOT REVEAL AND DAMAGE TO THE SHEATH. THE VOLUME IN THE DELIVERY SYSTEM BALLOON WAS NOMINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870018 EDWARDS COMMANDER DELIVERY SYSTEM WITH S3U AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9750CM23A 63144979

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention