BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDWARDS ESHEATH INTRODUCER SET

    MDR report key: 12540270 · Received September 28, 2021

    Report

    Report Number
    2015691-2021-05395
    Event Type
    Malfunction
    Date Received
    September 28, 2021
    Date of Event
    August 18, 2021
    Report Date
    November 12, 2021
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103191219
    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. THE ESHEATH WAS VISUALLY INSPECTED AND THE FOLLOWING WAS OBSERVED: THE LINER REMAINED UNEXPANDED 7 INCHES FROM THE DISTAL TIP AND THE TIP REMAINED UNOPENED. THE MOST PROXIMAL 3 INCHES OF UNEXPANDED LINER WAS LIFTED. THE SHEATH SHAFT WAS KINKED 4 INCHES FROM THE DISTAL TIP. THE SHEATH SHAFT WAS DAMAGED 5 INCHES FROM THE SHEATH HOUSING. THE SHEATH SHAFT MATERIAL WAS STRETCHED AT THE SAME LOCATION. THE DISTAL TIP WAS OPENED JUST ALONG THE AXIAL SCORE LINE AND SHEATH SHAFT MATERIAL FURTHER SPLIT OPEN. MINOR DAMAGE WAS OBSERVED ON THE SOFT TIP. THE LINER HAD TWO TEARS: THE FIRST TEAR WAS 3 INCHES IN LENGTH, LOCATED 4 INCHES FROM THE SHEATH HOUSING. THE SECOND TEAR WAS 0.5 INCHES IN LENGTH, LOCATED 4.75 INCHES FROM THE SHEATH HOUSING CONNECTED ON BOTH ENDS. THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND THE WORK ORDERS DID NOT REVEAL ANY MANUFACTURING NONCONFORMANCE ISSUES THAT WOULD HAVE CONTRIBUTED TO THE COMPLAINT 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. THE REPORTED COMPLAINTS WERE CONFIRMED BASED ON THE CONDITION OF THE RETURNED DEVICE. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED THROUGH EVALUATION OF THE RETURNED DEVICE. A REVIEW OF MANUFACTURING MITIGATIONS, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND LOT HISTORY SUPPORTED THAT A MANUFACTURING NON-CONFORMANCE LIKELY DID NOT CONTRIBUTE TO THE REPORTED EVENTS. A REVIEW OF IFU/TRAINING MATERIALS REVEALED NO DEFICIENCIES. PER THE TRAINING MANUAL, 'PUSH FORCE CAN VARY DUE TO ANGLE OF INSERTION, VESSEL DIAMETER, TORTUOSITY AND DEGREE OF CALCIFICATION.' THE CASE NOTES AND PROVIDED IMAGERY REVEALED THE PATIENT HAD 'HAD MODERATE TORTUOSITY [OF BOTH ACCESS VESSELS], BUT WITH A LARGE CALIBER AND MILD CALCIFICATIONS NOT NEAR THE ANGLES'. ADDITIONALLY, THE SHEATH SOFT TIP WAS DAMAGED AND DISTAL TIP WAS SPLIT, BOTH OF WHICH ARE INDICATIVE OF THE SHEATH TIP'S INTERACTION WITH CALCIFICATION. THE PRESENCE OF CALCIFICATION WITHIN THE ACCESS VESSEL CAN CREATE A CONSTRAINED CONDITION AND LIKELY CONTRIBUTED TO DIFFICULTY INSERTING THE SHEATH INTO THE PATIENT. TORTUOSITY MAY RESULT IN A NON-COAXIAL INSERTION, FURTHER CONTRIBUTING TO INSERTION DIFFICULTIES. FURTHERMORE, THE COMPLAINT DESCRIPTION STATES, 'THE DELIVERY WAS INSERTED INSIDE THE ESHEATH, WHICH AFTER A FEW CENTIMETERS INSIDE THE EXTERNAL ILIAC IS BLOCKED, NOT ALLOWING ADVANCEMENT.' SUCH CALCIFICATION AND TORTUOSITY CAN ALSO CONTRIBUTE TO RESISTANCE INTRODUCING AND ADVANCING THE DELIVERY SYSTEM. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION, TORTUOSITY) MAY HAVE CONTRIBUTED TO THE RESISTANCE WHEN INSERTING THE DELIVERY SYSTEM INTO THE SHEATH AND THE SHEATH DISTAL TIP SPLIT. A PRODUCT RISK ASSESSMENT WAS PREVIOUSLY PERFORMED PER MANAGEMENT DISCRETION TO ASSESS THE RISKS ASSOCIATED WITH HIGH PUSH FORCE OF THE SAPIEN 3 ULTRA VALVE WITH THE COMMANDER DELIVERY SYSTEM AND ESHEATH CONFIGURATION. IN ADDITION, A CAPA WAS PREVIOUSLY INITIATED TO CAPTURE FURTHER INVESTIGATION AND ANY POSSIBLE CORRECTIVE OR PREVENTATIVE ACTION ACTIVITIES. THE LINER TEAR AND SHEATH SHAFT DAMAGE LIKELY OCCURRED DUE TO EXCESSIVE DEVICE MANIPULATION DURING ADVANCEMENT OF DELIVERY SYSTEM. AS THE DELIVERY SYSTEM WAS MANIPULATED TO OVERCOME THE OBSERVED RESISTANCE DURING DEVICE ADVANCEMENT, IT MAY HAVE RESULTED IN VALVE STRUT INTERACTION WITH THE SHEATH SHAFT AND LINER, LEADING TO THE OBSERVED DAMAGE AND LINER TEARS. AS SUCH, AVAILABLE INFORMATION SUGGESTS THAT PROCEDURAL FACTORS (EXCESSIVE MANIPULATION, VALVE CAUGHT ON LINER, VALVE CAUGHT ON SHEATH) MAY HAVE CONTRIBUTED TO THE LINER TEAR AND SHEATH SHAFT DAMAGE. NO LABELING, TRAINING, OR IFU DEFICIENCIES WERE IDENTIFIED. THEREFORE, NO CORRECTIVE AND PREVENTATIVE ACTION NOR PRA IS REQUIRED AT THIS TIME. 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 · 1

    THE INVESTIGATION IS IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EDWARDS RECEIVED NOTIFICATION FROM OUR AFFILIATE IN ITALY THAT A PATIENT WHO UNDERWENT AN IMPLANT OF A 26MM SAPIEN 3 ULTRA VALVE, IN AORTIC POSITION VIA LEFT TRANSFEMORAL APPROACH. DURING THE PREPARATION OF THE MAIN ACCESS AFTER PLACING THE CLOSURE SYSTEMS, DIFFICULTIES WERE ENCOUNTERED IN ADVANCING THE GUIDES AND CATHETERS. IT WAS IMMEDIATELY EVIDENT THE LACK OF ELASTICITY OF THE ARTERIES. THE AMPLATZ GUIDE WIRE WAS POSITIONED AGAIN IN THE AORTIC ARCH, AND THE INTRODUCER ESHEATH WAS INSERTED, WHICH DID NOT ADVANCE BEYOND THE MIDDLE SECTION OF THE COMMON ILIAC. TO OBTAIN GREATER SUPPORT, A 'ZIPLINE' TECHNIQUE WAS PERFORMED CAPTURING THE GUIDE WIRE IN THE AORTIC ARCH WITH A SNARE LOOP SYSTEM, AND THEN TRY TO ADVANCE THE INTRODUCER WHILE KEEPING THE GUIDE TENSIONED IN AN ATTEMPT TO STRAIGHTEN THE COURSE. AFTER HAVING ADVANCED THE INTRODUCER WITH DIFFICULTY, THE COURSE OF THE VESSEL APPEARED STRAIGHTER. AFTER HAVING CATHETERIZED THE VENTRICLE, THE COMMANDER DELIVERY SYSTEM WAS INSERTED INTO THE ESHEATH, BUT AFTER A FEW CENTIMETERS INSIDE THE EXTERNAL ILIAC WAS BLOCKED, NOT ALLOWING ADVANCEMENT. LOOKING AT THE SCOPE, IT WAS NOTICED THAT IN A PARTICULAR POINT THE ESHEATH HAD A SMALL FOLD THAT THE VALVE WAS UNABLE TO OVERCOME. IT WAS DECIDED TO STOP THE PROCEDURE AND EVALUATE A TRANS-APICAL APPROACH. DURING REMOVAL, AN ESHEATH 'BREAKAGE' WAS FOUND. THE POINT OF RUPTURE WAS NOTED WHEN THE ESHEATH WAS WITHDRAWN FROM THE FEMORAL ARTERY WITH ITS DILATOR INSERTED. PROBABLY THAT POINT WAS WHERE THE VALVE WAS 'GOING TO STICK'. THERE WAS NO PATIENT INJURY AND THE PATIENT OUTCOME WAS GOOD. AS PER MEDICAL OPINION, THE ROOT CAUSE OF THE EVENT MAY HAVE BEEN THE LACK OF ELASTICITY OF THE ARTERIES. THIS LITTLE ELASTICITY WAS NOT PREDICTABLE IN THE PATIENT EVALUATION PHASE. PER INITIAL VISUAL INSPECTION OF THE RETURNED ESHEATH, THERE WAS A DISTAL TIP SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441034 EDWARDS ESHEATH INTRODUCER SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9610ES14 63566137 00690103191219

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male