BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSFEMORAL BALLOON

    MDR report key: 11867027 · Received May 21, 2021

    Report

    Report Number
    2015691-2021-03100
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    December 11, 2020
    Report Date
    December 7, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    UDI-DI
    00690103195088
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED, ONLY IMAGES (INTRAOPERATIVE CINE ETC.) WERE RETURNED. AS NO PRODUCT WAS RETURNED, NO VISUAL OR FUNCTIONAL TESTING OR DIMENSIONAL INSPECTION WAS PERFORMED AS NO PRODUCT WAS RETURNED. AS TECHNICAL SUMMARY THAT WAS WRITTEN BY EDWARDS LIFESCIENCES APPLIES TO THIS COMPLAINT EVENT, AN ENGINEERING EVALUATION IS NOT REQUIRED. IMAGERY WAS PROVIDED FOR REVIEW AND MULTIPLE OBSERVATIONS WERE MADE. A PRE-EXISTING BIOPROSTHESIS WAS SEEN IN THE MITRAL POSITION. DUE TO UNFAVORABLE PROJECTION OF THE IMAGE, IT APPEARED THAT THE BAV BALLOON WAS IN THE MIDDLE OF THE MITRAL VALVE, BUT IN REALITY, IT WAS ACTUALLY NOT. ANY INTERACTION BETWEEN THV DEVICES AND MITRAL VALVE OCCURRED FROM THE POSTERIOR (OUTSIDE THE VALVE) OR LATERAL SIDE OF THE MITRAL VALVE STRUT. THE BAV BALLOON BURST AT FULL INFLATION. DURING INFLATION OF THE BAV BALLOON, THERE WAS MINIMAL CONTACT BETWEEN THE BALLOON AND THE POSTERIOR OR LATER SIDE OF THE STENT. DURING INFLATION OF THE 23MM COMMANDER DELIVERY SYSTEM BALLOON, IT APPEARED THAT THE BALLOON DID CONTACT THE MITRAL VALVE STENT POST AND CREATED A MINIMUM INWARDS MOVEMENT, BUT THE POST IS SEEN TO FLEX BACK TO ITS ORIGINAL POSITION UPON BALLOON DEFLATION. THIS DEFLECTION IS CONSIDERED NORMAL. THE AMOUNT OF DEFLECTION APPEARS TO BE IN THE ACCEPTABLE RANGE. AS THERE WAS NO REPORT OF MITRAL REGURGITATION AT THE CONCLUSION OF THV SAPIEN 3 IMPLANTATION, IT IS UNLIKELY THAT THE MITRAL BIOPROTHESIS LEAFLET WAS TORN AS A RESULT OF THV BAV INFLATION CONTACTING WITH THE MITRAL PROTHESIS STRUT. AA 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 WAS CONFIRMED BASED ON THE PROVIDED IMAGERY. DUE TO THE UNAVAILABILITY OF THE COMPLAINT DEVICE, ENGINEERING WAS UNABLE TO PERFORM ANY VISUAL INSPECTION, FUNCTIONAL TESTING, OR DIMENSIONAL ANALYSIS. THEREFORE, THE PRESENCE OF A MANUFACTURING NON-CONFORMANCE WAS UNABLE TO BE DETERMINED. A DETAILED ROOT CAUSE ANALYSIS FOR SIMILAR RETURNED COMPLAINTS HAS BEEN SUMMARIZED IN A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES. THE TECHNICAL SUMMARY PROVIDES THE DETAILS WHY BALLOONS ARE SUBJECT TO INCREASED RISK OF BURST IN A CALCIFIED ANNULUS. AS REPORTED IN THIS COMPLAINT, ''WHILE BEING INFLATED, THE BALLOON RUPTURED AFTER CONTACTING WITH A STENT POST OF A PREEXISTING CARPENTIER EDWARDS PERIMOUNT (CEP) VALVE IN MITRAL POSITION.'' THE CASE NOTES REVEALED THE PATIENT HAD MILD CALCIFICATION PRESENT IN THE STJ AND ON THE LEAFLETS. IT IS POSSIBLE THAT CALCIFICATION PRESENT IN THE LANDING ZONE COULD HAVE WEAKENED THE BALLOON MATERIAL CONTRIBUTING THE BURST. IT IS LIKELY THE CONTRIBUTING FACTOR TO THE BURST AS SUPPORTED BY THE TECHNICAL SUMMARY. 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. THE TECHNICAL SUMMARY ALSO OUTLINES THE EXTENSIVE MANUFACTURING MITIGATIONS IN PLACE TO PREVENT THIS TYPE OF MALFUNCTION (VISUAL AND DIMENSIONAL INSPECTIONS, LEAK TESTING, AND FUNCTIONAL BALLOON BURST TESTING THAT OCCURS WITH EVERY MANUFACTURED LOT). THESE INSPECTIONS AND TESTING SUPPORT THAT IT IS UNLIKELY THAT A DEFECT PRESENT IN MANUFACTURING CONTRIBUTED TO THE COMPLAINT. ADDITIONALLY, THE BALLOON MAY HAVE INTERACTED WITH THE EXISTING SURGICAL VALVE IN THE MITRAL POSITION. ANY INTERACTION WITH THE EXIST VALVE MAY HAVE FURTHER COMPROMISED THE STRUCTURE OF THE BALLOON AND CONTRIBUTED TO THE BURST. AVAILABLE INFORMATION THEREFORE SUGGESTS THAT PATIENT FACTORS (CALCIFICATION, PRE-EXISTING SURGICAL VALVE) LIKELY CONTRIBUTED TO THE COMPLAINT EVENT. THE TECHNICAL SUMMARY IS APPLICABLE TO THIS COMPLAINT AS THE CASE NOTES STATES THAT CALCIFICATION WAS PRESENT IN THE PATIENT ANATOMY AND CAUSED THE BALLOON TO BURST. AS SUCH, AN ENGINEERING EVALUATION IS NOT REQUIRED. SINCE NO EDWARDS DEFECT WAS IDENTIFIED, NO CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED. THE COMPLAINT WAS CONFIRMED. NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. AVAILABLE INFORMATION SUGGESTS THAT PATIENT FACTORS (CALCIFICATION, PRE-EXISTING SURGICAL VALVE) LIKELY CONTRIBUTED TO THE COMPLAINT EVENT. NO LABELING OR IFU/TRAINING INADEQUACIES WERE IDENTIFIED. SINCE NO EDWARDS DEFECTS WERE IDENTIFIED, NO CORRECTIVE OR PREVENTIVE ACTION NOR PRA IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    SUPPLEMENTAL MDR FOR ADDITIONAL INFORMATION RECEIVED. A NEW ADVERSE EVENT (HEMOLYTIC ANEMIA) WAS REPORTED IN THE ARTICLE. THREE (3) MONTHS AFTER TAVI, THE PATIENT DEVELOPED HEMOLYTIC ANEMIA. TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED SEVERE MITRAL REGURGITATION FROM THE LEAFLET ON THE AORTIC VALVE SIDE, WHICH WAS CONSIDERED TO BE THE CAUSE OF HEMOLYSIS. SURGICAL REDO MVR WAS PERFORMED, AND THE TORN BIOPROSTHETIC MITRAL VALVE WAS RETRIEVED. THE PATIENT'S ANEMIA RAPIDLY IMPROVED AFTER REDO SURGERY. ARTICLE REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AS FOUND REPORTED BY OUR AFFILIATES IN (B)(6) , A BALLOON RUPTURE AND MITRAL LEAFLET TEAR REQUIRING SURGICAL INTERVENTION WERE REPORTED. DURING A TRANSFEMORAL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) IN AORTIC POSITION, BALLOON AORTIC VALVULOPLASTY (BAV) WAS PERFORMED WITH A 20 MM EDWARDS TRANSFEMORAL BALLOON CATHETER. DURING INFLATION THE BAV BALLOON RUPTURED. IT WAS REPORTED THE RUPTURE MAY HAVE OCCURED AFTER CONTACTING WITH THE STENT POST OF THE PREEXISTING CARPENTIER EDWARDS PERIMOUNT (CEP) VALVE IN MITRAL POSITION. A 23 MM SAPIEN 3 VALVE WAS DEPLOYED 90:10 AORTIC/VENTRICULAR IN THE AORTIC POSITION AS INTENDED. NO ADVERSE EVENT OCCURRED AT THAT TIME. APPROXIMATELY 2 MONTHS AFTER TAVI, SEVERE MITRAL REGURGITATION (MR) OF THE PERIMOUNT (CEP) PROSTHESIS DEVELOPED, AND IMAGING REVEALED THE PATIENT'S PRE-EXISTING MITRAL CEP STENT APPEARED 'BENT'. THE PATIENT UNDERWENT SURGICAL MITRAL VALVE REPLACEMENT (MVR). IT WAS REPORTED A LEAFLET OF THE EXPLANTED CEP VALVE WAS TORN. THE SURGEON ALLEGED THAT THE BAV DURING TAVI WAS THE MOST LIKELY CAUSE OF CEP STENT DEFORMATION, LEADING TO A TORN LEAFLET. PER THE SURGEON, 'THE LEAFLET TEAR WAS ATTRIBUTED TO DAMAGE BY BAV AND NOT DUE TO SPONTANEOUS DETERIORATION'. EVIDENCE SUPPORTING THIS ALLEGATION HAS BEEN REQUESTED FROM THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763898 EDWARDS TRANSFEMORAL BALLOON AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9350BC20JP 63336195 00690103195088

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Required Intervention