BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS LIFESCIENCES SHEATH

    MDR report key: 22004336 · Received May 12, 2025

    Report

    Report Number
    2015691-2025-03748
    Event Type
    Injury
    Date Received
    May 12, 2025
    Date of Event
    April 17, 2025
    Report Date
    June 2, 2025
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYB
    PMA / PMN Number
    K200258
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE SEE MANUFACTURER REPORT NUMBER: 2015691-2025-03743 FOR DETAILS OF THE OTHER EVENT. IN THIS CASE, THE EXACT SHEATH MODEL NUMBER USED IS NOT AVAILABLE. THEREFORE, SECTIONS D1 (BRAND NAME) AND D4 (ADDITIONAL DEVICE INFORMATION) OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS LIFESCIENCES SHEATH. THE POSSIBLE PMA/510K NUMBERS ASSOCIATED WITH AN UNKNOWN EDWARDS LIFESCIENCES SHEATH ARE: K200258 EDWARDS ESHEATH INTRODUCER SET - MODEL NUMBERS: 9610ES14, 9610ES16 AND K200258 EDWARDS ESHEATH+ INTRODUCER SET - MODEL NUMBERS: 914ESP, 916ESP. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURY INCLUDING HEMATOMA, PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, ATRIUM, SEPTUM, MYOCARDIUM OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND MAY REQUIRE INTERVENTION. A PROCEDURAL OR POST PROCEDURAL BLEED/HEMORRHAGE WITHOUT AN OBVIOUS SOURCE OF BLEEDING IS A RARE BUT POTENTIALLY LIFE-THREATENING COMPLICATION OF CORONARY/CARDIAC INTERVENTIONAL PROCEDURES AND TENDS TO OCCUR MORE FREQUENTLY IN THE PRESENCE OF MORE AGGRESSIVE ANTICOAGULATION REGIMENS. POSSIBLE SOURCES INCLUDE PUNCTURE OF THE FEMORAL ARTERY ABOVE THE INGUINAL LIGAMENT AND ABOVE THE INFERIOR EPIGASTRIC ARTERY, ALLOWING THE RESULTANT BLEEDING TO EXTEND INTO THE RETROPERITONEAL SPACE, OR INADVERTENT TRAUMA OR PERFORATION OF THE ANNULAR STRUCTURE OR VENTRICLES DURING THE PROCEDURE. THIS TYPE OF BLEEDING MAY NOT BE RECOGNIZED UNTIL THE POST PROCEDURAL PERIOD. EDWARDS EXTENSIVELY TRAINS PHYSICIANS BEFORE THEY ARE QUALIFIED TO USE THE TRANSCATHETER HEART VALVE (THV). TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS, AND PROCTORED PROCEDURES. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME, THE EVENT MAY BE DUE TO THE MECHANISMS DESCRIBED ABOVE. 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 THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION AND INCLUDES ADDITIONAL INFORMATION PROVIDED AND FROM THE UPDATED INVESTIGATION. THE FOLLOWING SECTIONS OF THIS REPORT HAVE BEEN CORRECTED/UPDATED: H6 (HEALTH EFFECT - CLINICAL CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS), H10 (RELATED REPORT NUMBERS) AND H11 (ADDITIONAL NARRATIVE/DATA). ADDITIONAL INFORMATION WAS RECEIVED REVEALING THE BLEEDING ON THE FEMORAL ARTERY WAS DUE TO A VASCULAR DISSECTION. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS ARE KNOWN POTENTIAL RISKS OR ADVERSE EVENTS ASSOCIATED WITH THE OVERALL TRANSCATHETER VALVE REPLACEMENT (TVR) PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, VASCULAR COMPLICATIONS ARE A WELL-RECOGNIZED COMPLICATION OF THE TRANSFEMORAL TVR PROCEDURE IN THIS ELDERLY POPULATION WITH MULTIPLE CO-MORBIDITIES. EDWARDS HAS REVIEWED MANY REPORTS, INCLUDING SCREENING DATA RECORDS AND SOURCE DOCUMENTATION OF VASCULAR COMPLICATIONS, AND HAS FOUND THAT THE ROOT CAUSE IS TYPICALLY RELATED TO A COMBINATION OF VESSEL SIZE, TORTUOSITY, AND CALCIFICATIONS. ALTHOUGH THE INCIDENCE IS DECREASING WITH SMALLER SHEATH/DELIVERY SYSTEM SIZES AND PHYSICIAN EXPERIENCE, THERE WILL CONTINUE TO BE CASES IN WHICH VASCULAR COMPLICATIONS WILL OCCUR. THE TRAINING MANUALS INSTRUCT ON PROCEDURAL CONSIDERATIONS FOR SHEATH INSERTION WITH REGARDS TO PROPER SCREENING CRITICAL TO REDUCING VASCULAR COMPLICATIONS. THE TRAINING MANUAL INSTRUCTS THE OPERATOR ON PROPER SHEATH INSERTION AND WITHDRAWAL TECHNIQUES, INCLUDING PRE-DILATING THE VESSEL WITH THE EDWARDS DILATORS, AS NEEDED. IT ALSO NOTES THAT CALCIFICATION MAY REDUCE LUMEN DIAMETER AND LIMIT OR PREVENT THE TRANSFEMORAL PASSAGE OF THE DEVICES. THE IFU CONTRAINDICATES PATIENTS WITH ILIO-FEMORAL VESSEL CHARACTERISTICS THAT WOULD PRECLUDE SAFE PLACEMENT OF SHEATHS SUCH AS SEVERE OBSTRUCTIVE CALCIFICATION OR SEVERE TORTUOSITY. PRE-PROCEDURE SCREENING AND ASSESSMENT OF THE FEMORAL/ILIAC ARTERY INTERNAL DIAMETERS WILL ENABLE THE CLINICIAN TO DETERMINE IF THE SAPIEN VALVE CAN BE DELIVERED TRANSFEMORALLY. ASSESSMENT OF LOCATION AND AMOUNT OF CIRCUMFERENTIAL CALCIUM WILL AID IN DETERMINING AREAS OF REDUCED VESSEL DIAMETERS. THE OPERATORS ARE TRAINED TO MEASURE MINIMUM VESSEL DIAMETER TAKING CALCIUM INTO ACCOUNT. THE TRAINING MANUAL ALSO LISTS THE MINIMUM RECOMMENDED VESSEL SIZE FOR EACH SIZE DEVICE. DESPITE THE BEST SCREENING TOOLS, A SMALL PERCENTAGE OF PATIENTS WILL HAVE FEMORAL/ILIAC VESSELS THAT ARE NOT AMENABLE TO THE TRANS-FEMORAL APPROACH OR WHERE INCREASED RESISTANCE IS ENCOUNTERED DURING INSERTION OF DEVICES. IN MANY CASES, THE VESSEL MINIMUM LUMINAL DIAMETER (MLD) MAY BE BORDERLINE OR BELOW THE INDICATED SIZE. IN ADDITION, SIGNIFICANT CALCIFICATION AND/OR TORTUOSITY, NOT ALWAYS APPRECIABLE ON IMAGING, COULD BE CONTRIBUTING FACTORS TO THE EVENT. THE MINIMUM REQUIRED VESSEL DIAMETER FOR A 14FR SHEATH IS 5.5 MM AND FOR A 16FR SHEATH, IT IS 6.0 MM. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AT THIS TIME, THE EVENT MAY BE DUE TO THE MECHANISMS DESCRIBED ABOVE. 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 THIS ADVERSE EVENT IS NOT REQUIRED AT THIS TIME. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. 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. AS SUCH, NEITHER A PRODUCT RISK ASSESSMENT, NOR CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED BY OUR EDWARDS LIFESCIENCES AFFILIATE IN FRANCE, DURING THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE WITH A 26 MM SAPIEN 3 ULTRA VALVE, THE VALVE EMBOLIZED INTO THE AORTA WHICH RESULTED IT BEING DEPLOYED IN THE DESCENDING AORTA. SUBSEQUENTLY, A NON-EDWARDS VALVE WAS IMPLANTED. AT THE END OF THE TAVR PROCEDURE, BLEEDING ON THE FEMORAL ARTERY WAS OBSERVED. AS A RESULT, TWO COVERED STENTS WERE PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811263 UNKNOWN EDWARDS LIFESCIENCES SHEATH INTRODUCER, CATHETER DYB EDWARDS LIFESCIENCES TF SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention