BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS TRANSCATHETER INTRODUCER SHEATH

    MDR report key: 9450812 · Received December 11, 2019

    Report

    Report Number
    2015691-2019-04591
    Event Type
    Injury
    Date Received
    December 11, 2019
    Date of Event
    May 1, 2007
    Report Date
    November 26, 2019
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: H6. REFERENCE CAPA-20-00141.

    Additional Manufacturer Narrative · 1

    THE TRANSFEMORAL SHEATH MODELS AND SIZES ARE UNKNOWN. POSSIBLE SHEATHS USED DURING THE STUDY PERIOD ¿ EDWARDS RETROFLEX 3TM INTRODUCER SHEATH SET ¿ 510K K09355, EDWARDS RETROFLEX 3 INTRODUCER SHEATH SET ¿ PMA P110021, OR EDWARDS EXPANDABLE INTRODUCER SHEATH SET ¿ PMA P130009. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR COMPLICATIONS, INCLUDING PERFORATION OR DISSECTION OF VESSELS WHICH MAY REQUIRE INTERVENTION, ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSFEMORAL TRANSCATHETER AORTIC VALVE REPLACEMENT PROCEDURE. ACCORDING TO LITERATURE REVIEW, AND AS DOCUMENTED IN A CLINICAL TECHNICAL SUMMARY WRITTEN BY EDWARDS LIFESCIENCES, VASCULAR COMPLICATIONS ARE A WELL-RECOGNIZED COMPLICATION OF THE TRANSFEMORAL TAVR 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 THV PHYSICIAN 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 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 PHYSICIAN 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 DIAMETERS FOR A 22FR. AND 24FR. RETROFLEX 3 INTRODUCER SHEATH ARE >7MM AND >8MM RESPECTIVELY. THE MINIMUM REQUIRED VESSEL DIAMETERS FOR A 16FR, 18FR. AND 20FR. EXPANDABLE INTRODUCER SHEATH ARE 6.0MM, 6.5MM AND 7.0MM RESPECTIVELY. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. ALTHOUGH THE EXACT NATURE OR TIMING OF THE VASCULAR COMPLICATIONS WAS PROVIDED, THE LIMITED AVAILABLE INFORMATION SUGGESTS PROCEDURAL AND/OR PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. 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 ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME. REFERENCE FOR ARTICLE: AMAT-SANTOS, I., RODÉS-CABAU, J., URENA, M., DELAROCHELLIÈRE, R., DOYLE, D., BAGUR, R., VILLENEUVE, J., CÔTÉ, M., NOMBELA-FRANCO, L., PHILIPPON, F., PIBAROT, P., AND DUMONT, E. INCIDENCE, PREDICTIVE FACTORS, AND PROGNOSTIC VALUE OF NEW-ONSET ATRIAL FIBRILLATION FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION. (2011). 2011.09.061 J. AM. COLL. CARDIOL. PUBLISHED ONLINE DEC 14, 2011; DOI:10.1016/J.JACC.2011.09.061. HTTP://CONTENT.ONLINEJACC.ORG/CGI/CONTENT/FULL/J.JACC.2011.09.061V1.

    Description of Event or Problem · 1

    AS REPORTED BY OUR AFFILIATE IN (B)(6) AND THROUGH AN ARTICLE, ¿INCIDENCE, PREDICTIVE FACTORS, AND PROGNOSTIC VALUE OF NEW-ONSET ATRIAL FIBRILLATION FOLLOWING TRANSCATHETER AORTIC VALVE IMPLANTATION¿, 195 PATIENTS WITH SEVERE SYMPTOMATIC AORTIC STENOSIS UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH A SAPIEN OR SAPIEN XT VALVE VIA THE TRANSFEMORAL (TF) OR TRANSAPICAL (TA) APPROACH BETWEEN MAY 2007 AND MAY 2011. ¿MAJOR¿ VASCULAR COMPLICATIONS OCCURRED IN THIRTEEN PATIENTS. NO FURTHER INFORMATION REGARDING THE EVENTS OR THE REQUIRED TREATMENTS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248081 EDWARDS TRANSCATHETER INTRODUCER SHEATH AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES TF SHEATH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention