BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN EDWARDS INTRODUCER SHEATH SET

    MDR report key: 17175402 · Received June 21, 2023

    Report

    Report Number
    2015691-2023-14077
    Event Type
    Injury
    Date Received
    June 21, 2023
    Date of Event
    August 1, 2015
    Report Date
    June 21, 2023
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REFERENCE ARTICLE OKAJIMA, KAZUE, IKKI KOMATSU, AND TODD B. SETO. LOW INCIDENCE OF PROSTHESIS-PATIENT MISMATCH FOLLOWING EXTREMELY SMALL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 20-MM SAPIEN 3. INTERNATIONAL JOURNAL OF ANGIOLOGY 31.02 (2021): 120-125. THE DATES OF THE EVENTS ARE UNKNOWN; HOWEVER, ACCORDING TO THE ARTICLE THE STUDY PERIOD WAS FROM AUGUST 2015 TO DECEMBER 2017. FOR THIS REASON, THE FIRST DAY OF THE REPORTED STUDY PERIOD (01-AUGUST 2015) WAS USED AS THE OCCURRENCE DATE. THE EXACT SHEATH MODEL NUMBER IS NOT AVAILABLE. THEREFORE, SECTIONS D1 AND D4 OF THIS REPORT WILL REFLECT AN UNKNOWN EDWARDS INTRODUCER SHEATH SET FOR THE SAPIEN 3 VALVE. THE POSSIBLE PMA NUMBERS ASSOCIATED WITH AN EDWARDS INTRODUCER SHEATH SET FOR THE SAPIEN 3 VALVES ARE: EDWARDS ESHEATH INTRODUCER SET K200258 AND CERTITUDE INTRODUCER SHEATH SET P140031. PER THE INSTRUCTIONS FOR USE (IFU), CARDIOVASCULAR INJURIES SUCH AS PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIAL OR VALVULAR STRUCTURES ARE KNOWN POTENTIAL RISKS OR ADVERSE EVENTS ASSOCIATED WITH THE OVERALL THV PROCEDURE AND MAY REQUIRE INTERVENTION. ACCORDING TO THE LITERATURE REVIEW, AND AS DOCUMENTED IN A TECHNICAL SUMMARY WRITTEN BY EW, VASCULAR COMPLICATIONS ARE A WELL-RECOGNIZED COMPLICATION OF THE TRANSFEMORAL THV 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 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. PREPROCEDURE 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 IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST THE CAUSE IS UNKNOWN. . 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, PER ARTICLE, "LOW INCIDENCE OF PROSTHESIS-PATIENT MISMATCH FOLLOWING EXTREMELY SMALL TRANSCATHETER AORTIC VALVE REPLACEMENT WITH 20-MM SAPIEN 3'', THE STUDY INCLUDES A TOTAL OF 201 PATIENTS WHO WERE TREATED WITH SAPIEN 3 VALVE (SP3) FROM AUGUST 2015 TO DECEMBER 2017 AT THE QUEENS MEDICAL CENTER, HONOLULU, HI. THE STUDY INCLUDED 21 PATIENTS WITH 20MM SAPIEN 3 VALVES, 67 WITH 23MM SAPIENT 3 VALVES, AND 113 WITH 26 OR 29MM SAPIEN 3 VALVES. EVENTS WERE CAPTURED FROM TABLE 2 PROCEDURAL OUTCOMES AND TABLE 3 HEMODYNAMIC PARAMETERS (POSTPROCEDURAL). THIS EVENT IS FOR AFTER VALVE IMPLANTATION, 3 PATIENTS HAD MAJOR VASCULAR COMPLICATIONS (1 REGARDING A 20MM S3; 2 REGARDING A 23MM S3).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2015723 UNKNOWN EDWARDS INTRODUCER SHEATH SET AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES UNKNOWN EDWARDS INTRODUCER SHEATH SET

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other