EDWARDS TF SHEATH UNKNOWN
Report
- Report Number
- 2015691-2021-06091
- Event Type
- Injury
- Date Received
- October 30, 2021
- Report Date
- November 15, 2021
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- NPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE. PLEASE REFERENCE RELATED MANUFACTURER REPORT NO: 2015691-2021-06027, MANUFACTURER REPORT NO: 2015691-2021-06032, MANUFACTURER REPORT NO: 2015691-2021-06091, MANUFACTURER REPORT NO: 2015691-2021-06088, MANUFACTURER REPORT NO: 2015691-2021-06089.
THE INTRODUCER SHEATH MODEL AND SIZE IS UNKNOWN. POSSIBLE SHEATH USED - EDWARDS RETROFLEX 3TM INTRODUCER SHEATH SET - PMA K093554, OR EDWARDS ASCENDRA INTRODUCER SHEATH SET - PMA P110021, OR EDWARDS ASCENDRA+ INTRODUCER SHEATH SET - PMA P130009, OR EDWARDS EXPANDABLE INTRODUCER SHEATH SET - PMA P130009, OR EDWARDS ESHEATH INTRODUCER SET - PMA P140031, OR CERTITUDE INTRODUCER SHEATH SET - PMA P140031. 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. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A DEVICE MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. WITH THE LIMITED INFORMATION PROVIDED, THE CAUSE AND TIMING OF THE REPORTED VASCULAR COMPLICATIONS COULD NOT BE DETERMINED. INVESTIGATION RESULTS SUGGEST IN ADDITION TO PROCEDURAL FACTORS (MANIPULATION OF THE DEVICES), PATIENT FACTORS NOT PROVIDED 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: HENRI LU, STEPHANE FOURNIER, JEGARUBAN NAMASIVAYAM, CHRISTIAN ROGUELOV, ENRICO FERRARI, ERIC EECKHOUT, PIERRE MONNEY, PIERGIORGIO TOZZI, CARLO MARCUCCI, OLIVIER MULLER, MATTHIAS KIRSCH, TRANSAPICAL APPROACH VERSUS TRANSCERVICAL APPROACH FOR TRANSCATHETER AORTIC VALVE REPLACEMENT: A RETROSPECTIVE MONOCENTRIC STUDY, INTERACTIVE CARDIOVASCULAR AND THORACIC SURGERY, VOLUME 31, ISSUE 6, DECEMBER 2020, PAGES 781-788, HTTPS://DOI.ORG/10.1093/ICVTS/IVAA202 THIS IS ONE OF FIVE MANUFACTURER REPORTS BEING SUBMITTED FOR THIS CASE.
AS REPORTED BY OUR AFFILIATE IN (B)(6), AND THROUGH AN ARTICLE, " TRANSAPICAL APPROACH VERSUS TRANSCERVICAL APPROACH FOR TRANSCATHETER AORTIC VALVE REPLACEMENT: A RETROSPECTIVE MONOCENTRIC STUDY", BETWEEN NOVEMBER 2008 AND MARCH 2020, 127 TRANSAPICAL (TA) TAVR PROCEDURES AND 49 TRANSCERVICAL (TC) TAVR PROCEDURES WERE PERFORMED. BALLOON-EXPANDABLE TRANSCATHETER HEART VALVES OF THE EDWARDS SAPIEN FAMILY WERE USED. DURING THE TAVR PROCEDURES, VASCULAR COMPLICATIONS OCCURRED IN 8 PATIENTS. INFORMATION REGARDING THE TYPE OF INJURY AND ANY ACTIONS TAKEN WAS NOT PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1623111 | EDWARDS TF SHEATH UNKNOWN | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | EDWARDS LIFESCIENCES | TF SHEATH UNKNOWN | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |