EDWARDS EXPANDABLE INTRODUCER SHEATH SET
Report
- Report Number
- 2015691-2022-09167
- Event Type
- Death
- Date Received
- November 10, 2022
- Date of Event
- July 21, 2022
- Report Date
- April 19, 2024
- Manufacturer
- EDWARDS LIFESCIENCES
- Product Code
- DYB
- UDI-DI
- 00690103194838
- PMA / PMN Number
- K200258
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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 EDWARDS LIFESCIENCES (TS39110), 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. 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 PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS ARE INCONCLUSIVE AS PATIENT AND PROCEDURAL FACTORS WERE NOT PROVIDED; HOWEVER, THE EVENT COULD BE RELATED 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. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.
A SUPPLEMENTAL MDR IS BEING SUBMITTED. SECTION D4, H4, H6: CLINICAL CODE AND H10 HAS BEEN UPDATED.
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 EDWARDS LIFESCIENCES (B)(4), 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. 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 DIAMETER FOR A 14FR ESHEATHR IS 5.5 MM. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST/INDICATE PATIENT'S ACCESS VESSEL ANATOMY (LESS THAN 5.5MM MLD, CALCIFICATION ) CAUSED OR CONTRIBUTED TO THIS EVENT. 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. PER THE INSTRUCTIONS FOR USE (IFU), POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE OVERALL PROCEDURE INCLUDE THROMBUS FORMATION, PLAQUE DISLODGMENT, AND EMBOLIZATION THAT MAY RESULT IN MYOCARDIAL INFARCTION, STROKE, DISTAL PERIPHERAL OCCLUSION, AND/OR DEATH. IT IS THE NATURAL TENDENCY OF THE BODY TO FORM A CLOT ON FOREIGN OBJECTS IN THE VASCULAR SPACE. THESE PATIENTS ARE ANTICOAGULATED FOR THE PROCEDURE AND INTERVENTIONAL BEST PRACTICES MANDATE METICULOUS WIPING AND FLUSHING OF THE DEVICES TO PREVENT AND/OR REMOVE THE CLOT. THE THV TRAINING MANUALS AND IFU INSTRUCT THE OPERATOR TO ADMINISTER HEPARIN AND MAINTAIN THE ACT AT = 250 SEC. THERE ARE MULTIPLE ETIOLOGIES FOR BOWEL ISCHEMIA/INFARCTION INCLUDING EMBOLIZATION OCCURRING AFTER DEVICE MANIPULATION, BAV, OR VALVE DEPLOYMENT AND THESE EVENTS CAN RESULT IN VARYING DEGREES OF PERMANENT IMPAIRMENT. ADDITIONALLY, PROLONGED HYPOTENSION CAN CONTRIBUTE TO DECREASED BOWEL PERFUSION AND ISCHEMIA POTENTIALLY LEADING TO TISSUE NECROSIS. IN THIS CASE, THERE WAS NO ALLEGATION OR INDICATION A PRODUCT MALFUNCTION CONTRIBUTED TO THIS ADVERSE EVENT. INVESTIGATION RESULTS SUGGEST MESENTERIC ARTERY EMBOLISM AND INTESTINAL OBSTRUCTION CAUSED OR CONTRIBUTED TO THIS EVENT OF DEATH. AS THE EVENT RELATIONSHIP 60 DAYS POST PROCEDURE TO THE VALVE AND THE TAVR PROCEDURE REMAIN UNKNOWN BY THE REPORTER, A CONSERVATIVE REPORT OF DEATH IS BEING SUBMITTED. 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.
AS REPORTED THROUGH THE (B)(4) REGISTRY, AFTER A TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION, WHEN THE SHEATH WAS REMOVED, ENDOVASCULAR TREATMENT (EVT) WAS PERFORMED BECAUSE THE AREA WHERE THE BALLOON WAS USED WAS DISSECTED (RIGHT COMMON ILIAC ARTERY). THE DISSECTED ISOLATED CAVITY WAS NOT CLOSED, SO A COVERED STENT WAS PERFORMED FROM THE CONTRALATERAL SIDE, AND ISOLATED CAVITY WAS CLOSED. THE PUNCTURE SITE OF THE RIGHT FEMORAL ARTERY HAD POOR HEMOSTASIS, SO IT WAS SURGICALLY REPAIRED. PER MEDICAL OPINION, THE RELATIONSHIP OF THE EVENT TO THE DEVICE WAS UNKNOWN AND TO THE PROCEDURE WAS NOT RELATED. PER THE FILED CLINICAL SPECIALIST, THE DISSECTION OF RIGHT COMMON ILIAC ARTERY AND POOR HEMOSTASIS OF ACCESS SITE WERE RELATED TO THE EW SHEATH. THE OUTCOME WAS DETERMINED AS RECOVERING.
AS REPORTED THROUGH THE JAPANESE TAVI REGISTRY, AFTER A TRANSFEMORAL TAVR PROCEDURE WITH A 23MM SAPIEN 3 VALVE IN THE AORTIC POSITION, WHEN THE SHEATH WAS REMOVED, ENDOVASCULAR TREATMENT (EVT) WAS PERFORMED BECAUSE THE AREA WHERE THE BALLOON WAS USED WAS DISSECTED (RIGHT COMMON ILIAC ARTERY). THE DISSECTED ISOLATED CAVITY WAS NOT CLOSED, SO A COVERED STENT WAS PERFORMED FROM THE CONTRALATERAL SIDE, AND ISOLATED CAVITY WAS CLOSED. THE PUNCTURE SITE OF THE RIGHT FEMORAL ARTERY HAD POOR HEMOSTASIS, SO IT WAS SURGICALLY REPAIRED. PER MEDICAL OPINION, THE RELATIONSHIP OF THE EVENT TO THE DEVICE WAS UNKNOWN AND TO THE PROCEDURE WAS NOT RELATED. PER THE FILED CLINICAL SPECIALIST, THE DISSECTION OF RIGHT COMMON ILIAC ARTERY AND POOR HEMOSTASIS OF ACCESS SITE WERE RELATED TO THE EW SHEATH. THE OUTCOME WAS DETERMINED AS RECOVERING. PER ADDITIONAL INFORMATION RECEIVED FROM THE JAPANESE TAVI REGISTRY, THE PATIENT DIED FROM MESENTERIC ARTERY EMBOLISM AND INTESTINAL OBSTRUCTION ON POSTOPERATIVE DAY 60. THE RELATIONSHIP IS UNCLEAR BECAUSE VASCULAR COMPLICATIONS OCCURRED DURING THE TAVR PROCEDURE. PER MEDICAL OPINION, THE EVENT RELATIONSHIP TO BOTH THE VALVE AND THE TAVR PROCEDURE WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2704325 | EDWARDS EXPANDABLE INTRODUCER SHEATH SET | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | DYB | EDWARDS LIFESCIENCES | 914ESJ | 64343072 | 00690103194838 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Female | Required Intervention| D |