EVOLUT FX VALVE
Report
- Report Number
- 2025587-2024-06783
- Event Type
- Death
- Date Received
- November 22, 2024
- Date of Event
- November 12, 2024
- Report Date
- February 17, 2025
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID: D-EVOLUTFX-34 (LOT: 0012432635); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2024. PRODUCT ID: L-EVOLUTFX-34 (LOT: 0012318216); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE: (B)(6) 2024. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
UPDATED DATA: H6. EVAL CODE METHOD; EVAL CODE RESULT; AND EVAL CODE CONCLUSION PRODUCT ANALYSIS: THE VALVE REMAINED IMPLANTED; THEREFORE, IT WAS NOT RETURNED TO MEDTRONIC FOR ANALYSIS. THE SUBJECT DCS WAS DISCARDED BY THE CUSTOMER; THEREFORE, WAS UNABLE TO BE RETURNED FOR ANALYSIS. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. PROCEDURAL IMAGES WERE SUBMITTED TO MEDTRONIC FOR REVIEW. THE DEVICE HISTORY RECORD FOR THE SUSPECT VALVE WAS REVIEWED AND SHOWED THIS PRODUCT MET ALL MANUFACTURING SPECIFICATIONS FOR PRODUCT RELEASED FOR DISTRIBUTION. NO ISSUES WERE IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. CONCLUSION: HEMODYNAMIC INSTABILITY CAN BE THE RESULT OF EFFECTS SUCH AS LOW CARDIAC OUTPUT AND HYPOTENSION, WHICH ARE KNOWN POTENTIAL ADVERSE EVENTS PER THE DEVICE IFU. WITH THE INFORMATION AVAILABLE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. POTENTIAL FACTORS THAT CAN INFLUENCE DISLODGEMENT INCLUDE TENSION APPLIED ON THE DCS DURING POSITIONING, CALCIFICATION LEVELS AND SHAPE OF THE NATIVE ANATOMY. DISLODGEMENT EVENTS DO NOT TYPICALLY INDICATE A DEVICE MALFUNCTION OR A FAILURE TO MEET MANUFACTURING SPECIFICATIONS. IN THIS CASE, THE CAUSE OF THE REPORTED DISLODGEMENT COULD NOT BE CONCLUSIVELY DETERMINED WITH THE LIMITED INFORMATION AVAILABLE. THE VALVE WAS RECAPTURED AND PULSELESS ELECTRICAL ACTIVITY OCCURRED. RESUSCITATION WAS PERFORMED FOR SIX MINUTES WITH A BRIEF RETURN OF SPONTANEOUS CIRCULATION (ROSC), THEN PERFORMED AGAIN FOR THREE MINUTES. AFTER ANOTHER ROSC, THE VALVE WAS IMPLANTED. AN INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW PORTION OF THE VALVE FRAME. INFOLDING COULD OCCUR DUE A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. INFOLDING EVENTS ARE TYPICALLY RELATED TO PATIENT ANATOMICAL FACTORS (EX. CALCIFICATION LEVEL, LEFT VENTRICULAR OUTFLOW TRACT (LVOT) ANOMALIES, COMPLIANCE OF THE ANNULUS, BICUSPID VALVE, ETC.) AND/OR PROCEDURAL FACTORS (EX. PRE-CASE PLANNING, SIZING, LOADING, USER TECHNIQUE, ETC.). ADDITIONALLY, THE VALVE FRAME IS CONSTRUCTED WITH NITINOL AND THE LATTICED STRUT DESIGN ALLOWS THE VALVE TO BE COMPRESSED AND LOADED INTO THE DELIVERY SYSTEM. DURING EITHER THE LOADING OR DEPLOYING/RECAPTURING PROCESS, THE STRUTS MAY CROSS OVER AND CATCH ON EACH OTHER WHILE BEING COMPRESSED, AND POTENTIALLY CAUSE INFOLDING. ACCORDING TO MEDTRONIC BEST PRACTICES, IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED, REMOVED FROM THE BODY, AND DISCARDED. NEW STERILE COMPONENTS MUST BE USED. BASED ON REVIEW OF THE PROCEDURAL IMAGES, A MISLOAD WAS IDENTIFIED AND THE MISLOADED VALVE WAS ATTEMPTED TO BE IMPLANTED BUT RESULTED IN AN INFOLD. DESPITE THE INFOLD, THE VALVE WAS FULLY RELEASED. THUS, THE ROOT CAUSE IS DEEMED TO BE A MISLOAD. IT WAS REPORTED THAT, UPON DEPLOYMENT, AN EXPANSION DEFECT WAS OBSERVED WITHIN THE VALVE FRAME. A POST-IMPLANT BALLOON DILATION WAS PERFORMED IN THIS CASE AND PER THE DEVICE IFU, IN THE EVENT THAT VALVE FUNCTION, OR SEALING IS IMPAIRED DUE TO EXCESSIVE CALCIFICATION OR INCOMPLETE EXPANSION, A POST-IMPLANT BALLOON DILATION OF THE BIOPROSTHESIS MAY IMPROVE VALVE FUNCTION AND SEALING. TO ENSURE PATIENT SAFETY, VALVE SIZE AND PATIENT ANATOMY MUST BE CONSIDERED WHEN SELECTING THE SIZE OF THE BALLOON USED FOR DILATION. THE BALLOON SIZE CHOSEN FOR DILATATION SHOULD NOT EXCEED THE DIAMETER OF THE NATIVE AORTIC ANNULUS. REFER TO THE SPECIFIC BALLOON CATHETER MANUFACTURER'S LABELING FOR PROPER INSTRUCTION ON THE USE OF BALLOON CATHETER DEVICES. WITH THE INFORMATION PROVIDED, A CONCLUSIVE CAUSE OF THE UNDER EXPANSION COULD NOT BE DETERMINED. CENTRAL REGURGITATION, INCLUDING AORTIC, IS A KNOWN POTENTIAL ADVERSE EFFECT PER THE DEVICE IFU AND CAN BE CAUSED BY A VARIETY OF FACTORS, INCLUDING VALVE POSITIONING, PATIENT ANATOMY, OR PRESENCE OF PRE-EXISTING PATIENT CONDITIONS. THE NON-MEDTRONIC (OSYPKA VACS II) BALLOON USED FOR PRE-DILATION UNDER RAPID PACING REPORTEDLY CAUSED THE AORTIC INSUFFICIENCY; HOWEVER, THIS COULD NOT BE CONFIRMED AND A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT PER THE DEVICE IFU. IT IS AN EFFECT THAT IS HIGHLY DEPENDENT ON THE PATIENT'S PRE-PROCEDURAL CONDITION AND CAN OCCUR DESPITE A NORMALLY FUNCTIONING DEVICE OR MODEL IMPLANT PROCEDURE. IN THIS CASE, A CONCLUSIVE CAUSE COULD NOT BE DETERMINED. REGURGITATION AND HEMODYNAMIC INSTABILITY MAY HAVE BEEN CONTRIBUTING FACTORS. CONDUCTION DISTURBANCES, SUCH AS ASYSTOLE, ARE KNOWN POTENTIAL ADVERSE EFFECTS PER THE DEVICE IFU. FACTORS THAT MAY IMPACT THE DEVELOPMENT OF CONDUCTION DISTURBANCES INCLUDE DEPTH OF IMPLANT, BASELINE CONDUCTION DEFECTS, AND ANATOMICAL CONSIDERATIONS. HOWEVER, WITH THE LIMITED INFORMATION AVAILABLE, A CONCLUSIVE CAUSE OF THIS CONDUCTION DISTURBANCE COULD NOT BE DETERMINED. CARDIAC ARREST IS LISTED UNDER THE POTENTIAL ADVERSE EVENTS PER THE DEVICE IFU, AND CAN BE RELATED TO SEVERAL FACTORS (PROCEDURE, PATIENT COMORBIDITIES, ETC.). A RELATIONSHIP OF THE CARDIAC ARREST TO THE DEVICE OR PROCEDURE COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE. PATIENT DEATH IS A POTENTIAL RISK ASSOCIATED WITH THE IMPLANTATION OF A BIOPROSTHESIS VALVE PER THE DEVICE IFU. A PROCEDURE- OR VALVE-RELATED DEATH IS AN INHERENT RISK WHEN THE PATIENT CONDITION IS SUCH THAT A TRANSCATHETER AORTIC VALVE IS NEEDED TO SUSTAIN CARDIAC FUNCTION, AND IT CAN OCCUR DESPITE AN IDEAL IMPLANT PROCEDURE OR DEVICE FUNCTIONALITY. IT WAS REPORTED THAT COMPLICATIONS OCCURRED AFTER A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY AND THE PATIENT DIED BUT IT IS NOT POSSIBLE TO VALIDATE CAUSE OF DEATH. NO NEW OR UNEXPECTED DEVICE OR THERAPY ISSUE IDENTIFIED. THE EVENT IS FORESEEN, WITHIN EXPECTED SEVERITY, DOCUMENTED IN RISK MANAGEMENT, AND INCLUDED IN MONITORING/TRENDING. THERE IS NO INFORMATION TO SUGGEST A DEVICE QUALITY DEFICIENCY MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: SECTION B5 - FOURTH PARAGRAPH. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME MEDTRONIC PRODUCT ID D-EVOLUTFX-34 LOT 0012432635 USE BY DATE 2026-SEP-06 UDI (B)(4). IMAGE REVIEW: FIVE STATIC IMAGES AND THREE MEDIA FILES WERE PROVIDED FOR REVIEW. FLUOROSCOPIC VALVE LOAD INSPECTION WAS PERFORMED AND A MISLOAD APPEARED TO BE PRESENT BY OVERLAP TO NODE 4. OVERLAP PRIOR TO NODE 4 IS CONSIDERED A GOOD LOAD; OVERLAP AT NODE 4 AND BEYOND IS CONSIDERED A MISLOAD. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), IF A MISLOAD IS DETECTED, DO NOT ATTEMPT TO RELOAD THE BIOPROSTHESIS. THE VALVE, CATHETER, LOADING SYSTEM, LOADING TRAY, AND SALINE MUST ALL BE REPLACED WITH NEW STERILE COMPONENTS. HOWEVER, THE MISLOADED VALVE WAS ATTEMPTED TO BE IMPLANTED RESULTING IN AN INFOLD. THE INFOLD IS CHARACTERIZED BY AN INWARD FOLD OR CREASE IN THE VALVE, EXTENDING FROM THE INFLOW. INFOLDING COULD OCCUR DUE A MISLOADED VALVE, ANATOMICAL CHARACTERISTICS SUCH AS CALCIUM, AND RECAPTURES. IF AN INFOLD IS IDENTIFIED, THE VALVE SHOULD BE RECAPTURED AND REMOVED FROM THE BODY. NEW STERILE COMPONENTS MUST BE USED. DESPITE THE INFOLD, THE VALVE WAS RELEASED. SUBSEQUENTLY, A POST IMPLANT DILATATION WAS PERFORMED WITH VISIBLE RESOLUTION OF THE INFOLD. IT WAS REPORTED THAT COMPLICATIONS OCCURRED AFTER A PRE-IMPLANT BALLOON DILATATION AND THE PATIENT DIED, BUT IT IS NOT POSSIBLE TO VALIDATE CAUSE OF DEATH WITH THE IMAGING PROVIDED. THE PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. UPDATED: H6 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE INVOLVING THE IMPLANTATION OF AN EVOLUT FX 34 MILLIMETER VALVE, COMPLICATIONS AROSE AFTER A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) USING A 22 MILLIMETER NON-MEDTRONIC BALLOON. THE PATIENT'S HEMODYNAMICS WORSENED, LEADING TO ASYSTOLE. IMMEDIATE CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, RESULTING IN RETURN OF SPONTANEOUS CIRCULATION (ROSC) AFTER A FEW MINUTES, AND THE PATIENT REQUIRED HIGH DOSES OF CATECHOLAMINES TO STABILIZE. DESPITE THE CRITICAL CONDITION, THE VALVE WAS IMPLANTED, BUT AN INFOLD WAS OBSERVED. IMMEDIATE POSTDILATION WAS PERFORMED USING A 24 MILLIMETER NON-MEDTRONIC BALLOON, AFTER WHICH THE PATIENT'S CONDITION STABILIZED, AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). UNFORTUNATELY, THE PATIENT PASSED AWAY A FEW HOURS AFTER THE SURGERY DUE TO ASYSTOLE.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE INVOLVING THE IMPLANTATION OF AN EVOLUT FX 34 MILLIMETER VALVE, COMPLICATIONS AROSE AFTER A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) USING A 22 MILLIMETER NON-MEDTRONIC BALLOON. THE PATIENT'S HEMODYNAMICS WORSENED, LEADING TO ASYSTOLE. IMMEDIATE CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, RESULTING IN RETURN OF SPONTANEOUS CIRCULATION (ROSC) AFTER A FEW MINUTES, AND THE PATIENT REQUIRED HIGH DOSES OF CATECHOLAMINES TO STABILIZE. DESPITE THE CRITICAL CONDITION, THE VALVE WAS IMPLANTED, BUT AN INFOLD WAS OBSERVED. IMMEDIATE POST DILATION WAS PERFORMED USING A 24 MILLIMETER NON-MEDTRONIC BALLOON, AFTER WHICH THE PATIENT'S CONDITION STABILIZED, AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). UNFORTUNATELY, THE PATIENT PASSED AWAY A FEW HOURS AFTER THE SURGERY DUE TO ASYSTOLE. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC (CORDIS) STANDARD WIRE WAS USED FOR THE PROCEDURE. THE NON-MEDTRONIC (OSYPKA VACS II) BALLOON USED FOR PRE-DILATION UNDER RAPID PACING CAUSED SEVERE AORTIC INSUFFICIENCY AND CONSEQUENTLY HYPERTENSION. DURING THE FIRST DEPLOYMENT ATTEMPT UNDER FAST PACING, AN INFOLD WAS NOTICED. THE VALVE WAS INSUFFICIENTLY EXPANDED AND DISLOCATED INTO THE AORTA AT THE NON-CORONARY CUSP (NCC) AREA. THE VALVE WAS RECAPTURED AND PULSELESS ELECTRICAL ACTIVITY (PEA) OCCURRED. RESUSCITATION WAS PERFORMED FOR SIX MINUTES WITH A BRIEF RETURN OF SPONTANEOUS CIRCULATION (ROSC), THEN PERFORMED AGAIN FOR THREE MINUTES. AFTER ANOTHER ROSC, THE VALVE WAS IMPLANTED. DUE TO THE INFOLD, BALLOON DILATATION WAS PERFORMED WITH A 22 MM BALLOON AND THEN WITH A 24 MM BALLOON. ANGIOGRAPHY SHOWED A GOOD RESULT WITHOUT RELEVANT RESIDUAL PARAVALVULAR INSUFFICIENCY. PROLONGED HYPOTENSION WAS OBSERVED AND REPEATEDLY TREATED WITH ADRENALINE BOLUSES. FOLLOWING CLOSURE OF THE PUNCTURE SITE OF THE RIGHT EXTERNAL ILIAC ARTERY WITH A NON-MEDTRONIC (ABBOTT PERCLOSE PROSTYLE) CLOSURE SYSTEM AND THE LEFT FEMORAL ARTERY WITH A 6 FRENCH NON-MEDTRONIC (ANGIO-SEAL) CLOSURE SYSTEM, ANOTHER CIRCULATORY ARREST OCCURRED WITH PEA. RESUSCITATION WAS PERFORMED FOR TWO MINUTES WITH ANOTHER ADMINISTRATION OF ADRENALINE. ECHOCARDIOGRAPHY SHOWED MODERATELY REDUCED SYSTOLIC FUNCTION OF THE LEFT VENTRICLE, NO GRADIENT OVER THE AORTIC VALVE, BUT SIGNIFICANT DILATION OF THE RIGHT VENTRICLE. PER THE PHYSICIAN, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE NOT A CONTRIBUTING CAUSE TO THE DEATH. NO AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED THAT NO SIGNIFICANT PROCEDURAL DELAY OCCURRED. DUE TO THE INSTABILITY, THE POST-IMPLANT BALLOON DILATION WAS PERFORMED QUICKLY. ADDITIONAL INFORMATION WAS RECEIVED THAT ACCORDING TO THE PHYSICIAN, THE PATIENT HAD A MEDICAL HISTORY OF MODERATELY IMPAIRED CARDIAC FUNCTION WITH DECOMPENSATED HEART FAILURE (NEW YORK HEART ASSOCIATION CLASS IV), FOLLOWING CORONARY BYPASS SURGERY. FURTHERMORE, THE SITUATION AFTER THE TRANSCATHETER HEART VALVE IMPLANT PROCEDURE IN THE ICU COULD NOT BE STABILIZED DESPITE CATECHOLAMINE ADMINISTRATION, LEADING TO THE PATIENT'S DEATH FROM BIVENTRICULAR PUMP FAILURE. IT WAS ALSO STATED THAT ULTRASOUND DID NOT ATTRIBUTE THE HEMODYNAMIC DETERIORATION TO THE NEW VALVE.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE INVOLVING THE IMPLANTATION OF AN EVOLUT FX 34 MILLIMETER VALVE, COMPLICATIONS AROSE AFTER A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) USING A 22 MILLIMETER NON-MEDTRONIC BALLOON. THE PATIENT'S HEMODYNAMICS WORSENED, LEADING TO ASYSTOLE. IMMEDIATE CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, RESULTING IN RETURN OF SPONTANEOUS CIRCULATION (ROSC) AFTER A FEW MINUTES, AND THE PATIENT REQUIRED HIGH DOSES OF CATECHOLAMINES TO STABILIZE. DESPITE THE CRITICAL CONDITION, THE VALVE WAS IMPLANTED, BUT AN INFOLD WAS OBSERVED. IMMEDIATE POSTDILATION WAS PERFORMED USING A 24 MILLIMETER NON-MEDTRONIC BALLOON, AFTER WHICH THE PATIENT'S CONDITION STABILIZED, AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). UNFORTUNATELY, THE PATIENT PASSED AWAY A FEW HOURS AFTER THE SURGERY DUE TO ASYSTOLE. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC (CORDIS) STANDARD WIRE WAS USED FOR THE PROCEDURE. THE NON-MEDTRONIC (OSYPKA VACS II) BALLOON USED FOR PRE-DILATION UNDER RAPID PACING CAUSED SEVERE AORTIC INSUFFICIENCY AND CONSEQUENTLY HYPERTENSION. DURING THE FIRST DEPLOYMENT ATTEMPT UNDER FAST PACING, AN INFOLD WAS NOTICED. THE VALVE WAS INSUFFICIENTLY EXPANDED AND DISLOCATED INTO THE AORTA AT THE NON-CORONARY CUSP (NCC) AREA. THE VALVE WAS RECAPTURED AND PULSELESS ELECTRICAL ACTIVITY (PEA) OCCURRED. RESUSCITATION WAS PERFORMED FOR SIX MINUTES WITH A BRIEF RETURN OF SPONTANEOUS CIRCULATION (ROSC), THEN PERFORMED AGAIN FOR THREE MINUTES. AFTER ANOTHER ROSC, THE VALVE WAS IMPLANTED. DUE TO THE INFOLD, BALLOON DILATATION WAS PERFORMED WITH A 22 MM BALLOON AND THEN WITH A 24 MM BALLOON. ANGIOGRAPHY SHOWED A GOOD RESULT WITHOUT RELEVANT RESIDUAL PARAVALVULAR INSUFFICIENCY. PROLONGED HYPOTENSION WAS OBSERVED AND REPEATEDLY TREATED WITH ADRENALINE BOLUSES. FOLLOWING CLOSURE OF THE PUNCTURE SITE OF THE RIGHT EXTERNAL ILIAC ARTERY WITH A NON-MEDTRONIC (ABBOTT PERCLOSE PROSTYLE) CLOSURE SYSTEM AND THE LEFT FEMORAL ARTERY WITH A 6 FRENCH NON-MEDTRONIC (ANGIO-SEAL) CLOSURE SYSTEM, ANOTHER CIRCULATORY ARREST OCCURRED WITH PEA. RESUSCITATION WAS PERFORMED FOR TWO MINUTES WITH ANOTHER ADMINISTRATION OF ADRENALINE. ECHOCARDIOGRAPHY SHOWED MODERATELY REDUCED SYSTOLIC FUNCTION OF THE LEFT VENTRICLE, NO GRADIENT OVER THE AORTIC VALVE, BUT SIGNIFICANT DILATION OF THE RIGHT VENTRICLE. PER THE PHYSICIAN, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE NOT A CONTRIBUTING CAUSE TO THE DEATH. NO AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED THAT NO SIGNIFICANT PROCEDURAL DELAY OCCURRED. DUE TO THE INSTABILITY, THE POST-IMPLANT BALLOON DILATION WAS PERFORMED QUICKLY.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE INVOLVING THE IMPLANTATION OF AN EVOLUT FX 34 MILLIMETER VALVE, CO MPLICATIONS AROSE AFTER A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) USING A 22 MILLIMETER NON-MEDTRONIC BALLOON. THE PATIENT'S HEMODYNAMICS WORSENED, LEADING TO ASYSTOLE. IMMEDIATE CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, RESULTING IN RETURN OF SPONTANEOUS CIRCULATION (ROSC) AFTER A FEW MINUTES, AND THE PATIENT REQUIRED HIGH DOSES OF CATECHOLAMINES TO STABILIZE. DESPITE THE CRITICAL CONDITION, THE VALVE WAS IMPLANTED, BUT AN INFOLD WAS OBSERVED. IMMEDIATE POSTDILATION WAS PERFORMED USING A 24 MILLIMETER NON-MEDTRONIC BALLOON, AFTER WHICH THE PATIENT'S CONDITION STABILIZED, AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). UNFORTUNATELY, THE PATIENT PASSED AWAY A FEW HOURS AFTER THE SURGERY DUE TO ASYSTOLE. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC (CORDIS) STANDARD WIRE WAS USED FOR THE PROCEDURE. THE NON-MEDTRONIC (OSYPKA VACS II) BALLOON USED FOR PRE-DILATION UNDER RAPID PACING CAUSED SEVERE AORTIC INSUFFICIENCY AND CONSEQUENTLY HYPERTENSION. DURING THE FIRST DEPLOYMENT ATTEMPT UNDER FAST PACING, AN INFOLD WAS NOTICED. THE VALVE WAS INSUFFICIENTLY EXPANDED AND DISLOCATED INTO THE AORTA AT THE NON-CORONARY CUSP (NCC) AREA. THE VALVE WAS RECAPTURED AND PULSELESS ELECTRICAL ACTIVITY (PEA) OCCURRED. RESUSCITATION WAS PERFORMED FOR SIX MINUTES WITH A BRIEF RETURN OF SPONTANEOUS CIRCULATION (ROSC), THEN PERFORMED AGAIN FOR THREE MINUTES. AFTER ANOTHER ROSC, THE VALVE WAS IMPLANTED. DUE TO THE INFOLD, BALLOON DILATATION WAS PERFORMED WITH A 22 MM BALLOON AND THEN WITH A 24 MM BALLOON. ANGIOGRAPHY SHOWED A GOOD RESULT WITHOUT RELEVANT RESIDUAL PARAVALVULAR INSUFFICIENCY. PROLONGED HYPOTENSION WAS OBSERVED AND REPEATEDLY TREATED WITH ADRENALINE BOLUSES. FOLLOWING CLOSURE OF THE PUNCTURE SITE OF THE RIGHT EXTERNAL ILIAC ARTERY WITH A NON-MEDTRONIC (ABBOTT PERCLOSE PROSTYLE) CLOSURE SYSTEM AND THE LEFT FEMORAL ARTERY WITH A 6 FRENCH NON-MEDTRONIC (ANGIO-SEAL) CLOSURE SYSTEM, ANOTHER CIRCULATORY ARREST OCCURRED WITH PEA. RESUSCITATION WAS PERFORMED FOR TWO MINUTES WITH ANOTHER ADMINISTRATION OF ADRENALINE. ECHOCARDIOGRAPHY SHOWED MODERATELY REDUCED SYSTOLIC FUNCTION OF THE LEFT VENTRICLE, NO GRADIENT OVER THE AORTIC VALVE, BUT SIGNIFICANT DILATION OF THE RIGHT VENTRICLE. PER THE PHYSICIAN, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE NOT A CONTRIBUTING CAUSE TO THE DEATH. NO AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS RECEIVED THAT NO SIGNIFICANT PROCEDURAL DELAY OCCURRED. DUE TO THE INSTABILITY, THE POST-IMPLANT BALLOON DILATION WAS PERFORMED QUICKLY. ADDITIONAL INFORMATION WAS RECEIVED THAT ACCORDING TO THE PHYSICIAN, THE PATIENT HAD A MEDICAL HISTORY OF MODERATELY IMPAIRED CARDIAC FUNCTION WITH DECOMPENSATED HEART FAILURE (NEW YORK HEART ASSOCIATION CLASS IV), FOLLOWING CORONARY BYPASS SURGERY. FURTHERMORE, THE SITUATION AFTER THE TRANSCATHETER HEART VALVE IMPLANT PROCEDURE IN THE ICU COULD NOT BE STABILIZED DESPITE CATECHOLAMINE ADMINISTRATION, LEADING TO THE PATIENT'S DEATH FROM BIVENTRICULAR PUMP FAILURE. IT WAS ALSO STATED THAT ULTRASOUND DID NOT ATTRIBUTE THE HEMODYNAMIC DETERIORATION TO THE NEW VALVE.
IT WAS REPORTED THAT DURING A TRANSCATHETER HEART VALVE PROCEDURE INVOLVING THE IMPLANTATION OF AN EVOLUT FX 34 MILLIMETER VALVE, CO MPLICATIONS AROSE AFTER A PRE-IMPLANT BALLOON AORTIC VALVULOPLASTY (BAV) USING A 22 MILLIMETER NON-MEDTRONIC BALLOON. THE PATIENT'S HEMODYNAMICS WORSENED, LEADING TO ASYSTOLE. IMMEDIATE CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, RESULTING IN RETURN OF SPONTANEOUS CIRCULATION (ROSC) AFTER A FEW MINUTES, AND THE PATIENT REQUIRED HIGH DOSES OF CATECHOLAMINES TO STABILIZE. DESPITE THE CRITICAL CONDITION, THE VALVE WAS IMPLANTED, BUT AN INFOLD WAS OBSERVED. IMMEDIATE POSTDILATION WAS PERFORMED USING A 24 MILLIMETER NON-MEDTRONIC BALLOON, AFTER WHICH THE PATIENT'S CONDITION STABILIZED, AND THEY WERE TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). UNFORTUNATELY, THE PATIENT PASSED AWAY A FEW HOURS AFTER THE SURGERY DUE TO ASYSTOLE. ADDITIONAL INFORMATION WAS RECEIVED THAT A NON-MEDTRONIC (CORDIS) STANDARD WIRE WAS USED FOR THE PROCEDURE. THE NON-MEDTRONIC (OSYPKA VACS II) BALLOON USED FOR PRE-DILATION UNDER RAPID PACING CAUSED SEVERE AORTIC INSUFFICIENCY AND CONSEQUENTLY HYPERTENSION. DURING THE FIRST DEPLOYMENT ATTEMPT UNDER FAST PACING, AN INFOLD WAS NOTICED. THE VALVE WAS INSUFFICIENTLY EXPANDED AND DISLOCATED INTO THE AORTA AT THE NON-CORONARY CUSP (NCC) AREA. THE VALVE WAS RECAPTURED AND PULSELESS ELECTRICAL ACTIVITY (PEA) OCCURRED. RESUSCITATION WAS PERFORMED FOR SIX MINUTES WITH A BRIEF RETURN OF SPONTANEOUS CIRCULATION (ROSC), THEN PERFORMED AGAIN FOR THREE MINUTES. AFTER ANOTHER ROSC, THE VALVE WAS IMPLANTED. DUE TO THE INFOLD, BALLOON DILATATION WAS PERFORMED WITH A 22 MM BALLOON AND THEN WITH A 24 MM BALLOON. ANGIOGRAPHY SHOWED A GOOD RESULT WITHOUT RELEVANT RESIDUAL PARAVALVULAR INSUFFICIENCY. PROLONGED HYPOTENSION WAS OBSERVED AND REPEATEDLY TREATED WITH ADRENALINE BOLUSES. FOLLOWING CLOSURE OF THE PUNCTURE SITE OF THE RIGHT EXTERNAL ILIAC ARTERY WITH A NON-MEDTRONIC (ABBOTT PERCLOSE PROSTYLE) CLOSURE SYSTEM AND THE LEFT FEMORAL ARTERY WITH A 6 FRENCH NON-MEDTRONIC (ANGIO-SEAL) CLOSURE SYSTEM, ANOTHER CIRCULATORY ARREST OCCURRED WITH PEA. RESUSCITATION WAS PERFORMED FOR TWO MINUTES WITH ANOTHER ADMINISTRATION OF ADRENALINE. ECHOCARDIOGRAPHY SHOWED MODERATELY REDUCED SYSTOLIC FUNCTION OF THE LEFT VENTRICLE, NO GRADIENT OVER THE AORTIC VALVE, BUT SIGNIFICANT DILATION OF THE RIGHT VENTRICLE. PER THE PHYSICIAN, THE VALVE AND DELIVERY CATHETER SYSTEM (DCS) WERE NOT A CONTRIBUTING CAUSE TO THE DEATH. NO AUTOPSY WAS PERFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2600284 | EVOLUT FX VALVE | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV | NPT | MEDTRONIC HEART VALVES DIVISION | EVOLUTFX-34 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 87 YR | Male | Death| R| L | SEE H11. |