BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT FX DCS

    MDR report key: 19721148 · Received July 11, 2024

    Report

    Report Number
    9612164-2024-03207
    Event Type
    Injury
    Date Received
    July 11, 2024
    Date of Event
    July 8, 2024
    Report Date
    September 4, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000365677
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC HAS REQUESTED ADDITIONAL INFORMATION PERTAINING TO THIS REPORTABLE EVENT. IF ADDITIONAL REPORTABLE INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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 Manufacturer Narrative · 0

    CORRECTED DATA: D3 - MANUFACTURE NAME, ADDRESS, CITY, COUNTRY AND POSTAL CODE WERE CORRECTED FROM MEDTRONIC (B)(6) TO MEDTRONIC HEART VALVES DIVISION, (B)(6) G2 - CORRECTED TO INCLUDE HEALTH CARE PROFESSIONAL. UPDATED DATA: H2 H3 H6 IMAGE REVIEW: INTRA PROCEDURAL FLUOROSCOPIC IMAGES WERE PROVIDED FOR REVIEW OF THE EVENT DESCRIPTION. PATIENT¿S EXECUTIVE SUMMARY WAS NOT PROVIDED FOR ANATOMICAL REVIEW. EVIDENCE SUPPORTS THAT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING AND EXCHANGING GUIDEWIRES AND SHEATHS THROUGH THE RIGHT TRANSFEMORAL ACCESS. FURTHERMORE, THE DELIVERY CATHETER SYSTEM FAILED TO BE ADVANCED PAST THE RIGHT FEMORAL ARTERY. SUBSEQUENTLY, A LONG EXTERNAL SHEATH WAS USED TO AID IN ADVANCEMENT OF THE DELIVERY CATHETER SYSTEM. EVIDENCE SUPPORTS THAT RESISTANCE WAS ENCOUNTERED AS THE DELIVERY CATHETER SYSTEM IS ATTEMPTED TO BE ADVANCED ACROSS THE AORTIC ARCH. THERE WAS A SIGNIFICANT BENT IN THE DELIVERY CATHETER SYSTEM CAUSING A SEPARATION BETWEEN THE NOSE CONE AND NITINOL CAPSULE. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), DURING USE THERE WILL BE SOME RESISTANCE WHEN THE CATHETER IS ADVANCED THROUGH THE VASCULATURE. IF THERE IS A SIGNIFICANT INCREASE IN RESISTANCE, STOP ADVANCEMENT AND INVESTIGATE THE CAUSE OF THE RESISTANCE (FOR EXAMPLE, MAGNIFY THE AREA OF RESISTANCE) BEFORE PROCEEDING. DO NOT FORCE PASSAGE. FORCING PASSAGE COULD INCREASE THE RISK OF VASCULAR COMPLICATIONS (FOR EXAMPLE, VESSEL DISSECTION OR RUPTURE). EVENTUALLY, THE DELIVERY CATHETER SYSTEM WAS SUCCESSFULLY ADVANCED. THERE WAS EVIDENCE THAT CARDIOPULMONARY RESUSCITATION WAS INITIATED SHORTLY AFTER THE VALVE WAS DEPLOYMENT TO JUST PRIOR TO THE POINT OF NO RECAPTURE, AND THE VALVE WAS RELEASED. AN ANGIOGRAM PERFORMED OF THE AORTA SHOWED AN AORTIC DISSECTION. OF NOTE, PER MEDTRONIC BEST PRACTICES, PHYSICIANS SHOULD CONSIDER THAT COMPLEX ANATOMICAL CONFIGURATIONS INCREASE THE RISK OF VASCULAR TRAUMA. THESE INCLUDE BUT ARE NOT LIMITED TO MULTIPLANAR CURVATURE OF THE AORTA, ACUTE ANGULATION OF THE AORTA, AND SEVERE CALCIFICATION. PER THE IFU, IF TWO OR MORE OF THESE FACTORS ARE PRESENT, CONSIDER AN ALTERNATIVE ACCESS ROUTE TO MITIGATE POTENTIAL FOR VASCULAR COMPLICATIONS. AS STATED IN THE IFU, POTENTIAL RISKS ASSOCIATED WITH THE IMPLANTATION OF THE EVOLUT FX BIOPROSTHESIS MAY INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: CARDIOVASCULAR INJURY (INCLUDING RUPTURE, PERFORATION, TISSUE EROSION, OR DISSECTION OF VESSELS, ASCENDING AORTA TRAUMA, VENTRICLE, MYOCARDIUM, OR VALVULAR STRUCTURES THAT MAY REQUIRE INTERVENTION). CONCLUSION: DIFFICULTIES ADVANCING THE DELIVERY CATHETER SYSTEM (DCS) THROUGH THE ACCESS VESSEL IS KNOWN TO BE RELATED TO FACTORS SUCH AS PATIENT ANATOMY AND PHYSICIAN TECHNIQUE, INCLUDING GUIDEWIRE AND INTRODUCER SHEATH SELECTION. IN THIS CASE, IT WAS NOTED RESISTANCE WAS ENCOUNTERED AS THE DCS WAS ATTEMPTED TO BE ADVANCED ACROSS THE AORTIC ARCH. THERE WAS A SIGNIFICANT BEND IN THE DELIVERY CATHETER SYSTEM CAUSING A SEPARATION BETWEEN THE NOSE CONE AND NITINOL CAPSULE. EVENTUALLY, THE DELIVERY CATHETER SYSTEM WAS SUCCESSFULLY ADVANCED TO THE TARGET SITE. IN THIS CASE, THE REPORTED DIFFICULTY ADVANCING ACROSS THE AORTIC ARCH MAY BE RELATED TO THE ANGULATION OF THE AORTA. VASCULAR RELATED COMPLICATIONS, SUCH AS BLEEDING AND DISSECTION, ARE A KNOWN POTENTIAL ADVERSE PATIENT EFFECT PER THE EVOLUT SYSTEM IFU, AND ARE TYPICALLY RELATED TO PATIENT FACTORS (ANATOMY, COMORBIDITIES, ETC.), AND/OR PROCEDURAL EFFECTS (SHEATH USED, USER TECHNIQUE, PUNCTURE CUT LOCATION, ETC.). IT WAS NOTED THAT DIFFICULTY WAS EXPERIENCED WHEN ATTEMPTING TO CROSS THE AORTIC ARCH. IT WAS REPORTED THAT THE DCS WAS BENT WHICH CAUSED A GAP BETWEEN THE NOSE CONE AND NITINOL CAPSULE. AS STATED IN THE IFU, DURING USE THERE WILL BE SOME RESISTANCE WHEN THE CATHETER IS ADVANCED THROUGH THE VASCULATURE. IF THERE IS A SIGNIFICANT INCREASE IN RESISTANCE, STOP ADVANCEMENT AND INVESTIGATE THE CAUSE OF THE RESISTANCE (FOR EXAMPLE, MAGNIFY THE AREA OF RESISTANCE) BEFORE PROCEEDING. DO NOT FORCE PASSAGE. FORCING PASSAGE COULD INCREASE THE RISK OF VASCULAR COMPLICATIONS (FOR EXAMPLE, VESSEL DISSECTION OR RUPTURE). THERE WAS NO INFORMATION TO SUGGEST A DEVICE MALFUNCTION OR A FAILURE TO MEET MANUFACTURING SPECIFICATIONS WAS RELATED TO THESE EVENTS. CONDUCTION DISTURBANCES ARE KNOWN POTENTIAL ADVERSE EFFECTS PER THE DEVICE IFU AND CAN BE RESOLVED WITH THE IMPLANT OF A PERMANENT PACEMAKER WITH THE RISK-BENEFIT RATIO IN FAVOR OF THE TRANSCATHETER AORTIC VALVE (TAV). FACTORS THAT MAY IMPACT THE DEVELOPMENT OF CONDUCTION DISTURBANCES INCLUDE DEPTH OF IMPLANT, BASELINE CONDUCTION DEFECTS, AND ANATOMICAL CONSIDERATIONS. IN THIS CASE, THE ASYSTOLE REPORTED IS LIKELY RELATED TO THE AORTIC DISSECTION 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, WHEN CROSSING THE DELIVERY CATHETER SYSTEM (DCS) AROUND THE AORTIC ARCH THE PATIENT HAD SEVERE PAIN. AN AORTIC DISSECTION WAS IDENTIFIED ON ANGIOGRAPHY. THE PATIENT WENT INTO ASYSTOLE AND THE FOLLOWING INTERVENTIONS WERE PERFORMED: CARDIOPULMONARY RESUSCITATION, INTUBATION, BLOOD PRODUCTS ADMINISTERED, AND AN ENDOGRAFT WAS PLACED. IT WAS ALSO NOTED THAT THE VALVE WAS IMPLANTED AND REMAINS ACTIVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2346515 EVOLUT FX DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVOLUTFX-2329 0012229254 00763000365677

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| L