BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUT PRO PLUS DCS

    MDR report key: 17445980 · Received August 2, 2023

    Report

    Report Number
    2025587-2023-03179
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    February 1, 2022
    Report Date
    May 2, 2024
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    UDI-DI
    00763000207854
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID L-EVPROP2329US; PRODUCT LOT/SERIAL NUMBER (B)(6); PRODUCT TYPE: LOADING SYSTEM; IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID EVPROPLUS-26US; PRODUCT LOT/SERIAL NUMBER (B)(6); PRODUCT TYPE: HEART VALVE; IMPLANT DATE (B)(6) 2022; EXPLANT DATE N/A PRODUCT ANALYSIS: THE PRODUCT WAS NOT RETURNED; THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: THE DELIVERY CATHETER SYSTEM (DCS) WAS NOT RETURNED FOR ANALYSIS AND NO PROCEDURAL IMAGES WERE PROVIDED FOR REVIEW. VASCULAR COMPLICATIONS, SUCH AS BLEEDING, PSEUDOANEURYSM AND HEMATOMA, ARE KNOWN POTENTIAL ADVERSE PATIENT EFFECTS PER THE EVOLUT PRO PLUS SYSTEM INSTRUCTIONS FOR USE (IFU), AND ARE TYPICALLY RELATED TO PATIENT FACTORS (ANATOMY, COMORBIDITIES, ETC.), AND/OR PROCEDURAL EFFECTS (SHEATH USED, USER TECHNIQUE, PUNCTURE CUT LOCATION, ETC.). BASED ON THE INFORMATION AVAILABLE, AN ASSIGNABLE ROOT CAUSE OF THE VASCULAR COMPLICATIONS COULD NOT BE DETERMINED AND A RELATIONSHIP TO THE DCS COULD NOT BE ESTABLISHED. HYPOTENSION IS A KNOWN POTENTIAL ADVERSE EFFECT PER 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 FROM THE INFORMATION AVAILABLE. THERE WAS NO INFORMATION TO SUGGEST THAT A DEVICE MALFUNCTION OR A FAILURE TO MEET MANUFACTURING SPECIFICATIONS WERE RELATED TO THESE EVENTS. H6. THE CODES PRESENT IN SECTION H6 CORRESPOND TO MULTIPLE COMPONENTS/PRODUCTS THAT COMPRISE THIS REPORTED EVENT. THIS REPORT WAS SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER D00916038. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    PREVIOUS REPORT(S) IN THIS SERIES SHOULD HAVE CONTAINED THE FOLLOWING NARRATIVE TEXT: "THIS REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION FOR CAPA 564121 PER (B)(4)." 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

    UPDATED DATA: B5, H6 THIS REGULATORY REPORT IS BEING SUBMITTED AS PART OF A RETROSPECTIVE REVIEW AND REMEDIATION PER (B)(4) RELATED TO CAPA PR 564122. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE, VIA THE RIGHT FEMORAL ARTERY, A PSE UDOANEURYSM WAS IDENTIFIED. THE MINIMUM DIAMETER OF THE ACCESS VESSEL WAS 5.0 MM. THE PATIENT¿S BLOOD PRESSURE BEGAN TO GRADUALLY DECREASE. INTRAVENOUS THERAPY (IV) FLUIDS WERE GIVEN BUT HYPOTENSION REMAINED. THE HEMOGLOBIN DROPPED FROM 13.3 GRAMS PER DECILITER (G/DL) PRE-PROCEDURE TO 10.2 G/DL AND MEDICATION WAS ADMINISTERED. THERE WAS NO VISIBLE BLEEDING. THE PATIENT RETURNED TO THE CATHETERIZATION LABORATORY AND A STENT WAS PLACED IN THE RIGHT SAPHENOUS FEMORAL ARTERY. FOLLOWING THE STENT PROCEDURE, LOWER BACK PAIN AND ABDOMINAL PAIN PRESENTED. HYPOTENSION AND A HEMOGLOBIN OF 8.9 G/DL WAS OBSERVED. TWO UNITS OF PACKED RED BLOOD CELLS WERE TRANSFUSED. ABDOMINAL DISTENTION AND DIFFICULTY BREATHING OCCURRED. A COMPUTED TOMOGRAPHY (CT) IDENTIFIED A LARGE RETROPERITONEAL HEMATOMA WITHOUT EXTRAVASATION. INTRAVENOUS MEDICATION THEN ALSO PROVIDED AS RESULT OF THE RETROPERITONEAL HEMATOMA. A CHEST X-RAY INDICATED HYPO-INFLATED LUNGS WITH LEFT BASILAR ATELECTASIS. THESE EVENTS WERE REPORTED AS PROCEDURAL RELATED BUT NOT RELATED TO THE DELIVERY CATHETER SYSTEM (DCS). THE RETROPERITONEAL HEMATOMA WAS CONSIDERED RESOLVED APPROXIMATELY 7 MONTHS LATER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE DAY FOLLOWING THE VALVE IMPLANT PROCEDURE, THE COMPUTED TOMOGRAPHY (CT) PERFORMED TO EVALUATE THE RETROPERITONEAL HEMATOMA HAD ALSO IDENTIFIED A SMALL LEFT PLEURAL EFFUSION AND A SMALL TO MODERATE RIGHT PLEURAL EFFUSION. THE CAUSE WAS NOT REPORTED. NO TREATMENT REPORTED. NO PATIENT SYMPTOMS REPORTED AS RESULT OF THE EFFUSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773802 EVOLUT PRO PLUS DCS AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV NPT MEDTRONIC HEART VALVES DIVISION D-EVPROP2329US 0010929363 00763000207854

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention "SEE H10...."