BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE SE 4.5MM OUS

    MDR report key: 9126189 · Received September 26, 2019

    Report

    Report Number
    3008114965-2019-01173
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    February 28, 2019
    Report Date
    September 5, 2019
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    [H.10]: MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THAT THE PRODUCT WAS RECEIVED BY THE PRODUCT ANALYSIS LAB ON 10/2/2019. THE RETURN PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE INVESTIGATIONAL FINDING OF THE RETURNED DEVICE. [CONCLUSION]: THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE MECHANICAL THROMBECTOMY PROCEDURE OF AN ACUTE CEREBRAL INFARCTION LOCATED AT THE NARROW AND TWISTED POSTERIOR COMMUNICATING ARTERY WITH TORTUOUS M1 AND M2 SEGMENTS, THE PHYSICIAN MADE TWO PASSES WITH THE 4.5MM REVIVE THROMBECTOMY DEVICE (FRS21452299 / L11260) TO THE TARGET POSITION IN ATTEMPT TO RETRIEVE THE CLOT; THE REVIVE STENT DID NOT EXPAND AS EXPECTED. IT WAS REPORTED THAT THE THROMBUS WAS CAPTURED IN THE DEVICE. WHEN THE PHYSICIAN WITHDREW THE STENT, HE ENCOUNTERED RESISTANCE. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED THE WITHDRAWAL AS PER THE INSTRUCTIONS FOR USE (IFU). AS A RESULT, THE PROWLER SELECT PLUS MICROCATHETER (CATALOG/LOT# UNK) WAS PUSHED TO WRAP THE STENT AND THE PHYSICIAN WITHDREW THE STENT AND MICROCATHETER AS A UNIT. THE REVIVE STENT DID NOT APPEAR DAMAGE. THE PROCEDURE WAS COMPLETED USING COMPETITOR DEVICE AND THE THE SAME PROWLER SELECT LUS MICROCATHETER AS THERE WAS NO ISSUE WITH THE PERFORMANCE OF THE MICROCATHETER. THE EVENT DID NOT RESULT IN A THROMBOEMBOLISM. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION. THE PRODUCT WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATIONAL FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: THE NON-STERILE 4.5MM REVIVE THROMBECTOMY DEVICE AND THE PROWLER SELECT PLUS MICROCATHETER WERE RECEIVED CONTAINED IN A POUCH. VISUAL INSPECTION WAS PERFORMED. THE DELIVERY WIRE AND THE BASKET WERE INSPECTED, AND THEY WERE OBSERVED TO BE IN GOOD CONDITION. THE INTRODUCER WAS NOT RETURNED. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED WITHOUT THE RETURN OF THE INTRODUCER. THUS, THE REPORTED ISSUE THAT THE 4.5MM REVIVE THROMBECTOMY DEVICE ENCOUNTERED RESISTANCE DURING THE WITHDRAWAL ATTEMPT COULD NOT BE CONFIRMED THROUGH FUNCTIONAL TESTING. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L11260) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE REPORTED ISSUE THAT THE REVIVE THROMBECTOMY DEVICE COULD NOT BE WITHDRAWN WAS NOT CONFIRMED AS THE RETURNED DEVICE DID NOT INCLUDE THE INTRODUCER. WITHOUT THE INTRODUCER, THE FUNCTIONAL ANALYSIS WAS PRECLUDED. THE EXACT CAUSE OF THE REPORTED DEVICE-RELATED ISSUE COULD NOT BE CONCLUSIVELY DETERMINED AS THERE WERE NO APPEARANCE OF DAMAGE OBSERVED ON THE DELIVERY WIRE OR ON THE BASKET COMPONENT OF THE DEVICE. BASED ON THE DEVICE HISTORY RECORD REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. IT IS POSSIBLE THAT CIRCUMSTANCES OF THE PROCEDURE SUCH AS VESSEL TORTUOSITY, AND / OR DEVICE MANIPULATION MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING THE PATIENT DATE OF BIRTH AND MEDICAL HISTORY WERE NOT PROVIDED. REVIVE SE IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IT IS SIMILAR TO THE REVIVE PV THAT IS DISTRIBUTED IN THE U.S. THE INITIAL REPORTER PHONE AND EMAIL ADDRESS ARE NOT AVAILABLE / REPORTED. PHYSICAL MANUFACTURER NAME: (B)(4). THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE AS INDICATED AS ¿OTHER¿ IN THIS SECTION AS THE REASON FOR NON-EVALUATION. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT (L11260)) PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NON-CONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE MECHANICAL THROMBECTOMY PROCEDURE OF AN ACUTE CEREBRAL INFARCTION LOCATED AT THE NARROW AND TWISTED POSTERIOR COMMUNICATING ARTERY WITH TORTUOUS M1 AND M2 SEGMENTS, THE PHYSICIAN MADE TWO PASSES WITH THE 4.5MM REVIVE THROMBECTOMY DEVICE (FRS21452299 / L11260) TO THE TARGET POSITION IN ATTEMPT TO RETRIEVE THE CLOT; THE REVIVE STENT DID NOT EXPAND AS EXPECTED. IT WAS REPORTED THAT THE THROMBUS WAS CAPTURED IN THE DEVICE. WHEN THE PHYSICIAN WITHDREW THE STENT, HE ENCOUNTERED RESISTANCE. IT WAS REPORTED THAT THE PHYSICIAN PERFORMED THE WITHDRAWAL AS PER THE INSTRUCTIONS FOR USE (IFU). AS A RESULT, THE PROWLER SELECT PLUS MICROCATHETER (CATALOG/LOT# UNK) WAS PUSHED TO WRAP THE STENT AND THE PHYSICIAN WITHDREW THE STENT AND MICROCATHETER AS A UNIT. THE REVIVE STENT DID NOT APPEAR DAMAGE. THE PROCEDURE WAS COMPLETED USING COMPETITOR DEVICE AND THE SAME PROWLER SELECT LUS MICROCATHETER AS THERE WAS NO ISSUE WITH THE PERFORMANCE OF THE MICROCATHETER. THE EVENT DID NOT RESULT IN A THROMBOEMBOLISM. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916917 REVIVE SE 4.5MM OUS EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL L11260

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR UNKPROWLERSELECT