BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EU 4.5X14MM STENT 12 MM DW TIP

    MDR report key: 13690048 · Received March 8, 2022

    Report

    Report Number
    3008114965-2022-00137
    Event Type
    Malfunction
    Date Received
    March 8, 2022
    Date of Event
    February 17, 2022
    Report Date
    July 6, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(6). THE INITIAL REPORTER PHONE: (B)(6). DEVICE EVALUATED BY MFR: 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. (B)(6) MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6133915. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2022-00138. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. 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 THAT THE PRODUCT WAS RECEIVED THE PRODUCT ANALYSIS LAB ON 28-JUN-2022. THE RETURN PRODUCT IS PENDING EVALUATION. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2022-00137 AND 3008114965-2022-00138. 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 A VASCULAR STENT PLACEMENT PROCEDURE, THE 4.5MM X 14MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC451412 / 6133915) WAS IMPEDED IN THE Y-CONNECTOR OF THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30638973) WHEN THE INTRODUCER WAS CONNECTED TO THE Y-CONNECTOR. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER TOGETHER. NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE. ON 11-APR-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A 67-YEAR-OLD MALE. THE TARGET VESSEL WAS THE V4 SEGMENT. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE STENT WAS NOT PUSHED INTO THE MICROCATHETER, IT WAS IMPEDED IN THE Y CONNECTOR; THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGED. THERE WAS NO DAMAGE OBSERVED ON THE PROWLER SELECT PLUS MICROCATHETER. IT WAS VERIFIED THAT THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB. THE DEVICE DID NOT MOVE OUT FORWARD OUT OF THE INTRODUCER DURING INSERTION THROUGH THE Y CONNECTOR O IN THE HUB. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A 4MM X 16MM ENTERPRISE 2 (ENCR401600) AND A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4.5MM X 14MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. THE STENT COMPONENT STILL INSIDE THE INTRODUCER. THERE WERE NO KINKS, NO APPEARANCE OF DAMAGE NOTED ON THE INTRODUCER OR ON THE DELIVERY WIRE. THE FUNCTIONAL TEST WAS PERFORMED. A LAB SAMPLE PROWLER SELECT PLUS MICROCATHETER WAS CONNECTED TO A Y CONNECTOR AND ON THE OTHER SIDE THE SYRINGE WAS ATTACHED, THEN IT WAS FLUSHED AND THE STENT WAS ADVANCED THROUGH UNTIL IT EXITED FROM THE DISTAL TIP. NO RESISTANCE NOR FRICTION WAS FELT DURING THE ADVANCEMENT OF THE STENT THROUGH THE Y CONNECTOR DURING THE TEST. ADDITIONALLY, THE DEPLOYED STENT WAS OBSERVED IN GOOD CONDITIONS, THERE WAS NO STRUCTURAL DAMAGE (I.E. NO BROKEN STRUTS, NO KINKS). THE FUNCTIONAL TEST WAS UNABLE TO REPLICATE THE ISSUE WITH THE MICROCATHETER, THE FUNCTIONAL TEST WAS PERFORMED WITH A LAB SAMPLE MICROCATHETER, AND THE ENTERPRISE DEVICE WORKED WITHOUT ISSUES. THIS SUGGESTS THAT THE ENTERPRISE DEVICE WAS NOT FULLY SEATED IN THE HUB OF THE MICROCATHETER, AND AS A RESULT, THE STENT COULD NOT BE ADVANCED THROUGH. THE IMPEDED CONDITION IN THE Y CONNECTOR FOUND DURING THE PROCEDURE COULD NOT BE REPLICATED IN THE LAB. THE ISSUE DOCUMENTED IN THE COMPLAINT WAS NOT CONFIRMED. HOWEVER, THERE MAY BE OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED WHILE USING THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6133915. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DOES CONTAIN THE FOLLOWING RECOMMENDATIONS: THE INTRODUCER MUST BE PROPERLY ENGAGED WITH THE INFUSION CATHETER HUB TO ENABLE STENT INTRODUCTION INTO THE INFUSION CATHETER. DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. 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. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2022-00138. 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 INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 11-APR-2022. [ADDITIONAL INFORMATION]: ON 11-APR-2022, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE PATIENT IS A 67-YEAR-OLD MALE. THE TARGET VESSEL WAS THE V4 SEGMENT. CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. THE STENT WAS NOT PUSHED INTO THE MICROCATHETER, IT WAS IMPEDED IN THE Y CONNECTOR; THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGED. THERE WAS NO DAMAGE OBSERVED ON THE PROWLER SELECT PLUS MICROCATHETER. IT WAS VERIFIED THAT THE INTRODUCER WAS FULLY SEATED AND SECURED IN THE HUB. THE DEVICE DID NOT MOVE OUT FORWARD OUT OF THE INTRODUCER DURING INSERTION THROUGH THE Y CONNECTOR O IN THE HUB. NOTHING UNUSUAL WAS NOTED ABOUT THE SYSTEM PRIOR TO USE. THE REPORTED EVENT DID NOT RESULT IN A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A 4MM X 16MM ENTERPRISE 2 (ENCR401600) AND A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X). MULTIPLE ATTEMPTS TO OBTAIN PRODUCT FOR ANALYSIS WERE UNSUCCESSFUL. IF PRODUCT IS RETURNED OR INFORMATION PROVIDED AT A LATER DATE, THE FILE WILL BE UPDATED ACCORDINGLY. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6133915. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS AND THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED AT THIS TIME. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE MANUFACTURING DOCUMENTATION REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE MANUFACTURING PROCESS. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION, ANEURYSM SIZE / VESSEL CHARACTERISTICS, DEVICE SELECTION, AND THE CONCOMITANT MICROCATHETER, MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. 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. UPDATED SECTIONS: A.2, A.3, B.4, G.3, G.6, H.2, H.3, H.6, AND H.10. THIS IS ONE OF 2 PRODUCTS INVOLVED WITH THE REPORTED COMPLAINT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE: 3008114965-2022-00138. 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 · 0

    THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A VASCULAR STENT PLACEMENT PROCEDURE, THE 4.5MM X 14MM ENTERPRISE® VASCULAR RECONSTRUCTION DEVICE (VRD) (ENC451412 / 6133915) WAS IMPEDED IN THE Y-CONNECTOR OF THE 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30638973) WHEN THE INTRODUCER WAS CONNECTED TO THE Y-CONNECTOR. THE PHYSICIAN REMOVED THE STENT AND THE MICROCATHETER TOGETHER. NEW DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT ADVERSE EVENT OR COMPLICATION ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338805 EU 4.5X14MM STENT 12 MM DW TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 6133915

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male PROWLER SELECT PLUS 150/5CM