BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EU 4.5X28MM STENT 12 MM DW TIP

    MDR report key: 15370014 · Received September 7, 2022

    Report

    Report Number
    3008114965-2022-00587
    Event Type
    Malfunction
    Date Received
    September 7, 2022
    Date of Event
    April 14, 2022
    Report Date
    September 7, 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

    PRODUCT COMPLAINT # (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO REPORT THE FINDINGS OF THE DEVICE INVESTIGATION. THE DELIVERY WIRE WAS FOUND SEPARATED, THE FINDINGS MEET US REGULATORY REPORTING CRITERIA. INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER PHONE: (B)(6). 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. 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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCS), AN EU 4.5X22MM STENT 12 MM DW TIP (ENC452212, 6812680) WAS IMPEDED IN INTRODUCER SHEATH AND COULD NOT BE PUSHED OUT. THE PHYSICIAN SWITCHED TO AN EU 4.5X28MM STENT 12 MM DW TIP (ENC452812, 6357999) BUT THE SAME ISSUE OCCURRED. THE DEVICES WERE NOT USED IN PATIENT. THE THIRD DEVICE WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. A NON-STERILE EU 4.5X28MM STENT 12 MM DW TIP WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND IT WAS OBSERVED THAT THE STENT WAS RETURNED SEPARATED FROM THE DELIVERY WIRE STUCK INSIDE THE INTRODUCER. THE DELIVERY WIRE WAS SEPARATED IN TWO FRAGMENTS. THE INTRODUCER WAS FOUND IN GOOD CONDITION (I.E., NO KINKS, NO FRACTURES, OR SEPARATIONS), HOWEVER, FOREIGN MATERIAL WAS OBSERVED INSIDE IT, PRESUMABLY DRY SALINE SOLUTION. NO OTHER DAMAGES WERE FOUND. A DIMENSIONAL ANALYSIS WAS PERFORMED, DEVICE¿S OUTER DIAMETER (OD) AND THE DISTAL INNER DIAMETER (ID) WERE CONFIRMED TO BE WITHIN SPECIFICATION. STENT COMPONENT WAS INSPECTED UNDER MICROSCOPE INSIDE THE INTRODUCER AND THERE IS NO EVIDENCE OF DAMAGE ON THE STENT COMPONENT. THE INTRODUCER WAS FLUSHED, AND AN ATTEMPT WAS MADE TO REMOVE THE STENT FROM THE INTRODUCER, HOWEVER, DUE TO IT BEING STUCK, IT COULD NOT BE REMOVED, DUE THIS CONDITION THE STENT COMPONENT COULD NOT BE EVALUATED. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THE IMPEDED CONDITION AS REPORTED COULD NOT BE TESTED IN THE LAB DUE TO THE STENT SEPARATED CONDITION AND DELIVERY WIRE BREAKAGE; HOWEVER, THE BROKEN CONDITION NOTED ON THE DELIVERY WIRE FRAGMENT SUGGESTS EXCESSIVE MANIPULATION AS A RESULT OF THE IMPEDED CONDITION. IT IS POSSIBLE THAT EXCESSIVE FORCE MAY HAVE INADVERTENTLY BEEN EXERTED ON THE ENTERPRISE SYSTEM TO MAKE THE STENT PASS THROUGH THE INTRODUCER, BENDING THE DELIVERY WIRE TO ACCOMMODATE THE STENT WHICH ULTIMATELY BROKE OFF. IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION AND VESSEL CHARACTERISTICS, MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. THE CUSTOMER COMPLAINT WAS CONFIRMED. A DEVICE HISTORY RECORD EVALUATION WAS PERFORMED, AND NO NON-CONFORMANCES WERE IDENTIFIED. IT SHOULD BE NOTED THAT PRODUCT FAILURE COULD BE CAUSED BY MULTIPLE FACTORS. THE INSTRUCTIONS FOR USE (IFU) DO CONTAIN THE FOLLOWING RECOMMENDATIONS: ¿ DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE TO A NEW ONE. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING A STENT ASSIST COIL EMBOLIZATION TO THE MIDDLE CEREBRAL ARTERY (MCS), AN EU 4.5X22MM STENT 12 MM DW TIP (ENC452212, 6812680) WAS IMPEDED IN THE INTRODUCER SHEATH AND COULD NOT BE PUSHED OUT. THE PHYSICIAN SWITCHED TO AN EU 4.5X28MM STENT 12 MM DW TIP (ENC452812, 6357999) BUT THE SAME ISSUE OCCURRED. THE DEVICES WERE NOT USED IN THE PATIENT. THE THIRD DEVICE WAS CHANGED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INJURY REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE EU 4.5X28MM STENT 12 MM DW TIP RECEIVED, THE DELIVERY WIRE WAS FOUND SEPARATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2485643 EU 4.5X28MM STENT 12 MM DW TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 6357999

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown EU 4.5X22MM STENT 12 MM DW TIP