BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE2 4MMX39MM

    MDR report key: 20054018 · Received August 23, 2024

    Report

    Report Number
    3008114965-2024-00789
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    August 1, 2024
    Report Date
    September 13, 2024
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10886704075318
    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)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE INITIAL REPORTER PHONE: (B)(6). SECTION H.3: THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6920565. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. 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. 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 ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE ON 11-SEP-2024. A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED ONCE THE PRODUCT INVESTIGATION HAS BEEN COMPLETED. UPDATED SECTIONS: B.4, D.9, G.3, G.6. H.2, H.3, H.6, AND H.11. 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. THE COMPLAINT PRODUCT WAS RETURNED AND RECEIVED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4 MM X 39 MM ENTERPRISE®2 STENT WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. IT WAS NOTED THAT ONLY THE DETACHED STENT WAS RETURNED FOR EVALUATION. THE STENT COMPONENT UNDERWENT MICROSCOPIC INSPECTION. NO ABNORMALITIES WERE OBSERVED ON THE STENT (I.E., NO BROKEN STRUTS, NO KINKS). BOTH ENDS OF THE STENT WERE NOTED TO BE COMPLETELY EXPANDED. THE REPORTED ISSUE DOCUMENTED IN THE COMPLAINT REGARDING THE MARKER BANDS CONVERGING WAS NOT CONFIRMED AS THE STENT WAS NOTED AS ALREADY EXPANDED ON BOTH ENDS AND THERE WERE NO DAMAGES FOUND DURING THE INSPECTION. IT IS POSSIBLE THAT THE MARKER BANDS MAY HAVE CONVERGED TOGETHER BUT OPPOSED TO THE VESSEL WALL DURING THE PROCEDURE. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER FACTORS THAT CONTRIBUTED TO THE FAILURE ENCOUNTERED DURING THE PROCEDURE THAT COULD NOT BE REPLICATED IN THE LABORATORY SETTING. THE STENT DETACHMENT WAS NOT ORIGINALLY REPORTED IN THE COMPLAINT, THEREFORE, THE EXACT TIME WHEN THIS CONDITION OCCURRED CANNOT BE DETERMINED. THIS CONDITION IS NOT CONSIDERED RELATED TO THE REPORTED ISSUE. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6920565. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. AS PART OF JOHNSON & JOHNSON MEDTECH 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: MAINTAIN ADEQUATE STENT LENGTH (APPROXIMATELY 5 MM) ON EACH SIDE OF THE ANEURYSM NECK TO ENSURE APPROPRIATE NECK COVERAGE. SELECT A STENT LENGTH THAT IS AT LEAST 10 MM LONGER THAN THE ANEURYSM NECK TO MAINTAIN A MINIMUM OF 5 MM ON EITHER SIDE OF THE ANEURYSM NECK. A LARGE DIFFERENTIAL IN DIAMETER BETWEEN THE PROXIMAL AND DISTAL SEGMENTS OF THE PARENT VESSEL MAY INCREASE THE RISK OF STENT MIGRATION. DO NOT APPLY UNDUE FORCE IF RESISTANCE IS ENCOUNTERED AT ANY POINT DURING STENT MANIPULATION. WITHDRAW THE UNIT AND ADVANCE A NEW ONE. 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. UPDATED SECTIONS: B.4, G.3, G.6. H.2, H.3, H.6, AND H.11. 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 02-SEP-2024. [ADDITIONAL INFORMATION]: ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED. PER THE INFORMATION, THE PROCEDURE WAS A ¿SPHERICAL EXPANSION + STENT IMPLANTATION.¿ THERE WERE NO VESSEL FACTORS THAT MAY HAVE CONTRIBUTED TO THE INCOMPLETE EXPANSION. THERE WAS NO EVIDENCE OF OBSTRUCTED BLOOD FLOW DUE TO THE REPORTED ISSUE. THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH HAD BEEN CHECKED AND FOUND TO BE WITHIN ACCEPTABLE CRITERIA. THERE HAD BEEN NO RESISTANCE DURING THE ADVANCEMENT OF THE STENT. AN ADEQUATE CONTINUOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. WHEN THE STENT WAS REMOVED, IT WAS STILL ON THE DELIVERY WIRE. THE STENT / STENT DELIVERY SYSTEM DID NOT APPEAR DAMAGED WHEN THE SYSTEM WAS REMOVED FROM THE PATIENT. THE REPLACEMENT WAS NOT ANOTHER 4 MM X 39 MM ENTERPRISE®2 STENT (ENCR403912); THE REPLACEMENT WAS A 4MM X 30MM ENTERPRISE 2 STENT (ENCR403012), ¿THE STENT WITH THE SAME LENGTH WAS NOT AVAILABLE FOR STOCK.¿ THE ADDITIONAL INFORMATION CONFIRMED THERE WAS NO NEGATIVE PATIENT IMPACT AND THE PHYSICIAN DID NOT CONSIDER THE 10-MINUTE DELAY TO BE CLINICALLY SIGNIFICANT. UPDATED SECTIONS: B.4, G.3, G.6, H.2, AND H.11. 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 AN ANGIOPLASTY PROCEDURE, THE 4 MM X 39 MM ENTERPRISE®2 STENT (ENCR403912 / 6920565) WAS DELIVERED INTO THE CONCOMITANT 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / LOT# UNKNOWN) AND PLACED IN THE TARGET LOCATION, THE PHYSICIAN INITIATED THE STENT RELEASE, BUT THE DISTAL MARKERS WERE CONVERGED TOGETHER. THE DISTAL MARKERS WERE UNABLE TO OPEN. THE PHYSICIAN RETRACTED THE STENT AND REMOVED THE STENT AND THE MICROCATHETER FROM THE PATIENT; THE PHYSICIAN REPLACED THE STENT AND COMPLETED THE PROCEDURE WITH THE REPLACEMENT STENT USING THE SAME ORIGINAL MICROCATHETER. THE PROCEDURE WAS DELAYED BY APPROXIMATELY 10 MINUTES. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1742338 ENTERPRISE2 4MMX39MM INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 6920565 10886704075318

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male PROWLER SELECT PLUS 150/5CM