BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE2 4MMX23MM

    MDR report key: 16595280 · Received March 22, 2023

    Report

    Report Number
    3008114965-2023-00163
    Event Type
    Injury
    Date Received
    March 22, 2023
    Date of Event
    March 6, 2023
    Report Date
    May 2, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    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, RACE, AND ETHNICITY WERE NOT PROVIDED. THE INITIAL REPORTER PHONE: (B)(6). THE INITIAL REPORTER EMAIL ADDRESS WAS NOT AVAILABLE / REPORTED. 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. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 7161646. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. INCOMPLETE STENT EXPANSION REQUIRING ADDITIONAL INTERVENTION AND NEUROLOGIC DEFICITS ARE KNOWN COMPLICATIONS ASSOCIATED WITH THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. INCOMPLETE EXPANSION COULD LEAD TO THROMBOSIS AND/OR MIGRATION OR EMBOLIZATION, RESULTING IN ISCHEMIA OR INFARCT. SINCE THE CEREBRAL THROMBOSIS REQUIRED MEDICAL INTERVENTION, HAS LED TO PROLONGATION OF THE SURGERY, AND CANNOT BE DISSOCIATED FROM THE APHASIA AND PARESIS EXPERIENCED BY THE PATIENT, AND ALSO BECAUSE THE INCOMPLETE STENT EXPANSION REQUIRED ADDITIONAL INTERVENTION TO REMOVE THE ENTERPRISE2 STENT TO PRECLUDE PATIENT COMPLICATIONS, THIS EVENT IS USFDA REPORTABLE UNDER TITLE 21 CFR 803 WITH A CLASSIFICATION OF ¿MALFUNCTION¿ AND ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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. 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 THE INVESTIGATION FINDING OF THE RETURNED DEVICE. THE COMPLAINT DEVICE WAS RETURNED FOR EVALUATION AND ANALYSIS. THE INVESTIGATION FINDING IS DOCUMENTED BELOW. INVESTIGATION SUMMARY: A NON-STERILE 4MM X 23MM ENTERPRISE 2 STENT WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. VISUAL INSPECTION WAS PERFORMED. IT WAS NOTED THAT ONLY THE STENT COMPONENT AND THE DELIVERY WIRE WERE RETURNED FOR EVALUATION. THE INTRODUCER WAS NOT RETURNED. THE DEVICE WAS INSPECTED UNDER THE MICROSCOPE. THE TIP OF THE DELIVERY WIRE WAS OBSERVED WITH KINKED DAMAGES. RESIDUES OF DRIED BLOOD WERE OBSERVED ALONG THE STENT COMPONENT. NO ABNORMALITIES WERE OBSERVED ON THE STENT COMPONENT (I.E., NO BROKEN STRUTS, NO KINKS). BOTH ENDS OF THE STENT WERE NOTED TO BE COMPLETELY EXPANDED. THE ISSUE REPORTED REGARDING THE INCOMPLETE EXPANSION OF THE STENT CANNOT BE CONFIRMED DUE TO THE STENT BEING FOUND IN GOOD NORMAL CONDITION. THE DAMAGES FOUND ON THE DELIVERY WIRE ARE SUSPECTED TO BE THE RESULT OF THE ATTEMPTS MADE TO ADVANCE THE STENT THROUGH THE MICROCATHETER; THIS DAMAGE IS NOT CONSIDERED RELATED TO THE ABILITY OF THE STENT TO EXPAND. ALTHOUGH NO PRODUCT DEFECT WAS IDENTIFIED, THERE MAY HAVE BEEN OTHER FACTORS THAT CONTRIBUTED TO THE FAILURE ENCOUNTERED DURING THE PROCEDURE, SUCH AS PATIENT'S ANATOMY, THAT COULD NOT BE REPLICATED IN THE LABORATORY SETTING. CEREBRAL THROMBOSIS, ARTERIAL OCCLUSION, CEREBRAL INFARCTION, AND ANEURYSM RUPTURE ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE ENTERPRISE 2 VRD AND ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. INCOMPLETE STENT EXPANSION IS ALSO A KNOWN POTENTIAL PROCEDURAL COMPLICATION ASSOCIATED WITH THE ENTERPRISE 2 VRD. INCOMPLETE EXPANSION COULD LEAD TO THROMBOSIS AND/OR MIGRATION OR EMBOLIZATION, RESULTING IN ISCHEMIA OR INFARCTION. WITH THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE REPORTED EVENT. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 7161646. 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. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. 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. 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 IN THE PRODUCT ANALYSIS LAB ON 25-APR-2023. THE RETURNED PRODUCT IS PENDING EVALUATION. 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.10. 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 THE 49-YEAR-OLD MALE PATIENT SUFFERED FROM AN ANEURYSM AT THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE. AFTER COIL DELIVERY INTO THE ANEURYSM, THE COMPLAINT DEVICE, A 4MM X 23MM ENTERPRISE 2 STENT (ENCR402312 / 7161646) WAS DELIVERED TO THE LOWER TRUNK OF THE LEFT MCA ALONG THE STENT MICROCATHETER (UNSPECIFIED DEVICE DETAILS) AND RELEASED 2/3 OF THE OVERALL STENT. THE DISTAL END OF THE STENT WAS WELL OPENED, THE PROXIMAL SECTION OF THE STENT THAT WAS RELEASED IN THE MIDDLE OF THE M1 SEGMENT OF THE MCA WAS UNABLE TO OPEN. THE TREATING PHYSICIAN PUSHED THE STENT THROUGH THE MICROCATHETER, THE DELIVERY WIRE, AND THE MICRO GUIDEWIRE, BUT THE STENT WAS STILL UNABLE TO EXPAND. IT WAS REPORTED THAT ANGIOGRAPHY WAS PERFORMED SHOWED, ¿LEFT MIDDLE CEREBRAL ARTERY THROMBOSIS, WHICH WAS NOT VISUALIZED.¿ AFTER IMMEDIATE ARTERIAL INFUSION OF TIROFIBAN HYDROCHLORIDE, ANGIOGRAPHY SHOWED NO IMPROVEMENT. A MICROCATHETER WAS THEN GUIDED TO THE DISTAL END OF THE LOWER TRUNK OF THE MCA AND THE PHYSICIAN DELIVERED A RECO FLOW RESTORATION (FR) DEVICE (MINITECH MEDICAL) TO CAPTURE THE ENTERPRISE 2 STENT AND THE THROMBUS; THEN THE INTERMEDIATE CATHETER WAS DELIVERED TO THE PROXIMAL SECTION OF THE ENTERPRISE 2 STENT AT THE M1 SEGMENT. THE RECO FR DEVICE AND THE ENTERPRISE 2 STENT WERE REMOVED AS A WHOLE TO THE INTERMEDIATE CATHETER AND THEN REMOVED FROM THE PATIENT¿S ANATOMY. REPEATED ANGIOGRAPHY SHOWED THE M1 SEGMENT AND THE LOWER TRUNK, BUT THE UPPER TRUNK WAS STILL NOT VISUALIZED. UROKINASE WAS ADMINISTERED FOR THROMBOLYSIS AND THE UPPER AND LOWER TRUNKS OF THE LEFT MCA M1/M2 WERE VISUALIZED, ALTHOUGH THE VISUALIZATION OF THE LOWER TRUNK WAS SLIGHTLY DELAYED. THE ANEURYSM WAS NOT VISUALIZED. AT THIS POINT, THE PROCEDURE WAS DEEMED COMPLETED, BUT THERE WAS AN APPROXIMATE TWO (2) HOURS DELAY IN THE PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). ON 17-MAR-2023, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CERENOVUS SALES REPRESENTATIVE VIA PHONE. THE INFORMATION INDICATED THAT THE TARGET ANEURYSM WAS AN UNRUPTURED LOBULATED ANEURYSM WITH THE NECK WITH OF 2.97MM, THE WIDTH OF THE ANEURYSM WAS 3.37MM, AND THE LENGTH WAS 4.40MM. THERE WAS NO VESSEL TRAUMA / INJURY THAT MAY HAVE RESULTED IN THE REPORTED THROMBOSIS IN THE LEFT MIDDLE CEREBRAL ARTERY. THE PHYSICIAN SUSPECTED THAT THE CAUSE OF THE CEREBRAL THROMBOSIS WAS DUE TO THE PROXIMAL STENT UNABLE TO OPEN. THE INFORMATION INDICATED THAT ON (B)(6) 2023, THE PATIENT WAS TRANSFERRED TO SICHUAN PROVINCIAL PEOPLE¿S HOSPITAL; THE PATIENT¿S HOSPITALIZATION WAS PROLONGED, BUT THE DURATION WAS NOT OBTAINABLE. THE PATIENT WAS SYMPTOMATIC WITH THE FOLLOWING SYMPTOMS: APHASIA, UPPER-LIMB MUSCLE STRENGTH GRADE 1, LOWER LIMB MUSCLE STRENGTH GRADE 4. THE INFERIOR TRUNK OF THE PARENT VESSEL IS TORTUOUS, AND THIS MAY HAVE BEEN A FACTOR THAT CONTRIBUTED TO THE INCOMPLETE EXPANSION OF THE DEVICE. THE THROMBUS WAS REMOVED WITH THE RECO FR DEVICE. THE USE OF UROKINASE WAS ADDITIONAL INTERVENTION TO REMOVE THE THROMBUS (TO VISUALIZE THE UPPER AND LOWER TRUNKS OF THE LEFT MIDDLE CEREBRAL ARTERY). THE TEMPERATURE INDICATOR LABEL ON THE INNER POUCH WAS CHECKED AND CONFIRMED TO BE WITHIN ACCEPTABLE CRITERIA. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT NUMBER NOT AVAILABLE). THE INTERMEDIATE CATHETER USED DURING THE PROCEDURE WAS A NON-CERENOVUS CATHETER (UNSPECIFIED BRAND). THERE WAS NO RESISTANCE ENCOUNTERED DURING THE ADVANCEMENT OF THE STENT. THERE WAS NO DAMAGE (I.E., KINK) OBSERVED ON THE CONCOMITANT MICROCATHETER. A CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. THE REPORTED TWO-HOUR DELAY WAS CORRECTED TO ONE-HOUR AND IT WAS NOT CONSIDERED TO BE CLINICALLY SIGNIFICANT. AFTER THE DELAY, THE PROCEDURE WAS DEEMED COMPLETE WHEN THE ANEURYSM WAS NOT VISUALIZED. THE PATIENT WAS THEN TRANSFERRED TO THE ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480641 ENTERPRISE2 4MMX23MM INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 7161646

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Male Required Intervention MICROCATHETER| RECO FLOW RESTORATION DEVICE (MINITECH MEDICAL)