BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE2 4MMX16MM NO TIP

    MDR report key: 17804210 · Received September 22, 2023

    Report

    Report Number
    3008114965-2023-00658
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    June 14, 2023
    Report Date
    September 22, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    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 DATE OF BIRTH, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION E.1: THE NAME, PHONE AND EMAIL ADDRESS OF THE INITIAL REPORTER ARE NOT AVAILABLE / REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE REMAINS IMPLANTED AND IS THUS NOT AVAILABLE FOR EVALUATION. LAKE REGION MEDICAL PERFORMED A REVIEW OF THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTION, AND PACKAGING OF THE LOT 6920551. THE HISTORY RECORD INDICATES THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. THERE WAS NO DEVICE PERFORMANCE ISSUE OR DEVICE MALFUNCTION REPORTED DURING THE PROCEDURE. TRANSIENT ISCHEMIC ATTACK AND ARTERIAL OCCLUSION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE USE OF THE ENTERPRISE 2 STENT DEVICE AND IS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. THERE WERE NO REPORTED QUALITY ISSUES / MALFUNCTIONS RELATED TO THE ENTERPRISE 2 STENT DEVICE, AS THE DEVICE PERFORMED AS INTENDED, COMPLETELY COVERING THE LESION WITH RESIDUAL STENOSIS BEING LESS THAN 20.8% AFTER THE SURGICAL PROCEDURE. PER THE PRINCIPAL INVESTIGATOR¿S ASSESSMENT, THE ADVERSE EVENT OF ¿TRANSIENT ISCHEMIC ATTACK¿ WAS POSSIBLY UNRELATED TO THE DEVICE, AND UNRELATED TO THE SURGERY. HOWEVER, THE EVENTS OF ¿TRANSIENT ISCHEMIC ATTACK¿ AND ¿ARTERIAL OCCLUSION¿ REQUIRED PROLONGED HOSPITALIZATION, A SURGICAL INTERVENTION AND MEDICINAL TREATMENT, AND THE CORRELATING RELATIONSHIP BETWEEN THE EVENTS TO THE DEVICE CANNOT BE RULED OUT. THEREFORE, THIS EVENT MEETS US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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 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.

    Description of Event or Problem · 0

    THE EVENT WAS REPORTED VIA THE ICAD STUDY IN CHINA. ON (B)(6) 2023, THE PATIENT, A 63-YEAR-OLD MALE WAS ADMITTED DUE TO INFARCTION SEIZURE FOR MORE THAN 3 MONTHS. THE PATIENT SIGNED THE INFORMED CONSENT ON (B)(6) 2023. THE PATIENT WAS ENROLLED AFTER PREOPERATIVE CONFIRMATION THAT HE MET ALL INCLUSION CRITERIA. ON (B)(6) 2023, INTRAOPERATIVE IMAGING SHOWED SEVERE ARTERIOSTENOSIS OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA). THE PATIENT UNDERWENT A VASCULAR STENT PLACEMENT PROCEDURE AND A 4.0MM X 16MM ENTERPRISE 2 STENT (CATALOG / LOT# UNKNOWN) WAS IMPLANTED. IT WAS REPORTED THAT AFTER THE PROCEDURE, THE ENTERPRISE STENT COMPLETELY COVERED THE TARGET SITE AND THE ANGIOGRAPHIC RESIDUAL STENOSIS WAS LESS THAN 20.8%. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2023 WITHOUT ANY DISCOMFORT. HE WAS DISCHARGED WITH THE FOLLOWING MEDICATION: ASPIRIN 100 MG Q.D PO; ATORVASTATIN CALCIUM TABLETS 20 MG Q.N PO; TICAGRELOR TABLETS 45 MG BID PO; NIFEDIPINE SUSTAINED-RELEASE TABLETS AND CONTROLLED-RELEASE TABLETS 30MG Q.D PO. ON (B)(6)2023, TICAGRELOR TABLETS WAS DISCONTINUED IN OUTPATIENT. ON (B)(6) 2023, THE PATIENT DEVELOPED TRANSIENT WEAKNESS OF THE RIGHT LIMB WITH POOR FINE MOTOR. THE PATIENT WENT TO THE HOSPITAL EMERGENCY DEPARTMENT FOR TREATMENT. IT WAS REPORTED THAT THE PATIENT HAD TRANSIENT APHASIA AND ¿UNSMOOTH SPEECH AFTER POOR SPEECH.¿ ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO THE TRANSIENT ISCHEMIC ATTACK (TIA) AS DIAGNOSED BY THE NEUROSURGERY DEPARTMENT. ON (B)(6) 2023, THE PATIENT UNDERWENT CEREBRAL ANGIOGRAPHY UNDER GENERAL ANESTHESIA. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) RESULT SHOWED THAT THE M1 SEGMENT OF THE LEFT MCA WAS BLOCKED (INTRA-STENT OCCLUSION), AND THE ANTERIOR CEREBRAL ARTERY COMPENSATED FOR THE MCA REGION THROUGH THE PIA MATTER. THROMBUS ASPIRATION AND INTRA-STENT THROMBOLYTIC THERAPY WERE ATTEMPTED. IT WAS REPORTED THAT NO THROMBUS WAS FOUND AFTER ¿5F YINSHE CATHETER ASPIRATION, AND 7ML TILOFIBAN FOR INJECTION WAS SLOWLY INJECTED THROUGH THE MICROCATHETER.¿ AFTER 5 MINUTES, 5F YINSHE CATHETER ASPIRATION WAS PERFORMED AGAIN, AND NO THROMBUS ASPIRATION WAS FOUND. RE-EXAMINATION SHOWED THAT THE LEFT MCA WAS STILL OCCLUDED, AND THE PROCEDURE WAS CONCLUDED. ¿ROUTINE EXPANSION, ANTI-SPASMATIC, ANTI-INFECTION, AND OTHER TREATMENT¿ WERE PROVIDED AFTER THE PROCEDURE. THE PRINCIPAL INVESTIGATOR (PI) ASSESSED THE TRANSIENT ISCHEMIC ATTACK EVENT AS A SERIOUS ADVERSE EVENT, MODERATE IN SEVERITY THAT WAS NOT UNANTICIPATED, AND WAS POSSIBLY UNRELATED TO THE STUDY DEVICE, UNRELATED TO THE STUDY PROCEDURE. THE EVENT DID REQUIRE INTERVENTION VIA THE ATTEMPT TO ASPIRATE THE THROMBUS; IT ALSO REQUIRED THE ADMINISTRATION OF MEDICATION VIA INTRA-STENT THROMBOLYTIC THERAPY. THE SECONDARY SURGICAL PROCEDURE WAS UNSUCCESSFUL, AS ¿REEXAMINATION SHOWED THAT THE LEFT MIDDLE CEREBRAL ARTERY WAS STILL BLOCKED¿. THE EVENT ALSO REQUIRED ¿PROLONGED INPATIENT HOSPITALIZATION¿ FOR CONTINUED ICU TREATMENT. THE EVENT WAS REPORTED AS NOT PERSISTENT, THE REPORTED OUTCOME WAS ¿SYMPTOM DISAPPEARED WITH SEQUELAE¿ WITH AN END DATE OF (B)(6) 2023. THE PATIENT¿S CURRENT GENERAL CONDITION IS REPORTED AS STABLE WITH ¿ONLY THE SYMPTOMS OF POOR FINE MOTOR FUNCTION REMAINED, AND THE REST OF THE NEUROLOGICAL DEFICIT SYMPTOMS DISAPPEARED, AND THE PATIENT WAS DISCHARGED. THEN HE WILL GO TO THE REHABILITATION HOSPITAL FOR REHABILITATION TREATMENT.¿ THERE WERE NO REPORTED DEVICE DEFICIENCIES RELATED TO THE ENTERPRISE STENT, AND THE DEVICE REMAINS IMPLANTED IN THE PATIENT. ON 13-SEP-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THE SEQUELAE THE PATIENT EXPERIENCED IS TRANSIENT WEAKNESS OF THE RIGHT LIMB, POOR FINE MOTOR ACTIVITY, TRANSIENT APHASIA WITH POOR FINE MOTOR ACTIVITY. THE PATIENT¿S HOSPITALIZATION WAS PROLONGED BY 4 DAYS. THE STUDY DEVICE WAS A 4MM X 16MM ENTERPRISE 2 VASCULAR RECONSTRUCTION DEVICE (VRD) (ENCR401600 / 6920551).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1673821 ENTERPRISE2 4MMX16MM NO TIP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 6920551

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R