BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EU ENT4.5MMD 14MML WNO DSTL TP

    MDR report key: 14696964 · Received June 15, 2022

    Report

    Report Number
    3008114965-2022-00439
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    June 9, 2022
    Report Date
    July 12, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    UDI-DI
    10878528009457
    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). INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, MEDICAL HISTORY, RACE, AND ETHNICITY WAS NOT REPORTED. INITIAL REPORTER PHONE: (B)(6). 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. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2022-00438.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UPDATED SECTIONS ON THIS MEDWATCH: B3, B4, B5, G3, G6, H2, H3, H6, H10 AND CONCOMITANT PRODUCT. SECTION B5: ADDITIONAL INFORMATION RECEIVED ON 20-JUN-2022 INDICATED THAT DURING THE PROCEDURAL DELAY, THE PHYSICIAN OBSERVED WHETHER THE FIRST STENT AFFECTED THE DISTAL PORTION OF THE VESSEL AND TOOK THE TIME TO PREPARE, DELIVER AND RELEASE THE SECOND STENT. HOWEVER, IT¿S UNKNOWN IF THE PROCEDURAL DELAY WAS CLINICALLY SIGNIFICANT. THE ENTERPRISE STENT LENGTH THAT WAS SELECTED WAS AT LEAST 10MM LONGER THAN THE ANEURYSM NECK TO MAINTAIN A MINIMUM OF 5MM ON EITHER SIDE OF THE ANEURYSM NECK. THE DISTAL AND PROXIMAL VESSEL DIAMETERS ARE UNKNOWN. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (LOT # 30727353) AND THE SYSTEM WAS USED WITH THE RECOMMENDED MICROCATHETER. EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE, AND IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER WITH THE ENTERPRISE DEVICE. THE MARKER POSITION WAS OBSERVED DURING THE COILING PROCEDURE TO ENSURE THAT THE STENT DOES NOT MIGRATE FROM ITS DEPLOYED POSITION. INTERACTION WITH ANOTHER DEVICE DID NOT CAUSE THE MIGRATION. THERE WASN¿T EVIDENCE OF OBSTRUCTION TO THE BLOOD FLOW DUE TO THE EVENT. THE PHYSICIAN RELEASED THE SECOND STENT IN THE TARGET POSITION, AND IT ALMOST EVENLY COVERED THE TUMOR NECK. ONCE AGAIN, ANGIOGRAPHY FOUND THAT IT MOVED TO THE DISTAL PORTION OF THE TARGET VESSEL AND DID NOT EVENLY COVER THE TUMOR NECK. NO FOLLOW-UP INTERVENTION WAS REQUIRED. THE DISTAL PORTION OF THE ANEURYSM WAS CURVED AND BIFURCATE AND THE DIAMETER OF THE ANEURYSM WAS 2MM WIDE AND THE HEIGHT WAS 3MM. THE MEDICAL IMAGING RECEIVED WAS REVIEWED BY MEDICAL AFFAIRS DIRECTOR AND THE ASSESSMENT READS AS FOLLOWS: ¿THE DESCRIPTION OF THE CASE SUGGESTS THAT THE STENT WAS DELIVERED BEFORE THE MARKERS ON THE PUSHER WIRE WERE VISIBLE. THE IMAGES PROVIDED SHOW THE LEFT MCA BEING TREATED FOR AN ANEURYSM, AND THE LOCATION OF THE FIRST STENT SHOWS THAT IT IS PLACED DISTAL TO THE ANTICIPATED LOCATION, WHICH SUPPORTS THIS DESCRIPTION. A SECOND STENT WAS PLACED AND SAID TO BE MIGRATING DISTALLY. THE LATTER IS DIFFICULT TO SEE IN THE IMAGE BUT MAY HAPPEN IN SEVERE STENOSIS OR ICAD IN THE MCA. THE ROOT CAUSE OF THE PROBLEM IS DIFFICULT TO ASSESS FROM THESE IMAGES, AND FURTHER ANALYSIS OF THE PUSHER WIRE (FOR EVENT NUMBER 1) MAY BE THE ONLY WAY TO GET MORE INFORMATION. IN ORDER TO UNDERSTAND THE SECOND PROBLEM, WE MAY NEED MORE DETAILED IMAGES OF THE FIRST LANDING ZONE, AND THE FINAL PLACEMENT, IN COMBINATION WITH MRI OR CT IMAGES OF THE LOCAL VASCULATURE¿. COMPLAINT CONCLUSION: IT WAS REPORTED THAT A PATIENT WITH A PREOPERATIVE DIAGNOSIS OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM, CEREBRAL ISCHEMIC LESION, AND EMPHYSEMA UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM USING AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400/6920527). PER THE EVENT DESCRIPTION, TRANSFEMORAL PUNCTURE, WHOLE CEREBRAL ANGIOGRAPHY, AND STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM WERE PERFORMED. A MICROCATHETER WAS PLACED IN POSITION AND THE PHYSICIAN PUSHED THE STENT INTO THE MICROCATHETER. THE DELIVERY WIRE WAS IN GOOD CONDITION DURING ITS DELIVERY, BUT IT DID NOT REACH THE REFERENCE MARKERS ON THE DELIVERY WIRE. AT THAT MOMENT, UNDER FLUOROSCOPY, THE PHYSICIAN FOUND THE STENT HAD BEEN RELEASED TO THE DISTAL END OF THE LESION SITE WITHOUT INTENTION, AND THAT THE STENT DID NOT COVER THE LESION SITE CORRECTLY. THE PHYSICIAN THEN RELEASED A NEW ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH DISTAL TIP (ENC451412/ 6920532) AND IT COMPLETELY COVERED THE ANEURYSM. AFTER SOME TIME, THE ANGIOGRAM SHOWED THAT THE STENT HAD MIGRATED ANTERIORLY. THE PROCEDURE WAS PROLONGED FOR ABOUT AN HOUR AND A HALF. THE PATIENT IS CURRENTLY STABLE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT DURING THE PROCEDURAL DELAY, THE PHYSICIAN OBSERVED WHETHER THE FIRST STENT AFFECTED THE DISTAL PORTION OF THE VESSEL AND TOOK THE TIME TO PREPARE, DELIVER AND RELEASE THE SECOND STENT. HOWEVER, IT¿S UNKNOWN IF THE PROCEDURAL DELAY WAS CLINICALLY SIGNIFICANT. THE ENTERPRISE STENT LENGTH THAT WAS SELECTED WAS AT LEAST 10MM LONGER THAN THE ANEURYSM NECK TO MAINTAIN A MINIMUM OF 5MM ON EITHER SIDE OF THE ANEURYSM NECK. THE DISTAL AND PROXIMAL VESSEL DIAMETERS ARE UNKNOWN. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS 150/5CM (LOT # 30727353) AND THE SYSTEM WAS USED WITH THE RECOMMENDED MICROCATHETER. EXCESSIVE FORCE WAS NOT APPLIED TO THE DEVICE, AND IT WAS NOT NECESSARY TO REMOVE THE MICROCATHETER WITH THE ENTERPRISE DEVICE. THE MARKER POSITION WAS OBSERVED DURING THE COILING PROCEDURE TO ENSURE THAT THE STENT DOES NOT MIGRATE FROM ITS DEPLOYED POSITION. INTERACTION WITH ANOTHER DEVICE DID NOT CAUSE THE MIGRATION. THERE WASN¿T EVIDENCE OF OBSTRUCTION TO THE BLOOD FLOW DUE TO THE EVENT. THE PHYSICIAN RELEASED THE SECOND STENT IN THE TARGET POSITION, AND IT ALMOST EVENLY COVERED THE TUMOR NECK. ONCE AGAIN, ANGIOGRAPHY FOUND THAT IT MOVED TO THE DISTAL PORTION OF THE TARGET VESSEL AND DID NOT EVENLY COVER THE TUMOR NECK. NO FOLLOW-UP INTERVENTION WAS REQUIRED. THE DISTAL PORTION OF THE ANEURYSM WAS CURVED AND BIFURCATE AND THE DIAMETER OF THE ANEURYSM WAS 2MM WIDE AND THE HEIGHT WAS 3MM. THE MEDICAL IMAGING RECEIVED WAS REVIEWED BY MEDICAL AFFAIRS DIRECTOR AND THE ASSESSMENT READS AS FOLLOWS: ¿THE DESCRIPTION OF THE CASE SUGGESTS THAT THE STENT WAS DELIVERED BEFORE THE MARKERS ON THE PUSHER WIRE WERE VISIBLE. THE IMAGES PROVIDED SHOW THE LEFT MCA BEING TREATED FOR AN ANEURYSM, AND THE LOCATION OF THE FIRST STENT SHOWS THAT IT IS PLACED DISTAL TO THE ANTICIPATED LOCATION, WHICH SUPPORTS THIS DESCRIPTION. A SECOND STENT WAS PLACED AND SAID TO BE MIGRATING DISTALLY. THE LATTER IS DIFFICULT TO SEE IN THE IMAGE BUT MAY HAPPEN IN SEVERE STENOSIS OR ICAD IN THE MCA. THE ROOT CAUSE OF THE PROBLEM IS DIFFICULT TO ASSESS FROM THESE IMAGES, AND FURTHER ANALYSIS OF THE PUSHER WIRE (FOR EVENT NUMBER 1) MAY BE THE ONLY WAY TO GET MORE INFORMATION. IN ORDER TO UNDERSTAND THE SECOND PROBLEM, WE MAY NEED MORE DETAILED IMAGES OF THE FIRST LANDING ZONE, AND THE FINAL PLACEMENT, IN COMBINATION WITH MRI OR CT IMAGES OF THE LOCAL VASCULATURE¿. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND IT INDICATED THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. STENT MIGRATION/EMBOLIZATION IS A KNOWN COMPLICATION ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS SUCH. A MIGRATION/EMBOLIZATION COULD POSSIBLY RESULT IN ISCHEMIA OR INFARCT. PREMATURE DEPLOYMENT OF THE STENT IN THE PATIENT MAY HAVE LED TO DAMAGE TO HEALTHY INTIMA, POSSIBLE SIDE BRANCH OCCLUSION, ISCHEMIA, INFARCT, AND/OR THE NEED FOR ADDITIONAL INTERVENTION. THE IFU WARNS THE OPERATOR TO OBSERVE STENT MARKER POSITION DURING COILING PROCEDURE TO ENSURE THAT THE STENT DOES NOT MIGRATE FROM ITS DEPLOYED POSITION. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE BASED ON THE INFORMATION PROVIDED; HOWEVER, IT IS POSSIBLE THAT ANEURYSM CHARACTERISTICS, VESSEL TORTUOSITY/SPASM, DEVICE SELECTION, DEVICE INTERACTION, AND OPERATOR TECHNIQUE MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE ALLEGED FAILURES RESULTED IN SURGICAL INTERVENTION (THE USE OF S SECOND STENT) AND SURGERY PROLONGATION, THEREFORE THE EVENTS MEETS MDR REPORTING CRITERIA AS A ¿SERIOUS INJURY¿. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. 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

    IT WAS REPORTED THAT A PATIENT WITH A PREOPERATIVE DIAGNOSIS OF A LEFT MIDDLE CEREBRAL ARTERY ANEURYSM, CEREBRAL ISCHEMIC LESION, AND EMPHYSEMA UNDERWENT STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM USING AN ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400/6920527). PER THE EVENT DESCRIPTION, TRANSFEMORAL PUNCTURE, WHOLE CEREBRAL ANGIOGRAPHY, AND STENT-ASSISTED COIL EMBOLIZATION OF THE ANEURYSM WERE PERFORMED. A MICROCATHETER WAS PLACED IN POSITION AND THE PHYSICIAN PUSHED THE STENT INTO THE MICROCATHETER. THE DELIVERY WIRE WAS IN GOOD CONDITION DURING ITS DELIVERY, BUT IT DID NOT REACH THE REFERENCE MARKERS ON THE DELIVERY WIRE. AT THAT MOMENT, UNDER FLUOROSCOPY, THE PHYSICIAN FOUND THE STENT HAD BEEN RELEASED TO THE DISTAL END OF THE LESION SITE WITHOUT INTENTION, AND THAT THE STENT DID NOT COVER THE LESION SITE CORRECTLY. THE PHYSICIAN THEN RELEASED A NEW ENTERPRISE VASCULAR RECONSTRUCTION DEVICE 4.5MM X 14MM WITH NO DISTAL TIP (ENC451400) AND IT COMPLETELY COVERED THE ANEURYSM. AFTER SOME TIME, THE ANGIOGRAM SHOWED THAT THE STENT HAD MIGRATED ANTERIORLY. THE PROCEDURE WAS PROLONGED FOR ABOUT AN HOUR AND A HALF. THE PATIENT IS CURRENTLY STABLE. IMAGES HAVE BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2807682 EU ENT4.5MMD 14MML WNO DSTL TP INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL 641CF2505 6920527 10878528009457

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Required Intervention EU ENT4.5MMD 14MML WNO DSTL TP| PROWLER SELECT PLUS 150/5CM