BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEB SL 17 SINGLE LAYER

    MDR report key: 8663084 · Received June 3, 2019

    Report

    Report Number
    2032493-2019-00153
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 10, 2019
    Manufacturer
    SEQUENT MEDICAL, INC
    Product Code
    OPR
    UDI-DI
    00854111006341
    PMA / PMN Number
    P170032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: FOLLOW-UP PATIENT INFORMATION WAS PROVIDED ON 6/24/19 BY PROF. (B)(6), NEUROSURGEON: AT THE TIME OF TRANSFER AFTER THE PROCEDURE TO THE SURGICAL INTENSIVE CARE WARD, THE PATIENT WAS ALERT AND RESPONSIVE, AND WAS STABLE IN TERMS OF HEMODYNAMICS AND RESPIRATION, WITHOUT FURTHER MEASURES. FINDINGS FOR PUPILS WERE NORMAL. HOWEVER, THERE WAS HEMIPARESIS ON THE LEFT. POST-INTERVENTIONAL COMPUTED TOMOGRAPHY AT FIRST SHOWED SUSPECTED BLEEDING IN THE RIGHT HEMISPHERE WITH NO INDICATION OF DEMARCATION OF AN INFARCTION. LATER, THE PATIENT'S CONSCIOUSNESS BECAME CLOUDED TO GLASGOW COMA SCALE 5. THE PATIENT WAS INTUBATED AS A PRECAUTION AND A FOLLOW-UP COMPUTED TOMOGRAPHY OF THE SKULL WAS CARRIED OUT, WHICH SHOWED INCIPIENT DEMARCATION OF AN INFARCTION IN THE PERFUSION AREA OF THE ANTERIOR RIGHT MIDDLE CEREBRAL ARTERY. THE PREVIOUS ENHANCEMENT OF CONTRAST MEDIUM, SUGGESTIVE OF BLEEDING, WAS REGRESSIVE IN THIS FOLLOW-UP IMAGE, SO THIS WAS SEEN AS MOST LIKELY BEING POST-INTERVENTIONAL DISCHARGE OF CONTRAST MEDIUM. ON THE FOLLOWING DAY, SEDATION WAS ENDED AND THE PATIENT EXHIBITED A DEFINITELY PROLONGED RECOVERY REACTION. HOWEVER, IN DUE COURSE THE PATIENT WAS CONVERTED TO A PRESSURE-SUPPORTED SPONTANEOUS RESPIRATION MODE AND FINALLY EXTUBATED WITHOUT ANY COMPLICATIONS. HER ALERTNESS WAS ALSO IMPROVED; IN DUE COURSE, A SLIGHT REDUCTION IN STRENGTH OF THE LEFT EXTREMITIES WAS REGRESSIVE, APART FROM LATENT HEMIPARESIS. THE REMAINDER OF THE INPATIENT STAY WAS FREE OF COMPLICATIONS, SO THE PATIENT WAS TRANSFERRED TO THE NORMAL WARD ON (B)(6) 2019, 6 DAYS AFTER THE PROCEDURE. AT THE TIME OF TRANSFER, THE PATIENT WAS SOMNOLENT, BUT RESPONSIVE AT ALL TIMES. FINDINGS FOR PUPILS WERE NORMAL. THE EXTREMITIES WERE MOVED BOTH SPONTANEOUSLY AND ON DEMAND. THE PATIENT WAS STABLE IN TERMS OF HEMODYNAMICS AND RESPIRATION. DIURESIS WAS QUALITATIVELY AND QUANTITATIVELY SUFFICIENT. IN DUE COURSE, THE PATIENT WAS ABLE TO BE MOBILIZED WITH PHYSIOTHERAPY. WITH NORMAL INPATIENT PROGRESS, PLANS WERE MADE TO TRANSFER THE PATIENT TO A REHABILITATION CENTER. AT THE TIME OF DISCHARGE THE PATIENT WAS ALERT AND RESPONSIVE, COOPERATIVE AND PARTIALLY ORIENTED AND SHE COMPLIED WITH REQUESTS. PUPILS ROUND, EQUAL, RESPONSIVE TO LIGHT, CENTRAL FACIAL PARESIS ON THE LEFT (DEFINITELY REGRESSIVE), SLIGHT DYSARTHRIA AND LATENT HEMIPARESIS ON THE LEFT. LABELED FOR SINGLE USE: CORRECTION.

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: (B2) DISABILITY OR PERMANENT DAMAGE ADDITIONAL INFORMATION: FOLLOW-UP PATIENT INFORMATION WAS PROVIDED BY THE CLINICAL SITE ON(B)(6) 2019, INDICATING THAT THE EVENT WAS RESOLVED ON 5/21/19 WITH SEQUELAE - " MILD PARESIS OF THE LEFT ARM".

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED. A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION DID NOT REVEAL ANY PRODUCTION-RELATED ISSUES RELEVANT TO THE COMPLAINT THAT OCCURRED DURING MANUFACTURING OF THE DEVICE. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND THE REMAINDER OF THE DEVICE WAS DISCARDED AT THE USER FACILITY; THEREFORE, A PRODUCT ANALYSIS COULD NOT BE PERFORMED. THE ROOT CAUSE HAS BEEN DETERMINED TO BE USER-RELATED, AS THE PHYSICIAN DID NOT FOLLOW THE DIRECTIONS FOR DEVICE DEPLOYMENT IN THE INSTRUCTIONS FOR USE (IFU).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT OF A RIGHT SIDE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM ON A PATIENT ENROLLED IN THE CLEVER CLINICAL TRIAL, THE WEB DEVICE TURNED SLIGHTLY INSIDE THE ANEURYSM AFTER DETACHMENT, PROBABLY DUE TO A FORWARD MOVEMENT OF THE MICROCATHETER FROM TOO MUCH TENSION INSIDE THE MICROCATHETER AND GUIDING SYSTEM. THE TILTED POSITION OF THE WEB WITHIN THE ANEURYSM RESULTED IN THE SHOULDER OF THE WEB PROTRUDING INTO THE UPPER BRANCH OF THE MCA. AFTER MANIPULATION WITH THE MICROCATHETER AND STABILIZATION OF THE WEB, THROMBUS DEVELOPED IN THE UPPER BRANCH OF THE MCA. A MECHANICAL THROMBECTOMY WAS PERFORMED AND 10MG OF ABCIXIMAB (REOPRO) WAS DELIVERED, AND 5,000 UNITS OF HEPARIN WAS ADMINISTERED INTRAVENOUSLY. A NEUROFORM ATLAS STENT WAS IMPLANTED TO PROTECT THE M1 AND THE ANEURYSM WAS OCCLUDED WITH EMBOLIZATION COILS. NO ANEURYSM RUPTURE OCCURRED. ANGIOGRAPHY PERFORMED AT THE END OF THE IMPLANTATION PROCEDURE DEMONSTRATED COMPLETE OCCLUSION OF THE ANEURYSM (RAYMOND-ROY OCCLUSION CLASSIFICATION I) AND PERSISTENT OCCLUSION OF THE MCA. THE PATIENT WAS PRESCRIBED DUAL ANTIPLATELET THERAPY WITH ASPIRIN AND PLAVIX DUE TO THE IMPLANTED STENT. THE PHYSICIAN CLEARLY STATED THAT THE DEVICE DID NOT MALFUNCTION. HE STATED THAT HE PUSHED ON THE DEVICE PUSHER TO MAKE SURE IT WAS WELL INSIDE THE ANEURYSM BEFORE DETACHMENT (HE MENTIONED THAT THE DEVICE SIZE CHOSEN MAY HAVE BEEN TOO BIG), BUT FORGOT TO RELEASE THE TENSION ON THE PUSHER AS DIRECTED IN THE IFU, SO WHEN THE WEB WAS DETACHED, THE TENSION IN THE SYSTEM WAS RELEASED AND ADVANCED THE CATHETER TIP FORWARD, PUTTING PRESSURE ON THE DEVICE WHICH CAUSED THE TWISTING AND INVAGINATION. THE PATIENT WAS MONITORED IN THE INTENSIVE CARE UNIT FOR 6 DAYS AFTER THE PROCEDURE AND WAS REPORTED TO BE DISCHARGED FROM THE HOSPITAL ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457014 WEB SL 17 SINGLE LAYER WOVEN ENDOBRIDGE (WEB) ANEURYSM EMBOLIZATION SYSTEM OPR SEQUENT MEDICAL, INC FG29070-030 17102308 00854111006341

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| O| R| S