UNKORBIT
Report
- Report Number
- 3008114965-2022-00194
- Event Type
- Death
- Date Received
- March 11, 2022
- Date of Event
- January 1, 2010
- Report Date
- March 11, 2022
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- KRD
- PMA / PMN Number
- K123560
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PRODUCT COMPLAINT # (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: PODGORNYAK, M. U., CHEREMISINA, V. M., SERGIENKO, S. K. (2010). EMERGENCY DIAGNOSIS OF COMPLICATIONS OF EMBOLIZATION OF CEREBRAL ANEURYSMS AND THEIR TREATMENT. MEDICAL VISUALIZATION, 6, 50¿58. THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. THE INITIAL REPORTER CONTACT INFORMATION IS NOT AVAILABLE. THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. DUE TO THE NATURE OF THE COMPLAINT, THE DEVICE (S) WERE NOT RETURNED FOR ANALYSIS NOR WAS THE STERILE LOT NUMBERS PROVIDED IN ORDER TO CONDUCT A LOT HISTORY REVIEW. AS A RESULT, WE ARE CLOSING THIS INVESTIGATION. IF THE COMPLAINT DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. 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.
THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE CITATION IS AS FOLLOWS: PODGORNYAK, M. U., CHEREMISINA, V. M., SERGIENKO, S. K. (2010). EMERGENCY DIAGNOSIS OF COMPLICATIONS OF EMBOLIZATION OF CEREBRAL ANEURYSMS AND THEIR TREATMENT. MEDICAL VISUALIZATION, 6, 50¿58. OBJECTIVE AND METHODS: THE PURPOSE OF THIS STUDY WAS TO ANALYZE THE METHODS OF CLINICAL EXAMINATION AND RADIOLOGICAL IMAGING OF PATIENTS WITH ANEURYSMAL DISEASE OF THE BRAIN AND RESULTS OF EMBOLIZATION OF ANEURYSMS WITH COMPLICATIONS. THE STUDY INCLUDED 57 PATIENTS WHO UNDERWENT EMBOLIZATION OF CEREBROVASCULAR ANEURYSMS AT THE NEUROSURGERY UNIT DEPARTMENT OF THE MARIINSKY HOSPITAL. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: TRUFILL COMPLEX FILL THREE-DIMENSIONAL COILS CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: AGILITY 10.14 GUIDEWIRE; PROWLER 14 MICROCATHETER CONCOMITANT NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: ATV 0.014, SOR GUIDEWIRE; VASCO 18 OR 14 GUIDEWIRE; COPERNIC BALLOON MICROCATHETER (BALT). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: CASE #1 - (B)(6) PATIENT UNDERWENT COIL EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACOA) ANEURYSM AND EXPERIENCED LOCAL VASOSPASM NOTED IN THE A2 SECTION OF THE RIGHT ANTERIOR CEREBRAL ARTERY (ACA). THE SPASM WAS CONTROLLED BY A SUPERSELECTIVE INJECTION OF 2MG OF NIMODIPINE DISSOLVED IN 20ML OF SALINE SOLUTION. CASE #2 - (B)(6) PATIENT UNDERWENT BALLOON-ASSISTED COIL EMBOLIZATION OF A RIGHT INTERNAL CAROTID ARTERY (SUPRACLINOID) ANEURYSM AND ACOA ANEURYSM. WHILE INSTALLING THE LAST MICROCOIL, IT STRETCHED AND DETACHED ITSELF, MIGRATION OF THE SPIRAL END BY 2CM WAS NOTED INTO THE ICA LUMEN. THE STRETCHED SECTION OF THE COIL WAS PRESSED AGAINST THE ICA WALL USING A BALLOON CATHETER. TWO DAYS AFTER THE SURGERY, THE PATIENT WAS DISCHARGED FOR OUTPATIENT TREATMENT WITHOUT NEUROLOGICAL IMPAIRMENT. CASE #4 - (B)(6) PATIENT UNDERWENT COIL EMBOLIZATION OF A RUPTURED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH THREE MICROCOILS AND EXPERIENCED EMBOLISM IN THE PARIETAL BRANCH OF THE MCA DURING THE PROCEDURE. THE MICROCATHETER WAS GUIDED INTO THE SITE OF THE THROMBOSED VESSEL; AFTER THE INFUSION OF 2500 UNITS OF HEPARIN THROUGH IT, THE VESSEL WAS RECANALIZED. THE PATIENT EXHIBITED RIGHT-SIDED HEMIPARESIS IN THE POSTOPERATIVE PERIOD WHICH REGRESSED WITH TREATMENT. TWO WEEKS AFTER SURGERY, THE PATIENT WAS DISCHARGED FOR OUTPATIENT TREATMENT. A TOTAL OF 10 PATIENTS EXPERIENCED VASOSPASM, IN 5 OF WHOM IT WAS INDUCED BY MANIPULATION IN THE AREA OF THE ICA. DIFFUSE VASOSPASM OCCURRED ONLY IN 1 PATIENT; LOCAL WAS NOTED IN 9 PATIENTS. CALCIUM ANTAGONIST (NIMOTOP) WAS INJECTED IN 9 OF THE 10 PATIENTS. IN 2 CASES, THE ANEURYSM WALL WAS PERFORATED BY THE MICROCOIL. IN BOTH CASES, THE EMBOLIZATION OF THE ANEURYSMS WAS CONTINUED UNTIL THE BLEEDING STOPPED. DESPITE THE PROPHYLACTIC USE OF A CONTINUOUS LAVAGE SYSTEM WITH INFUSION OF HEPARIN SOLUTION, CEREBRAL VESSEL OCCLUSIONS OCCURRED IN 3 PATIENTS (INCLUDING CASE #4 MENTIONED ABOVE). SELECTIVE ADMINISTRATION OF 2500 AND 5000 U OF HEPARIN WAS USED TO RESTORE BLOOD FLOW IN 2 CASES, AND ANOTHER 7.5 MG OF ALTEPLASE WAS ADDITIONALLY USED IN ONE THESE PATIENTS. 5 PATIENTS EXPERIENCED A LOSS OF THE END OR SECTIONS OF THE COIL INTO THE VESSEL¿S LUMEN UP TO 2 CM (INCLUDING CASE #2 MENTIONED ABOVE). IN 2 CASES, THE COIL WAS ¿FORCED¿ TO THE VESSEL WALL BY AN ASSISTING BALLOON. IN ALL CASES, THE BLOOD FLOW WAS NOT DISTURBED, AND NO CLINICAL MANIFESTATIONS OF THIS COMPLICATION WERE OBSERVED. ONE PATIENT EXPERIENCED THROMBOEMBOLISM OF THE FRONTAL BRANCH OF THE MCA COMBINED WITH INTRACRANIAL HEMORRHAGE AGAINST THE BACKGROUND OF LEUKEMIA, AND DIED A FEW DAYS AFTER THE OPERATION FROM BRAIN EDEMA AND DISLOCATION AS A RESULT OF CEREBRAL ISCHEMIA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1185216 | UNKORBIT | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | MEDOS INTERNATIONAL SARL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| D | AGILITY 10.14 GUIDEWIRE| ATV 0.014, SOR GUIDEWIRE| COPERNIC BALLOON MICROCATHETER (BALT)| PROWLER 14 MICROCATHETER| VASCO 18 OR 14 GUIDEWIRE |