BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTAFILL10 2MM X 8CM

    MDR report key: 15759715 · Received November 9, 2022

    Report

    Report Number
    3008114965-2022-00738
    Event Type
    Injury
    Date Received
    November 9, 2022
    Date of Event
    September 19, 2022
    Report Date
    December 6, 2022
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    KRD
    UDI-DI
    10886704077022
    PMA / PMN Number
    K150319
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). PATIENT IDENTIFIER: (B)(6). PROCODE: KRD/HCG. 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. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). 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. THIS IS ONE OF SIXTEEN PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2022-00726, 3008114965-2022-00727, 3008114965-2022-00728, 3008114965-2022-00729, 3008114965-2022-00730, 3008114965-2022-00731, 3008114965-2022-00732, 3008114965-2022-00733,3008114965-2022-00734, 3008114965-2022-00735, 3008114965-2022-00736, 3008114965-2022-00737, 3008114965-2022-00739, 3008114965-2022-00740 AND 3008114965-2022-00741. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THE DEVICE REMAINS IMPLANTED, THEREFOR, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 30536993 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. VESSEL PERFORATION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF EMBOLIC COILS IN ENDOVASCULAR COIL EMBOLIZATION OF INTRACRANIAL ANEURYSMS AND IS LISTED IN THE INSTRUCTIONS FOR USE, BOTH FOR GALAXY/DELTAFILL COILS, AS SUCH. HOWEVER, THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM/VESSEL CHARACTERISTICS, DEVICE SELECTION, DEVICE INTERACTION, AND OPERATOR TECHNIQUE, THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT RATHER THAN THE DESIGN OR MANUFACTURE OF THE DEVICE. PER THE INFORMATION PROVIDED, THE DEVICE PERFORMED AS INTENDED. HOWEVER, THE PRINCIPAL INVESTIGATOR ASSESSED THE REPORTED ADVERSE EVENT OF ¿ANEURYSM RUPTURED¿ AS POSSIBLY RELATED TO THE STUDY DEVICE. IN ADDITION, THE PATIENT WAS HOSPITALIZED, AND THE ADVERSE EVENT REQUIRED AN ENDOVASCULARLY INTERVENTION. THUS, THE EVENT MEETS MDR REPORTING CRITERIA WITH THE CLASSIFICATION OF ¿SERIOUS INJURY¿ FOR ALL IMPLANTED STUDY COILS. 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). SECTION B5: ADDITIONAL INFORMATION RECEIVED ON 29-NOV-2022 AND 5-DEC-2022. SUMMARY OF ADDITIONAL INFORMATION PROVIDED: THE DIAGNOSTIC TESTS/EVALUATIONS VALUE HAS BEEN CHANGED FROM ¿NO¿ TO ¿YES¿. THE ADVERSE EVENT TERM VALUE "ANEURYSM RUPTURE/BLEED" HAS BEEN CHANGED TO "TARGET ANEURYSM RUPTURE / BLEED". THE RELATIONSHIP TO THE STUDY DEVICE HAS BEEN CHANGED FROM ¿POSSIBLE¿ TO NOT RELATED. WITH THE RECENTLY PROVIDED INFORMATION, CODING AND REPORTABILITY REMAINS THE SAME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE, WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY THE STERLING STUDY, A 67-YEAR-OLD MALE PATIENT (SUBJECT 00971-020), WITH A MEDICAL HISTORY OF CONTROLLED HYPERLIPIDEMIA, CLASS 1 OBESITY (BMI OF 30 TO < 35), CONTROLLED HYPERTENSION AND BEING A CURRENT SMOKER UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED MIDLINE BASILAR ARTERY ANEURYSM ON (B)(6) 2022. MODIFIED RANKING SCALE (MRS) SCORE WAS 0. PER IMMEDIATE PRE-PROCEDURE DIGITAL SUBTRACTION ANGIOGRAPHY PERFORMED THE ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 13MM, DOME 15MM, MAXIMUM ANEURYSM DIAMETER 15MM, NECK SIZE 8.5MM, AND THE DOME-TO-NECK RATIO OF 1.8MM. THE PARENT VESSEL DIAMETER WAS 4.1MM. COIL EMBOLIZATION WAS PERFORMED USING THE FOLLOWING EIGHT (8) CERENOVUS COILS: TWO (2) GALAXY G3 8MM X 24CM (GLY120824/K10393), A GALAXY G3 6MM X 20CM (GLY120620/30490147), A GALAXY G3 6MM X 20CM (GLY120620/ K10607), TWO (2) GALAXY G3 5MM X 15CM (GLY120515/30357953), A GALAXY G3 5MM X 15CM (GLY120515/30422339), A DELTAFILL10 5MM X 15CM (DLF100515/30415692), A DELTAFILL10 5MM X 15CM (DLF100515/30379777), A GALAXY G3 4MM X 12CM (GLY120412/30522183), A DELTAFILL10 2MM X 8CM (DLF100208/30418880), A DELTAFILL10 2MM X 8CM (DLF100208/30407127), TWO DELTAFILL10 2MM X 8CM (DLF100208/30536993), A DELTAFILL10 3MM X 8CM (DLF100308/L15912) AND A DELTAXSFT10 2MM X 4CM (DLX100204/30481266) WERE IMPLANTED. ALL COILS WERE IMPLANTED VIA AN EXCELSIOR XT-17 (STRYKER NEUROVASCULAR) MICROCATHETER AND A NEUROFORM ATLAS STENT (STRYKER NEUROVASCULAR) AND A LVIS STENT (MICROVENTION) STENT WERE ALSO IMPLANTED. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS CONSIDERED COMPLETE, AND THE STUDY COILS WERE SUCCESSFULLY IMPLANTED AT THE TARGET SITE. PACKING DENSITY WITHOUT G3 MINI COILS (USING ANGIOSUITE) WAS 18% AND AT THE CONCLUSION OF THE PROCEDURE (USING ANGIOSUITE) WAS 18%. THE IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION (MRRC) SCORE WAS CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSM SAC. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2022 WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0. THE 180-DAY (6-MONTH) FOLLOW-UP VISIT WAS PERFORMED IN THE CLINIC ON (B)(6) 2022 WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0 AND THE STATUS OF THE ANEURYSM DIDN¿T CHANGE SINCE THE DISCHARGE, I.E. NO NEWLY RUPTURED OR RE-RUPTURED ANEURYSM. MAGNETIC RESONANCE ANGIOGRAPHY (MRA) WAS PERFORMED AND SHOWED A MRRC CLASS IIIA SCORE: RESIDUAL ANEURYSM WITH CONTRAST WITHIN COIL INTERSTICES. IT WAS LATER REPORTED THAT ON (B)(6) 2022, THE PATIENT EXPERIENCED AN ANEURYSM RUPTURE WITH A SEVERITY OF SEVERE. THE ADVERSE EVENT WAS CLASSIFIED AS SERIOUS, RESULTING IN AN ENDOVASCULAR COIL EMBOLIZATION AND AN IN-PATIENT OR PROLONGED HOSPITALIZATION. THE ADMISSION DATE WAS (B)(6) 2022 AND DISCHARGE DATE WAS (B)(6) 2022. THE RELATIONSHIP TO THE STUDY DEVICE WAS DEEMED CAUSAL. IN THE OPINION OF THE PRINCIPAL INVESTIGATOR, THE ADVERSE EVENT WAS UNEXPECTED/UNANTICIPATED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022 INDICATED THAT THE RELATIONSHIP TO THE STUDY DEVICE HAS BEEN CHANGED FROM CAUSAL RELATIONSHIP TO POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2649170 DELTAFILL10 2MM X 8CM NEUROVASCULAR EMBOLIZATION DEVICE KRD MEDOS INTERNATIONAL SARL DLF100208 30536993 10886704077022

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention DELTAFILL10 2MM X 8CM| DELTAFILL10 2MM X 8CM| DELTAFILL10 2MM X 8CM| DELTAFILL10 3MM X 8CM| DELTAFILL10 5MM X 15CM| DELTAFILL10 5MM X 15CM| DELTAXSFT10 2MM X 4CM| EXCELSIOR XT-17 MICROCATHETER (STRYKER)| GALAXY G3 4MM X 12CM| GALAXY G3 5MM X 15CM| GALAXY G3 5MM X 15CM| GALAXY G3 5MM X 15CM| GALAXY G3 6MM X 20CM| GALAXY G3 6MM X 20CM| GALAXY G3 8MM X 24CM| GALAXY G3 8MM X 24CM| LVIS STENT (MICROVENTION) STENT| NEUROFORM ATLAS STENT (STRYKER NEUROVASCULAR)