GALAXY G3 6MM X 20CM
Report
- Report Number
- 3008114965-2022-00431
- Event Type
- Injury
- Date Received
- June 14, 2022
- Date of Event
- December 15, 2021
- Report Date
- July 20, 2022
- Manufacturer
- MEDOS INTERNATIONAL SARL
- Product Code
- KRD
- UDI-DI
- 10886704077541
- PMA / PMN Number
- K150319
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT # PC-(B)(4). PATIENT IDENTIFIER: (B)(6). PROCODE: KRD/HCG. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE L14866 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED 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 COMPANY IS SEEKING THIS INFORMATION THROUGH THE EVENT INVESTIGATION. THIS IS ONE OF TEN PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2022-00427,3008114965-2022-00428, 3008114965-2022-00429, 3008114965-2022-00430, 3008114965-2022-00431, 3008114965-2022-00432, 3008114965-2022-00433, 3008114965-2022-00434, 3008114965-2022-00435 AND 3008114965-2022-00436. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.
PRODUCT COMPLAINT # ==> (B)(4) UPDATED SECTIONS ON THIS MEDWATCH: B4, B5, G3, G6, H2, H6 AND H10. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. SECTION B5: ADDITIONAL INFORMATION RECEIVED ON(B)(6)2022 INDICATED THAT COIL COMPACTION OCCURRED BECAUSE THE ANEURYSM WAS NOT COMPLETED OBLITERATED AFTER THE FIRST TREATMENT AND WOULD HAVE NEEDED A Y STENT FOR IT TO BE COMPLETELY OBLITERATED AS OPPOSED TO A SINGLE STENT. BEING A BIFURCATION ANEURYSM THERE IS ALWAYS A RISK OF COMPACTION OR RECANALIZATION, ESPECIALLY IF NOT FULLY OBLITERATED. IT DID REMAIN WITHIN THE SAC. THE PATIENT WAS NOT SYMPTOMATIC AND WAS FOUND ON A FOLLOW-UP ANGIOGRAM IN NOVEMBER. COMPLAINT CONCLUSION: AS REPORTED BY THE STERLING STUDY, A 64-YEAR-OLD FEMALE PATIENT (SUBJECT 992-043) WITH A HISTORY OF DIABETES, CONTROLLED HYPERTENSION, BEING A PREVIOUS SMOKER, DEPRESSION, HEPATITIS C, AND CHRONIC BACK PAIN, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) SACCULAR ANEURYSM WITH MODIFIED RANKIN SCALE (MRS) SCORE 2 ON (B)(6)-2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 11.5MM, DOME 9.8MM, MAXIMUM ANEURYSM DIAMETER 10.8MM, NECK SIZE 7.1MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.5MM. COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/ L16383), A GALAXY G3 6MM X 10CM (GLY120610/L13911), A GALAXY G3 6MM X 15CM (GLY120615/K10645), A GALAXY G3 6MM X 20CM (GLY120620/L14866), A GALAXY G3 8MM X 24CM (GLY120824/30530863), GALAXY G3 7MM X 15CM (GLY120715/L15636), GALAXY G3 9MM X 25CM (GLY120925/L13514), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/304943930, A GALAXY G3 XSFT 3MM X 4CM (GLX120304/30370440), AND A 2.5MM X 4MM GALAXY G3 XTRASOFT (30371932). THREE (3) NON- CERENOVUS COILS WERE USED: TWO TARGET 360 ULTRA AND ONE TARGET 360 NANO (ALL STRYKER). A NEUROFORM ATLAS STENT (STRYKER) WAS ALSO IMPLANTED. ALL COILS WERE IMPLANTED VIA AN EXCELSIOR SL10 MICROCATHETER (STRYKER). 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 WITH 17% ANGIOSUITE PACKING DENSITY. THE IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS III: RESIDUAL NECK. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6)-2021 WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 2. THE 180-DAY (6-MONTH) FOLLOW-UP VISIT WAS PERFORMED IN THE CLINIC ON (B)(6)2021, WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS PERFORMED AT THIS 180-DAY (6-MONTH) FOLLOW-UP AND SHOWED A MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSM SAC. THE STATUS OF THE TARGET ANEURYSM HAS NOT CHANGED SINCE THE PREVIOUS VISIT (NEWLY RUPTURED OR RE-RUPTURED). ON (B)(6)2021 THE PATIENT EXPERIENCED A RECURRENCE OF THE ANEURYSM, WHICH WAS RETREATED WITH FOUR (4) NON-CERENOVUS COILS (STRYKER-TARGET): ONE 30, ONE 360 ULTRA, AND TWO 360 NANO. THE MODIFIED RAYMOND-ROY CLASSIFICATION FOR THE TARGET ANEURYSM FOLLOWING RETREATMENT WAS CLASS II: RESIDUAL NECK. THE PATIENT DID NOT EXPERIENCE AN INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)-2022 INDICATING THAT COIL COMPACTION OCCURRED BECAUSE THE ANEURYSM WAS NOT COMPLETED OBLITERATED AFTER THE FIRST TREATMENT AND WOULD HAVE NEEDED A Y STENT FOR IT TO BE COMPLETELY OBLITERATED AS OPPOSED TO A SINGLE STENT. BEING A BIFURCATION ANEURYSM THERE IS ALWAYS A RISK OF COMPACTION OR RECANALIZATION, ESPECIALLY IF NOT FULLY OBLITERATED. IT DID REMAIN WITHIN THE SAC. THE PATIENT WAS NOT SYMPTOMATIC AND WAS FOUND ON A FOLLOW-UP ANGIOGRAM IN NOVEMBER. THE DEVICE REMAINS IMPLANTED; THEREFORE, NO FURTHER INVESTIGATION CAN BE PERFORMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER, AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED ANEURYSM RECANALIZATION AND COIL COMPACTION ARE KNOWN POTENTIAL COMPLICATIONS WITH COIL EMBOLIZATION PROCEDURES. COIL COMPACTION IS THE DECREASE IN INTERSPACES BETWEEN THE LOOPS OF THE COILS, WHICH LEADS TO SMALLER COIL MESH. IT OCCURS OVER TIME AFTER COIL PLACEMENT. PER ADDITIONAL INFORMATION PROVIDED ON (B)(6)-2022, COIL COMPACTION OCCURRED. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE FOR REVIEW; HOWEVER, RETURN OF BLOOD FLOW INTO THE ANEURYSM DUE TO COIL COMPACTION MAY INCREASE THE RISK FOR ANEURYSM RUPTURE AND POSSIBLY REQUIRE ADDITIONAL INTERVENTION. SINCE THE ANEURYSM RECANALIZATION NECESSITATED RE-TREATMENT TO PREVENT FURTHER INJURY OR COMPLICATIONS, THE EVENT MEETS MDR REPORTING CRITERIA FOR ALL 10 IMPLANTED CERENOVUS 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 EVENTS WERE RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS REPORTED BY THE STERLING STUDY, A 64-YEAR-OLD FEMALE PATIENT (SUBJECT 992-043) WITH A HISTORY OF DIABETES, CONTROLLED HYPERTENSION, BEING A PREVIOUS SMOKER, DEPRESSION, HEPATITIS C, AND CHRONIC BACK PAIN, UNDERWENT COIL EMBOLIZATION OF AN UNRUPTURED RIGHT MIDDLE CEREBRAL ARTERY (MCA) SACCULAR ANEURYSM WITH MODIFIED RANKIN SCALE (MRS) SCORE 2 ON 03-AUG-2021. THE DIMENSION OF THE ANEURYSM WAS AS FOLLOWS: HEIGHT 11.5MM, DOME 9.8MM, MAXIMUM ANEURYSM DIAMETER 10.8MM, NECK SIZE 7.1MM, AND THE DOME-TO-NECK RATIO OF 1.4MM. THE PARENT VESSEL DIAMETER WAS 3.5MM.COIL EMBOLIZATION WAS PERFORMED WITH TEN (10) CERENOVUS COILS: A GALAXY G3 XSFT 3.5MM X 7.5CM (GLX123575/ L16383), A GALAXY G3 6MM X 10CM (GLY120610/L13911), A GALAXY G3 6MM X 15CM (GLY120615/K10645), A GALAXY G3 6MM X 20CM (GLY120620/L14866), A GALAXY G3 8MM X 24CM (GLY120824/30530863), GALAXY G3 7MM X 15CM (GLY120715/L15636), GALAXY G3 9MM X 25CM (GLY120925/L13514), A GALAXY G3 XSFT 4MM X 10CM (GLX120410/304943930, A GALAXY G3 XSFT 3MM X 4CM (GLX120304/30370440), AND A 2.5MM X 4MM GALAXY G3 XTRASOFT (30371932). THREE (3) NON- CERENOVUS COILS WERE USED: TWO TARGET 360 ULTRA AND ONE TARGET 360 NANO (ALL STRYKER). A NEUROFORM ATLAS STENT (STRYKER) WAS ALSO IMPLANTED. ALL COILS WERE IMPLANTED VIA AN EXCELSIOR SL10 MICROCATHETER (STRYKER). 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 WITH 17% ANGIOSUITE PACKING DENSITY. THE IMMEDIATE POST-PROCEDURE MODIFIED RAYMOND-ROY CLASSIFICATION SCORE WAS CLASS III: RESIDUAL NECK. THERE WERE NO REPORTED STUDY DEVICE DEFICIENCIES OR INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2021 WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 2. THE 180-DAY FOLLOW-UP VISIT WAS PERFORMED IN THE CLINIC ON 03-NOV-2021, WITH A MODIFIED RANKIN SCALE (MRS) SCORE OF 0. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) WAS PERFORMED AT THIS 180-DAY (6-MONTH) FOLLOW-UP AND SHOWED A MODIFIED RAYMOND-ROY CLASSIFICATION SCORE OF CLASS II: RESIDUAL NECK = PERSISTENCE OF ANY PORTION OF THE ORIGINAL DEFECT OF THE ARTERIAL WALL BUT WITHOUT OPACIFICATION OF THE ANEURYSM SAC. THE STATUS OF THE TARGET ANEURYSM HAS NOT CHANGED SINCE THE PREVIOUS VISIT (NEWLY RUPTURED OR RE-RUPTURED).ON (B)(6) 2021 THE PATIENT EXPERIENCED A RECURRENCE OF THE ANEURYSM, WHICH WAS RETREATED WITH FOUR (4) NON-CERENOVUS COILS (STRYKER-TARGET): ONE 30, ONE 360 ULTRA, AND TWO 360 NANO. THE MODIFIED RAYMOND-ROY CLASSIFICATION FOR THE TARGET ANEURYSM FOLLOWING RETREATMENT WAS CLASS II: RESIDUAL NECK. THE PATIENT DID NOT EXPERIENCE AN INTRA-OPERATIVE ANEURYSM RUPTURE OR THROMBOEMBOLIC EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1248177 | GALAXY G3 6MM X 20CM | NEUROVASCULAR EMBOLIZATION DEVICE | KRD | MEDOS INTERNATIONAL SARL | GLY120620 | L14866 | 10886704077541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Female | Required Intervention | EXCELSIOR SL10 MICROCATHETER (STRYKER)| GALAXY G3 6MM X 10CM| GALAXY G3 6MM X 15CM| GALAXY G3 6MM X 20CM| GALAXY G3 8MM X 24CM| GALAXY G3 9MM X 25CM| GALAXY G3 XSFT 2.5MM X 5CM| GALAXY G3 XSFT 3.5MM X 7.5CM| GALAXY G3 XSFT 3MM X 4CM| GALAXY G3 XSFT 4MM X 10CM |