GALAXY G3 MINI 1.5MM X 3CM
Report
- Report Number
- 3008114965-2018-00805
- Event Type
- Injury
- Date Received
- November 14, 2018
- Date of Event
- October 30, 2018
- Report Date
- November 1, 2018
- Manufacturer
- REFER TO SECTION H10
- Product Code
- KRD
- UDI-DI
- 10886704080145
- PMA / PMN Number
- K171862
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED FROM THE CLINICAL DATABASE ON 01 DECEMBER 2020. [ADDITIONAL INFORMATION]: ON 01 DECEMBER 2020, ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL DATABASE. THE INFORMATION WAS TO UPDATE THE END DATE OF THE TARGET ANEURYSM RUPTURE WITH SUBARACHNOID HEMORRHAGE EVENT FROM ON (B)(6) 2020 TO ON (B)(6) 2018. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00804 AND 3008114965-2018-00805. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED ON 29 SEPTEMBER 2021. [ADDITIONAL INFORMATION]: MODIFIED INFORMATION WAS RECEIVED ON 29 SEPTEMBER 2021. THE INFORMATION WAS REVIEWED. THE OUTCOME OF THE TARGET ANEURYSM RUPTURE WAS CHANGED FROM ¿RECOVERED / RESOLVED" TO " RECOVERED / RESOLVED WITH SEQUELAE.¿ THERE IS NO NEW INFORMATION THAT ALTERS THE PREVIOUS FILE TYPE DETERMINATION, CODING, AND/OR REPORTABILITY DETERMINATIONS. ANEURYSM RUPTURE, SUBARACHNOID HEMORRHAGE AND COIL PROTRUSION INTO THE PARENT VESSEL ARE KNOWN PROCEDURAL COMPLICATIONS RELATED TO THE COIL EMBOLIZATION PROCEDURES AND IS LISTED IN THE IFU AS SUCH. MANIPULATION OF DEVICE IN OR NEAR THE INTRACRANIAL ANEURYSM INCREASE THE RISK OF RUPTURING THE FRAGILE ANEURYSM WALL. THE SUDDEN MOVEMENT OF THE MICROCATHETER AND COIL DURING COIL IMPLANTATION APPEARS TO HAVE CAUSED THE RUPTURE. ADVANCEMENT OF A MICROCATHETER THROUGH VESSEL TORTUOSITY CAN RESULT IN STORED ENERGY THAT WHEN RELEASED CAN RESULT IN SUDDEN ADVANCEMENT OF THE MICROCATHETER. SINCE THE ANEURYSM RUPTURE AND SAH ARE SERIOUS INJURIES, IT MEETS MDR REPORTING CRITERIA FOR THE MICRUSFRAME COIL. SINCE THE GALAXY G3 RESULTED IN PROTRUSION INTO THE PARENT ARTERY AND NEAR OCCLUSION AND WAS TREATED WITH THE STENT INTENDED FOR USE FOR Y STENTING IT MEETS MDR REPORTABILITY AS A SERIOUS INJURY DUE TO THE POTENTIAL FOR STROKE DUE TO ARTERIAL OCCLUSION AND NEED FOR TREATMENT TO TREAT COIL PROTRUSION. THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00804 AND 3008114965-2018-00805. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.
[H.10]: MANUFACTURER¿S REF. NO:(B)(4). THE PURPOSE OF THIS MDR IS TO INCLUDE THE ADDITIONAL EVENT INFORMATION RECEIVED FROM THE CLINICAL DATABASE ON (B)(6)2020 , AND TO MAKE A CORRECTION TO THE MANUFACTURE INFORMATION IN SECTION G. [ADDITIONAL INFORMATION]: ON (B)(6)2020 , ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL DATABASE. THE PATIENT WAS DISCHARGED TO HOME WITH NON-SKILLED NURSING CARE ON (B)(6)2018 . THE 180-DAY FOLLOW-UP VISIT WAS CONDUCTED IN-CLINIC ON (B)(6)2019 . NO IMAGING WAS PERFORMED, BUT THE STATUS OF THE TARGET ANEURYSM AT THE TIME OF THIS FOLLOW-UP VISIT WAS ¿UNRUPTURED.¿ THE MODIFIED RANKING SCALE SCORE (MRS) WAS 0. THE TARGET ANEURYSM RUPTURE WITH SUBARACHNOID HEMORRHAGE EVEN WAS CONSIDERED RESOLVED ON (B)(6)2020 . CORRECTED SECTION: G.1. UPDATED SECTIONS: G.4. G.7, H.2. AND H.10. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE COMPLAINT AND THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 3008114965-2018-00804 AND 3008114965-2018-00805. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN (B)(4) DAYS OF RECEIPT.
(B)(4). PATIENT HEIGHT: 137.2 CENTIMETERS (CM). PROCODE: KRD/HCG. PHYSICAL MANUFACTURER NAME: CODMAN AND SHURTLEFF INC., DBA DEPUY SYNTHES PRODUCTS, INC. ((B)(4)). CONCOMITANT MEDICAL PRODUCTS DUE TO CHARACTER LIMITATION: SL-10 (STRYKER) MICROCATHETER, 2 NEUROFORM ATLAS (STRYKER) STENTS (3X15MM & 3X21MM), TRAXCESS 14 (MICROVENTION) MICROWIRE. [COMPLAINT CONCLUSION] AS REPORTED VIA THE STERLING REGISTRY, A (B)(6)-YEAR OLD FEMALE (PATIENT (B)(6)), WITH A HISTORY OF CARDIAC ARRHYTHMIA, HEADACHES, SMOKING, AND CONTROLLED HYPERTENSION EXPERIENCED SEVERE INTRAOPERATIVE TARGET ANEURYSM RUPTURE DURING DEPLOYMENT OF A 3MM X 5.4CM MICRUSFRAME10 (MFR100305/L10115) THERMO-MECHANICAL COIL. LATER, A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L12447) THERMO-MECHANICAL COIL PARTIALLY PROTRUDED INTO THE ANEURYSM NECK AND PARENT VESSEL WITH CLOT, RESULTING IN NEAR VESSEL OCCLUSION FOR ONE MINUTE, BUT DID NOT RESULT IN PATIENT INJURY. AT THE TIME OF THE ANEURYSM RUPTURE, THE PATIENT¿S SYSTOLIC BLOOD PRESSURE IMMEDIATELY DROPPED TO BELOW 100 AND THE PATIENT WAS ADMINISTERED 50MG OF PROTAMINE FOR HEPARIN REVERSAL AND A 250CC BOLUS OF 3% HYPERTONIC SALINE. THE PATIENT WAS HYPERVENTILATED, AND NEUROSURGERY WAS CONTACTED IMMEDIATELY. THEY WERE ABLE TO FINISH DEPLOYING THE NEUROFORM ATLAS (STRYKER) STENT WITH DETACHMENT AND RAPID COILING OF THE REMAINING COILS. THE SL-10 (STRYKER) MICROCATHETER WAS ADVANCED OVER THE TRAXCESS 14 (MICROVENTION) MICROWIRE ACROSS THE ANEURYSM NECK, SPANNING INTO THE RIGHT PERICALLOSAL ARTERY AND THE SECOND NEUROFORM ATLAS STENT WAS ADVANCED AND DEPLOYED SUCCESSFULLY ACROSS THE ANEURYSM NECK WITH NO DIFFICULTY, SPANNING BETWEEN THE RIGHT PERICALLOSAL ARTERY AND THE RIGHT A2 ANTERIOR CEREBRAL ARTERY (ACA). THE FOLLOW-UP INTERNAL CAROTID ARTERY ANGIOGRAM SHOWED NO EVIDENCE OF DISTAL EMBOLIZATION AND CONFIRMED PATENCY OF THE Y-STENTS, AS WELL AS COMPLETE OBLITERATION OF THE RIGHT PERICALLOSAL ARTERY ANEURYSM. MODIFIED RAYMOND-ROY CLASSIFICATION WAS CLASS 1 (COMPLETE OBLITERATION). AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS EMERGENTLY PLACED IN THE ANGIOGRAPHY SUITE BY THE NEUROSURGERY TEAM. THE PATIENT WAS KEPT INTUBATED AND TRANSFERRED TO THE NEURO INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. A LEFT FEMORAL CENTRAL LINE WAS PLACED BY THE NEURO ICU TEAM. COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD PERFORMED POSTOPERATIVELY REVEALED ACUTE SUBARACHNOID HEMORRHAGE. THE PATIENT WAS SYMPTOMATIC WITH DROWSINESS AND ALTERED MENTATION/CONFUSION FOR FOUR TO FIVE DAYS AND IS NOW BACK TO BASELINE WITH NO STROKE DEFICITS. AFTER SEVERAL DAYS, THE EVD WAS REMOVED AND THE PATIENT HAS BEEN DOING WELL WITHOUT ANY EVIDENCE OF CEREBRAL VASOSPASM. THE EVENT HAS NEARLY RESOLVED, AND THE PATIENT REMAINED HOSPITALIZED FOR MONITORING WITH POSSIBLE DISCHARGE ON (B)(6) 2018. IT WAS LAST REPORTED THAT THE PATIENT¿S MODIFIED RANKIN SCALE (MRS) SCORE WAS 1 AND NIH STROKE SCALE SCORE WAS 0. ACCORDING TO THE INVESTIGATOR, THE ANEURYSM RUPTURE WAS PROBABLY RELATED TO THE STUDY DEVICE. THE INVESTIGATOR SUSPECTED THAT THE CAUSE OF THE RUPTURE WAS THE PROXIMAL ACA VESSEL TORTUOSITY AND THE FORWARD MOTION OF THE MICROCATHETER AND COIL DURING DEPLOYMENT OF THE FRAMING COIL. PRE-TREATMENT ANGIOGRAPHY REVEALED AN ANTERIOR CIRCULATION BIFURCATION ANEURYSM OF THE RIGHT PERICALLOSAL ARTERY. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 2.8MM, DOME WIDTH 2.6MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO OF 0.8MM. THE MAXIMUM ANEURYSM DIAMETER WAS 4.0MM AND THE PARENT VESSEL DIAMETER WAS 1.4MM. 10MG NICARDIPINE WAS INFUSED TO REDUCE THE LIKELIHOOD OF ARTERIAL SPASM. THE PHYSICIAN SUCCESSFULLY POSITIONED THE SL-10 (STRYKER) MICROCATHETER IN THE ANEURYSM AFTER CROSSING THE DEPLOYED NEUROFORM ATLAS STENT. THE 3MM X 5.4CM MICRUSFRAME10 WAS BEING DEPLOYED AND IN THE SECOND HALF OF THE COIL, NO KICKBACK OR RESISTANCE WAS FELT, BUT THE COIL AND MICROCATHETER MOVED FORWARD THROUGH THE ANEURYSM WALL, RESULTING IN ANEURYSM RUPTURE. THE FOLLOWING GALAXY G3 MINI COILS WERE THEN SUCCESSFULLY DEPLOYED: ONE 2MM X 4CM (GLM920040/L12027) AND ONE 1.5MM X 3CM (GLM915030/L12447). AFTER DEPLOYING A SECOND 1.5MM X 3MM GALAXY G3 MINI (GLM915030/L12447), THE EMBOLIC COIL MIGRATED INTO THE RIGHT PERICALLOSAL ARTERY RESULTING IN NEAR OCCLUSION OF THE VESSEL. THE EVENT WAS TREATED WITH PLACEMENT OF THE SECOND NEUROFORM ATLAS STENT THAT WAS USED FOR THE Y-STENTING. THE PHYSICIAN DID NOT FEEL THAT THE BRIEF ARTERIAL OCCLUSION WAS CLINICALLY SIGNIFICANT. THE ANEURYSM RUPTURE WAS TREATED WITH THE SAME COILS THAT WERE PLANNED TO BE USED FOR TREATMENT OF THE ANEURYSM IF THE RUPTURE HAD NOT OCCURRED. NO FOLLOW-UP TREATMENT IS SCHEDULED, WITH THE EXCEPTION OF A ROUTINE DIAGNOSTIC ANGIOGRAM. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS COMPLETE WITH COILS MAINTAINED WITHIN THE ANEURYSM SAC AND NO EVIDENCE OF A DEVICE MALFUNCTION. THERE WAS NO REPORT OF AN INTRAOPERATIVE THROMBO-EMBOLIC EVENT. PACKING DENSITY AT THE CONCLUSION OF THE PROCEDURE (USING ANGIOCALC) WAS 29.30 %. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PLAVIX 75MG WAS INITIATED ON (B)(6) 2017 AND WAS CONTINUED AT DISCHARGE. ASPIRIN 81MG WAS STARTED ON (B)(6) 2018 AND WAS CONTINUED AT DISCHARGE. HEPARIN 7000 UNITS WERE GIVEN DURING THE PROCEDURE AND HEPARIN 5000 UNITS SC TID WAS INITIATED ON (B)(6) 2018 AND DISCONTINUED ON (B)(6) 2018. NO FURTHER INFORMATION AS PROVIDED. THE 1.5MM X 3CM GALAXY G3 MINI COIL WAS NOT RETURNED FOR EVALUATION. A REVIEW OF MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESSES RELATED TO THE REPORTED COMPLAINT. THERE WERE NO NONCONFORMANCES RELATED TO DEVICE MANUFACTURE OR INSPECTION. ALL PRODUCT REJECTED DURING MANUFACTURING WAS IDENTIFIED AS SCRAP AND PROPERLY ACCOUNTED FOR. COIL PROTRUSION INTO THE PARENT VESSEL AND ARTERIAL OCCLUSION ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH COIL EMBOLIZATION AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). WIDE-NECK ANEURYSMS ARE PRONE TO COIL PROTRUSION. RECENT ADVANCEMENTS IN VASCULAR RECONSTRUCTION DEVICES AND COILS HAVE ALLOWED FOR THE APPLICATION OF COIL EMBOLIZATION FOR EVEN RELATIVELY WIDE-NECK ANEURYSMS. GEOMETRICALLY COMPLEX ANEURYSMS THAT POSE A TECHNICAL CHALLENGE, SUCH AS WIDE-NECKED BIFURCATION ANEURYSMS, ARE SOMETIMES TREATED WITH ENDOVASCULAR STENT-ASSISTED COILING. USE OF A SINGLE STENT INVOLVES DEPLOYING THE STENT ACROSS A VESSEL LUMEN AT THE NECK OF THE LESION TO PROVIDE MECHANICAL SUPPORT AND PREVENT POTENTIAL COIL PROLAPSE INTO THE VESSEL LUMEN. Y-STENTING, INVOLVES PLACING TWO STENTS IN THE ADJACENT ARTERIES IN A Y CONFIGURATION. IT IS GENERALLY BELIEVED THAT PROTRUSION OF ONLY A FEW LOOPS DOES NOT POSE AN ADDITIONAL RISK IF APPROPRIATE ANTIPLATELET THERAPY IS USED. ALTERNATIVELY, MODERATE TO SEVERE COIL PROTRUSION INTO THE PARENT ARTERY MAY NECESSITATE COIL RETRIEVAL OR STENT DEPLOYMENT IN THE PARENT ARTERY. HOWEVER, THERE ARE FEW REPORTS ASSESSING THE FREQUENCY OF THROMBO-EMBOLIC EVENTS, ASSOCIATED WITH VARIOUS DEGREES OF COIL PROTRUSION. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE INFORMATION AVAILABLE FOR REVIEW; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING ANEURYSM SIZE/CHARACTERISTICS (I.E. WIDE-NECK) AND THE MANIPULATION OF DEVICES IN AND OUT OF THE ANEURYSM SAC, MAY HAVE CONTRIBUTED TO THE COIL PROTRUSION AND SUBSEQUENT ARTERIAL OCCLUSION. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE/PREVENTIVE ACTION MAY BE TRIGGERED AT A LATER TIME. 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. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT 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 3008114965-2018-00804 & 3008114965-2018-00805.
AS REPORTED VIA THE STERLING REGISTRY, A (B)(6)-YEAR OLD FEMALE (PATIENT (B)(6)), WITH A HISTORY OF CARDIAC ARRHYTHMIA, HEADACHES, SMOKING, AND CONTROLLED HYPERTENSION EXPERIENCED SEVERE INTRAOPERATIVE TARGET ANEURYSM RUPTURE DURING DEPLOYMENT OF A 3MM X 5.4CM MICRUSFRAME 10 (MFR100305/L10115) THERMO-MECHANICAL COIL. LATER, A 1.5MM X 3CM GALAXY G3 MINI (GLM915030/L12447) THERMO-MECHANICAL COIL PARTIALLY PROTRUDED INTO THE ANEURYSM NECK AND PARENT VESSEL WITH CLOT, RESULTING IN NEAR VESSEL OCCLUSION FOR ONE MINUTE, BUT DID NOT RESULT IN PATIENT INJURY. AT THE TIME OF THE ANEURYSM RUPTURE, THE PATIENT¿S SYSTOLIC BLOOD PRESSURE IMMEDIATELY DROPPED TO BELOW 100 AND THE PATIENT WAS ADMINISTERED 50MG OF PROTAMINE FOR HEPARIN REVERSAL AND A 250CC BOLUS OF 3% HYPERTONIC SALINE. THE PATIENT WAS HYPERVENTILATED, AND NEUROSURGERY WAS CONTACTED IMMEDIATELY. THEY WERE ABLE TO FINISH DEPLOYING THE NEUROFORM ATLAS (STRYKER) STENT WITH DETACHMENT AND RAPID COILING OF THE REMAINING COILS. THE SL-10 (STRYKER) MICROCATHETER WAS ADVANCED OVER THE TRAXCESS 14 (MICROVENTION) MICROWIRE ACROSS THE ANEURYSM NECK, SPANNING INTO THE RIGHT PERICALLOSAL ARTERY AND THE SECOND NEUROFORM ATLAS STENT WAS ADVANCED AND DEPLOYED SUCCESSFULLY ACROSS THE ANEURYSM NECK WITH NO DIFFICULTY, SPANNING BETWEEN THE RIGHT PERICALLOSAL ARTERY AND THE RIGHT A2 ANTERIOR CEREBRAL ARTERY (ACA). THE FOLLOW-UP INTERNAL CAROTID ARTERY ANGIOGRAM SHOWED NO EVIDENCE OF DISTAL EMBOLIZATION AND CONFIRMED PATENCY OF THE Y-STENTS, AS WELL AS COMPLETE OBLITERATION OF THE RIGHT PERICALLOSAL ARTERY ANEURYSM. MODIFIED RAYMOND-ROY CLASSIFICATION WAS CLASS 1 (COMPLETE OBLITERATION). AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS EMERGENTLY PLACED IN THE ANGIOGRAPHY SUITE BY THE NEUROSURGERY TEAM. THE PATIENT WAS KEPT INTUBATED AND TRANSFERRED TO THE NEURO INTENSIVE CARE UNIT (ICU) IN STABLE CONDITION. A LEFT FEMORAL CENTRAL LINE WAS PLACED BY THE NEURO ICU TEAM. COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD PERFORMED POSTOPERATIVELY REVEALED ACUTE SUBARACHNOID HEMORRHAGE. THE PATIENT WAS SYMPTOMATIC WITH DROWSINESS AND ALTERED MENTATION/CONFUSION FOR FOUR TO FIVE DAYS AND IS NOW BACK TO BASELINE WITH NO STROKE DEFICITS. AFTER SEVERAL DAYS, THE EVD WAS REMOVED AND THE PATIENT HAS BEEN DOING WELL WITHOUT ANY EVIDENCE OF CEREBRAL VASOSPASM. THE EVENT HAS NEARLY RESOLVED, AND THE PATIENT REMAINED HOSPITALIZED FOR MONITORING WITH POSSIBLE DISCHARGE ON (B)(6) 2018. IT WAS LAST REPORTED THAT THE PATIENT¿S MODIFIED RANKIN SCALE (MRS) SCORE WAS 1 AND NIH STROKE SCALE SCORE WAS 0. ACCORDING TO THE INVESTIGATOR, THE ANEURYSM RUPTURE WAS PROBABLY RELATED TO THE STUDY DEVICE. THE INVESTIGATOR SUSPECTED THAT THE CAUSE OF THE RUPTURE WAS THE PROXIMAL ACA VESSEL TORTUOSITY AND THE FORWARD MOTION OF THE MICROCATHETER AND COIL DURING DEPLOYMENT OF THE FRAMING COIL. PRE-TREATMENT ANGIOGRAPHY REVEALED AN ANTERIOR CIRCULATION BIFURCATION ANEURYSM OF THE RIGHT PERICALLOSAL ARTERY. THE UNRUPTURED ANEURYSM HAD THE FOLLOWING DIMENSIONS: HEIGHT 2.8MM, DOME WIDTH 2.6MM, NECK SIZE 3.2MM, AND DOME-TO-NECK RATIO OF 0.8MM. THE MAXIMUM ANEURYSM DIAMETER WAS 4.0MM AND THE PARENT VESSEL DIAMETER WAS 1.4MM. 10MG NICARDIPINE WAS INFUSED TO REDUCE THE LIKELIHOOD OF ARTERIAL SPASM. THE PHYSICIAN SUCCESSFULLY POSITIONED THE SL-10 (STRYKER) MICROCATHETER IN THE ANEURYSM AFTER CROSSING THE DEPLOYED NEUROFORM ATLAS STENT. THE 3MM X 5.4CM MICRUSFRAME 10 WAS BEING DEPLOYED AND IN THE SECOND HALF OF THE COIL, NO KICKBACK OR RESISTANCE WAS FELT, BUT THE COIL AND MICROCATHETER MOVED FORWARD THROUGH THE ANEURYSM WALL, RESULTING IN ANEURYSM RUPTURE. THE FOLLOWING GALAXY G3 MINI COILS WERE THEN SUCCESSFULLY DEPLOYED: ONE 2MM X 4CM (GLM920040/L12027) AND ONE 1.5MM X 3CM (GLM915030/L12447). AFTER DEPLOYING A SECOND 1.5MM X 3MM GALAXY G3 MINI (GLM915030/L12447), THE EMBOLIC COIL MIGRATED INTO THE RIGHT PERICALLOSAL ARTERY RESULTING IN NEAR OCCLUSION OF THE VESSEL. THE EVENT WAS TREATED WITH PLACEMENT OF THE SECOND NEUROFORM ATLAS STENT THAT WAS USED FOR THE Y-STENTING. THE PHYSICIAN DID NOT FEEL THAT THE BRIEF ARTERIAL OCCLUSION WAS CLINICALLY SIGNIFICANT. THE ANEURYSM RUPTURE WAS TREATED WITH THE SAME COILS THAT WERE PLANNED TO BE USED FOR TREATMENT OF THE ANEURYSM IF THE RUPTURE HAD NOT OCCURRED. NO FOLLOW-UP TREATMENT IS SCHEDULED, WITH THE EXCEPTION OF A ROUTINE DIAGNOSTIC ANGIOGRAM. IN THE OPINION OF THE INVESTIGATOR, TREATMENT OF THE TARGET ANEURYSM WAS COMPLETE WITH COILS MAINTAINED WITHIN THE ANEURYSM SAC AND NO EVIDENCE OF A DEVICE MALFUNCTION. THERE WAS NO REPORT OF AN INTRAOPERATIVE THROMBO-EMBOLIC EVENT. PACKING DENSITY AT THE CONCLUSION OF THE PROCEDURE (USING ANGIOCALC) WAS 29.30 %. PLATELET REACTIVITY TESTING WAS NOT PERFORMED. PLAVIX 75MG WAS INITIATED ON (B)(6) 2017 AND WAS CONTINUED AT DISCHARGE. ASPIRIN 81MG WAS STARTED ON (B)(6) 2018 AND WAS CONTINUED AT DISCHARGE. HEPARIN 7000 UNITS WERE GIVEN DURING THE PROCEDURE AND HEPARIN 5000 UNITS SC TID WAS INITIATED ON (B)(6) 2018 AND DISCONTINUED ON (B)(6) 2018. THE COILS REMAIN IMPLANTED IN THE PATIENT AND ARE THUS NOT AVAILABLE FOR EVALUATION. NO FURTHER INFORMATION AS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 908757 | GALAXY G3 MINI 1.5MM X 3CM | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION | KRD | REFER TO SECTION H10 | GLM915030 | L12447 | 10886704080145 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Required Intervention | REFER TO SECTION H10. |