XTRASOFT ORBIT GALAXY DETACHABLE COIL

Report

Report Number: 3008264254-2015-00044
Event Type: Injury
Date Received: July 13, 2015
Date of Event: May 3, 2013
Report Date: August 18, 2015
Manufacturer: CODMAN AND SHURTLEFF, INC
Product Code: HCG
PMA / PMN Number: K093973
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

THE TRUELINE STUDY REPORTED THAT DURING THE DEPLOYMENT OF THE 3RD CODMAN TRUFILL COIL, A PERFORATION OF THE ANEURYSM SAC HAS BEEN OBSERVED, CAUSING A SUBARACHNOID HEMORRHAGE (SAH). ADDITIONALLY, IT WAS NOTED THAT THE THIRD COIL CAUSED THE SAH; NAMELY C. GALAXY COMPLEX XTRA 3,5MMX7,5 /15727743. NO OTHER DEVICES WERE ASSOCIATED WITH THE SUBARACHNOID HEMORRHAGE, AND ALL GUIDELINES WERE FOLLOWED DURING DELIVERY OF THE DEVICE. THE SAH HAS BEEN IMMEDIATELY STOPPED DURING THE PROCEDURE WITH THE BALLOON AND ADDITIONAL COILS WERE USED. THE DEVICES USED DURING THE PROCEDURE CONSISTED 1 UNIT C. GALAXY COMPLEX FILL 5MMX15 (225150) NUM LOT : 15700136/ 640CF0515, AND 1 UNIT C. CERECYTE 10 PRESIDIO 06X260MM (183491) NUM LOT : C16535. DURING THE EVENT, A REMODELING BALLON, HYPERGLIDE 4 X 15MM, WAS KEPT INFLATED AND COILING CONTINUED UNTIL BLEEDING HAD BEEN STOPPED. HEPARIN WAS REVERSED BY THE ANESTHETIST BY INTRAVENOUS INJECTION OF PROTAMINE SULFATE. DURING THE EVENT, A SLIGHT, ADDITIONAL FORCE WAS APPLIED TO MAKE THE DISTAL PORTION OF THE THIRD COIL ADVANCE INTO THE ANEURYSM. A CT SCAN WAS PERFORMED AT THE END OF THE PROCEDURE, SHOWING A GRADE FISHER 4 SUBARACHNOID HEMORRHAGE. A CONTROL CT WAS DONE 3 DAYS LATER, SHOWING THE NEARLY COMPLETE RESOLUTION OF THE BLEEDING. THERE WAS NO DISABILITY REPORTED WITH THE EVENT AND NO CLINICAL SIGNIFICANCE. THE EVENT WAS CONSIDERED SERIOUS ADVERSE EVENT AND LIFE THREATENING. THE EVENT WAS HIGHLY PROBABLE TO THE EVENT AND POSSIBLE RELATED TO THE TRUFILL COILS, BUT UNRELATED TO THE DISEASE. ANGIOGRAPHY WAS CONDUCTED AFTER THE PROCEDURE. THE TARGET SITE WAS THE POSTERIOR COMMUNICATING ARTERY DISCOVERED WITHOUT SYMPTOM. TREATMENT WAS CONDUCTED WITH MORE OR EQUAL TO 70% TRUFILL COIL AND USED ADDITIONAL TECHNIQUE. THE RESULTS WERE SATISFACTORY, BUT SAH WAS OBSERVED DURING THE COILING PROCEDURE. THERE WAS 100% OCCLUSION OF THE ANEURYSM WITH SATISFACTORY RESULTS WITH COMPLETE OCCLUSION. THE PATIENT WAS DISCHARGED NINE DAYS AFTER INDEX PROCEDURE. THIRTY DAY FOLLOW-UP WAS CONDUCTED WITH NO ADVERSE EVENT REPORTED, ALSO THE ONE YEAR REPORT WAS CONDUCTED WITHOUT SYMPTOMS NO ADVERSE EVENT. ANGIOGRAPHY AT ONE YEAR SHOWED COMPLETE OCCLUSION 100% COMPARE TO INDEX PROCEDURE, AND NO RECANALIZATION. THE PATIENT COMPLETED THE STUDY. MEDICATIONS CONSISTED OF PRE-PROCEDURE OF EFFEXOR, SERESTA, AND POST PROCEDURE WITH LISANXIA 10MG, VENLAFANXINE 75,MG, CONTRAMAL 100MG, AND DOLIPRANE 500MG. RIGHT POSTERIOR COMMUNICATING ARTERY, HEIGHT 7.8MM NECK 4 MM, NON RUPTURED, PROCEDURE DESCRIPTION : COILS PLACEMENT WITH BALLOON REMODELING TECHNIQUE, COMPLETE OCCLUSION. THE COIL WAS NOT RETURNED; THEREFORE THE ROOT CAUSE OF THE EVENTS CANNOT BE DETERMINED. REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THE LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. SUBARACHNOID HEMORRHAGE, RUPTURED ANEURYSM AND RECANALIZATION OF THE ANEURYSM ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE COILS AS OUTLINED IN THE INSTRUCTIONS FOR USE. CLINICAL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. BASED ON THE REPORTED INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

Additional Manufacturer Narrative · 1

THE TRUELINE STUDY REPORTED THAT DURING THE DEPLOYMENT OF THE 3RD CODMAN TRUFILL COIL, A PERFORATION OF THE ANEURYSM SAC HAS BEEN OBSERVED, CAUSING A SUBARACHNOID HEMORRHAGE (SAH). ADDITIONALLY, IT WAS NOTED THAT THE THIRD COIL CAUSED THE SAH; NAMELY C. GALAXY COMPLEX XTRA 3,5MMX7,5 /(B)(4). NO OTHER DEVICES WERE ASSOCIATED WITH THE SUBARACHNOID HEMORRHAGE, AND ALL GUIDELINES WERE FOLLOWED DURING DELIVERY OF THE DEVICE. THE SAH HAS BEEN IMMEDIATELY STOPPED DURING THE PROCEDURE WITH THE BALLOON AND ADDITIONAL COILS WERE USED. THE DEVICES USED DURING THE PROCEDURE CONSISTED 1 UNIT C. GALAXY COMPLEX FILL 5MMX15 ((B)(4)) NUM LOT : 15700136/ 640CF0515, AND 1 UNIT C. CERECYTE 10 PRESIDIO 06X260MM (183491) NUM LOT : C16535. DURING THE EVENT, A REMODELING BALLOON, HYPERGLIDE 4 X 15MM, WAS KEPT INFLATED AND COILING CONTINUED UNTIL BLEEDING HAD BEEN STOPPED. HEPARIN WAS REVERSED BY THE ANESTHETIST BY INTRAVENOUS INJECTION OF PROTAMINE SULFATE. DURING THE EVENT, A SLIGHT, ADDITIONAL FORCE WAS APPLIED TO MAKE THE DISTAL PORTION OF THE THIRD COIL ADVANCE INTO THE ANEURYSM. A CT SCAN WAS PERFORMED AT THE END OF THE PROCEDURE, SHOWING A GRADE FISHER 4 SUBARACHNOID HEMORRHAGE. A CONTROL CT WAS DONE 3 DAYS LATER, SHOWING THE NEARLY COMPLETE RESOLUTION OF THE BLEEDING. THERE WAS NO DISABILITY REPORTED WITH THE EVENT AND NO CLINICAL SIGNIFICANCE. THE EVENT WAS CONSIDERED SERIOUS ADVERSE EVENT AND LIFE THREATENING. THE EVENT WAS HIGHLY PROBABLE TO THE EVENT AND POSSIBLE RELATED TO THE TRUFILL COILS, BUT UNRELATED TO THE DISEASE. ANGIOGRAPHY WAS CONDUCTED AFTER THE PROCEDURE. THE TARGET SITE WAS THE POSTERIOR COMMUNICATING ARTERY DISCOVERED WITHOUT SYMPTOM. TREATMENT WAS CONDUCTED WITH MORE OR EQUAL TO 70% TRUFILL COIL AND USED ADDITIONAL TECHNIQUE. THE RESULTS WERE SATISFACTORY, BUT SAH WAS OBSERVED DURING THE COILING PROCEDURE. THERE WAS 100% OCCLUSION OF THE ANEURYSM WITH SATISFACTORY RESULTS WITH COMPLETE OCCLUSION. THE PATIENT WAS DISCHARGED NINE DAYS AFTER INDEX PROCEDURE. THIRTY DAY FOLLOW-UP WAS CONDUCTED WITH NO ADVERSE EVENT REPORTED, ALSO THE ONE YEAR REPORT WAS CONDUCTED WITHOUT SYMPTOMS NO ADVERSE EVENT. ANGIOGRAPHY AT ONE YEAR SHOWED COMPLETE OCCLUSION 100% COMPARE TO INDEX PROCEDURE, AND NO RECANALIZATION. THE PATIENT COMPLETED THE STUDY. MEDICATIONS CONSISTED OF PRE-PROCEDURE OF EFFEXOR, SERESTA, AND POST PROCEDURE WITH LISANXIA 10MG, VENLAFANXINE 75,MG, CONTRAMAL 100MG, AND DOLIPRANE 500MG. RIGHT POSTERIOR COMMUNICATING ARTERY, HEIGHT 7.8MM NECK 4 MM, NON RUPTURED, PROCEDURE DESCRIPTION : COILS PLACEMENT WITH BALLOON REMODELING TECHNIQUE, COMPLETE OCCLUSION. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Additional Manufacturer Narrative · 1

UDI# (B)(4). THE PRODUCT REMAINS IMPLANTED, AND WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem · 1

THE TRUELINE STUDY REPORTED FOR PATIENT WITH ID (B)(6) THAT DURING THE DEPLOYMENT OF THE 3RD CODMAN TRUFILL COILS, A PERFORATION OF THE ANEURYSM SAC HAS BEEN OBSERVED, CAUSING A SUBARACHNOID HEMORRHAGE (SAH). THE SAH HAS BEEN IMMEDIATELY STOPPED DURING THE PROCEDURE WITH THE BALLOON AND ADDITIONAL COILS WERE USED. THE DEVICE USED DURING THE PROCEDURE CONSISTED ON 1 UNIT C. GALAXY COMPLEX XTRA 3,5MMX7,5 (225133) NUM LOT : 15727743/ 640CX3575 10886704030706, 1 UNIT C. GALAXY COMPLEX FILL 5MMX15 (225150) NUM LOT : 15700136/ 640CF0515 10886704030300, AND 1 UNIT C. CERECYTE 10 PRESIDIO 06X260MM (183491) NUM LOT : C16535 00878528003021. NO OTHER DEVICES WERE ASSOCIATED WITH THE SUBARACHNOID HEMORRHAGE, AND ALL GUIDELINES WERE FOLLOWED DURING DELIVERY OF THE DEVICE. DURING THE EVENT, A REMODELING BALLON, HYPERGLIDE 4 X 15MM, WAS KEPT INFLATED AND COILING CONTINUED UNTIL BLEEDING HAD BEEN STOPPED. HEPARIN WAS REVERSED BY THE ANESTHETIST BY INTRAVENOUS INJECTION OF PROTAMINE SULFATE. DURING THE EVENT, A SLIGHT, ADDITIONAL FORCE WAS APPLIED TO MAKE THE DISTAL PORTION OF THE THIRD COIL ADVANCE INTO THE ANEURYSM. A CT SCAN WAS PERFORMED AT THE END OF THE PROCEDURE, SHOWING A GRADE FISHER 4 SUBARACHNOID HEMORRHAGE. A CONTROL CT WAS DONE 3 DAYS LATER, SHOWING THE NEARLY COMPLETE RESOLUTION OF THE BLEEDING. THERE WAS NO DISABILITY REPORTED WITH THE EVENT AND NO CLINICAL SIGNIFICANCE. THE EVENT WAS CONSIDERED SERIOUS ADVERSE EVENT AND LIFE THREATENING. THE EVENT WAS HIGHLY PROBABLE TO THE EVENT AND POSSIBLE RELATED TO THE TRUFILL COILS, BUT UNRELATED TO THE DISEASE. ANGIOGRAPHY WAS CONDUCTED AFTER THE PROCEDURE. THE TARGET SITE WAS THE POSTERIOR COMMUNICATING ARTERY DISCOVERED WITHOUT SYMPTOM. TREATMENT WAS CONDUCTED WITH MORE OR EQUAL TO 70% TRUFILL COIL AND USED ADDITIONAL TECHNIQUE. THE RESULTS WERE SATISFACTORY, BUT SAH WAS OBSERVED DURING THE COILING PROCEDURE. THERE WAS 100% OCCLUSION OF THE ANEURYSM WITH SATISFACTORY RESULTS WITH COMPLETE OCCLUSION. THE PATIENT WAS DISCHARGED NINE DAYS AFTER INDEX PROCEDURE. THIRTY DAY FOLLOW-UP WAS CONDUCTED WITH NO ADVERSE EVENT REPORTED, ALSO THE ONE YEAR REPORT WAS CONDUCTED WITHOUT SYMPTOMS NO ADVERSE EVENT. ANGIOGRAPHY AT ONE YEAR SHOWED COMPLETE OCCLUSION 100% COMPARE TO INDEX PROCEDURE, AND NO RECANALIZATION. THE PATIENT COMPLETED THE STUDY. MEDICATIONS CONSISTED OF PRE-PROCEDURE OF EFFEXOR, SERESTA, AND POST PROCEDURE WITH LISANXIA 10MG, VENLAFANXINE 75,MG, CONTRAMAL 100MG, AND DOLIPRANE 500MG. RIGHT POSTERIOR COMMUNICATING ARTERY, HEIGHT 7.8MM NECK 4 MM, NON RUPTURED, PROCEDURE DESCRIPTION : COILS PLACEMENT WITH BALLOON REMODELING TECHNIQUE, COMPLETE OCCLUSION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
452681	XTRASOFT ORBIT GALAXY DETACHABLE COIL	ARTIFICIAL EMBOLIZATION DEVICE	HCG	CODMAN AND SHURTLEFF, INC		15727743

Patients

Seq	Age	Sex	Outcome	Treatment
1	55 YR		Life Threatening\| R