MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC XTRASOFT ORBIT GALAXY DETACHABLE COIL; ARTIFICIAL EMBOLIZATION DEVICE

Catalog Number 640CX3505

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Aneurysm (1708); Infarction, Cerebral (1771); Thrombosis (2100); Transient Ischemic Attack (2109)

Event Date 06/08/2013

Event Type  Injury  

Event Description

This complaint is from a clinical study ¿(b)(6).The index procedure took place on (b)(6) 2011.The procedure was coil embolisation of unknown vessels, assisted with vrd (enc452212/01425604) at right cavernous sinus of the patient.The patient suffered transient ischemic attack 2.5 years after the initial procedure that caused the paralysis and numbness of the left side of the body.Argatroban was administered by an intravenous drip injection, and bayaspirin and plavix were orally administered.The patient was able to recuperate.According to the physician, the relationship of the event to the vrd was unrelated, however, it is related to the procedure for the recanalization of the aneurysm neck was identified, and the physician believes that the thrombus formed at this part caused the attack.Nevertheless, the physician believes that the attack was unpredictable.The outcome of aneurysm recanalisation 3 months after the event was indicated as ¿resolved without sequeale¿.The patient had a medical history of hypertension.

Manufacturer Narrative

Previous to the index procedure, the diameter of the unruptured saccular aneurysm neck was 3.5mm, and the neck to sac ratio was 3.5mm:5.1mm.The maximum width was 5.4mm.The parent vessel size diameter proximal was 3.9mm and distally was 3.9mm.No information regarding mrs, inr, pt, ptt and the occlusion rate of aneurysm.After the index procedure, the diameter of the neck to sac ratio was 4.0mm:6.2mm.The maximum width was 6.2mm.The parent vessel size diameter of both the proximal and the distally were 3.8mm.The occlusion rate was 95%, and the raymond class was 2.The 1st year follow-up was conducted.Angiography was done for the examination.The size of the aneurysm was same as after the procedure, and also the occlusion rate and the raymond class were same.The 2nd year follow-up was conducted.The detail of the examination is not available.The 3rd year follow-up was conducted.Mra was taken for the examination.It was confirmed that the vrd was successfully positioning the coils inside the aneurysm.The size of the aneurysm neck, the neck to sac ratio, and both the proximal and distal diameter of the parent vessel sizes at the time of 3rd year follow-up were unknown.The inr, pt, ptt, and the occlusion rate were also unknown.Mrs at the time of both previous and after the procedure, 1st year and 3rd year follow-up were 0.Antiplatelet therapy included bayaspirin 100mg/day: (b)(6) 2013 ~ ongoing, plavix 75mg/day: (b)(6) 2013 ~ (b)(6) 2013, and 25mg/day: (b)(6) 2013 ~ (b)(6) 2014.During the procedure, jailed-technique was utilized.No information regarding the previous coil embolisation was provided.No further information is available and procedural images are not available.An unspecified roadmaster th (goodman, type unknown) was used for the guiding catheter.For the microcatheter, both an unspecified prowler select plus (lot unknown) and an unspecified excelsior sl-10 (stryker, type unknown) were used.For the guide wire, two unspecified chikai (asahi intecc, type unknown) were used for vrd and the coil embolization.6 orbit galaxy complex g (one 4mmx8cm, one 3mmx4cm, two 2.5mmx2.5cm, two 3.5mmx5cm ¿ all 0.012 inch diameter) were used.The first recanalization was identified at the time of the 1st follow-up.The coil embolization was conducted.The date of the procedure unknown and no information of the coils used is available.There is no report of the further vrd procedure being performed.The patient¿s condition was ¿resolved without sequelae¿ about 2 weeks later.The occlusion rate was 90%.The second recanalization was identified 5 months after the first recanalization and the re-embolisation and pharmacotherapy were conducted for the treatment.For the pharmacotherapy, plavix 75mg has been orally administered daily and heparin 5000 units was administered through an intravenous drip injection.The 3rd coil embolisation was assisted with additional vrd stent placement.No information of the coils and the vrd used are available.It was reported on the same day that the patient¿s condition was ¿resolved without sequelae¿.According to the physician, both events were neither related with the procedure nor devices.Concomitant medical products and therapy dates: roadmaster th (goodman, type unknown).Prowler select plus (lot unknown).Excelsior sl-10 (stryker, type unknown).2 chikai (asahi intecc, type unknown).2 orbit galaxy complex xtrasoft coil 2.5 x 2.5 (640cx2525/unk).Orbit galaxycomplex xtrasoft coil 3 x 4 (640cx0304/unk).Orbit galaxy complex xtrasoft coil 3.5 x 5 (640cx3505/unk).Orbit galaxy tight distal loop complex xtrasoft coil 4 x 8 (640cx0408/unk).Cc: as reported via the (b)(6) study, a (b)(6)-year-old female with a history of hypertension experienced recanalization approximately 13 months and 18 months after the index procedure, and experienced a tia approximately 29 months after the procedure followed by further recanalization 32 months after the index procedure.At the time of the index procedure, the patient underwent stent assisted coil embolization with placement of an enterprise stent (enc452212/01425604) and 6 orbit coils (640cx0408 x 1, 640cx0304 x 1, 640cx2525 x 2, 640cx3505 x 2) for treatment of a right cavernous sinus aneurysm.The lot numbers of the coils were unknown.Previous to the index procedure, the diameter of the unruptured saccular aneurysm neck was 3.5mm, and the neck to sac ratio was 3.5mm:5.1mm.The maximum width was 5.4mm.The parent vessel size diameter proximal was 3.9mm and distally was 3.9mm.No information regarding mrs, inr, pt, ptt and the occlusion rate of aneurysm.During the procedure, jailed-technique was utilized.After the index procedure, the diameter of the neck to sac ratio was 4.0mm:6.2mm.The maximum width was 6.2mm.The parent vessel size diameter of both the proximal and the distally were 3.8mm.The occlusion rate was 95%, and the raymond class was 2.At the time of the 13 month recanalization, the occlusion rate was 90%, the modified rankin scale was 0, and the patient was treated with coil embolization (devices used were unknown), and the event resolved without sequelae.At the time of the 18 month recanalization, the patient was treated with re-embolization (devices and occlusion rate unknown), plavix 75mg, and intravenous heparin 5000 units.The event resolved without sequelae.The investigator felt that recanalizations were not related to the index procedure or enterprise stent.Approximately 11 months after the second recanalization, the patient experienced a transient ischemic attack (tia) with symptoms of paralysis and numbness to the left side of her body.She was treated with intravenous argatroban and oral bayaspirin and plavix.It was reported that the patient recuperated.According to the investigator, the event was not related to the enterprise stent, however, was related to the recanalization of the aneurysm neck.The physician believed that a thrombus formed at the aneurysm neck which caused the tia.Approximately 3 months later, the patient underwent additional stent assisted coil embolization for further recanalization (devices and occlusion rate unknown).It was reported that the event resolved without sequelae.At the time of the 3 year study follow-up, the patient¿s modified rankin scale was 0, and mra confirmed that the enterprise stent was successfully positioning the coils inside the aneurysm.(b)(4): the device was implanted and not available for analysis.(b)(6) reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 01425604.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with (b)(6)¿s internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at (b)(6) and was determined to be acceptable.(b)(4): the devices were implanted and not available for analysis.In addition, the lot numbers were not available; therefore, a review of the manufacturing documentation could not be performed.Aneurysm recanalization after coil embolization is a known event and has been estimated to occur in anywhere from 5% to 38% of coiled aneurysms.Factors which may have a correlation with recanalization post coil embolization include neck size, packing density, and inflow angle.The ifu precautions that multiple embolization procedures may be required to achieve the desired occlusion of some vessels or aneurysms.Thrombosis and neurological deficits are known complications associated with recanalization of aneurysms and are potential adverse events associated with the use of the enterprise stent and is listed in the instructions for use (ifu) as such.The patient¿s history of hypertension may have contributed to the events.With review of the information, and as reported, there is no indication of any device performance issues.Therefore, no corrective actions will be taken at this time.This is 1 of 7 reports associated with (b)(4).

Manufacturer Narrative

Updated cc: as reported via the (b)(4) study, a (b)(6) female with a history of hypertension experienced recanalization approximately 13 months and 18 months after the index procedure, and experienced a tia and cerebral infarction approximately 29 months after the procedure followed by further recanalization 32 months after the index procedure.At the time of the index procedure, the patient underwent stent assisted coil embolization with placement of an enterprise stent (enc452212/01425604) and 6 orbit coils (640cx0408 x 1, 640cx0304 x 1, 640cx2525 x 2, 640cx3505 x 2) for treatment of a right cavernous sinus aneurysm.The lot numbers of the coils were unknown.Previous to the index procedure, the diameter of the unruptured saccular aneurysm neck was 3.5mm, and the neck to sac ratio was 3.5mm:5.1mm.The maximum width was 5.4mm.The parent vessel size diameter proximal was 3.9mm and distally was 3.9mm.No information regarding mrs, inr, pt, ptt and the occlusion rate of aneurysm.During the procedure, jailed-technique was utilized.After the index procedure, the diameter of the neck to sac ratio was 4.0mm:6.2mm.The maximum width was 6.2mm.The parent vessel size diameter of both the proximal and the distally were 3.8mm.The occlusion rate was 95%, and the raymond class was 2.At the time of the 13 month recanalization, the occlusion rate was 90%, the modified rankin scale was 0, and the patient was treated with coil embolization (devices used were unknown), and the event resolved without sequelae.At the time of the 18 month recanalization, the patient was treated with re-embolization (devices and occlusion rate unknown), plavix 75mg, and intravenous heparin 5000 units.The event resolved without sequelae.The investigator felt that recanalizations were not related to the index procedure or enterprise stent.Approximately 11 months after the second recanalization, the patient experienced a transient ischemic attack (tia) with symptoms of paralysis and numbness to the left side of her body, later she was also diagnosed with a cerebral infarction.Location of the infarction has been concluded as not the vrd-grafted lesion site.However, it was the ipsilateral.The outcome as of (b)(6) 2013 was indicated as ¿resolved without sequelae.¿ she was treated with intravenous argatroban and oral bayaspirin and plavix.It was reported that the patient recuperated.According to the investigator, the event was not related to the enterprise stent, however was related to the recanalization of the aneurysm neck.The physician believed that a thrombus formed at the aneurysm neck which caused the tia.Approximately 3 months later, the patient underwent additional stent assisted coil embolization for further recanalization (devices and occlusion rate unknown).It was reported that the event resolved without sequelae.At the time of the 3 year study follow-up, the patient¿s modified rankin scale was 0, and mra confirmed that the enterprise stent was successfully positioning the coils inside the aneurysm.(b)(4): the device was implanted and not available for analysis.Lake region medical reviewed the device history records relative to the manufacturing, inspecting and packaging of lot 01425604.The device history record review also included a review of the certificate of conformance received from specialty coatings systems and nitinol devices and components, along with lake region medical¿s internal receiving inspection records for the stents issued to the complaint lot.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.(b)(4): the devices were implanted and not available for analysis.In addition, the lot numbers were not available; therefore, a review of the manufacturing documentation could not be performed.Aneurysm recanalization after coil embolization is a known event and has been estimated to occur in anywhere from 5% to 38% of coiled aneurysms.Factors which may have a correlation with recanalization post coil embolization include neck size, packing density, and inflow angle.The ifu precautions that multiple embolization procedures may be required to achieve the desired occlusion of some vessels or aneurysms.Thrombosis and neurological deficits are known complications associated with recanalization of aneurysms and are potential adverse events associated with the use of the enterprise stent and is listed in the instructions for use (ifu) as such.Cerebral infarction is known potential adverse event associated with neurovascular stent implantation procedures and is listed in the ifu as such.The act of cerebral stent implantation inherently produces a localized vessel injury potentially leading to release of atheromatous material into the downstream flow or vessel spasm in reaction to the introduction of the devices that may slow or completely occlude the blood flow.The introduction of interventional devices and stent implantation may lead to a slowing or stoppage of blood flow to the downstream vessels and structures of the brain causing infarctions of these structures.There is no evidence of manufacturing issues that may have contributed to the reported event; therefore, no corrective action is required at this time.This action (inherent risk of the procedure) combined with the patient¿s complex medical status, vessel characteristics and procedural factors may have contributed to the event.The patient¿s history of hypertension may have contributed to the events.With review of the information, and as reported, there is no indication of any device performance issues.Therefore, no corrective actions will be taken at this time.This is 1 of 7 reports associated with complaint 1-1291744783.

• Brand Name: XTRASOFT ORBIT GALAXY DETACHABLE COIL
• Type of Device: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: duane durbin ; miami lakes, FL 33014
• MDR Report Key: 3942239
• MDR Text Key: 4640107
• Report Number: 1226348-2014-30053
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 640CX3505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR