MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC TRUFILL DCS ORBIT MINI COMPLEX FILL; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	637CF0615
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hydrocephalus (3272)
Date of Event	07/17/2008
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Fifteen guglielmi detachable coils (gdc18: 280 cm, gdc10: 220 cm) and two orbit coils were implanted.Article attached to this mdr: misaki, k., uchiyama, n.Mohri, m., et al.(2010).Unusual delayed hydrocephalus after bare platinum coil embolization of an unruptured aneurysm.Neurol med chir (tokyo) 50, 581-585, 2010.This is 1 of 2 mdrs associated with this complaint with report numbers of 3008264254-2017-00091 and 3008264254-2017-00090.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
In the literature article ¿unusual delayed hydrocephalus after bare platinum coil embolization of an unruptured aneurysm¿ by kouichi misaki, naoyuki uchiyama, masanoa mohri, yuichi hirota, yutaka hayashi, jun-ichiro hamada, published neurol med chir (tokyo) 50, 581-585, 2010, the authors present a case of a patient who developed hydrocephalus after embolization of an incidentally detected unruptured large internal carotid artery aneurysm with bare platinum coils including two orbit complex fill coils (catalog 637cf0615, lots 13297196 and 13259950).A (b)(6) woman was admitted for endovascular treatment of an incidentally detected aneurysm of the left internal carotid artery.Magnetic resonance imaging revealed no aneurysmal thrombus formation and no peri-aneurysmal brain edema, and no evidence of subarachnoid hemorrhage, ventricular obstruction, or neoplasm.Three days prior to the procedure administration of aspirin (100mg/day) was begun.Endovascular occlusion was performed under general anesthesia, and systemic heparinization.Fifteen guglielmi detachable coils (gdc18: 280 cm, gdc10: 220 cm) and two orbit coils with a total length of 515 cm were positioned in the aneurysm.Post-embolization angiography revealed occlusion of most of the aneurysm sac, but a small area around the neck showed opacification.No thromboembolic complications or aneurysm rupture occurred during the procedure.She was afebrile and neurologically intact after the procedure, but complaint of mild headache 18 hours later that had improved 7 days later without steroid administration.Mr imaging on the 6th post-embolization day disclosed thin aneurysm wall enhancement on time-of-flight (tof) images with gadolinium, which was seen more clearly 3 months later.Fluid-attenuated inversion recovery images showed extensive brain edema adjacent to the treated aneurysm on the 6th post treatment day, which had disappeared 3 months after treatment.Computed tomography (ct) showed lateral ventricles gradually enlarged and the evans index (ratio of the maximum width of the frontal horns to the maximum width of the inner table of the cranium) increased from 0.27 at admission 0.29, but she exhibited no obvious symptoms of hydrocephalus.7 months after post treatment she presented with gradually progressing disorientation, gait disturbance and urine incontinence.Ct imaging showed enlargement of the lateral ventricles.Mri showed no acute stroke or perfusion anomalies and no aneurysm wall enhancement or brain edema.The 30ml of csf was removed by lumbar tap, which improved her condition without symptom recurrence for 2 months.She did not require shunt placement.Additional information provided by the author indicated that the patient was currently doing well with mrs 1.
Additional Manufacturer Narrative
Conclusion: the dhr review of the manufacturing documentation associated with this lot 13259950 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.Hydrocephalus, as described by neurologic deficits, is a known potential adverse event associated with the use of the codman embolic coils and is listed in the ifu.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests that patient specific factors, immune system response to device implantation, as well as location of the target site may have contributed to the reported event.There is no current safety signal identified related to the reported event(s) based on review of complaint history for the devices no further actions are needed at this time.This is 1 of 2 mdrs associated with this complaint with report numbers of 3008264254-2017-00091 and 3008264254-2017-00090.

• Brand Name: TRUFILL DCS ORBIT MINI COMPLEX FILL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• MDR Report Key: 6653487
• Report Number: 3008264254-2017-00090
• Device Sequence Number: 1285907
• Product Code: HCG
• UDI-Device Identifier: 10886704029465
• UDI-Public: (01)10886704029465(17)090630(10)13259950
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K053197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2009
• Device Catalogue Number: 637CF0615
• Device Lot Number: 13259950
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 07/19/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR