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

Catalog Number UNKGALAXY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Inflammation (1932); Thrombus (2101)

Event Date 03/01/2007

Event Type  Injury  

Manufacturer Narrative

Common device name: krd/hcg.Concomitant medical products: 1 gdc, 1 trufill dcs (catalog and lot number not provided in article), and 3 hydrogel-coated coils.Date of event, product code, and lot number not available.Udi: unknown part number, attempts to obtain product part number were unsuccessful, udi unavailable.Literature article attached to mdr: im, s.H., han, m.H., kwon, b.J.Et al.(2007).Aseptic meningitis after embolization of cerebral aneurysms using hydrogel-coated coils: report of three cases.Ajnr am j neuroradiol 28:511¿12, mar 2007.Conclusion: the device was not available for analysis.In addition, the lot number was not provided; therefore, a dhr could not be performed.Aseptic meningitis is not listed in the instruction for use (ifu); however, infection, allergic reactions, ischemia at an undesired location, stroke are known procedural complications and are listed in the ifu.The root cause of the event could not be determined based on the information provided; however, multiple products were used and implanted during the procedure and these may have contributed to the event.Since there was no evidence of a manufacturing issue related to the event, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

In the literature article ¿aseptic meningitis after embolization of cerebral aneurysms using hydrogel-coated coils: report of three cases¿ by s.-h.Im, m.H.Han, b.J.Kwon, c.Jung, j.E.Kim, d.H.Han, published ajnr am j neuroradiol 28:511¿12, mar 2007, the authors report the development of aseptic meningitis in 3 patients with aneurysms treated with hydrogel-coated coils.A (b)(6) man was admitted for endovascular treatment of an incidentally detected 6.0 x 5.9 x 4.8 mm aneurysm of the right mca bifurcation.The aneurysm was occluded with 1 gdc, 1 trufill dcs (catalog and lot number not provided in article), and 3 hydrogel-coated coils.Aneurysm volumetric packing attenuation of 75% was achieved with these coils.He had no postoperative neurologic deficits.High fever (39°c) developed 20 hours after procedure.He had severe persistent headache, chills, and agitation.Neurologic examination demonstrated meningismus, but findings were otherwise normal.The csf wbc was 1656 x 10^6/l.The csf protein and glucose concentrations were 73 mg/dl and 74 mg/dl, respectively.Csf cultures were negative for bacterial meningitis.His symptoms resolved following administration of systemic corticosteroids.He was discharged on the 7th hospital day.Two weeks after treatment, sudden left upper extremity weakness developed.Acute multifocal ischemic infarctions in the right parietal lobe were demonstrated on brain mr imaging.Cerebral angiography revealed durable occlusion of the aneurysm and a small amount of clot at the site of the aneurysm.Antiplatelet medication was recommended.The patient subsequently recovered and was discharged home.No additional information could be obtained from the author.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• Type of Device: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 6637453
• MDR Text Key: 77452160
• Report Number: 1226348-2017-00072
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKGALAXY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 68 YR