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 Weakness (2145); Reaction (2414)

Event Date 01/06/2017

Event Type  Injury  

Manufacturer Narrative

Procode: krd/hcg.Concomitant product(s): two sl-10 microcatheter, taxcess 14 microwire, target 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.Article attached to mdr: oh, s.W., na, y.S., lee, h.J.Et al.(2016).Delayed enhancing lesions after coil embolization of aneurysms: clinical experience and benchtop analyses.J neurointervent surg 2017;0:1¿5.Doi:10.1136/neurintsurg-2016-012833.Conclusion: the device was not available for analysis.In addition, the lot number was not available; therefore, a dhr could not be performed.The potential for a reaction to the foreign body is always present when implantation of medical devices is performed.It is a routine portion of the patient¿s assessment, by the implanting physician or other health care professionals, in the follow up examinations.Review of the available information suggests that the concomitant microcatheter may have contributed to the reported events.There was no evidence to suggest the event was related to a manufacturing issue; therefore, no corrective actions will be taken at this time.This is an initial/final mdr report.

Event Description

In the literature article (oh, s.W., na, y.S., lee, h.J.Et al.(2016).Delayed enhancing lesions after coil embolization of aneurysms: clinical experience and benchtop analyses.J neurointervent surg 2017;0:1¿5.Doi:10.1136/neurintsurg-2016-012833), the authors report their experiences of cause of delayed enhancing lesions complication in patients treated for cerebral aneurysms and to investigate the cause of the lesions by benchtop analyses.In case# 1, the patient was treated for an unruptured aneurysm that was located at the right ophthalmic artery.Delivery of the subsequent filling coils was attempted with multiple coils (target 360 soft 8/200, 7/200, and 6/150 mm) but failed owing to the friction.The coils and the microcatheter were discarded.An orbit galaxy (codman) coil was additionally used in case 1.The angiographic coil embolization was near complete.During the outpatient follow-up, patient presented with intermittent left arm weakness.Patient was treated with steroids and anticoagulant.The symptomatic patient showed gradual improvement of symptoms after receiving the medication for 7 days.Brain mr evaluations performed revealed multiple enhancing lesions in the hemisphere 27 days after the procedure.The authors concluded brain lesions were caused by fragmentation and emboli of the inner coating wall of the microcatheter.Development of unusual friction during coil delivery may be a sign of damage of the microcatheter inner wall and the device should be discarded.From a prospectively collected database consisting of 886 patients with aneurysms treated endovascularly between january 2010 and december 2015, the article discussed three patients who showed dels on follow-up ct/mr after coil embolization were selected.Double microcatheter technique was used in all cases.Steam shaping of the microcatheter tip was performed at the discretion of the operator.The interval from evt to initial lesion detection on ct or mr was 32.7 days (range 27¿37 days).The lesions measured 3.0±1.4 mm (range 0.8¿8.3 mm) in size.The numbers of lesions were 3, 30, and 107, respectively.The lesions showed solid enhancement without evidence of necrosis, and surrounding t2 hyperintensity without diffusion restriction, suggesting vasogenic edema.The lot and catalog numbers of the codman coils were not provided in the articles.No additional information could be obtained from the author, including the catalog and lot numbers of the codman coils.

• 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 ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 6659432
• MDR Text Key: 78128517
• Report Number: 3008264254-2017-00092
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: KN
• 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: 05/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2017
• 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: 05/28/2017
• 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): Other; Required Intervention