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 Neurological Deficit/Dysfunction (1982); Dysphasia (2195)

Event Date 08/01/2008

Event Type  Injury  

Manufacturer Narrative

Procode d2b: krd/hcg.Udi: unknown part number, attempts to obtain product part number were unsuccessful, udi unavailable.Date of event, product code, and lot number not available.Attempts to obtain additional information from the author were unsuccessful.This is an initial/final mdr report.Article attached to this mdr: van, w.J., rooij, w.J.Sluzewski, m.(2008).Endovascular treatment of giant serpentine aneurysms.Published doi 10.3174/ajnr.A1071 conclusion: the device was not available for analysis.In addition, the lot number was not provided; therefore, a dhr could not be performed.Stroke or cerebral infarction and neurological deficits are known complications associated with coil embolization procedures and is listed in the instructions for use.The root cause of the event could not be determined; however, the event may have been related to the patient¿s pre-procedure neurological condition.Since there was no evidence to suggest the white matter hyperintensities and neurological symptoms were related to a manufacturing issue, no corrective actions will be taken at this time.

Event Description

In the literature article ¿endovascular treatment of giant serpentine aneurysms¿ by w.J.Van rooij, m.Sluzewski, g.N.Beute, published doi 10.3174/ajnr.A1071, the authors presented a patient (case 2) who experienced slurred speech several hours post implantation of an unspecified number of trufill orbit coils, and 2 days later mr imaging showed several new punctate white matter hyperintensities.The (b)(6) female had presented with several episodes of dysphasia that lasted 5¿10 minutes during the previous 2 months.Ct showed a multilobular hyperattenuated structure in the left sylvian fissure.Additional mr imaging suggested a partially thrombosed serpentine left middle cerebral artery aneurysm with various stages of clot formation, confirmed at 2d and 3d angiography.A microballoon (hyperform; ev3, (b)(4)) was positioned just proximal to the dilated segment of the middle cerebral artery branch and inflated for test occlusion.No symptoms developed during the 30-minute test occlusion.The next day, with the patient under general anesthesia, the aneurysm lumen was completely occluded with trufill orbit coils.Several hours later, she gradually developed slurred speech that recovered after rapid volume expansion.Repeat t2-weighted mr imaging 2 days later showed several new punctuate white matter hyperintensities in the left parietal region.However, during 3 months of follow-up, she has been free of symptoms with no new episodes of dysphasia.No additional information was available, including catalog and lot number of the coils or the number of the coils implanted.

• 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: 6646710
• MDR Text Key: 77741350
• Report Number: 3008264254-2017-00084
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2017
• 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: 05/23/2017
• 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
• Treatment: BALLOON (HYPERFORM, EV3)
• Patient Outcome(s): Disability
• Patient Age: 68 YR