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

Catalog Number UNKGALAXY

Device Problem No Apparent Adverse Event (3189)

Patient Problem Aneurysm (1708)

Event Date 01/01/2013

Event Type  Injury  

Event Description

Recurrence of aneurysm after orbit galaxy coil embolization (b)(4) "short-term outcome for saccular cerebral aneurysm treated with the orbit galaxy detachable coil system" (b)(4) reported 12 patients treated at primary aneurysm coiling with orbit galaxy coils from (b)(6) 2010 - (b)(6) 2012 had recurrence of their aneurysm.The mean time to recurrence was 7 months.There was no incidence of rebleed in this group of patients.

Manufacturer Narrative

Additional information will be submitted within 30 days of receipt.

Manufacturer Narrative

No further information was obtained although multiple attempts were made.The lot numbers of the orbit coils that were implanted in the aneurysms when the events occurred are not known; therefore device history record reviews cannot be completed.The coils remains implanted and the delivery systems are not available for analyses.Aneurysm recanalization after coil embolization is a known event and has been estimated to occur anywhere from 5% to 38% of coiled aneurysms.Factors which may have a correlation with recanalization post coil embolization include larger aneurysm size, neck size, packing density, and inflow angle.With review of the available information there is no indication of any manufacturing issues related to the event.Therefore, no corrective actions will be taken at this time.

• Brand Name: ORBIT GALAXY DETACHABLE COIL SYSTEM
• 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: matthew king ; miami lakes, FL 33014 ; 5088283106
• MDR Report Key: 3547063
• MDR Text Key: 17389642
• Report Number: 1226348-2013-10096
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• 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?: No
• Date Manufacturer Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability