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 Problem Reaction (2414)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

Procode: krd/hcg.Since the lot number is not available, the manufacturing and expiration dates are unknown.Patient age, weight, medical history were not provided.Unknown part number, all 3 attempts to obtain product information were unsuccessful, udi unavailable.Additional information will be submitted within 30 days of receipt.This is 1 of 7 mdr reports being submitted for this event with associated report numbers of 3008264254-2017-00121, 3008264254-2017-00122, 3008264254-2017-00123, 3008264254-2017-00125, 3008264254-2017-00126, and 3008264254-2017-00127.

Event Description

A patient reported that she had concerns about metal allergies and indicated that she was experienced serious health concerns since having unspecified orbit galaxy coils implanted 10 years ago.She stated that she was diagnosed with moderate to severe chronic allergic urticaria.She has itching especially on the back of her head and scalp along with redness and itching of her chest.She also had an episode of difficulty breathing.Her treatment has included methotrexate, steroids and antihistamines.She has undergone allergy testing and was found to only be allergic to nickel.She had 7 orbit galaxy coils of unknown catalog and lot number for treatment of a brain aneurysm 10 years ago.The allergy symptoms began approximately 2 years after coil implantation.She stated that her physician is unsure of the cause of the allergy.She indicated that her symptoms were less severe at the present time.She has not been hospitalized for this event.

Manufacturer Narrative

Conclusion: a patient reported that she had concerns about metal allergies and indicated that she was experienced serious health concerns since having unspecified orbit galaxy coils implanted 10 years ago.She stated that she was diagnosed with moderate to severe chronic allergic urticaria.She has itching especially on the back of her head and scalp along with redness and itching of her chest.She also had an episode of difficulty breathing.Her treatment has included methotrexate, steroids and antihistamines.She has undergone allergy testing and was found to only be allergic to nickel.She had 7 orbit galaxy coils of unknown catalog and lot number for treatment of a brain aneurysm 10 years ago.The allergy symptoms began approximately 2 years after coil implantation.She stated that her physician is unsure of the cause of the allergy.She indicated that her symptoms were less severe at the present time.She has not been hospitalized for this event.The devices were not available for analysis.In addition, the lot numbers were not provided; therefore, a dhr review could not be performed.Allergic reaction is a complication that can occur during embolization procedures and is listed in the ifu as such.There os a theoretical risk that nickel may be present in trace amounts, but in the absence of product specific information (lot #) we cannot confirm whether nickel was/is present in her implanted coils.There is no current safety signal identified related to the reported event based on review of complaint history for the device.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.

• 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: 6848346
• MDR Text Key: 85130562
• Report Number: 3008264254-2017-00124
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• 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?: No
• Date Manufacturer Received: 09/22/2017
• 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
• Treatment: A TOTAL OF 7 ORBIT GALAXY COILS WERE PLACED.
• Patient Outcome(s): Required Intervention