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

Catalog Number 640CF0615

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/03/2015

Event Type  Injury  

Manufacturer Narrative

Pro code: krd/hcg.Concomitant medical products: shouryu14 (kaneka medix, (b)(4)) 4 mm×10 mm balloon, headway17 microcatheter (terumo, (b)(4)), ed¿spiral coil (7 mm × 20 cm; kaneka medix), ed infini (16 mm×10 cm; kaneka medix) and another nine ed extra soft coils (kaneka medix), 2¿3.5 mm in diameter article attached to this mdr: uwatoko, t., tsumoto, t., wada, n., et al.(2016).Dermatitis caused by metal allergy after coil embolization for unruptured cerebral aneurysm.J neurointervent surg 2016;8:e42.Doi:10.1136/neurintsurg-2015-011981.(b)(4).Date of event and lot number not available.Three attempts to obtain additional information from the author were unsuccessful.This is an initial/final mdr report.Conclusion: the device was not available for analysis.In addition, the lot number was not provided; 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 specific patient immune response issues and underlying aneurysmal disease process may have contributed to the reported events.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.No further actions are required at this time.

Event Description

In the literature article ¿dermatitis caused by metal allergy after coil embolization for unruptured cerebral aneurysm¿ by takeshi uwatoko, tomoyuki tsumoto, naoko wada, kazunori urabe, et.Al., published j neurointervent surg 2016;8:e42.Doi:10.1136/neurintsurg-2015-011981.Rep, it was reported that a female patient had an allergic dermatitis after implantation of multiple embolic coils, including galaxy complex codman coil (catalog 640cf0615; lot unk).Per the article a cerebral aneurysm was incidentally found in a (b)(6) woman in the right internal carotid artery on magnetic resonance angiography.She had a history of hypertension, but no history of allergy.Cerebral angiography showed a saccular aneurysm projecting medially to the paraclinoid portion of the right internal carotid artery, about 8 mm in maximum diameter and about 3.8 mm in neck diameter.Coil embolization was performed under general anesthesia in (b)(6) 2013.Coil embolization was performed using the balloon remodeling technique.First, a shouryu14 (kaneka medix, (b)(4)) 4 mm × 10 mm balloon was placed in the neck of the aneurysm.A headway17 microcatheter (terumo, (b)(4)) was placed in the aneurysm with a microwire, and an ed¿spiral coil (7 mm×20 cm; kaneka medix) was placed as a frame.Thereafter, galaxy complex fill coils 6 mm×15 cm, (catalog and lot unknown), ed infini (16 mm×10 cm; kaneka medix) and another nine ed extra soft coils (kaneka medix), 2¿3.5 mm in diameter, were placed into the aneurysm.The final volume embolic rate was 25% and the aneurysm disappeared with the neck remnant.The patient was discharged without symptoms 6 days after treatment.About 1 month after treatment she complained of swelling in both eyelids and rash on the neck.Drug eruption was initially suspected because a calcium antagonist had been changed to an angiotensin receptor antagonist just before coil embolization.Antihypertensive medication for the patient was therefore changed and she was followed up.About 6 months postoperatively, swelling around the lips and rash around the neck remained.We consulted a dermatologist in our hospital.Patch testing was performed, including a platinum reagent.A faintly positive result was seen for the platinum reagent and definite positive reactions were recognized against daily cosmetics, nickel, and chromium.The patient therefore changed the cosmetics she was using and dental metal was removed.One year after coil embolization the skin symptoms persisted without obvious improvement.At that time she told us that the skin symptoms had recently worsened the day after wearing a platinum necklace.A second patch test, which included a reagent triturated from the same type of platinum coil used for embolization, was then carried out.Positive reactions were confirmed for the coil reagent, platinum, and gold.Judging from this test, the platinum coils used for embolization were considered responsible for the skin symptoms and low-dose oral steroids and antihistamines were administered.The symptoms subsequently showed gradual improvement.No additional information, include galaxy lot numbers, 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 ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 5088288374
• MDR Report Key: 6650014
• MDR Text Key: 77863634
• Report Number: 3008264254-2017-00085
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 640CF0615
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2017
• 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): Required Intervention; Disability