MAUDE Adverse Event Report: BALT USA, LLC OPTIMA COIL SYSTEM

Model Number UNKNOWN

Device Problem Migration (4003)

Patient Problems Aneurysm (1708); Patient Problem/Medical Problem (2688)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

An evaluation of the actual complaint sample could not be performed as the device was implanted and reported unavailable.The physician noted that there were no complications deploying the coils during the procedure.However, it was also noted that the physician would bring the patient back at a later time to insert a pipeline, thus implying the neck of aneurysm was wide.On (b)(6) 2018, a cta follow up was done showing the coils still intact.On (b)(6) 2018 the patient had a stroke and the md suspected was the result of a significant amount of the proximal coil being displaced into the parent artery.Coil prolapse into the parent artery is a well-characterized complication of endovascular treatment.Coils that protrude into the parent vessel after deployment can be carried into distal vessels with the potential to create a thrombogenic mass.Based on studies reporting large series of patients, coil prolapse (also called protrusion, herniation, or displacement) occurs in up to 4.5% (112/2497) of patients treated with any coil device.Coil prolapse may result from a variety of causes, including size mismatch between the coils and aneurysm, inadequate position of the microcatheter, coil instability after detachment, excessive embolization, microcatheter or stent related problems, or from being pushed by subsequent coil embolization.Prolapse occurred in aneurysms with wide or "loose" necks in 15 studies.Thus, the cause is typically not associated with the coil itself, but rather due to procedural or operator-related complications, including placement of multiple coils, which has the potential to displace one or more coils into the parent artery.Root cause in this case is believed to be an inherent procedural complication, notably due to the reported wide neck of the treatment site.Lack of immediate support in the form of a pipeline further increased the risk of proximal coil displacement into the parent artery.Lack of device return prevented deeper evaluation of the reported issue.

Event Description

It was reported that: "dr.(b)(6) had his first optima case on (b)(6) 2018.It was a sah off the ica which he was trying to place some coils to protect the dome and then bring her back to place a pipeline.He placed the following coils in order 8x27 cs10 / 6x20 cs10 / 4x10 cs10 / 3x6 cs10.All were deployed without incident.The patient went home on (b)(6) 2018 after having a cta done which showed all coils still intact.On (b)(6) 2018, the patient had a stroke which the md suspected was the result of a significant amount of the proximal coil being displaced into the parent artery and down into the pcom.I have attached pictures of the angiogram taken on (b)(6) 2018.".

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA COIL
• Manufacturer (Section D): BALT USA, LLC; 29 parker; irvine CA 92618
• Manufacturer Contact: charles yang ; 29 parker; irvine 92618 ; 9497881443
• MDR Report Key: 7991803
• MDR Text Key: 124592255
• Report Number: 3009698517-2018-00012
• Device Sequence Number: 1
• Product Code: HCG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening