MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number OPTI0254CSS10

Device Problem Insufficient Information (3190)

Patient Problems Aneurysm (1708); Rupture (2208)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Balt usa's reference number: (b)(4).To whom it may concern: on (b)(6) 2020, balt usa has been notified of an event regarding the use of multiple optima coil.Details reported as follows: "cerebral granulomatosis." an evaluation of the actual complaint sample could not be performed as the device was unavailable for return.Based on the provided information, root cause could not be definitively determined.Lack of device return prevented deeper evaluation of the reported issue.Upon review of literature searching for "cerebral granulomatosis in aneurysm coiling", we found a publication (a mini meta-analysis) reviewing polymer induced emboli.From 1997 to 2016 only 32 patients were found in the literature.This was associated with various nv system diagnosis and treatments.None of the noted cases were directly related to bare platinum coils like optima.In a second publication cruz et al (ajnr.A3976) concluded "we did not find this complication exclusive to the use of any particular device.Imaging and clinical characteristics suggest a foreign body reaction such as aseptic abscess and granuloma.We suggest that the cause of these lesions might be shedding of hydrophilic coating from endovascular devices into the blood stream".While this is not a complete analysis of the literature it does trend towards: a very rare occurrence.Not specific to bare platinum coils.Typically associated with devices that have polymer coatings.Review of the lot history record did not reveal any in-process or lot-specific issue that could account for the observation.No additional complaints against lot number f191200043 have been made for the same issue.Comprehensive analysis of this failure mode has remained subject to monitoring for any unacceptable increase in trend.

Event Description

It was reported through a clinical study: "cerebral granulomatosis".

• Brand Name: OPTIMA COIL SYSTEM
• Type of Device: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• Manufacturer Contact: moises colin ; 29 parker; irvine 92618
• MDR Report Key: 10570824
• MDR Text Key: 208090109
• Report Number: 3014162263-2020-00023
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00818053021503
• UDI-Public: 00818053021503
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K172390
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2021
• Device Model Number: OPTI0254CSS10
• Device Catalogue Number: N/A
• Device Lot Number: F191200043
• Date Manufacturer Received: 08/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2019
• 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): Hospitalization; Life Threatening