MAUDE Adverse Event Report: BALT USA OPTIMA COIL SYSTEM

Model Number	OPTI0101CSS10
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Aneurysm (1708); Rupture (2208)
Date of Event	08/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Balt usa's reference number: (b)(4).To whom it may concern: on august 26, 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 f191200049 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 or Problem Description
It was reported through a clinical study: "cerebral granulomatosis.".

• Brand Name: OPTIMA COIL SYSTEM
• Common Device Name: OPTIMA
• Manufacturer (Section D): BALT USA; 29 parker; irvine CA 92618
• MDR Report Key: 10570823
• Report Number: 3014162263-2020-00021
• Device Sequence Number: 2704784
• Product Code: HCG
• UDI-Device Identifier: 00818053021374
• UDI-Public: 00818053021374
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/16/2021
• Device Model Number: OPTI0101CSS10
• Device Lot Number: F191200049
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening