MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM MINI 1.5MM X 3CM; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number	MCR091530
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: pc (b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (31136144) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.With the information available and without the complaint product available to be returned for analysis, the reported product issue documented in the complaint cannot be confirmed through functional evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint device; however, it is possible that clinical and procedural factors, including device manipulation / interaction may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.Since there was no evidence to suggest the event was related to a manufacturing or design issue, no corrective actions will be taken at this time.This is one of 2 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2024-00018 and 3008114965-2024-00019.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.
Event or Problem Description
The healthcare professional reported that during the endovascular embolization procedure targeting ¿a very complicated¿ recanalized large left posterior cerebral artery (pca) aneurysm with mild vessel tortuosity, a 2mm x 8cm cerepak heliform xsft (xhe120208 / 31162599) was advanced through a headway® duo 156 microcatheter (microvention) without resistance.The physician attempted to use the manual detachment approach.It was reported that breaking the coil at the scoring mark was difficult and the pull wire broke; forceps were used in an unsuccessful attempt to pull the pull wire back.The coil did not detach and the system was taken out with the coil intact.A 1.5mm x 3cm cerepak freeform mini (mcr091530 / 31136144) was advanced through the same microcatheter with minimal friction around the manual break marks.The manual break was attempted.The coil detached inside the microcatheter and the coil was pushed forward into the aneurysm using the delivery system.The coil was left in the aneurysm and treated as an implant.There was no report of any negative patient impact.Per the complaint information, only the 2mm x 8cm cerepak heliform xsft (xhe120208) is available for return; the components of the 1.5mm x 3cm cerepak freeform mini (mcr091530) were not collected for analysis.On 09-jan-2024, responses were received to additional information request.Per the additional information, the lot number of the 1.5mm x 3cm cerepak freeform mini (mcr091530) is 31136144.When the 2mm x 8cm cerepak heliform xsft coil was removed, it was not stretched; it was still attached to the delivery system when it was removed.The additional information also indicated that after implanting the 1.5mm x 3cm freeform mini, the procedure was considered completed, ¿only one coil was used for the entire case.¿ there was no evidence of any blood flow restriction / reduction as a result of the reported issue.The information also confirmed there was no negative patient impact and the reported issue resulted in minimal delay.

• Brand Name: FREEFORM MINI 1.5MM X 3CM
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS, INC.; calle circuito int norte 1820; parque industrial salvacar; juarez 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 18548134
• Report Number: 3008114965-2024-00019
• Device Sequence Number: 15440274
• Product Code: KRD
• UDI-Device Identifier: 10886704082972
• UDI-Public: 10886704082972
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K220040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: MCR091530
• Device Lot Number: 31136144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Initial Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HEADWAY® DUO 156 MICROCATHETER (MICROVENTION)
• Patient Sex: Unknown