MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X6; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	640CX0306
Medical Device Problem Codes	Stretched (1601); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (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.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not available / reported.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (31032521) 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.Coil- unraveling/stretching- during placement can cause premature detachment, separation, protrusion, or herniation into parent vessel, which could result in non-target site embolization, ischemia, or infarct.Coil-protrusion into the parent vessel can result in non-target site embolization, ischemia, or infarct, or may require additional intervention.In this case, the event required the implantation of a second stent to stabilize the coil¿s position and to preclude patient harm.Based on the additional intervention required, this event meets us fda reporting criteria under 21 cfr 803 with a classification of ¿serious injury.¿ the file will be re-reviewed if additional information is received at a later date.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 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 a stent-assisted endovascular coil embolization procedure targeting a ruptured posterior communicating artery (pcom) aneurysm, after implantation of the first stent (unspecified brand) the physician filled the aneurysm with the 3mm x 6cm orbit galaxy complex xtrasoft coil (640cx0306 / 31032521).It was reported that the coil could not be placed well at the target site due to the aneurysm being long and fusiform in shape.The physician adjusted the placement of the coil in the aneurysm several times and the coil became unraveled / stretched.The physician detached the coil and released the second stent (competitor brand) in the first stent.Part of the coil outside of the aneurysm was fixed between the two stents and the procedure was completed.The concomitant microcatheter, an sl-10® microcatheter (stryker) was not replaced.The patient is reported to be in stable condition post-op.There was no report of any negative patient impact.On 01-apr-2024, additional information was received.Per the information, the target aneurysm was a ruptured posterior communicating artery aneurysm that was fusiform in shape.There was no difficulty in getting the coil to conform to the aneurysm wall.The brand of the first stent implanted was a competitor stent.Adequate continuous flush was maintained through the microcatheter.The information indicated that the microcatheter repositioned over the coil while the coil was deployed or partially deployed out of the distal end of the microcatheter.There was a one-to-one relationship between the coil and delivery wire verified with fluoro prior to repositioning.Coil entanglement was not suspected to be a contributing factor to the unraveled / stretched condition of the coil.There was no additional damage noted on the device aside from the reported unraveled / stretched condition of the coil when it was removed.There was no evidence of blood flow restriction / reduction as a result of the reported issue.There was no report of any delay in the procedure due to the reported issue.

• Brand Name: OG CMPLX XTRASOFT COIL 3X6
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CERENOVUS INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 19034252
• Report Number: 3008114965-2024-00336
• Device Sequence Number: 7104427
• Product Code: KRD
• UDI-Device Identifier: 10886704030591
• UDI-Public: 10886704030591
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K093973
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 640CX0306
• Device Lot Number: 31032521
• 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: 03/20/2024
• Initial Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2023
• 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: SL-10® MICROCATHETER (STRYKER); STENT (UNSPECIFIED BRAND); STENT (UNSPECIFIED BRAND)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown