MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG TDL CMPLX FRAME COIL 9X30; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number 640CR0930

Device Problems Material Separation (1562); Failure to Advance (2524)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/06/2023

Event Type  malfunction  

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.Section h.3: the device is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30706306) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no non-conformances related to device manufacture or inspection.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 Description

The healthcare professional reported that during an endovascular embolization procedure, the complaint coil, a 9mm x 30cm orbit galaxy complex frame of the same product code: (640cr0930 / 30706306) became impeded in the middle section of the concomitant microcatheter (competitor brand) and could not be further advanced.The physician retracted the coil and found the device broken into two pieces.The physician used a micro guidewire to remove the remaining portion of the coil inside the microcatheter.A new coil was used as replacement to complete the procedure using the original microcatheter.There was no report of any negative patient impact.On 15-sep-2023, additional information was received.The requested that the event description be updated as follows: during an endovascular embolization procedure, the complaint coil, a 9mm x 30cm orbit galaxy complex frame of the same product code (640cr0930 / 30706306) became impeded in the middle section of the concomitant microcatheter (competitor brand) and could not be further advanced.The physician removed the coil and microcatheter from the patient for inspection and found that the coil broke into two (2) pieces.The physician then used a micro guidewire to remove the remaining portion of the coil from inside the microcatheter.A new coil was used to complete the procedure using the original microcatheter.On 15-sep-2023, additional information was also received.Per the additional information, the target of the procedure was at the ¿starting part of the posterior communicating artery.¿ the microcatheter used was an sl-10® microcatheter (stryker).A continuous flush had been maintained through the microcatheter.The information indicated that when the reported issue with the complaint coil becoming impeded in the middle section of the microcatheter, it was during the repositioning in the aneurysm (withdrawal / re-withdrawal).The embolic coil component was confirmed to have been broken into two (2) pieces.The information confirmed that the microcatheter was already removed from the patient¿s anatomy when the remaining coil was removed from the microcatheter using the micro guidewire.The coil was all removed from the microcatheter and not delivered to the target site.There was no portion of the complaint coil left in the patient; the complaint coil was replaced to complete the procedure.It was replaced with another 9mm x 30cm orbit galaxy complex frame of the same product code (640cr0930).There was no additional damages noted on the coil.The reported issue did not result in any reduced / restricted blood flow in the parent vessel.The information confirmed that the micro guidewire was used to remove the portion of the coil that became broken inside the microcatheter; it was not used as intervention to remove the broken coil from the patient.There was no clinically significant delay in the procedure as a result of the reported issue.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 9mm x 30cm orbit galaxy complex frame was received contained in the decontamination pouch.Visual inspection was performed.No appearance of damage was observed.The device label was returned, indicating that the device lot number is 30706306, which confirms that the correct device was received.The device was inspected under a microscope.Under magnification, it was observed that the coil was already detached from the delivery system and was observed to be in good condition (i.E., no kink, no stretched condition or with non-concentric loops) and was noted to still be in one piece.The gripper was found in good condition; no elongation marks were found that suggest that the coil was mechanically detached from the unit.The issue documented in the complaint that the coil became impeded in the middle section of the concomitant microcatheter could not be evaluated through a proper functional test since the coil was already detached from the unit.This condition was not originally reported in the complaint, and it is suggested that it appeared during the withdrawal and re-insertion of the device.It is possible that clinical and procedural factors, including device manipulation and operator's technique, may have contributed to the reported failure.According to the risk documentation, delivery tube / embolic coil not pushing through the microcatheter is a potential issue that can occur during coil placement due to: 1) excessively tortuous anatomy; or 2) clot formation in the microcatheter.With the limited information available, the root cause remains speculative, however, there is no indication that the issues encountered during the procedure are a result of a defect inherently related to the device.The multiple kinked conditions found on the hypo-tube are suspected of having appeared during the handling of the device during the withdrawal and re-insertion of the device.These conditions are not considered related to the reported failure.The issue regarding a coil being broken in two pieces was not able to be confirmed since the coil was found to be in good condition and in one piece.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.A review of manufacturing documentation associated with this lot (30706306) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points along the manufacturing process to prevent device damages from leaving the facility.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) do contain the following recommendations: if unusual friction is still noticed during advancement or retraction of the microcoil system, verify flush lines are open and properly pressurized.Then slowly withdraw the entire microcoil system and examine for damage.Replace it with a new microcoil system.If friction still exists, withdraw and examine the delivery catheter system.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device on 03-oct-2023.A supplemental 3500a report will be submitted once the product investigation has been completed.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.

• Brand Name: OG TDL CMPLX FRAME COIL 9X30
• Type of Device: 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 ; 3035526892
• MDR Report Key: 17804843
• MDR Text Key: 324233970
• Report Number: 3008114965-2023-00665
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/09/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 640CR0930
• Device Lot Number: 30706306
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/07/2023
• Initial Date FDA Received: 09/23/2023
• Supplement Dates Manufacturer Received: 10/03/2023; 10/09/2023
• Supplement Dates FDA Received: 10/03/2023; 10/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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
• Treatment: SL-10® MICROCATHETER (STRYKER)