MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM MINI 1MM X 2CM; CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM

Catalog Number	MCR091020
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Section h3 - 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.Section h4.Device manufacture date: not available at time of report.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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.This is one of three products involved with the complaint and the associated manufacturer report numbers are 3008114965-2023-00718, 3008114965-2023-00719.
Event or Problem Description
As reported by the field, during a coil embolization, the left middle meningeal artery(mma) was accessed with a stryker sl-10 microcatheter.A freeform mini 1mm x 2cm was successfully delivered and detached.Next a freeform mini 1mm x 2cm (mcr091020, 31092858) was delivered but would not detach after two attempts with the mechanical detachment handle (mdh1, 101456956).The coil and delivery system were successfully removed from the patient via the sl-10 catheter.This coil and delivery system was saved by the account and will be returned as part of the complaint.A second freeform mini 1mm x 2cm (mcr091020, 3109258)) was delivered but would not deploy after two attempts with the mechanical detachment handle (mdh1) and using the manual break deployment technique.While attempting to remove the coil and delivery system through the sl-10 catheter, the coil detached with half of the coil in the artery and the other half in the catheter.The physician then took the delivery wire of a stryker target coil, pushed it through the sl-10 and pushed the remaining mcr091020 out the catheter and into the vessel.From there, the physician continued the embolization with competitive coils successfully.Additional information received indicated that 4 cerepak freeform mini coils were implanted during the procedure.There had not been any resistance during advancement of the devices through the microcatheter or positioning difficulty in the aneurysm.There was no damage to the embolic coils or any device components.The vessel was ¿very straightforward¿, no challenging anatomy.It was clarified that the second mcr091020 coil was implanted in the desired location.There was no patient injury.The procedure was prolonged by approximately three minutes and the delay was not clinically significant.
Additional Manufacturer Narrative
Product complaint#: (b)(4).Complaint conclusion: as reported by the field, during a coil embolization, the left middle meningeal artery(mma) was accessed with a stryker sl-10 microcatheter.A freeform mini 1mm x 2cm was successfully delivered and detached.Next a freeform mini 1mm x 2cm (mcr091020, 31092858) was delivered but would not detach after two attempts with the mechanical detachment handle (mdh1, 101456956).The coil and delivery system were successfully removed from the patient via the sl-10 catheter.This coil and delivery system was saved by the account and will be returned as part of the complaint.A second freeform mini 1mm x 2cm (mcr091020, 3109258) was delivered but would not deploy after two attempts with the mechanical detachment handle (mdh1) and using the manual break deployment technique.While attempting to remove the coil and delivery system through the sl-10 catheter, the coil detached with half of the coil in the artery and the other half in the catheter.The physician then took the delivery wire of a stryker target coil, pushed it through the sl-10 and pushed the remaining mcr091020 out the catheter and into the vessel.From there, the physician continued the embolization with competitive coils successfully.Additional information received indicated that 4 cerepak freeform mini coils were implanted during the procedure.There had not been any resistance during advancement of the devices through the microcatheter or positioning difficulty in the aneurysm.There was no damage to the embolic coils or any device components.The vessel was ¿very straightforward¿, no challenging anatomy.It was clarified that the second mcr091020 coil was implanted in the desired location.There was no patient injury.The procedure was prolonged by approximately three minutes and the delay was not clinically significant.The medical imaging was reviewed by cerenovus sr.Medical affairs director and the assessment reads as follows: ¿the image provided shows the mma embolization took place bilaterally with both a liquid embolic agent as well as a string of detachable coils.The image itself doesn't provide a pointer to the cause of the non-detachment nor the subsequent unplanned detachment in the microcatheter.The anatomy doesn't appear challenging, nor are there loops visible in the trajectory.The devices used (pusher wire and handle) may provide more insight when returned and analyzed by r&d¿.The device remains implanted; therefore, no further investigation can be performed.The lot number provided could not be confirmed as valid.As a result, the mre review cannot be conducted.Should the correct lot number be made available at a later date, the complaint file will be reopened and an mre review will be performed and documented.With the information available and without the product available for analysis, the reported customer complaints could not be confirmed.The exact cause of the event could not be determined; however, there are circumstances of the procedure that may have contributed to the reported failure.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.As part of the post market surveillance program, information from this complaint is trended to identify statistical signals for consideration of further correction action.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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.

• Brand Name: FREEFORM MINI 1MM X 2CM
• Common Device Name: CEREPAK FREEFORM MINI DETACHABLE COIL SYSTEM
• 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 ; 3035526892
• MDR Report Key: 17905857
• Report Number: 3008114965-2023-00720
• Device Sequence Number: 8224695
• Product Code: KRD
• UDI-Device Identifier: 10886704082910
• UDI-Public: 10886704082910
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K220040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: MCR091020
• Device Lot Number: 3109258
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 11/17/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: FREEFORM MINI 1MM X 2CM.; MECHANICAL DETACHMENT HANDLE.; STRYKER SL-10 MICROCATHETER.
• Patient Sex: Male