MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 6MM X 11.9CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100611
Medical Device Problem Codes	Separation Failure (2547); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A report from the field indicated that during a coil embolization of a basilar tip aneurysm in a female patient, a 6mm x 11.9cm micrusframe10 (mfr100611/l15688) was safely positioned into the aneurysm sac as the first framing coil, but the microcoil failed to detach.The physician repositioned the concomitant sl-10 45 (stryker) microcatheter and redeployed the coil.Once again, he pressed the detachment button with no coil detachment.The physician did this a total of four times without success and ultimately decided to remove the coil from the patient.At some point during the attempt to detach the coil, the enpower control cable (ecb00018200/30585092) was replaced, but the issue continued.The physician began to retract the coil out of the aneurysm.He got the coil about halfway into the microcatheter when it finally detached.The physician then attempted to push the coil into the aneurysm since this now was the only option.The last loop of the coil kicked the concomitant microcatheter out of the aneurysm resulting in coil protrusion into the basilar artery.The patient was scheduled for a heart procedure later in the week, so placing the patient on anticoagulation therapy and leaving the protruded coil was not considered a good option.Therefore, the physician attempted to snare and remove the coil, but the coil got hung up upon retrieval and was unable to be removed.Ultimately, a stent was successfully deployed across the coil to secure it to the vessel wall.A total of four competitor coils were implanted and the procedure was completed without any untoward events.The patient awoke with no deficits but will be monitored.The surgery was delayed a total of 30 minutes because of the attempt to retrieve the coil from the patient.The same detachment control box (dcb) was used to detach subsequent coils.The complaint devices are not available for evaluation.No further information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.The device was implanted; therefore, no further investigation can be performed.A manufacturing record evaluation was performed for the finished device l15688 number, and no non-conformances related to the malfunction were identified.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Product complaint # = > (b)(4).Section b5: additional information was received on (b)(6) 2021 indicating that the patient was a 56-year-old male patient.His baseline nihss score was 0.This was an outpatient aneurysm treatment.Post-procedure, the patient¿s neurological status was unchanged.The current health condition of the patient is ¿normal¿ with nihss score of 0-1.Pre-deployment electrical testing was performed, and no failure was noted.The user ensured that the connecting cable was fully seated with the connector end of the dpu wire and output connector of the dcb.No system faults were observed.The dimensions of the basilar artery aneurysm were as follows: neck 3.2mm, height 8.1mm, and width 4.8mm.The vessel was neither tortuous nor calcified.Aneurysm neck remodeling had been performed with a neuroform atlas (stryker) stent prior to this procedure, and the patient was brought back to coil the aneurysm through the stent.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that during a coil embolization of a basilar tip aneurysm in a female patient, a 6mm x 11.9cm micrusframe10 (mfr100611/l15688) was safely positioned into the aneurysm sac as the first framing coil, but the microcoil failed to detach.The physician repositioned the concomitant sl-10 45 (stryker) microcatheter and redeployed the coil.Once again, he pressed the detachment button with no coil detachment.The physician did this a total of four times without success and ultimately decided to remove the coil from the patient.At some point during the attempt to detach the coil, the enpower control cable (ecb00018200/30585092) was replaced, but the issue continued.The physician began to retract the coil out of the aneurysm.He got the coil about halfway into the microcatheter when it finally detached.The physician then attempted to push the coil into the aneurysm since this now was the only option.The last loop of the coil kicked the concomitant microcatheter out of the aneurysm resulting in coil protrusion into the basilar artery.The patient was scheduled for a heart procedure later in the week, so placing the patient on anticoagulation therapy and leaving the protruded coil was not considered a good option.Therefore, the physician attempted to snare and remove the coil, but the coil got hung up upon retrieval and was unable to be removed.Ultimately, a stent was successfully deployed across the coil to secure it to the vessel wall.A total of four competitor coils were implanted and the procedure was completed without any untoward events.The patient awoke with no deficits but will be monitored.The surgery was delayed a total of 30 minutes because of the attempt to retrieve the coil from the patient.The same detachment control box (dcb) was used to detach subsequent coils.Additional information was received on (b)(6) 2021 indicating that the patient was a 56-year-old male patient.His baseline nihss score was 0.This was an outpatient aneurysm treatment.Post-procedure, the patient¿s neurological status was unchanged.The current health condition of the patient is ¿normal¿ with nihss score of 0-1.Pre-deployment electrical testing was performed, and no failure was noted.The user ensured that the connecting cable was fully seated with the connector end of the dpu wire and output connector of the dcb.No system faults were observed.The dimensions of the basilar artery aneurysm were as follows: neck 3.2mm, height 8.1mm, and width 4.8mm.The vessel was neither tortuous nor calcified.Aneurysm neck remodeling had been performed with a neuroform atlas (stryker) stent prior to this procedure, and the patient was brought back to coil the aneurysm through the stent.The device remains implanted; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device l15688 number, and no non-conformances related to the malfunction were identified.Failure of the coil to detach and unintended detachment during withdrawal are known potential complications associated with the use of the micrusframe10 in coil embolization procedures.Factors that can contribute to detachment issues include failure to confirm secure connection of the cable to the device positioning unit (dpu) and detachment control box (dcb).The instructions for use (ifu) advises the user to ensure that the connecting cable is fully seated with the connector end of the dpu wire and output connector of the dcb.The user should verify that the microcoil delivery system is fully connected and that no faults are indicated on the dcb.If a fault exists, all connections should be reseated between the dpu, the dcb, and the connecting cable.If a fault still persists, the connecting cable should be replaced.If this does not correct the error, the dcb should be replaced.If the microcoil delivery system still continues to have a fault, the microcoil should be retrieved and replaced with a new microcoil system.If after depressing the detach button on the dcb, the dcb should be replaced if the light and audible tone do not activate.Also, if the system ready light is not illuminated and there is no detachment after two detachment attempts, the dcb should be replaced.If detachment still does not occur, the microcoil system should be carefully withdrawn and replaced.With the information provided and without the return of the associated devices, it is not possible to determine the root cause of the event.However, the event may have been related to a combination of multiple factors experienced in the clinical setting rather than the design or manufacture of the device.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MICRUSFRAME10 6MM X 11.9CM
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• MDR Report Key: 12599367
• Report Number: 3008114965-2021-00507
• Device Sequence Number: 17193614
• Product Code: KRD
• UDI-Device Identifier: 10886704077855
• UDI-Public: 10886704077855
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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: 03/31/2022
• Device Model Number: MFR100611
• Device Catalogue Number: MFR100611
• Device Lot Number: L15688
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENPOWER CONTROL CABLE; SL-10 45 (STRYKER) MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR