MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 5MM X 17CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number MFR100517

Device Problem Failure to Advance (2524)

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

Event Date 07/06/2023

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 and email address are not available / reported.Based on complaint information, the device is not available to be returned for analysis.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.A review of manufacturing documentation associated with this lot (30768294) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.With the information available and without the complaint product available to be returned for analysis, the reported 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 sample; 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 5 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00528, 3008114965-2023-00530, 3008114965-2023-00531, and 3008114965-2023-00532.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.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 targeting an internal carotid artery (ica) aneurysm, the first coil, a 5mm x 9.7cm micrusframe 10 (mfr100509 / 30820694) was used with a headway® 17 microcatheter (microvention) and it reportedly failed to detach.It was replaced with a 5mm x 17cm micrusframe 10 (mfr100517 / 30768294), but ¿it was stuck and could not be delivered.¿ it was replaced with three (3) consecutive 5mm x 17cm micrusframe 10 (mfr100517), one more from lot 30768294 and two (2) from lot 30871999, and all encountered the same issue, becoming impeded in the microcatheter.The headway 17 microcatheter was then replaced with an sl-10® microcatheter (stryker).There was no report of any negative patient impact.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 07-aug-2023 and 10-aug-2023.[additional information]: on 07-aug-2023, the cerenovus sales representative provided additional information related to the products used; the information was then confirmed and clarified on 10-aug-2023.The information confirmed that the procedure date was (b)(6) 2023.The first coil was a 2mm x 8cm galaxy g3 xsft that was used successfully with the headway® 17 microcatheter (microvention).The second coil was the 5mm x 9.7cm micrusframe 10 (mfr100509 / 30820694) that had issue with detachment, the coil was successfully removed from the patient.It was not stretched when it was removed; it was still attached to the delivery system when it was removed.The information indicated that this coil was only used with the headway 17 microcatheter.A pre-deployment electrical check was performed.The fault light was not seen during the procedure.Upon pressing the power button, all lights became illuminated.During the detachment cycle, the detachment light illuminated and the audible signal beep was heard.All connections appeared to fit properly without the application of excessive force.The third, fourth, fifth, and sixth coils were the 5mm x 17cm micrusframe 10 (mfr100517).Related to these coils, the third, fourth, and fifth coils became impeded in the headway 17 microcatheter.The sixth coil was impeded in the sl-10 microcatheter (stryker).A continuous flush was not maintained through the microcatheters, the information indicated that the microcatheters were flushed before the coils were used.There was no issue related to either the headway 17 microcatheter or the sl-10 microcatheter that may have contributed to the reported impeded issue.On 10-aug-2023, clarifying information was received.The information indicated that there were four (4) 5mm x 17cm micrusframe 10 (mfr100517) coil used.The first three (3) were impeded in the headway 17 microcatheter.The 4th coil was impeded in the sl-10 microcatheter.The information indicated that a total of seven (7) coils were used for the procedure, they are as follows: one (1) 2mm x 8cm galaxy g3 xsft that was successfully used with the headway 17 microcatheter.One (1) 5mm x 9.7cm micrusframe 10 (mfr100509 / 30820694).Two (2) 5mm x 17cm micrusframe 10 (mfr100517) from lot: 30768294.Two (2) 5mm x 17cm micrusframe 10 (mfr100517) from lot: 30871999.The 7th coil used was the replacement coil after the last of the 5mm x 17cm micrusframe 10 got stuck in the sl-10 microcatheter.The catalog and lot number of this 7th coil was not provided.However, it was stated that the reported issues were resolved with this replacement coil.There was no clinically significant delay in the procedure due to the reported issue.Based on the additional information received, this 5mm x 17cm micrusframe 10 (mfr100517 / 30768294) was used with the headway® 17 microcatheter (microvention).This is one of 5 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00528, 3008114965-2023-00529, 3008114965-2023-00530, 3008114965-2023-00531, and 3008114965-2023-00532.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: MICRUSFRAME10 5MM X 17CM
• 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. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17495449
• MDR Text Key: 321559943
• Report Number: 3008114965-2023-00529
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077831
• UDI-Public: 10886704077831
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K150319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2023

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 Catalogue Number: MFR100517
• Device Lot Number: 30768294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/09/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2022
• 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: HEADWAY® 17 MICROCATHETER (MICROVENTION); HEADWAY® 17 MICROCATHETER (MICROVENTION); SL-10® MICROCATHETER (STRYKER)