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

Model Number MFR100611

Device Problems Separation Failure (2547); Difficult or Delayed Separation (4044)

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

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.The initial reporter phone is not reported / available.[conclusion]: the healthcare professional reported that during a complex posterior communicating artery (pcom) aneurysm coil embolization procedure, the first micrusframe coil, a 6mm x 11.9cm micrusframe 10 (mfr100611 / k10236) was deployed, however, after it was resheathed, it failed to redeploy effectively and was replaced with another micrusframe coil of the same size but from a different lot number.The 6mm x 11.9cm micrusframe 10 (mfr100611 / 30593190) failed to detach two times and then it was successfully deployed on the third attempt.The remainder of the coil embolization was completed using stryker filling coils.The reported issue resulted in a 15-minute procedure delay.The procedure was successfully completed without any patient adverse event or complication.On 28-jun-2022, additional information was received.The information indicated that the first micrusframe coil was from lot k10236.The second micrusframe from lot 30593190 did successfully detach on the third attempt and was implanted in the target aneurysm.The enpower detachment control box 2 (dcb 2) (dcb2000500 / lot# unknown) was used.The enpower control cable was used.A pre-deployment electrical check was performed.The low battery and the fault lights were not seen during the case.Upon pressing the power button, all the lights illuminated; the green system ready light illuminated.On the third attempt to detach the second micrusframe coil, the detachment light illuminated and the audible signal beep was heard.All connections fit properly without force.Based on complaint information, the device remains implanted and is thus not available for evaluation.A review of manufacturing documentation associated with this lot (30593190) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.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.Difficulty to detach and failure to detach are a known potential product issues associated with the use of the device.The ifu contains several cautions relating to these situations, including instructions for troubleshooting should they be encountered during use.Per the ifu: ¿if a fault light is detected, the system ready light is not illuminated, or there is no detachment after two detachment attempts, replace the dcb unit.If detachment still does not occur, carefully withdraw the entire microcoil system, and redeploy a new microcoil system.¿ with the information provided but without the product available for return, the reported issue that the complaint device was difficulty to detach and did not detach until the third attempt could not be investigated via product analysis/evaluation.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, aneurysm size / vessel characteristics, device selection, and the concomitant microcatheter, may have contributed to the reported issue.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 4.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 a complex posterior communicating artery (pcom) aneurysm coil embolization procedure, the first micrusframe coil, a 6mm x 11.9cm micrusframe 10 (mfr100611 / k10236) was deployed, however, after it was resheathed, it failed to redeploy effectively and was replaced with another micrusframe coil of the same size but from a different lot number.The 6mm x 11.9cm micrusframe 10 (mfr100611 / 30593190) failed to detach two times and then it was successfully deployed on the third attempt.The remainder of the coil embolization was completed using stryker filling coils.The reported issue resulted in a 15-minute procedure delay.The procedure was successfully completed without any patient adverse event or complication.On 28-jun-2022, additional information was received.The information indicated that the first micrusframe coil was from lot k10236.The second micrusframe from lot 30593190 did successfully detach on the third attempt and was implanted in the target aneurysm.The enpower detachment control box 2 (dcb 2) (dcb2000500 / lot# unknown) was used.The enpower control cable was used.A pre-deployment electrical check was performed.The low battery and the fault lights were not seen during the case.Upon pressing the power button, all the lights illuminated; the green system ready light illuminated.On the third attempt to detach the second micrusframe coil, the detachment light illuminated and the audible signal beep was heard.All connections fit properly without force.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on(b)(6).2022.[additional information]: on (b)(6).2022, additional information was received.The information indicated that the microcatheter used was an echelon¿ 10 microcatheter (medtronic).The reported issue resulted in an additional 10-15 minutes of uncertainty was not deemed clinically significant but ¿did cause panic intra-op.¿ 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 6MM X 11.9CM
• 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): CODMAN & SHURTLEFF, INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14962705
• MDR Text Key: 303155599
• Report Number: 3008114965-2022-00459
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077855
• UDI-Public: 10886704077855
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/20/2022

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: 05/31/2024
• Device Model Number: MFR100611
• Device Catalogue Number: MFR100611
• Device Lot Number: 30593190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/24/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/20/2022
• Supplement Dates FDA Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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: ECHELON¿ 10 MICROCATHETER (MEDTRONIC); ENPOWER CONTROL CABLE; ENPOWER DCB 2