MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 3MM X 12CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number DLF180312

Device Problems Entrapment of Device (1212); Stretched (1601); Difficult to Advance (2920); Premature Separation (4045)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

The healthcare professional reported that during a transvenous embolization procedure for a dural arteriovenous fistula, the 3mm x 12cm deltafill 18 coil (dlf180312 / 30396178) was the 8th coil used.It was reported that at the time of induction, there was slight resistance felt in the excelsior® sl-10® microcatheter (stryker), but delivery was possible.The complaint coil was inserted as it is.The coil mass was not aggregated and the coil was re-wound several times.The complaint coil became unraveled during the re-winding.As the coil remained in the microcatheter, the physician attempted to extrude the coil with the guidewire but was not successful.The coil was removed with the entire system.After that, the physician made an approach with the microcatheter and again implanted seven additional coils and the procedure was completed.There was no negative impact to the patient; no patient adverse event or patient complication reported.On 12-jul-2022, additional information was received.The information indicated that the complaint coil had not been withdrawn and repositioned.No resistance was reported between the guidewire and the microcatheter when the target site was being accessed.There were no kinks on the microcatheter.The reported issue occurred during the repositioning in the aneurysm (withdrawal / re-withdrawal).The microcatheter was not repositioned over the coil while the coil was deployed out of the distal end of the microcatheter; the coil was not used like a guidewire to reposition the microcatheter.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Procode is krd/hcg.The initial reporter phone: (b)(6).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 the manufacturing documentation associated with this lot (30396178) top and sub assembly 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.All product rejected during manufacturing was identified as scrap and properly accounted for.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.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to include the additional event information received on 29-jul-2022.[additional information]: on 29-jul-2022, additional information was received.The information indicated that there was a one-to-one relationship between the coil and delivery wire verified with fluoro prior to repositioning.The information indicated that coil entanglement with previously placed coil is probable, ¿this is a factor that the complaint device got entangled with the implanted coil and stretched.¿ there was no additional damage noted on the coil aside from the reported unraveled condition when the coil was removed; the coil was not detached when it was removed.The excelsior® sl-10® microcatheter was replaced with another microcatheter.There was no blood flow restriction / reduction as a result of the reported issue.The procedure was prolonged for about 10 to 15 minutes, but there were no clinical impacts.Updated sections: b.4, g.3, g.6, h.2, h.6, and h.10.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 was received in the product analysis lab on 11-aug-2022.The returned product is pending evaluation.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.[conclusion]: the healthcare professional reported that during a transvenous embolization procedure for a dural arteriovenous fistula, the 3mm x 12cm deltafill 18 coil (dlf180312 / 30396178) was the 8th coil used.It was reported that at the time of induction, there was slight resistance felt in the excelsior® sl-10® microcatheter (stryker), but delivery was possible.The complaint coil was inserted as it is.The coil mass was not aggregated and the coil was re-wound several times.The complaint coil became unraveled during the re-winding.As the coil remained in the microcatheter, the physician attempted to extrude the coil with the guidewire but was not successful.The coil was removed with the entire system.After that, the physician made an approach with the microcatheter and again implanted seven additional coils and the procedure was completed.There was no negative impact to the patient; no patient adverse event or patient complication reported.On 12-jul-2022, additional information was received.The information indicated that the complaint coil had not been withdrawn and repositioned.No resistance was reported between the guidewire and the microcatheter when the target site was being accessed.There were no kinks on the microcatheter.The reported issue occurred during the repositioning in the aneurysm (withdrawal / re-withdrawal).The microcatheter was not repositioned over the coil while the coil was deployed out of the distal end of the microcatheter; the coil was not used like a guidewire to reposition the microcatheter.On 29-jul-2022, additional information was received.The information indicated that there was a one-to-one relationship between the coil and delivery wire verified with fluoro prior to repositioning.The information indicated that coil entanglement with previously placed coil is probable, ¿this is a factor that the complaint device got entangled with the implanted coil and stretched.¿ there was no additional damage noted on the coil aside from the reported unraveled condition when the coil was removed; the coil was not detached when it was removed.The excelsior® sl-10® microcatheter was replaced with another microcatheter.There was no blood flow restriction / reduction as a result of the reported issue.The procedure was prolonged for about 10 to 15 minutes, but there were no clinical impacts.The complaint device was returned for evaluation and analysis.The investigation finding is documented below.Investigation summary: a non-sterile 3mm x 12cm deltafill 18 was returned contained in the decontamination pouch.Visual inspection was performed.Only the coil component was returned for evaluation.The coil component underwent microscopic inspection.Under magnification, it was observed to be in severely stretched condition.Although the issue documented regarding the coil entanglement cannot be evaluated as it is specific to the procedure at the time of occurrence and cannot be replicated in the lab, based on the appearance of the returned coil component, the customer complaint regarding the coil becoming entangled and unraveled was confirmed.Coil stretching is a known potential issue associated with the use of this device.The instructions for use (ifu) provides proper handling instructions for the device to prevent such issues from occurring.With the information available, the most likely cause of the coil stretching can be attributed to the device getting entangled with the implanted coils, as it was indicated that it was the 8th coil used and the issue occurred during the repositioning in the aneurysm, which resulted in the coil entanglement and subsequent stretching when it was being withdrawn / re-withdrawn.The issue documented that there was resistance felt in the microcatheter could not be tested for since only the coil component was returned and it was severely stretched.It was reported that coil delivery was possible, it is unknown if the coil became kinked or damaged as a result of force being inadvertently applied to overcome the resistance, which might have contributed to the coil entanglement.However, a root cause remains speculative and inconclusive due to the limited evidence available.There is no indication that the issue reported in the complaint results from a defect inherently related to the device.The exact timing of the coil detachment could not be determined.It could be reasonably suggested that the stretch resistant fiber snapped while the coil was being stretched, then the coil unraveled and eventually pulled free during the post-operative handling of the device as the coil was reported not to be detached when it was removed.A review of the manufacturing documentation associated with this lot (30396178) top and sub assembly 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.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure could be caused by multiple factors.The instructions for use (ifu) does contain the following recommendations: if unusual friction is noticed during advancement or retraction of the microcoil system, verify the clear tab is unlocked and pulled out from the re-sheathing tool approximately 1 in.If unusual friction is noticed during advancement or retraction of the microcoil system through the introducer, open the rhv main valve, and partially withdraw the distal end of the introducer to expose its tip within the rhv.Tighten the rhv main valve and flush the y-connector of the rhv with sterile saline and verify that fluid exits the slit in the clear portion of the introducer.After flushing, reinsert the introducer into the infusion catheter hub 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.

• Brand Name: DELTAFILL18 3MM X 12CM
• 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: 15003949
• MDR Text Key: 301031278
• Report Number: 3008114965-2022-00461
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704077190
• UDI-Public: 10886704077190
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: DLF180312
• Device Catalogue Number: DLF180312
• Device Lot Number: 30396178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2020
• 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: ENPOWER CONTROL CABLE; EXCELSIOR® SL-10® MICROCATHETER (STRYKER)