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

Catalog Number DLF180312

Device Problems Fracture (1260); Difficult to Advance (2920)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

The healthcare professional reported that during a coil embolization of the inferior mesenteric artery (ima) prior to stent graft implantation, the complaint devices, a 3mm x 12cm deltafill 18 coil (dlf180312 / 30942954) and a 150cm x 5cm, 2 markers prowler select lpes (606s155x / 30633467) were used in accordance with the instructions for use (ifus).It was reported that while inserting the complaint coil as the 11th coil, via the introducer into the prowler select microcatheter, strong resistance was felt inside the microcatheter.When the delivery wire was pulled, the coil was found to have become fractured inside the microcatheter.The coil and the microcatheter were replaced and the procedure was successfully completed.Continuous flush was reported as not maintained during the procedure.There was no negative patient impact reported.On 11-oct-2023, limited additional information was provided.The information confirmed that the coil became fractured inside the microcatheter.On 18-oct-2023, additional information was received.The information indicated that strong resistance was not experienced with the previous coils.Per the information, continuous flush was not maintained ¿because the y-connector was not used.¿ the replacement coil was another 3mm x 12cm deltafill 18 (dlf180312).The replacement microcatheter was another prowler select plus lpes (606s155x).The reported issue resulted in an approximately 3-minute delay in the procedure which was not considered to be clinically significant.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).Information regarding patient identifier, date of birth, age, gender, and weight were not provided.Section d.2b: procode is krd/hcg.Section e.1: the initial reporter phone: (b)(6).The initial reporter email address was not provided.Section h.3: 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 manufacturing documentation associated with this lot (30942954) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.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.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 report the investigation finding of the returned device.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 coil was received contained in the decontamination pouch.Visual inspection was performed.It was noted that the coil was returned separated from the system.No other appearance of damages were observed.The coil underwent microscopic inspection.Under magnification, the embolic coil was observed to be stretched in one proximal portion and this was mechanically detached from the delivery system since the resistance heating (rh) coil was noted to be not softened indicating that the detachment process was not initiated.No other damages were noted in the device.The issue regarding the coil being fractured was confirmed since the coil was returned for evaluation mechanically detached.At the same time due to the conditions in which the coil was received, the reported issue in the complaint regarding resistance cannot be evaluated.The complaint detailed that a continuous flush was not maintained and according to the risk documentation, friction and difficulty to advance are potential issues that can occur during microcoil placement due to continuous saline flush not established, which can result in device damage.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.The issue regarding the coil being fractured was confirmed since the coil was returned for evaluation mechanically detached.The stretched condition of the coil is suggested to have appeared during the device withdrawal, where excessive force may have inadvertently been applied.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.According to the risk documentation, friction is a potential issue that can occur during microcoil re-sheathing due an rhv not being adequately loosened or the introducer sheath being too tight within rhv, which can result in the coil stretching.A review of manufacturing documentation associated with this lot (30942954) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.It should be noted that multiple factors could cause product failure.The instructions for use (ifu) contain the following precautions: ¿ 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.¿ 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.¿if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the dpu wire while retracting the microcoil under fluoroscopy.If the microcoil movement is not one-to-one with the dpu wire, or if repositioning is difficult, the microcoil may have become stretched and could possibly break.Gently remove and discard the microcoil 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.

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 (b)(6) 2023.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.

• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 17991347
• MDR Text Key: 326393395
• Report Number: 3008114965-2023-00713
• 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
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DLF180312
• Device Lot Number: 30942954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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: PROWLER SELECT LPES.
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian