MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 4MM X 15CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180415
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the field, during an endovascular aneurysm repair (evar) of the inferior mesenteric artery (ima), a deltafill18 4mm x 15cm coil ( dlf180415, 30412474) was used.At the time of coil placement, although it was winded well at first, the physician felt strong resistance gradually, and then a prowler select plus microcatheter (psp) kicked back greatly.The complaint coil was removed, and the procedure was completed.There was no reported patient injury.Additional information received indicated that it was not necessary to remove the microcatheter.No damage was noted on the microcatheter during manipulation of the device or upon removal from the patient.The device did not appear damaged at any time.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.No excessive force was applied to the device.Based on the analysis of the device received, the embolic coil has a stretched condition.
Additional Manufacturer Narrative
Product complaint # (b)(4).The purpose of this mdr submission is to report the findings of the device investigation.Based on the analysis of the device received, the embolic coil has a stretched condition.The findings meet us regulatory reporting criteria.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg, (b)(6).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.Complaint conclusion: as reported by the field, during an endovascular aneurysm repair (evar) of the inferior mesenteric artery (ima), a deltafill18 4mm x 15cm coil ( dlf180415, 30412474) was used.At the time of coil placement, although it was winded well at first, the physician felt strong resistance gradually, and then a prowler select plus microcatheter (psp) kicked back greatly.The complaint coil was removed, and the procedure was completed.There was no reported patient injury.Additional information received indicated that it was not necessary to remove the microcatheter.No damage was noted on the microcatheter during manipulation of the device or upon removal from the patient.The device did not appear damaged at any time.Nothing was noted to be obstructing the microcatheter.The introducer was flushed until liquid was visible at the distal end of the slit in the clear tube.No excessive force was applied to the device.A non-sterile deltafill18 4mm x 15cm was received for analysis, the device was inspected, and it was found that the device is in good normal conditions, no damages or anomalies were observed during the visual analysis.The device was inspected under a microscope, and it was found that the embolic coil has a stretched condition.A manufacturing record evaluation (mre) was performed for the finished device 30412474 number, and no non-conformance was found during the review.Cerenovus conducted a visual inspection and microscopic examination of the returned device.The visual analysis of the returned sample determined that the device is in good normal conditions, no damages or anomalies were observed on it.A microscopic test was performed, and it was found that the embolic coil has a stretched condition.Although the customer complaint regarding ¿coil - positioning difficulty¿ could not be evaluated since it is specific to the patient and procedure at the time of occurrence and cannot be replicated in the lab, the stretched condition could be related with the customer experience at the procedure time.However, this cannot be conclusively determined.Based on the findings during the analysis, the customer complaint was confirmed.A manufacturing record evaluation was performed, and no non-conformances related to the reported complaint condition were identified.Positioning difficulty is a potential complication associated with the use of the device.It should be noted that product failure is multifactorial.The instructions for (ifu) use contain the following recommendations: ¿ the selected coils typically will be of decreasing size and the physician may continue to implant microcoils until he or she determines that the aneurysm has been successfully treated.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and the evidence presented by the returned device; however, it is possible that clinical and procedural factors, including device manipulation and device interaction, may have contributed to the reported failure and damages on the returned system.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: DELTAFILL18 4MM X 15CM
• 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: 12738087
• Report Number: 3008114965-2021-00548
• Device Sequence Number: 19209164
• Product Code: KRD
• UDI-Device Identifier: 10886704077206
• UDI-Public: 10886704077206
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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: 06/30/2023
• Device Model Number: DLF180415
• Device Catalogue Number: DLF180415
• Device Lot Number: 30412474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2021
• Initial Report FDA Received Date: 11/02/2021
• 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: UNKPROWLERSELECT