MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 7MM X 33CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF180733
Medical Device Problem Codes	Entrapment of Device (1212); Stretched (1601); Positioning Problem (3009); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Procode: krd/hcg.Initial reporter phone: (b)(6).Type of reportable event: serious injury: the portion of the coil outside the target site in the abdominal aorta was not tethered in position by an additional device and as such remains fully exposed to blood flow and may act as a nidus for thrombus formation.Therefore, the event meets mdr reporting criteria with the classification of "serious injury".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.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: a report from the field indicated that during a coil embolization at the splenic artery, a 7mm x 33cm deltafill18 (dlf180733/30393933) was selected for use as the 13th coil, however, resistance was encountered as the coil was being advanced inside of the coil mass.The physician attempted to resheath the coil, but the coil became unraveled, and the delivery and coil were damaged/broken.The physician then removed the concomitant leonis mova (sumitomo bakelite) microcatheter.During this maneuver, the coil, which was placed in the blood vessel, was pulled with the microcatheter.The coil was ultimately left in the patient at the abdominal aorta.The physician plans to follow-up and monitor the unraveled ¿thin¿ coil.There was no report of patient injury.Additional information received indicated that excessive force had not been applied to the device.The device was reportedly used and prepped according to the instructions for use (ifu).No further details could be obtained.The device was not returned as it remains implanted.A manufacturing record evaluation was performed for the finished device 30393933 number, and no non-conformances related to the reported complaint condition were identified.Positioning difficulty, entanglement with previously placed coils, unraveled/stretched, and unintended detachment are known potential procedural complications associated with the deltafill18 coil.The deltafill18 ifu cautions that if repositioning of the microcoil is necessary, carefully observe the motion of the microcoil in respect to the device positioning unit (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.The microcoil system should be gently removed.If the microcoil is positioned at a relative sharp angle to the microcatheter, a microcoil may stretch or break as it is being withdrawn.By repositioning the distal tip of the microcatheter at or slightly inside the ostium (neck) of the aneurysm, the microcoil may be more easily funneled back into the microcatheter.In this situation, it appears that the operator advanced the coil into the coil mass and the coil became intertwined with the previously placed coils.The operator attempted to reposition the coil and during this maneuver, the coil while entangled with the other coils, likely stretched and mechanically detached from the dpu wire (pending clarification).With the amount of information available and without films of the event or return of the associated devices, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors including vessel/target site characteristics, device selection, device interaction, and operator technique that may have contributed rather than the design or manufacture of the device.Excessive force applied to a coil through repeated coil deployments or manipulation can increase the possibility of coil damage and unintended detachment.The portion of the coil outside the target site in the abdominal aorta was not tethered in position by an additional device and as such remains fully exposed to blood flow and may act as a nidus for thrombus formation.The file will be re-reviewed if additional information is received at a later date.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 events were related to a manufacturing or design issue, no corrective actions will be taken at this time.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
A report from the field indicated that during a coil embolization at the splenic artery, a 7mm x 33cm deltafill18 (dlf180733/30393933) was selected for use as the 13th coil, however, resistance was encountered as the coil was being advanced inside of the coil mass.The physician attempted to resheath the coil, but the coil became unraveled, and the delivery and coil were damaged/broken.The physician then removed the concomitant leonis mova (sumitomo bakelite) microcatheter.During this maneuver, the coil, which was placed in the blood vessel, was pulled with the microcatheter.The coil was ultimately left in the patient at the abdominal aorta.The physician plans to follow-up and monitor the unraveled ¿thin¿ coil.There was no report of patient injury.Additional information received indicated that excessive force had not been applied to the device.The device was reportedly used and prepped according to the instructions for use (ifu).No further details could be obtained.

• Brand Name: DELTAFILL18 7MM X 33CM
• 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: 11967216
• Report Number: 3008114965-2021-00244
• Device Sequence Number: 17246944
• Product Code: KRD
• UDI-Device Identifier: 10886704076940
• UDI-Public: 10886704076940
• Combination Product (Y/N): N
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/21/2021

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: 05/31/2023
• Device Model Number: DLF180733
• Device Catalogue Number: DLF180733
• Device Lot Number: 30393933
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2021
• Initial Report FDA Received Date: 06/09/2021
• 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: LEONISMOVA, SUMITOMO BAKELITE MICROCATHETER