MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL DELTAFILL18 14MM X 45CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	DLF181445
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.This is one of two products involved with the complaint and the associated manufacturer report numbers are 3008114965-2021-00182.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 a coil embolization at the internal iliac artery after a thoracic endovascular aortic repair (tver) stent grafting, an unspecified microcatheter (mc) was delivered to the target lesion at the subclavian artery.Two micrusframe coils (unknown product/lot number) were able to be advanced through the mc without any problems and implanted.A 14mm x 45cm deltafill18 coil (dlf181445, l13550) was used, but it got kinked in the catheter after deliver.Therefore, it was removed and a 14mm x 45cm deltafill18 (dlf181445, l13466) was used, but it became unraveled during advancement through the same microcatheter.It was replaced with another coil (different lot number).Also, the wire of a 16mm x 50cm deltafill18 coil (dlf181650, l13380) was bent during deliver and not able to be delivered.It was replaced with another coil (different lot number).The procedure completed safely.Additional information received indicated that no excessive force was used at any time with the devices.No further information is available.The device was discarded; therefore, no further investigation can be performed.A manufacturing record evaluation (mre) was performed for the finished device l13550 number, and no non-conformances related to the reported complaint condition were identified.With the information available and without the product available for analysis, the reported customer complaint of ¿coil - unraveled/stretched-during use¿ could not be confirmed.Based on the (mre), there is no indication that the event is related to the device manufacturing process.Assignment of root cause for the event remains speculative and inconclusive, based on the limited information provided and without the return of the complaint devices; however, it is possible that clinical and procedural factors, including device manipulation/interaction, aneurysm size and 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 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.
Event or Problem Description
As reported by the field, during a coil embolization at the internal iliac artery after a thoracic endovascular aortic repair (tver) stent grafting, an unspecified microcatheter (mc) was delivered to the target lesion at the subclavian artery.Two micrusframe coils (unknown product/lot number) were able to be advanced through the mc without any problems and implanted.A 14mm x 45cm deltafill18 coil (dlf181445, l13550) was used, but it got kinked in the catheter after delivery.Therefore, it was removed and a 14mm x 45cm deltafill18 (dlf181445, l13466) was used, but it became unraveled during advancement through the same microcatheter.It was replaced with another coil (different lot number).Also, the wire of a 16mm x 50cm deltafill18 coil (dlf181650, l13380) was bent during delivery and not able to be delivered.It was replaced with another coil (different lot number).The procedure completed safely.Additional information received indicated that no excessive force was used at any time with the devices.No further information is available.

• Brand Name: DELTAFILL18 14MM X 45CM
• 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: 11745283
• Report Number: 3008114965-2021-00183
• Device Sequence Number: 4066084
• Product Code: KRD
• UDI-Device Identifier: 10886704077138
• UDI-Public: 10886704077138
• 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): 04/15/2021

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: 07/31/2021
• Device Model Number: DLF181445
• Device Catalogue Number: DLF181445
• Device Lot Number: L13466
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/29/2021
• 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: DELTAFILL18 14MM X 45CM; DELTAFILL18 16MM X 50CM; UNSPECIFIED MICROCATHETER