MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 2.5MM X 3.3CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number	MFR100253
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/23/2019
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.The customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.(b)(4).Lot: the lot number was not provided at the time of the report.(b)(4).This information was not provided in the reported event or available at the time of report submission.The company is seeking this information through the event investigation.A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
As reported by a healthcare professional, during an aneurysm coil embolization procedure, a 2.5mm x 3.3cm micrusframe10 coil (mfr100253, unknown lot) came back to the unspecified microcatheter after it was detached.One minute later, the physician pushed the coil back inside of the aneurysm.No patient complications or surgical delay occurred as a result of the event.No further information was provided at the time of complaint initiation.
Additional Manufacturer Narrative
Product complaint # (b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.Complaint conclusion: as reported by a healthcare professional, during an aneurysm coil embolization procedure, a 2.5mm x 3.3cm micrusframe10 coil came back to the unspecified microcatheter after it was detached.One minute later, the physician pushed the coil back inside of the aneurysm.No patient complications or surgical delay occurred as a result of the event.The device is not available for evaluation.No further information was provided at the time of complaint initiation.The device will not be returned for analysis and therefore, no further investigation can be performed at this time.As a result, we are closing this investigation.The manufacturing record evaluation (mre) cannot be performed due to the lot number was not provided.Coil protrusion into parent vessel is a known potential complication associated with coil embolization procedures.According to the referenced literature, coil herniation into the parent artery may occasionally occur in aneurysms after coil detachment for several reasons, particularly wide-neck aneurysms.These include coil instability in the aneurysm sac, excessive embolization, microcatheter-related factors, and being pushed by subsequent coil embolization.Assignment of root cause for the event remains speculative and inconclusive based on the minimal information provided; however, it is possible that clinical and procedural factors, including aneurysm/vessel characteristics, device manipulation, and device interaction, may have contributed.Multiple attempts to obtain additional information were unsuccessful.If information is provided at a later date, the file will be reopened and processed accordingly.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: MICRUSFRAME10 2.5MM X 3.3CM
• 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: 9287116
• Report Number: 3008114965-2019-01230
• Device Sequence Number: 1892366
• Product Code: KRD
• UDI-Device Identifier: 10886704077770
• UDI-Public: 10886704077770
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2019

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 Catalogue Number: MFR100253
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 01/16/2020
• 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: UNKNOWN MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention