MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 4MM X 11.5CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100412
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/06/2020
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: the customer contact information, including name, occupation, phone, fax, and e-mail address, was not reported.(b)(4).A supplemental report will be submitted if new facts arise which materially alter information submitted in a previous mdr report.
Event or Problem Description
A report from the field indicated that approximately one month following a coil embolization of an unruptured paraclinoid internal carotid artery aneurysm with a 4mm x 11.5cm micrusframe10 (mfr100412/s13585) and two competitor coils, ¿some substance other than thrombus was flying to the periphery¿.The physician suspected that the substance was the implanted micrusframe10 coil as it was not seen after the procedure.The patient has not experienced any clinical symptoms as a result of the event.The coil embolization procedure occurred on (b)(6) 2020.It was stated that it was very difficult to deliver the microcatheter to the target aneurysm during the procedure; sl-10 (stryker) and headway17 (terumo) microcatheters were utilized.The complaint coil is not available for evaluation.No further information provided at the time of complaint initiation.
Additional Manufacturer Narrative
Product complaint # (b)(4).Section b5: additional information received indicted that the physician suspects that the substance was the implanted coil because it was not seen shortly after the procedure.It was visualized one month after the procedure.The cause of the event is unknown.Procedural/follow-up imaging is not available for evaluation.No further information could be obtained.Section e1: initial reporter phone: (b)(6).Complaint conclusion: a report from the field indicated that approximately one month following a coil embolization of an unruptured paraclinoid internal carotid artery aneurysm with a 4mm x 11.5cm micrusframe10 (mfr100412/s13585) and two competitor coils, ¿some substance other than thrombus was flying to the periphery¿.The physician suspected that the substance was the implanted micrusframe10 coil as it was not seen after the procedure.The patient has not experienced any clinical symptoms as a result of the event.The coil embolization procedure occurred on (b)(6) 2020.It was stated that it was very difficult to deliver the microcatheter to the target aneurysm during the procedure; sl-10 (stryker) and headway17 (terumo) microcatheters were utilized.The complaint coil is not available for evaluation.Additional information received indicated that the physician suspects that the substance was the implanted coil because it was not seen shortly after the procedure.It was visualized one month after the procedure.The cause of the event is unknown.Procedural/follow-up imaging is not available for evaluation.No further information could be obtained.The micrusframe10 coil remains implanted therefore, no additional investigation can be performed.A manufacturing record evaluation was performed for the finished device s13585 number, and no non-conformances related to the reported complaint condition were identified.Coil migration is a known potential complication associated with the use of micrusframe in coil embolization procedures.With the amount of information available and without films of the event, it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel/aneurysm characteristics and procedural factors may have contributed.Details regarding intervention/treatment and patient outcome could not be obtained.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 event was related to a manufacturing or design issue, no corrective actions will be taken at this time.

• Brand Name: MICRUSFRAME10 4MM X 11.5CM
• 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: 9853204
• Report Number: 3008114965-2020-00069
• Device Sequence Number: 19466259
• Product Code: KRD
• UDI-Device Identifier: 10886704077817
• UDI-Public: 10886704077817
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2020

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: 02/29/2020
• Device Model Number: MFR100412
• Device Catalogue Number: MFR100412
• Device Lot Number: S13585
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 04/13/2020
• 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: HEADWAY17 (TERUMO) MICROCATHETER; SL-10 (STRYKER) MICROCATHETER; TWO COMPETITOR COILS