MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 4X6; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	640CX0406
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	Aneurysm (1708)
Type of Reportable Event	Serious Injury
Event or Problem Description
This complaint is from a literature source.The citation is as follows: hayashi, naoki & kawanishi, masahiko & shindo, atsushi & okubo, shuichi & osaka, naohiro & osaka, kunihiko & tamiya, takashi.(2019).A ruptured internal carotid-posterior communicating artery aneurysm with pure acute subdural hematoma and oculomotor palsy without subarachnoid hemorrhage: a literature review surgery for cerebral stroke.47.373-380.10.2335/scs.47.373.Objective and methods: this article presents a case of pure acute subdural hematoma (asdh) caused by intracranial aneurysm rupture.Lot, model and catalog number are not available, but the suspected cerenovus device possibly associated with reported adverse events: 4mm x 6cm orbit galaxy complex xtrasoft coil.Concomitant cerenovus devices that were also used in this study: n/a.Concomitant non-cerenovus devices that were also used in this study: 7f launcher guiding catheter (medtronic); 4mm x 7mm hyperform balloon (medtronic); excelsior sl-10 microcatheter (stryker); 360 soft coils (stryker); target 360 ultra coils (stryker).Adverse event(s) and provided interventions: a (b)(6) female who underwent balloon-assisted coil embolization of a ruptured left internal carotid-posterior communicating artery aneurysm with 4mm x 6cm orbit galaxy complex xtrasoft coil and competitor coils (stryker) experienced aneurysm body filling due to coil compaction early on, requiring repeat coil embolization on day 18.Complete occlusion was obtained, and the patient recovered without any neurological deficits.
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).This complaint is from a literature source.The citation is as follows: hayashi, naoki & kawanishi, masahiko & shindo, atsushi & okubo, shuichi & osaka, naohiro & osaka, kunihiko & tamiya, takashi.(2019).A ruptured internal carotid-posterior communicating artery aneurysm with pure acute subdural hematoma and oculomotor palsy without subarachnoid hemorrhage: a literature review surgery for cerebral stroke.47.373-380.10.2335/scs.47.373.Procode is (b)(6).The expiration date of the device is not known as the device lot number is not available / not reported.The initial reporter phone and email address are not available / reported.The device manufacture date is not known as the device lot number is not available / not reported.Due to the nature of the complaint, the device (s) were not returned for analysis nor was the sterile lot numbers provided in order to conduct a lot history review.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.Since the aneurysm recanalization secondary to coil compaction required surgical intervention to preclude permanent impairment/injury, the event is considered serious and mdr reportable.The file will be re-reviewed if additional information is received at a later date.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.The manufacturer will submit a supplemental report if new facts arise which materially alter information submitted in a previous mdr report.Additional information will be submitted within 30 days of receipt.

• Brand Name: OG CMPLX XTRASOFT COIL 4X6
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MEDOS INTERNATIONAL SARL; chemin-blanc 38; le locle neuchatel CH-24 00; SZ CH-2400
• Manufacturer (Section G): CODMAN & SHURTLEFF, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvarcar; juarez chihuahua 32574 ; MX 32574
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 949789-8687
• MDR Report Key: 13621140
• Report Number: 3008114965-2022-00156
• Device Sequence Number: 4725862
• Product Code: KRD
• UDI-Device Identifier: 10886704030621
• UDI-Public: 10886704030621
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K093973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 640CX0406
• Device Catalogue Number: 640CX0406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 360 SOFT COILS (STRYKER).; 4MM X 7MM HYPERFORM BALLOON (MEDTRONIC).; 7F LAUNCHER GUIDING CATHETER (MEDTRONIC).; EXCELSIOR SL-10 MICROCATHETER (STRYKER).; TARGET 360 ULTRA COILS (STRYKER).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown