MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL MICRUSFRAME10 5MM X 9.7CM; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	MFR100509
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer¿s ref.No: (b)(4).Information regarding patient date of birth was not provided.Section d.2b: procode is krd/hcg.Section e.1: the name, phone and email address of the initial reporter are not available / reported.Based on complaint information, the device was not available to be returned for analysis.A review of manufacturing documentation associated with this lot (30656522) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.Product analysis cannot be conducted as the product was not returned for analysis.No determination of causes and possible contributing factors could be made.As such, the investigation will be closed.Coil herniation into parent vessel is a known procedural occurrence.The root cause of the event cannot be determined.However, there are clinical and procedural factors including aneurysm/vessel characteristics, device interaction, device selection, and operator technique that may have contributed to the coil herniation.With the information available and without the complaint product available to be returned for analysis, the reported issue in the complaint related to the herniation / prolapsing of the complaint coil cannot be investigated through product evaluation and analysis.Based on the manufacturing documentation review, there is no indication that the event is related to the device manufacturing process.As part of the post market surveillance program, information from this complaint is trended for statistical signals and corrective / preventive action may be triggered at a later time.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by cerenovus, or its employees that the report constitutes an admission that the product, cerenovus, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.
Event or Problem Description
The device malfunction was reported via the sterling study.On (b)(6) 2023, the 42-year-old male patient with a history of lumbar spinal surgery underwent coil embolization of a midline ruptured saccular aneurysm with spherical morphology in the anterior circulation (bifurcation of the anterior communicating artery) with the following dimensions: height: 5.5mm, width: 5.2mm, depth: 4.6mm, neck: 2.5mm, maximum aneurysm diameter 6.8.Dome-to-neck ratio 2.1.The 5mm x 9.7cm micrusframe 10 (mfr100509 / 30656522) was placed via an sl-10® microcatheter (stryker).Angiography showed herniation / prolapse of coil into the left a1/a2 junction.The coil was removed and resheathed.It was replaced with a 4mm x 8cm target xl 360 soft (stryker), which was used to frame the aneurysm.The following coils were subsequently implanted: 3mm x 6cm galaxy g3 xsft (glx120306 / 30637469), 2.5mm x 3.5cm galaxy g3 mini (glm925035 / 30830578), 2.5mm x 3.5cm galaxy g3 mini (glm925035 / 30830578), 2.5mm x 4.5cm galaxy g3 mini (glm925045 / 30727829), 2mm x 4cm galaxy g3 mini (glm920040 / 30768284), 2mm x 3mm galaxy g3 mini (glm920030 / 30790686), and 1.5mm x 2.5cm galaxy g3 mini (glm915025 / 30419306).There was no intra-operative adverse event.Per the principal investigator (pi), the treatment of the target aneurysm was considered complete with the study coils fully implanted at the target site.On 13-jun-2023, additional information was received.The information indicate that the complaint coil was deployed easily.It initially conformed to the aneurysm wall.On repeat angiography, the coil was no longer conformed to the aneurysm wall and had herniated into the parent vessel.It was after it had herniated that it was decided to remove the coil and replaced it with a target xl framing coil (stryker).

• Brand Name: MICRUSFRAME10 5MM X 9.7CM
• 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): CERENOVUS INC. (FREMONT); 47709 fremont blvd; fremont CA 94538
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-6892
• MDR Report Key: 17122342
• Report Number: 3008114965-2023-00350
• Device Sequence Number: 6487459
• Product Code: KRD
• UDI-Device Identifier: 10886704077848
• UDI-Public: 10886704077848
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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: Study,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2023

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: 09/30/2024
• Device Model Number: MFR100509
• Device Catalogue Number: MFR100509
• Device Lot Number: 30656522
• 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: 05/31/2023
• Initial Report FDA Received Date: 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2021
• 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: SL-10® MICROCATHETER (STRYKER)
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White