MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL FREEFORM XSFT 3MM X 4 CM; NEUROVASCULAR EMBOLIZATION DEVICE

Catalog Number XCR120304

Device Problems Material Separation (1562); Difficult or Delayed Separation (4044)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4) information regarding patient identifier, date of birth, weight, race, and ethnicity were not provided.Section d.2b: procode is krd/hcg.Section h.3: the coil component remains implanted and is not available for return.The remainder of the device component is available to be returned for evaluation and testing.However, it has not been received to date as indicated as ¿other¿ in this section as the reason for non-evaluation.Based on the complaint information, the coil component was detached and implanted.A review of manufacturing documentation associated with this lot (31131259) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: (b)(4).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 Description

The healthcare professional reported that the 48-year-old male patient underwent a pharyngeal-carotid artery (ca) vessel sacrifice procedure targeting the left common carotid artery (lcca), a 6fr sheath -right femoral artery, 6fr benchmark¿ distal access catheter (penumbra) with 5fr vtk select catheter (unspecified brand) were introduced to the lcca along with an excelsior® xt-27® microcatheter (stryker) and synchro2® 0.014¿ guidewire (stryker).A 3mm-5mm micro vascular plug (mvp) (medtronic) was deployed in the lcca segment.The excelsior® xt-27® microcatheter was removed.The sl-10® 45° microcatheter (stryker) and the synchro 14 guidewire at the proximal to where the plug was deployed was removed.The following cerepak freeform coils were placed: 4mm x 12cm cerepak freeform (scr120412 / 31140706), 5mm x 15cm cerepak freeform (scr120515 / 31090186), 6mm x 20cm cerepak freeform (scr120620 / 31058141), 6mm x 15cm cerepak freeform (scr120615 / 31136146), 4mm x 10cm cerepak freeform (scr120410 / 31140705), 6mm x 20cm cerepak freeform xtrasoft (xcr120620 / 31131261), 4mm x 12cm cerepak freeform (scr120515 / 31090186), 6mm x 20cm cerepak freeform (scr120620 / 31058141), 6mm x 25cm cerepak heliform (shd180625 / 31140717), 5mm x 10cm cerepak freeform (scr120510 / 31090185), 4mm x 8cm cerepak freeform xtrasoft (xcr120408 / 31126838), and 3mm x 4cm cerepak freeform xtrasoft (xcr120304 / 31131259) were advanced and detached.There were two coils that had issue with detachment.The first coil, a 3mm x 6cm cerepak freeform (scr120306 / 31058140) was advanced and detachment attempts were made.Two (2) attempts were made with the cerepak tm mechanical detachment handle (mdh1 / 97988374) and one (1) manual break.All attempts failed to detach the coil.The strong was attempted to be pulled with hemostat, but it broke and the coil was removed without incident.The second coil, a 3mm x 4cm cerepak freeform xtrasoft (xcr120304 / 31131259) did detach after two(2) detachment attempts were made.The 3mm x 4cm cerepak freeform xtrasoft coil was implanted, but fragments of coil delivery system and pusher tube were collected.The procedure was successfully completed with great results.The patient was reported to be doing well post-procedure.There was no negative patient impact reported.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the remaining product component was received in the product analysis lab on 01-nov-2023.The returned device component is pending evaluation.A supplemental 3500a report will be submitted once the product investigation has been completed.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00762, 3008114965-2023-00764, and 3008114965-2023-00765.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.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report the investigational finding of the returned device.The coil component remains implanted and is not available for return.The remainder of the device was returned and received for evaluation and analysis.The investigation is documented below.Investigation summary: a non-sterile 3mm x 4cm cerepak freeform xtrasoft was received contained in the decontamination pouch.Visual inspection was performed.The embolic coil was not attached to the delivery system; this is consistent with the event description.The detachment tube was observed separated as it was pulled out from the rotating hemostasis valve (rhv).A review of manufacturing documentation associated with this lot (31131259) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.The issues reported regarding the difficulty to detach, and separated condition of the delivery tube were confirmed based on the findings mentioned above.The separated condition suggests that the rhv was not fully opened at the time of removal of the delivery unit from the microcatheter; however, with the limited information available this remains speculative, and a conclusive cause cannot be determined.Factors not described within the information available such as device manipulation, operator's technique, anatomical tortuosity, etc., may have contributed to the issue encountered.There is no indication that the issue reported in the complaint is a result of a defect inherently related to the device.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Devices undergo 100% inspection at different points during the manufacturing process to prevent damage from leaving the facility.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.Updated sections: b.4, g.3, g.6.H.2, h.3, h.6, and h.10.This is one of 3 products involved with the reported complaint.The associated manufacturer report numbers are: 3008114965-2023-00762, 3008114965-2023-00764, and 3008114965-2023-00765.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: FREEFORM XSFT 3MM X 4 CM
• Type of Device: 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.; calle circuito int norte 1820; parque industrial salvacar; juarez 32574 ; MX 32574
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 303552-689
• MDR Report Key: 18080848
• MDR Text Key: 327500152
• Report Number: 3008114965-2023-00765
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704083634
• UDI-Public: 10886704083634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K220040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: XCR120304
• Device Lot Number: 31131259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 3MM-5MM MICRO VASCULAR PLUG (MVP) (MEDTRONIC); 5FR VTK SELECT CATHETER (UNSPECIFIED BRAND); 6FR SHEATH (UNSPECIFIED BRAND); BENCHMARK¿ DISTAL ACCESS CATHETER (PENUMBRA); EXCELSIOR® XT-27® MICROCATHETER (STRYKER); MECHANICAL DETACHMENT HANDLE; SL-10® 45° MICROCATHETER (STRYKER); SYNCHRO2® 0.014¿ GUIDEWIRE (STRYKER)
• Patient Age: 48 YR
• Patient Sex: Male