MAUDE Adverse Event Report: MEDOS INTERNATIONAL SARL OG CMPLX XTRASOFT COIL 3X8; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number 640CX0308

Device Problem Premature Separation (4045)

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

Event Date 11/14/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Information regarding patient identifier, date of birth, age, gender, weight, race, and ethnicity were not provided.Procode is krd/hcg.(b)(6).The initial reporter email address is not available / reported.(b)(6).The embolic coil has been implanted.The complaint information indicates that component of the device 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.If the device returns, a device investigation will be performed.A review of manufacturing documentation associated with this lot (30571051) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformances related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.Premature detachment necessitating additional intervention is a known potential complication associated with the use of embolic coils in endovascular embolization.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors, including aneurysm / vessel characteristics, device selection, device interaction, and operator technique that may have contributed rather than the design or manufacture of the device.The file will be re-reviewed if additional information is received at a later date.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 during an aneurysm coil embolization procedure, a 3mm x 8cm orbit galaxy complex xtrasoft coil (640cx0308 / 30571051) became prematurely detached when 7/8 of the coil was placed into the aneurysm sac.As a result, the physician placed a stent (size / brand / manufacturer not specified) to affix the remaining 1/8 of the coil still outside the aneurysm to the vessel wall.The procedure was completed without any patient injury.Additional information was received on 29-nov-2021.The information indicated that this was an irregular aneurysm.No further information could be obtained.

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).The purpose of this mdr submission is to report that the product analysis lab received the complaint device component on 04-jan-2022.A supplemental 3500a report will be submitted once the product investigation has been completed.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 component.[conclusion]: the healthcare professional reported that during an aneurysm coil embolization procedure, a 3mm x 8cm orbit galaxy complex xtrasoft coil (640cx0308 / 30571051) became prematurely detached when 7/8 of the coil was placed into the aneurysm sac.As a result, the physician placed a stent (size / brand / manufacturer not specified) to affix the remaining 1/8 of the coil still outside the aneurysm to the vessel wall.The procedure was completed without any patient injury.Additional information was received on 29-nov-2021.The information indicated that this was an irregular aneurysm.No further information could be obtained.The embolic coil has been implanted.The complaint information indicates that component of the device is available to be returned for evaluation and testing.The complaint device component was returned for evaluation and analysis.The investigational finding is documented below.Investigation summary: a non-sterile 3mm x 8cm orbit galaxy complex xtrasoft coil was received contained in a pouch.Visual inspection was performed.The hypotube was observed kinked at 9 inches and 38.5 inches from the proximal end.The embolic coil component remains implanted and was not returned for analysis.No other damages or anomalies were observed during the visual inspection.Microscopic inspection was performed.Under magnification, the headpiece was observed still inside the pebax.The headpiece was inspected and welding residues were observed between the headpiece and the anchor.The headpiece underwent scanning electron microscope (sem) analysis.It was confirmed that no traces of the coil remained on the headpiece.Due to the shape of the weld remaining on the headpiece, it was concluded that the coil was properly welded.Elemental compositions showed that the weld is composed mainly of tin (sn) and gold (au).No traces of the coil made of titanium (ti) was noted.Solder batch records used on the device were reviewed and it was found that the batch met the released requirements and composition.The failure mode was assessed by the manufacturing team and the research and development (r&d) team.It was concluded that there was no manufacturing issue with the device or with the solder joint.The reported complaint issue was confirmed due to the findings observed.Per r&d assessment, it is likely that the primary failure mode appears to have been that the stretch resistant fiber broke while the coil was being stretched, then the coil unraveled and pulled free (prematurely detached) from the headpiece, however, this cannot be conclusively determined.Therefore, it is difficult to determine the exact contributing factors that may have resulted in the observed failure mode.It is suspected that the 3mm x 8cm orbit galaxy complex xtrasoft coil was used as a finishing coil and it may have gotten caught with previously implanted coils, or it may have been deployed repeatedly during the attempt to achieve the desired shape and configuration in the aneurysm since the additional information received indicated that the target lesion was an irregular aneurysm.A review of manufacturing documentation associated with this lot (30571051) presented no issues during the manufacturing or inspection processes related to the reported complaint.There were no nonconformance's related to device manufacture or inspection.All product rejected during manufacturing was identified as scrap and properly accounted for.As part of the cerenovus quality process, all devices are manufactured, inspected, and released to approved specifications.Premature detachment necessitating additional intervention is a known potential complication associated with the use of embolic coils in endovascular embolization.With the amount of information available and without procedural films, it is not possible to determine the root cause of the event.However, there are clinical and procedural factors, including aneurysm / vessel characteristics, device selection, device interaction, and operator technique that may have contributed rather than the design or manufacture of the device.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.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 3X8
• 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): 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 ; 949789-868
• MDR Report Key: 12930860
• MDR Text Key: 285675732
• Report Number: 3008114965-2021-00578
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 10886704030607
• UDI-Public: 10886704030607
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K093973
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: 640CX0308
• Device Catalogue Number: 640CX0308
• Device Lot Number: 30571051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/04/2021
• Supplement Dates Manufacturer Received: 01/04/2022; 05/13/2022
• Supplement Dates FDA Received: 01/04/2022; 05/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2021
• 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
• Patient Outcome(s): Required Intervention