MAUDE Adverse Event Report: COOK INC NESTER PLATINUM EMBOLIZATION MICROCOIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Codes	Material Separation (1562); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported following deployment of nester platinum embolization microcoil to treat a type 3 endoleak, the coil remained stretched instead of coiling up.The physician then attempted to remove the coil using a snare, but it "fell apart." the patient had to be opened to remove the device.Aortic stents were also removed and replaced, presumably to treat the type 3 endoleak.The physician later clarified that the coil was deployed and "not faulty," but separated during snaring.He also stated "everything went fine." no other adverse effects were reported.
Additional Manufacturer Narrative
This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported the patient's hospitalization was prolonged due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction: d8 investigation ¿ evaluation presbyterian hosp (united states) informed cook on (b)(6) 2022 of an incident that occurred on the same date involving an mwce-18-14-6-nester-01 (nester platinum embolization microcoil) from lot 14376968.When the user deployed the coil, it remained elongated; therefore, removal with a snare was attempted.At this time, the device ¿fell apart¿, so open surgery was performed to remove the device.No other adverse events were reported due to this occurrence.Reviews of the complaint history, device history record (dhr), quality control, and instructions for use (ifu) were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the reported complaint device lot 14376968 revealed no relevant non-conformances.A database search did not identify any other events associated with the reported device lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.The current instructions for use [t_nec2_rev0] does not have wording about this specific failure.Based on the available information, no device return, and the results of the investigation, cook has concluded that component failure unrelated to manufacturing or design deficiencies contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: NESTER PLATINUM EMBOLIZATION MICROCOIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 13659199
• Report Number: 1820334-2022-00329
• Device Sequence Number: 5046300
• Product Code: KRD
• UDI-Device Identifier: 00827002473294
• UDI-Public: (01)00827002473294(17)261230(10)14376968
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K153778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2022

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: N/A
• Device Catalogue Number: MWCE-18-14-6-NESTER-01
• Device Lot Number: 14376968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2022
• Supplement Date Received by Manufacturer: 04/12/2022; 11/23/2022
• Initial Report FDA Received Date: 03/03/2022
• Supplement Report FDA Received Date: 04/13/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/30/2021
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male