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

Model Number	N/A
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Renal Impairment (4499); Insufficient Information (4580); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/02/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation: materials resource analyst ii.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
It was reported that a nester platinum embolization microcoil unraveled.During deployment, the coil became stuck in the patient's artery.When the physician attempted to remove the coil, the coil unraveled.Multiple attempts to retrieve the stuck coil were unsuccessful; therefore, the coil remains in the patient.Additional information regarding the event and patient outcome has been requested but is currently unavailable.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b3, b5, e4 correction: b2, h6 - annex e and f.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
In additional information received on 06jul2022, it was reported that the issue occurred during a renal bleed embolization procedure.The coil got stuck on a previously deployed coil in the left main renal artery.The unravelling and fracture of the microcoil following attempted retrieval left behind the central coring element of the coil that extended from the left main renal artery to the right external iliac artery.This lead to the inability to complete more proximal embolization.The patient underwent a radical left nephrectomy in the or and required prolonged hospitalization due to this occurrence.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported by a representative of lbj general hospital (houston, usa) that a nester platinum embolization microcoil (rpn: mwce-18-14-4-nester-01; lot#: 13916357) unraveled.The device was required for a renal bleed embolization procedure.During deployment, the coil became entangled with a previously deployed coil in the left main renal artery.The physician then attempted to remove the coil, but it elongated and fractured.The retained coil extended from the left main renal artery to the right external iliac artery.This led to the inability to complete more proximal embolization.As result, the patient underwent a radical left nephrectomy in the operating room (or) and required prolonged hospitalization due to this occurrence.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures of the device, 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.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook also reviewed the device history record (dhr).The dhr for lot 13916357 records no relevant non-conformances.A database search for complaints on the reported lot found one additional related complaint reported from the field that was concluded to have been component failure.Cook also reviewed product labeling.The current instructions for use [t_nec2_rev0] state the following: "warnings: positioning of embolization coils and microcoils should be done with particular care.Coils should not be left too close to the inlets of arteries and should be intermeshed with previously placed coils if possible.A minimal but sufficient arterial blood flow should remain to hold the coils against the previously placed coils until a solid clot ensure permanent fixation.If difficulties occur when deploying the embolization coil, withdraw the wire guide, coil and angiographic catheter simultaneously as a unit.Precautions: perform an angiogram prior to embolization to determine correct catheter position." the information provided upon review of dhr, product labeling, and dmr, does not indicate the device was manufactured out of specification.There is no evidence of nonconforming material in house or in the field.Based on the information provided, no returned device, 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 14877192
• Report Number: 1820334-2022-01139
• Device Sequence Number: 5631468
• Product Code: KRD
• UDI-Device Identifier: 00827002473270
• UDI-Public: (01)00827002473270(17)260517(10)13916357
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/18/2023

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 Expiration Date: 05/17/2026
• Device Model Number: N/A
• Device Catalogue Number: MWCE-18-14-4-NESTER-01
• Device Lot Number: 13916357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 07/06/2022; 01/17/2023
• Initial Report FDA Received Date: 06/30/2022
• Supplement Report FDA Received Date: 07/13/2022; 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• 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: Disability; Other; Required Intervention
• Patient Sex: Unknown