MAUDE Adverse Event Report: COOK INC MREYE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Chest Pain (1776); Swelling/ Edema (4577); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an unknown patient had retracta detachable embolization coils and mreye embolization coils placed.Fourteen months after placement, the patient underwent a scan and it was discovered the coils migrated to the pulmonary artery.The patient is asymptomatic.Additional information including event details and further patient information and outcome have been requested, but are currently unknown.The reports with the following patient identifiers capture the coils involved in this incident: (b)(6).
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
In additional information received on 04mar2022, it was reported that the anatomical target vessel was the left hypogastric vein, 9mm.One year later, the patient was hospitalized with chest pain and incidental coil in a pulmonary artery branch.Coil migration was originally discovered on 24dec2021.Evaluation by interventional radiology for possible retrieval was done at the facility, but was declined by the patient.The patient believes that their chest pain and recurrent leg swelling resulted from this embolization and is seeking a second opinion for retrieval.No anticoagulation medications are being used by the patient.
Additional Manufacturer Narrative
Correction: h6 - annex e & 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.
Additional Manufacturer Narrative
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 28feb2022, it was reported that this was a venous embolization procedure.No other embolic treatments were used.
Additional Manufacturer Narrative
Investigation ¿ evaluation.(b)(6) (united states) informed cook on 07jan2022 of an incident involving a mreye embolization coil(rpn: imwce-35-5-8; lot: 13017293).The reports with the following patient identifiers capture the coils involved in this incident: 1820334-2022-00078, 1820334-2022-00079, 1820334-2022-00080, 1820334-2022-00081 (this report), and 1820334-2022-00082.It was reported that the coils were initially placed on 11dec2020 for venous embolization in a 9 mm left hypogastric vein of a 57 year old male.Approximately one year after placement, on 24dec2021, the patient was hospitalized with chest pain.Upon scanning, incidental coils in a pulmonary artery branch were discovered.Evaluation by interventional radiology for possible retrieval was done at the facility, but was declined by the patient.The patient believes that their chest pain and recurrent leg swelling resulted from this embolization and is seeking a second opinion for retrieval.No anticoagulation medications are being used by the patient.No other adverse events were reported for this patient.A review of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures were conducted during the investigation.The customer did not return the complaint device for evaluation; 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 dhr.The dhr for lot 13017293 records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.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 reviewed product labeling.The current instructions for use [t_ce_imwce_rev6] state the following: "warnings positioning of embolization coils 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 previously placed coils until a solid clot ensures permanent fixation.The purpose of these suggestions is to minimize the possibility of loose coils becoming dislodged and obstructing a normal and essential arterial channel.Precautions perform an angiogram prior to embolization to determine correct catheter position.This product is intended for use by physicians trained and experienced in arterial and venous vessel embolization techniques.Standard techniques for placement of vascular access sheaths, angiographic catheters, and wire guides should be employed.Coil delivery technique and coil size selection long-term occlusion depends on achieving cross sectional occlusion of the blood vessel, and coaxial catheters provide the ability to control placement of coils and permanent occlusion.The combination of the coaxial technique and either the anchor or scaffold technique significantly enhances stability of coil deployment.In general, the first coil selected should have a diameter that is 20% larger, or 2 mm oversized, than the vessel that is being occluded." based on the information provided and the results of the investigation, it was determined the cause of this event is related to component failure unrelated to manufacturing or design deficiencies.It is possible that the coils that were used were not large enough, leading to migration, but this cannot be definitively confirmed.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: MREYE EMBOLIZATION COIL
• 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: 13285434
• Report Number: 1820334-2022-00081
• Device Sequence Number: 11995277
• Product Code: KRD
• UDI-Device Identifier: 00827002424234
• UDI-Public: (01)00827002424234(17)250310(10)13017293
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K150931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/18/2022

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: 03/10/2025
• Device Model Number: N/A
• Device Catalogue Number: IMWCE-35-5-8
• Device Lot Number: 13017293
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/07/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 03/04/2022; 10/06/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 03/08/2022; 03/24/2022; 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2020
• 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: Other; Hospitalization
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 34 KG