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

Model Number N/A

Device Problems Difficult to Advance (2920); Migration (4003)

Patient Problems Embolism/Embolus (4438); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/20/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 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 or that a death or serious injury occurred; nor is it admission 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 Description

It was reported that a mreye embolization coil migrated.The device was required for embolization of a sequester artery.During the procedure, the user placed two unknown coils.When attempting to place a third, mreye coil, the coil would not advance out of the catheter.Upon attempted removal, the mreye coil embolized the right iliac artery.As a result, the patient experienced "borderline compartment syndrome" and a "possible trophic problem".The following day, an arteriotomy surgery was required to remove the coil from the right iliac artery.The patient also required an extended stay in the "ite".No other adverse effects were reported for this incident.

Event Description

Additional information was received.The access site was the right femoral artery.The target vessel was a left pulmonary sequester feeding vessel originating from the celiac trunk.The treatment site within the vessel was about 2 cm after the origin from the celiac trunk.The patient was not on chronic medication, except heparin as standard during catheterization.No other embolic treatments were used.It was also noted that the physician typically uses all variants of imwce coils.A total of four mreye coils were used during the procedure.The first three coils were deployed without difficulty; however, difficulty was experienced with the fourth coil as it could not be removed from the delivery catheter.The coil was stuck and was half-way out of the catheter.Multiple attempts to deploy the coil were unsuccessful, so removal of the coil and the catheter was attempted.During removal of the catheter, the coil was inadvertently deployed in the iliac artery.Multiple attempts for percutaneous retrieval of the coil from the bilateral femoral arteries was attempted but were ultimately unsuccessful.As a result, surgical retrieval of the coil was performed.The procedure was aborted after the event with the fourth coil, and the feeding vessel was still partially patent.The following day, surgical revision of right iliac artery was performed.The patient experienced mild compartment syndrome in the right lower leg the device was not noted to be damaged upon opening.The coils were not stretched or compressed.There was no difficulty advancing the pusher stylet and pushing the coils through the shipping cartridge.The coils were deployed using a cook wire guide.The patient did not experience any allergic reactions to the coils.

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 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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Correction: h10 - e2402 was selected to capture the report of "borderline compartment syndrome" and a "possible trophic problem".Investigation ¿ evaluation: it was reported by (b)(6) that on (b)(6) 2022 a mreye embolization coil (rpn: imwce-35-5-3; lot#: 14855330) migrated.The device was required by a 16-month-old male for embolization of a left pulmonary sequester feeding vessel originating from the celiac trunk.The access site was the right femoral artery and the treatment site within the vessel was about 2 cm after the origin from the celiac trunk.A total of four mreye coils were used during the procedure.The 4 fr catheter (sr4038, 80cm; manufacturer unknown) was flushed prior to each coil deployment.The first three coils were deployed with the wire guide (cook; recht voerdraad tsf-35-145) without difficulty; however, difficulty was experienced with the fourth coil as it could not be removed from the delivery catheter.The coil was stuck and was half-way out of the catheter.Multiple attempts to deploy the coil were unsuccessful, so removal of the coil and the catheter was attempted.During removal of the catheter, the coil was inadvertently deployed in the iliac artery.Multiple attempts for percutaneous retrieval of the coil from the bilateral femoral arteries was attempted but were ultimately unsuccessful.As a result, surgical retrieval of the coil was performed.The patient experienced mild compartment syndrome in the right lower leg.The procedure was aborted after the event with the fourth coil, and the feeding vessel was still partially patent.The following day, surgical revision of right iliac artery was performed.Reviews of the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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.In response to this incident, cook reviewed the device history record (dhr).The dhr for lot 14855330 records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.Cook also 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 the 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.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.Prior to introduction of the embolization coil, flush the angiographic catheter with saline.The information provided upon review of the dmr, ifu, and dhr suggest that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out 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 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
• Type of Device: 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: 16399533
• MDR Text Key: 309881534
• Report Number: 1820334-2023-00156
• Device Sequence Number: 1
• Product Code: KRD
• UDI-Device Identifier: 00827002424197
• UDI-Public: (01)00827002424197(17)270722(10)14855330
• Combination Product (y/n): N
• PMA/PMN Number: K150931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IMWCE-35-5-3
• Device Lot Number: 14855330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2022
• 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: 2 UNKNOWN COILS BY UNKNOWN MANUFACTURER; 3 COOK MREYE EMBOLIZATION COIL IMWCE-35-5-3; COOK GUIDE WIRE RECHT VOERDRAAD TSF-35-145; UNKNOWN CF 2.5; UNKNOWN KATH.ANGIOGRAFIE SR4038 JR2.0 4FR 80CM
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 16 MO
• Patient Sex: Male