MAUDE Adverse Event Report: WILLIAM COOK EUROPE MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Catalog Number IMWCE-3-PDA3

Device Problems Break (1069); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Catalog# is unknown but referred to as pda coil.Similar to device under 510(k) k150964.Investigation is still in progress.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 Description

Description of event according to initial reporter: breakage of pda coil that was placed in 7-8 years ago for ductus arteriosus closure was found.Patient outcome: unknown.

Manufacturer Narrative

Manufacturers ref# (b)(4).Investigation is still in progress.This report is required by the fda under 21cfr 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 Description

Additional information received on 18nov2022: on (b)(6) 2007: coil embolization for ductus arteriosus using imwce-3-pda-3 was performed.On (b)(6) 2008: no problem was confirmed at 1-year-follow-up.Follow-up exam was performed in 2012, 2013, 2014, 2015 and 2017.Elongation of the coil was started to be observed in 2012 when the patient was 6 years old.At follow-up in nov2018: total elongation of the coil was confirmed.On (b)(6) 2022: breakage of the coil was confirmed.Imaging was taken from the front and the side.The physician commented as below: i will take ct imaging in (b)(6) 2022 to check further.Since the configuration of the coil had been changed with age, it is possible that the part of the coil that is in the aorta side is in somewhere other than the pda such as the arterial media.There was no symptoms on the patient, therefore additional procedure is not planned as of today.

Manufacturer Narrative

Manufacturers ref# (b)(4).Summary of investigational findings: the pda coil was found elongated after six years and broken after 9-10 years.No symptoms and no additional procedure planned.Per the complaint report, the flipper pda closure detachable coil was deployed in 2007 for a pda.The original placement images were not submitted for review.Over this time, there has been slow elongation of the coil and more recently there has been development of a fracture within the coil.This fracture and elongation are confirmed to be present on the cta submitted for review.The initial placement images are not submitted for review to truly evaluate the degree of change that is present, and the original configuration of the coil packing in the pda.Presumably, the child has grown in the past 7-8 years, and with this growth, the occluded pda has also elongated during this time.Importantly, the pda is completely occluded.Furthermore, the fractured coil should have no clinical relevance.The coil is still extravascular with no evidence of extending into the lumen of either the aorta or the pulmonary artery, and should never extend into these structures based on its positioning.There is no risk of fracture fragment embolization or migration as it the entire coil packing and fracture fragments are most likely encased in fibrous scar tissue at this point.The elongation and fracture are most likely related to the stretching of this fibrous scar tissue as the patient grows and potentially some metal fatigue related to pulsations transmitted from cardiac motion.There are adequate controls in place to ensure that this type of device is manufactured to specifications.Cook was unable to conduct a review of the dhr, as the lot number of the complaint device was not provided for the investigation.Cook medical will continue to monitor for similar events.This report is required by the fda under 21cfr 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 Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
• Type of Device: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• Manufacturer (Section G): WILLIAM COOK EUROPE; sandet 6, dk-4632; bjaeverskov
• Manufacturer Contact: lissi walmann ; sandet 6, dk-4632; bjaeverskov
• MDR Report Key: 15578606
• MDR Text Key: 301560977
• Report Number: 3002808486-2022-00972
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IMWCE-3-PDA3
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Life Threatening
• Patient Age: 15 YR