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

Catalog Number UNKNOWN

Device Problem Premature Activation (1484)

Patient Problems Occlusion (1984); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

Manufacturers ref# (b)(4).Similar to device marketed under pma/510(k): k150964.Investigation is still in progress.

Event Description

Description of event according to initial reporter: a 6.5pda5 coil was deployed but was not anchored properly in the aortic ampulla and therefore, was removed.A 5pda5 coil was placed in the ductus arteriosus.Just as the wire was being rotated to release the coil, the coil rotated and migrated to the left pulmonary artery.Patient outcome: did any unintended section of the device remain inside the patient¿s body? - no.Was the patient hospitalized or was there prolonged hospitalization? - ni.Did the patient require any additional procedures due to this occurrence? yes - coil.Migration to the left pulmonary artery as the coil was released.The coil lay parallel to the vessel and despite multiple attempts it could not be retrieved.At this point, the distal left pulmonary artery was found to be essentially occluded and, therefore, a thoracotomy was performed in order to retrieve the coil surgically combined with pda closure.The patient recovered well from surgery and was discharged from the hospital on day 3.At follow- up 6 months later, no complications were reported.Has the complainant reported any adverse effects on the patient due to this occurrence? - yes.Has the complainant reported that the product caused or contributed to the adverse effects? conversion to open repair to retrieve coil that migrated and essentially occluded the pulmonary artery.

Event Description

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

Manufacturer Narrative

Manufacturer ref#: (b)(4).Summary of investigational findings: an article described that during placement the coil rotated and migrated to the left pulmonary artery and could not be retrieved.The distal left pulmonary artery was found essentially occluded and the coil was surgically removed.No product was returned for analysis, but an angiogram in the article demonstrated a loop coil completely occluding the left lower pulmonary artery.However, based on the information provided with the article only, it would be inappropriate to speculate at what may or may not have caused the coil to rotate and migrate, unless the delivery wire was rotated during insertion.The ifu caution that rotating the delivery wire during insertion might cause the coil to inadvertently detach from the delivery wire.The ifu also caution that an angiogram must be performed prior to embolization for measuring length and diameter of the pda and that it is important to follow the loading procedure carefully to avoid complications during attachment and detachment of the coil, thus ensuring a proper position.It is noted that the patient recovered well from surgery and was discharged from hospital at day 3.Cook was unable to conduct a review of the device history record, 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 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.

• Brand Name: MREYE FLIPPER PDA CLOSURE DETACHABLE EMBOLIZATION COIL
• Type of Device: DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): WILLIAM COOK EUROPE; sandet 6; bjaeverskov 4632 ; DA 4632
• MDR Report Key: 11370926
• MDR Text Key: 240665330
• Report Number: 3002808486-2021-00148
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 MO