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

Catalog Number UNKNOWN

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Manufacturer ref# (b)(4).Similar to device marketed under pma/510(k): k150964.Summary of investigational findings: an article described that the coil did not sit properly in the aortic ampulla.The coil was removed and another smaller (5mm) cook coil was successfully placed.No product was returned for analysis and based on the information provided with the article only, it would be inappropriate to speculate at what may or may not have caused the 6.5mm coil to ¿not sit properly¿.However, since replacement coil is smaller (5mm) reference is made to ifu cautioning that an angiogram must be performed prior to embolization for measuring length and diameter of the pda.Ifu also caution 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.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.

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: the coil migrated to the left pulmonary artery as the coil was released.The coil laid 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.Conversion to open repair to retrieve coil that migrated and essentially occluded the pulmonary artery.

• 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; bjaeverskov 4632
• Manufacturer Contact: lissi walmann ; sandet 6; bjaeverskov 4632 ; 56868686
• MDR Report Key: 11990708
• MDR Text Key: 255924822
• Report Number: 3002808486-2021-01345
• 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,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/15/2021
• Initial Date FDA Received: 06/14/2021
• 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 Age: 16 MO