MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE ILIAC; STENT, ILIAC

Catalog Number SC840FG

Device Problem Inaccurate Delivery (2339)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/24/2017

Event Type  Injury  

Manufacturer Narrative

Image review the images capture the lesion site in the subclavian artery as reported by the account.The attempted delivery of the complete se 8 x 40mm device is captured by the images.A still image shows the stent partially deployed.In the next image, the expanded stent is visible in the vessel.An unidentified balloon is expanded at the proximal end of the deployed stent.The 0.014¿ wire and 3mm balloon are visible, loaded through a cell of the the expanded stent.The images capture the withdrawal of the stent through the iliac artery.(b)(4).

Event Description

The physician was attempting to deploy a complete se stent at the origin of left subclavian ( distal to the aorta).The target lesion in the left distal subclavian artery was fibrous with little tortuosity and no calcification.Prior to the procedure, embolic protection was not used and no damage was noted to the packaging.No issues were noted when removing the device from the hoop tray.The device was prepped per the ifu with no issues noted.The lesion was not predilated and the device was not passed through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used.It is reported that when the physician attempted to deploy the stent, it jumped out of the sheath, more than 20mm in the aorta.The stent was extracted from external iliac as it was free in the aorta.The physician passed a 014¿¿ wire through stent stunts and then he loaded through the wire a 3mm balloon.After the balloon passed the struts, it was inflated it and then dragged down to the iliac to the extraction point.To complete the procedure, another stent was implanted into the lesion and the misplaced stent was removed from the patient.Patient status is reported as very good.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: COMPLETE SE ILIAC
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6342729
• MDR Text Key: 67803106
• Report Number: 9612164-2017-00188
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P090006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/24/2017

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 Expiration Date: 09/06/2018
• Device Catalogue Number: SC840FG
• Device Lot Number: 0008207669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: 01/24/2017
• Supplement Dates FDA Received: 09/29/2017
• Date Device Manufactured: 09/06/2016
• 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): Required Intervention