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

Catalog Number SC680LG

Device Problems Difficult to Remove (1528); Inaccurate Delivery (2339); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2016

Event Type  malfunction  

Manufacturer Narrative

Product analysis: the distal tip on the retractable sheath was damaged.The proximal end of the distal tip was partially flared and raised indicating that it may have snagged during removal.There was no further damage visible to the returned device.Image review: based on review of the procedural images it appears the physician was attempting to treat a narrowing in the common hepatic artery or the gastric artery possible due to the presence of a tumour.The images capture the deployment of two stents with radiopaque markers visible suggesting these may be complete se stents.There are no images showing the complete se delivery system or the removal difficulties reported.(b)(4).

Event Description

It was reported that the physician was attempting to use a complete se stent, lesion details unknown.No issues reported during advancement or during deployment of the device.After the stent was deployed, it's delivery system could not be retracted normally and its tip was adhered to the stent.No force was applied to remove the delivery system.The stent was displaced and moved from its intended delivery location.It is reported that the deployed stent was removed from the patient along with the deliver system.No intervention was required and no further treatment was required at the lesion site due to the difficulties removing the delivery system.No injury to the patient.

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: 5867955
• MDR Text Key: 51815388
• Report Number: 9612164-2016-00832
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2017
• Device Catalogue Number: SC680LG
• Device Lot Number: 0007813753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2015
• 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: 76 YR