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

Catalog Number SC6150LG

Device Problems Difficult or Delayed Positioning (1157); Device Operates Differently Than Expected (2913); Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was using one complete se stent to treat a moderately calcified and slightly tortuous sfa lesion.The device was prepped per the ifu without issues noted.During the procedure, embolic protection was not used.It was reported that resistance was encountered as the device was being loaded onto the sheath.The device passed through a previously deployed stent.It was reported that resistance was encountered when advancing the device but that excessive force was not used.It was reported that when the device reached the lesion site, the stent jumped and deployed prematurely.The physician needed to use another stent to complete the procedure.No patient injury was reported.

Manufacturer Narrative

The device was loaded through the sheath without difficulty.The stent was deployed in the target area.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: the device delivery system was returned for evaluation without the stent or the red safety clip.Visual inspection was completed.Inspection of the blue slider/front grip gap confirmed that the current position of this section of the handle was sufficiently proximal to facilitate the partial deployment of the stent.Inspection of the inner member confirmed that no detachment had occurred which could have resulted in the stent deployment.No resistance was noted when advancing a 0.035 inch guidewire along the inner lumen.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: 7288119
• MDR Text Key: 100640150
• Report Number: 9612164-2018-00388
• 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,Followup
• Report Date: 07/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2018
• Device Catalogue Number: SC6150LG
• Device Lot Number: 0008347084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2016
• 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
• Patient Age: 69 YR