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

Catalog Number SC8100LG

Device Problems Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was attempting to use a complete se stent to treat a moderately calcified and non tortuous mid common iliac artery lesion exhibiting calcified plaque and 85% stenosis.The device was removed from its packaging and inspected with no issues noted.No damage noted to device packaging.The device was prepped before use with no issues noted.During the procedure, the lesion was pre-dilated.The stent did not pass through a previously deployed stent.No resistance was encountered while advancing the device and no excessive force used.It was reported that the stent length was shortened by about 2cm.To complete the procedure, the physician then implanted an 8x12mm stent to compensate for the stent retraction.No stent recoil occurred.No patient injury reported.

• 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: 7272863
• MDR Text Key: 100143830
• Report Number: 9612164-2018-00357
• 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
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2018
• Device Catalogue Number: SC8100LG
• Device Lot Number: 0008217200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Date Device Manufactured: 09/13/2016
• 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: 61 YR
• Patient Weight: 63