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

Catalog Number	SC6120LV
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the physician was attempting to use a complete se stent to treat a cto, moderately calcified and mild tortuosity mid sfa lesion.No damage noted to device packaging and no issues were noted when removing the devices from the hoop/tray.The device was inspected prior to use, no issues noted.The device was prepped as per ifu with no issues noted.The lesion was pre-dilated.It was reported that after stent deployment resistance was encountered during removal of the delivery system and the tip of the device detached.The physician used another stent to jail the tip of the complete se stent to the vessel wall.No clinical sequelae reported.
Additional Manufacturer Narrative
Product analysis: the device returned with the tip detached from the inner member.The inner member material at the detachment site was jagged.The inner member was kinked immediately distal to the middle member.Kinks were visible along the catheter shaft.(b)(4) uf/ importer report # (b)(6) the patient has a history of hypertension, hepatic/ renal dysfunction, diabetes, pad and ckd stage v.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: COMPLETE SE ILIAC
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6224659
• Report Number: 9612164-2017-00009
• Device Sequence Number: 665121
• Product Code: NIO
• UDI-Device Identifier: 00613994726780
• UDI-Public: 00613994726780
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2018
• Device Catalogue Number: SC6120LV
• Device Lot Number: 0008084219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2017
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided; 02/01/2017
• Initial Report FDA Received Date: 01/05/2017
• Supplement Report FDA Received Date: 03/02/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR