MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X30; STENT, ILIAC

Catalog Number	C08030SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/18/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).During an endovascular interventional procedure, a non-cordis guidewire crossed the lesion and a smart control iliac 8 x 30 was inserted.It was delivered to the lesion, however, it was advanced too far and could not cover the lesion.Therefore, another smart control stent (c08040s) was used.A non cordis balloon catheter was also used.The procedure finished successfully.There was no reported patient injury.The product was clinically used and it will not be returned for analysis.The target lesion was the left external iliac artery.A contralateral approach was made.The patient¿s information, vessel level of tortuosity, calcification and rate of stenosis was unknown.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.No difficulty was encountered while advancing/tracking the sds towards the lesion.Additional procedural details were requested but are unknown.The product was not returned for analysis.A device history record (dhr) review of lot 17601184 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)- deployment difficulty - inaccurate placement¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown, however level of tortuosity, calcification and rate of stenosis may have contributed to the reported event.The product information for safety warns ¿do not attempt to drag or reposition the stent, as this may result in unintentional stent deployment.Introduction of stent delivery system a.Ensure locking pin is still in place.B.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Neither the dhr nor the information available suggests a design or manufacturing related cause for the reported burst; therefore, no corrective/preventive action will be taken.
Event or Problem Description
A non-cordis guidewire crossed the lesion and a smart control, iliac 8 x 30 was inserted.It was delivered to the lesion, however, it advanced too far and could not cover the lesion.Therefore another smart control stent (c08040s) was used additionally.A non cordis balloon catheter was used.The procedure finished successfully.There was no reported patient injury.The product was clinically used and it will not be returned for analysis.The target lesion was the left external iliac artery.A contralateral approach was made.The patient¿s information, patient¿s vessel level of tortuosity, calcification and rate of stenosis was unknown.The product was stored and handled according to the ifu.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.No difficulty was encountered while advancing/tracking the sds towards the lesion.Additional procedural details were requested but are unknown.

• Brand Name: SMART CONTROL, ILIAC 8X30
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 6840708
• Report Number: 9616099-2017-01387
• Device Sequence Number: 10940534
• Product Code: NIO
• UDI-Device Identifier: 20705032024072
• UDI-Public: 20705032024072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: 14201 NW 60T
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Catalogue Number: C08030SL
• Device Lot Number: 17601184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 09/03/2017
• 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: Hospitalization; Life Threatening; Required Intervention