MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 10X30; STENT, ILIAC

Model Number	C10030SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18049435 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
A 10x30 iliac smart stent was inserted from the left brachial region and being delivered, however, the stent ¿advanced and fell down the aorta.After that, the device locked to the plaque in the middle of the descending aorta.The doctor decided to follow up without any additional treatment.¿ this was a percutaneous transluminal angioplasty (pta) case from the brachiocephalic artery.A 6f non-cordis guiding sheath was initially inserted from the left brachial region.A 014 non-cordis guidewire crossed the lesion and a 5x30 non-cordis balloon catheter was used for pre-dilation.The device will be returned for analysis.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, h1, h2, h3 and h6.A 10x30 iliac smart stent was inserted from the left brachial region and being delivered, however, the stent ¿advanced and fell down the aorta.After that, the device locked to the plaque in the middle of the descending aorta.The doctor decided to follow up without any additional treatment.¿ this was a percutaneous transluminal angioplasty (pta) case from the brachiocephalic artery.A 6f non-cordis guiding sheath was initially inserted from the left brachial region.A 014 non-cordis guidewire crossed the lesion and a 5x30 non-cordis balloon catheter was used for pre-dilation.The device will be returned for analysis.Additional information was requested; however, the information could not be obtained.The device was returned for analysis.A non-sterile unit of product ¿smart control, iliac 10x30¿ was received coiled inside of a clear plastic bag.The part was unpacked to perform the evaluation.The unit was received fully deployed.The stent was not included in the shipment to be analyzed.A kinked/bent conditions were observed located approximately at 70 cm from the distal end.No other damages or anomalies were observed at the inspected device.Dimensional analysis was performed to verify the usable length of the unit.Result was found within specification.Functional analysis was not performed due to the unit was returned fully deployed.A product history record (phr) review of lot 18049435 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)-ses ~ deployment difficulty - premature/in patient - during advancement¿ was not confirmed due to the unit was received fully deployed.The usable length dimension was found within specification.The exact cause of the reported event could not be conclusive determined during the product analysis.Procedural or handling factors such as the user¿s interaction with the device might have contributed to this issue.Additionally, the reported event mentions that the brachial artery was used but there is not treatment area mentioned.It is unclear if the device was used off label.Per the instructions for use (ifu) ¿the cordis s.M.A.R.T.Control nitinol stent system is indicated for use in patients with atherosclerotic disease of peripheral arteries, including iliac and superficial femoral, for tipss procedures and for palliation of malignant neoplasms in the biliary tree.Neither the phr review, nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
A 10x30 iliac smart stent was inserted from the left brachial region and being delivered, however, the stent ¿advanced and fell down the aorta.After that, the device locked to the plaque in the middle of the descending aorta.The doctor decided to follow up without any additional treatment.¿ this was a percutaneous transluminal angioplasty (pta) case from the brachiocephalic artery.A 6f non-cordis guiding sheath was initially inserted from the left brachial region.A 014 non-cordis guidewire crossed the lesion and a 5x30 non-cordis balloon catheter was used for pre-dilation.The device will be returned for analysis.Additional information was requested; however, the information could not be obtained.

• Brand Name: SMART CONTROL, ILIAC 10X30
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14246559
• Report Number: 9616099-2022-05599
• Device Sequence Number: 20055448
• Product Code: NIO
• UDI-Device Identifier: 20705032024577
• UDI-Public: (01)20705032024577(17)23073(10)18049435
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: C10030SL
• Device Catalogue Number: C10030SL
• Device Lot Number: 18049435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 04/28/2022
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER (5*30 STERLING, BOSTON SCIENTIFIC; GUIDEWIRE (014 CHIKAI); GUIDING SHEATH (6FR DESTINATION)
• Patient Sex: Unknown