MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 6X40ML; STENT, ILIAC

Catalog Number	C06040ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Stenosis (2263); Claudication (2550)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot (15616980) 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
As reported by the smart pms for sfa study, four years post implantation of a smart (smart control, iliac 6 x 40 ml) self¿expanding stents (ses) on the superficial femoral artery, the patient had intermittent claudication appeared and heavy stenosis in the right superficial femoral artery, also the patient had intermittent claudication appeared and stenosis in front of the stent in the lesion and occlusion in the stent both were confirmed by vessel echography.An endovascular repair procedure was performed to the patient on an unknown date.None of these events were relevant to the index procedure or the cordis product.
Additional Manufacturer Narrative
After further review of additional information received the sections have been updated accordingly.As reported by the smart pms for sfa study, four years post implantation of a smart (smart control, iliac 6x40ml) self¿expanding stent (ses) on the superficial femoral artery, the patient had intermittent claudication appeared and heavy stenosis in the right superficial femoral artery.The stenosis in front of the stent previously placed and occlusion in the stent both were confirmed by vessel echography.An endovascular repair procedure was performed to the patient on an unknown date.None of these events were relevant to the index procedure or the cordis product.The device was not returned for analysis.A review of the manufacturing documentation for lot number 15616980 revealed no non-conformances or process excursion during the manufacturing and inspection processes that can be associated with the reported event.Without medical records and procedural films available for review, the reported events from the smart pms for sfa study could not be confirmed.Claudication is a condition in which cramping pain in the leg is induced by exercise, typically caused by poor circulation of blood in the arteries of the legs.Stenosis is a narrowing of the vessel.Occlusion of a stent does not represent a device malfunction.Clinical factors that may have contributed to this event may include patient comorbidities, pharmacological or lesion characteristics.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.
Additional Manufacturer Narrative
After further review of additional information received the sections have been updated accordingly.Additional information received indicates that the total length of the stented segment was 4cm.There was only one stent placed during the procedure.As reported by the smart pms for sfa study, four years post implantation of a smart (smart control, iliac 6x40ml) self¿expanding stent (ses) on the superficial femoral artery, the patient had intermittent claudication appeared and heavy stenosis in the right superficial femoral artery.The stenosis in front of the stent previously placed and occlusion in the stent both were confirmed by vessel echography.An endovascular repair procedure was performed to the patient on an unknown date.Additional information received stated that the total length of the stented segment was 4cm.There was only one stent placed during the procedure.None of these events were relevant to the index procedure or the cordis product.The device was not returned for analysis.A review of the manufacturing documentation for lot number 15616980 revealed no non-conformances or process excursion during the manufacturing and inspection processes that can be associated with the reported event.Without medical records and procedural films available for review, the reported events from the smart pms for sfa study could not be confirmed.Claudication is a condition in which cramping pain in the leg is induced by exercise, typically caused by poor circulation of blood in the arteries of the legs.Stenosis is a narrowing of the vessel.Occlusion of a stent does not represent a device malfunction.Clinical factors that may have contributed to this event may include patient comorbidities, pharmacological or lesion characteristics.Based on the minimal information provided, it is not possible to draw a clinical conclusion or determine a root cause for the reported events.Given the limited information available for review at this time, there is nothing to suggest that the reported event is related to the design and manufacturing process of the device; therefore no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• Brand Name: SMART CONTROL, ILIAC 6X40ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7068296
• Report Number: 9616099-2017-01633
• Device Sequence Number: 10998964
• Product Code: NIO
• UDI-Device Identifier: 20705032023495
• UDI-Public: 20705032023495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/15/2018

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: 04/30/2014
• Device Catalogue Number: C06040ML
• Device Lot Number: 15616980
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 02/01/2018; 02/05/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 02/01/2018; 02/15/2018
• 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; Disability
• Patient Age: 72 YR
• Patient Weight: 50