MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 7X80; STENT, ILIAC

Catalog Number	C07080SL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Reocclusion (1985); Vascular System (Circulation), Impaired (2572)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, approximately three and a half years after the implantation of two smart control stents the patient¿s ankle-brachial index (abi) decreased and an occlusion was confirmed in the right common femoral artery.A target lesion revascularization (tlr) was performed and the patient recovered on the same day.The patient was an (b)(6).The patient¿s weight was (b)(6).The index target lesion was from the proximal portion to the middle portion of the right femoral artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.The device was not returned for evaluation as it remains implanted.A review of the manufacturing documentation associated with lot 15851700 presented no issues during the manufacturing process that can be related to the reported event.Without the return of the device for analysis or procedural films, the reported event could not be confirmed and the exact cause could not be determined.Restenosis and occlusion are known potential adverse events associated with implanting stents.Restenosis is often associated with the progression of artery disease.The act of stent implantation produces intended damage to the intima of the vessel wall in order to remodel the wall and reestablish patency of the vessel.The disruption of the intimal layers triggers the immune system to heal the damaged areas, thus activating the clotting mechanism as well as the inflammatory response.The combination of inflammatory response and clotting cascade can lead to thrombus formation in side of the stent and instigate vessel remodeling around the stent, producing gaps between the stent and the vessel wall.Given the limited information available for review, patient, lesion and/or pharmacological factors may have contributed to the reported events.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.This is 1 of 2 products involved with the reported event and the associated manufacturer report numbers are 9616099-2017-01284 and 9616099-2017-01285.
Event or Problem Description
As reported, approximately three and a half years after the implantation of two smart control stents the patient¿s ankle-brachial index (abi) decreased and an occlusion was confirmed in the right common femoral artery.A target lesion revascularization (tlr) was performed and the patient recovered on the same day.The patient was an (b)(6).The patient¿s weight was (b)(6).The index target lesion was from the proximal portion to the middle portion of the right femoral artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.

• Brand Name: SMART CONTROL, ILIAC 7X80
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6760793
• Report Number: 9616099-2017-01284
• Device Sequence Number: 1723349
• Product Code: NIO
• UDI-Device Identifier: 20705032023891
• UDI-Public: 20705032023891
• 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,s
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: C07080SL
• Device Lot Number: 15851700
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 6 FR GUIDING CATHETER; UNKNOWN 6 FR SHEATH INTRODUCER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 45