MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 7X150MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C07150ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Claudication (2550)
Date of Event	08/02/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
Three years after a smart stent was implanted in the middle portion of the right femoral artery, re-vascularization was performed on the target lesion.Three months later, intermittent claudication was confirmed and one year later, intermittent claudication was confirmed again.Percutaneous transluminal angioplasty was performed and the patient recovered.The smart stent was implanted in the target lesion without any issue.The ankle-brachial index level was confirmed to have been decreased.This is a case from (b)(6) smart pms for sfa.
Additional Manufacturer Narrative
Three years after a smart stent was implanted in the middle portion of the right femoral artery, re-vascularization was performed on the target lesion.Three months later, intermittent claudication was confirmed and one year later, intermittent claudication was confirmed again.Percutaneous transluminal angioplasty was performed, and the patient recovered.The smart stent was implanted in the target lesion without any issue.The ankle-brachial index level was confirmed to have been decreased.This is a case from japan smart pms for sfa.No other information was provided.The device was not returned for analysis.A product history record (phr) review of lot 15844403 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The adverse events of intermittent claudication and peripheral artery restenosis cannot be confirmed due to the nature of the events and the relationship to this device.Thrombosis, stenosis, and/or restenosis are commonly indicated events.Patients that require stents typically exhibit signs of thrombosis and restenosis prior to receiving these devices.Reports of these conditions after the device has been successfully deployed have not been linked to known manufacturing processes or criteria of the stent.According to the instructions for use, which is not intended as a mitigation, the following events are amongst those listed as potential adverse effects secondary to intravascular stent implantation: ¿arterial occlusion / thrombus, remote from puncture site, arterial occlusion / restenosis of the treated vessel, embolization, arterial, ischemia / infarction of tissue/organ, venous occlusion / thrombosis, remote from puncture site.¿ neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SMART 120 150, SFA - 7X150MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 7494093
• Report Number: 9616099-2018-02120
• Device Sequence Number: 1339339
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: 20705032063439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2018

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: 03/31/2015
• Device Model Number: C07150ML
• Device Catalogue Number: C07150ML
• Device Lot Number: 15844403
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/10/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 07/30/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 56