MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA- 6X120MM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C06120ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	04/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).The product remains implanted and is thus not available for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
This is a case from (b)(6) for sfa and the case number is (b)(4).A smart stent and a smart control stent was implanted in the middle portion of the right femoral artery.Five years later, lower extremity arteriography confirmed in-stent re-occlusion in the right superficial femoral artery.An unknown balloon catheter was "use" for dilation and a stent was implanted.The abi level of the lesion have been decrease and was confirmed to be 0.52 and 0.98.The right below the knee had a pain when the patient rested.Target lesion was revascularization was performed and the patient recovered.
Additional Manufacturer Narrative
This is a case from japan smart pms for sfa and the case number is (b)(4).A smart stent and a smart control stent was implanted in the middle portion of the right femoral artery.Five years later, lower extremity arteriography confirmed in-stent re-occlusion in the right superficial femoral artery.An unknown balloon catheter was use for dilation and a stent was implanted.The abi level of the lesion have been decrease and was confirmed to be 0.52 and 0.98.The right below the knee had a pain when the patient rested.Target lesion was revascularization was performed and the patient recovered.The product was not returned for analysis.A device history record review of lot 15845078 was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.In-stent restenosis (isr) is associated with the progression of atherosclerotic disease and is a known potential adverse event following stent implantation and does not represent a device failure.Intra-arterial stent placement is a treatment of the disease process, it is not a preventive or cure for the progression of symptoms of atherosclerotic artery disease.Vessel occlusion, restenosis, intimal hyperplasia or recurrent strictures are well known documented potential complications of this type of procedure and are listed in the ifu as such.In the literature, in-stent stenosis rates range from 11% to 39% from 6 to 12 months after stent placement.Rates were higher in older patients with more severe atherosclerosis and depended on the type of stenosis treated.Isr is more prevalent in ostial stent placement procedures.Stenoses in stents are usually treated with intrastent pta or placement of a second stent.Factors that may have influenced this event include patient, procedural, pharmacological and lesion.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.The dhr reviews does not suggests that the reported failures could be related to the manufacturing process of the unit.Therefore no corrective action will be taken.

• Brand Name: SMART 120 150, SFA- 6X120MM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes 33014
• MDR Report Key: 8169321
• Report Number: 9616099-2018-02586
• Device Sequence Number: 1459041
• Product Code: FGE
• UDI-Device Identifier: 20705032063385
• UDI-Public: 20705032063385
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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: C06120ML
• Device Catalogue Number: C06120ML
• Device Lot Number: 15845078
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/22/2018
• Supplement Date Received by Manufacturer: 01/03/2019
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 01/03/2019
• 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: Life Threatening