MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 6X100; SELF EXPANDING STENT

Model Number	C06100SL
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	07/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Please note that the initial report was filed under report number 9616099-2016-00575.No further reports will be submitted under that initial report number as the complaint handling system is no longer available. the report is also related to the previous report filed under 9616099-2016-00574 for which a new report is also required but the new report number is not currently available.As reported by the japan smart pms for sfa, after an unspecified time when a 120 150, sfa - 6x150mm smart stent and a 6x100 smart control iliac stent were placed in the middle portion to the distal portion of the femoral artery with unknown stenosis of a (b)(6) male patient with unknown medical history, the periodic survey reported that the following items were entered as "occlusion" on the list; patency, dus, the proximal portion of stenosis psv, and the maximum psv of stenosis.The patient is now under observation, and no treatment was applied." additional information was received that dus means doppler ultra sound.It not known which stent was patent but both stents had psv.  it is unknown if the original lesion was calcified or the vessel tortuous, if the stents were overlapping, if the stents were deployed with good wall apposition and if ivus was done post procedure.  no additional information available.  the products remain implanted and are thus not available for evaluation.  device history record reviews were performed and showed that the two lot of products met all requirements per the applicable manufacturing quality plan.  restenosis is a known potential adverse event associated with implanting peripheral artery stents and is often associated with the progression of peripheral vascular disease.Based on the available information there is no evidence to suggest that the event was design or manufacturing related therefore no corrective action will be taken.
Event or Problem Description
As reported by the japan smart pms for sfa, after an unspecified time when a 120 150, sfa - 6x150mm smart stent and a 6x100 smart control iliac stent were placed in the middle portion to the distal portion of the femoral artery with unknown stenosis of a (b)(6) male patient with unknown medical history, the periodic survey reported that the following items were entered as "occlusion" on the list; patency, dus, the proximal portion of stenosis psv, and the maximum psv of stenosis.The patient is now under observation, and no treatment was applied." additional information was received that dus means doppler ultra sound.It not known which stent was patent but both stents had psv.It is unknown if the original lesion was calcified or the vessel tortuous, if the stents were overlapping, if the stents were deployed with good wall apposition and if ivus was done post procedure.No additional information available.

• Brand Name: SMART CONTROL, ILIAC 6X100
• Common Device Name: SELF EXPANDING STENT
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6000236
• Report Number: 9616099-2016-00633
• Device Sequence Number: 889752
• Product Code: NIO
• UDI-Device Identifier: 20705032023655
• UDI-Public: (01)20705032023655(17)130731(10)15672188
• 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,study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2016

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: 07/31/2013
• Device Model Number: C06100SL
• Device Catalogue Number: C06100SL
• Device Lot Number: 15672188
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2016
• Initial Report FDA Received Date: 10/05/2016
• 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