MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 8X60; SELF EXPANDING STENTS (NIO)

Model Number	C08060SL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	04/04/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device remains implanted in the patient and is not available for inspection.  (b)(6).Information was received from a clinical study indicating that a patient was enrolled in the study and had a smart control iliac 8 x 60 stent implanted in the target lesion during the index procedure with no reported issue.The target lesion was the middle portion of the left femoral artery.The lesion was reported to be: a 60.9% stenosis, mildly calcified and mildly tortuous.Approximately thirty-four months after the study index procedure, the patient expired.The details of the cause of death were unknown.Additional information was requested but was reported to be unknown: was an autopsy performed; if no autopsy performed, can you please provide a cause of death; what is the patient¿s medical history; what was the patient¿s medical regimen post-procedure; was the patient compliant with the medical regimen; was the reported ae reported to be related or unrelated to the study device by the study investigator/physician; was the reported ae reported to be related or unrelated to the study index procedure device by the study investigator/physician.No additional information is available.  the device remains implanted in the patient and is not available for inspection.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Based on the information provided and the inability to assign or determine a root cause, no corrective actions will be taken at this time.  there are possible patient, and pharmacological factors that may have contributed to the reported event.Without the return of the actual complaint product the event reported by the customer cannot be confirmed, nor can any conclusion regarding root cause be drawn.  based on the minimal available information, there is no evidence to suggest that the event was design or manufacturing related therefore no corrective action will be taken.  please note that this is the initial/final report for this product.
Event or Problem Description
As reported, the patient was enrolled in a clinical study (b)(6) and the case number is (b)(4).The patient had a smart control iliac 8 x 60 stent implanted in the target lesion during the index procedure with no reported issue.The target lesion was the middle portion of the left femoral artery.The lesion was reported to be: a 60.9% stenosis, mildly calcified and mildly tortuous.Approximately thirty-four months after the study index procedure, the patient expired.The details of the cause of death were unknown.Additional information was requested but was reported to be unknown: was an autopsy performed; if no autopsy performed, can you please provide a cause of death; what is the patient's medical history; what was the patient's medical regimen post-procedure; was the patient compliant with the medical regimen; was the reported ae reported to be related or unrelated to the study device by the study investigator/physician; was the reported ae reported to be related or unrelated to the study index procedure device by the study investigator/physician.No additional information is available.

• Brand Name: SMART CONTROL, ILIAC 8X60
• Common Device Name: SELF EXPANDING STENTS (NIO)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 5981978
• Report Number: 9616099-2016-00621
• Device Sequence Number: 611678
• Product Code: NIO
• UDI-Device Identifier: 20705032024157
• UDI-Public: 20705032024157
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2016

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: 02/28/2015
• Device Model Number: C08060SL
• Device Catalogue Number: C08060SL
• Device Lot Number: 15830345
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/06/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2016
• Initial Report FDA Received Date: 09/27/2016
• 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: Death
• Patient Weight: 70