MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 6X40ML; STENT, ILIAC

Catalog Number	C06040ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Heart Failure (2206)
Date of Event	08/18/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
As reported by the smart pms for sfa study, approximately five years post implantation of the smart control (iliac 6x40ml) self¿expanding stent (ses) in the proximal portion of the right femoral artery, the patient was admitted to the hospital because of heart failure and the patient expired five days later.The event is considered not related to the index procedure or the device.The official cause of death was heart failure.The patient did not have any significant medical history that may have contributed to his death.No other information was reported.The device was not returned for analysis.A product history record (phr) review of lot 15621159 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 reported adverse events of ¿heart failure¿ and ¿death¿ could not be confirmed.The device, procedural images, and medical records were not received for analysis.Heart failure is a condition in which the heart is unable to pump enough blood to the rest of the body to meet demands.Causes of this condition are coronary artery disease, hypertension, hypotension, disorders of the heart valves and disorders of the rhythm of the heart.There is no clear medical evidence of a relationship between these events and the previously implanted smart stent in the patient¿s right femoral artery.The phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.
Event or Problem Description
As reported by the smart pms for sfa study, approximately five years post implantation of the smart control (iliac 6x40ml) self¿expanding stent (ses) on the proximal portion of the right femoral artery, the patient was admitted to the hospital because of heart failure and the patient expired five days later.The event is considered not related to the index procedure or the device.Additional information received indicates that the official cause of death was heart failure.The patient did not have any significant medical history that may have contributed to his death.

• Brand Name: SMART CONTROL, ILIAC 6X40ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8051340
• Report Number: 9616099-2018-02506
• Device Sequence Number: 1484559
• Product Code: NIO
• UDI-Device Identifier: 20705032023495
• UDI-Public: 20705032023495
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/08/2018

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: 04/30/2014
• Device Catalogue Number: C06040ML
• Device Lot Number: 15621159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/08/2018
• 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: 50