MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 8X40ML; STENT, ILIAC

Catalog Number	C08040ML
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Date of Event	03/15/2016
Type of Reportable Event	Death
Additional Manufacturer Narrative
The product remains implanted and is thus not available for analysis.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the patient was implanted with a smart control stent in the target lesion without issue.The patient was an (b)(6) female.Her (b)(6).The original target lesion was the proximal portion of the right femoral artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.Approximately three years later, the patient expired.The death certificate is unavailable and the cause of death is unknown.
Additional Manufacturer Narrative
As reported, the patient was implanted with a smart control stent in the target lesion without issue.The patient was an (b)(6) female.Her (b)(6).The original target lesion was the proximal portion of the right femoral artery.The patient¿s vessel level of tortuosity and calcification was unknown.The rate of stenosis was unknown.Approximately three years later, the patient expired.The death certificate is unavailable and the cause of death is unknown.The device was not returned for evaluation as it remains implanted.A review of the manufacturing documentation associated with this lot 15673016 presented no issues during the manufacturing process that can be related to the reported event.Death is a well-known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Although a definitive root cause cannot be determined and the death certificate is unavailable, patient history, clinical status, comorbidities, and/or pharmacological factors may have been possible contributing factors for the patient outcome.Based on the device history record review, lack of information and the inability to assign or determine a root cause, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: SMART CONTROL, ILIAC 8X40ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6793905
• Report Number: 9616099-2017-01320
• Device Sequence Number: 129860
• Product Code: NIO
• UDI-Device Identifier: 20705032024096
• UDI-Public: 20705032024096
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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: 06/30/2014
• Device Catalogue Number: C08040ML
• Device Lot Number: 15673016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 08/16/2017
• Initial Report FDA Received Date: 08/15/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN 0.014 GUIDEWIRE; UNKNOWN 6F SHEATH
• Outcome Attributed to Adverse Event: Death
• Patient Age: 82 YR
• Patient Weight: 56