MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 7X100; STENT, ILIAC

Catalog Number	C07100SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During an interventional endovascular procedure, a smart control iliac stent 7x100 was unable to cross the lesion.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.The device was prepped per the ifu and there were no anomalies during prep.There were no kinks or other damages noted prior to inserting the product into the patient.The procedure was completed successfully.One non-sterile precise smart control, iliac 7x100 was received coiled inside a plastic bag.The stent was received partially displayed (4 mm).The locking pin was not located in its correct position and it was not received for analysis.No other discrepancies were found on the received unit.A review of the manufacturing documentation associated with lot 17646129 presented no issues during the manufacturing process that can be related to the reported event.The complaint of "stent delivery system (sds)-ses - failure to cross" reported by the customer was not confirmed due to the nature of the complaint.The outer diameter of the device was found to be within specification.The reported complaint of "stent delivery system (sds)-ses - deployment difficulty - partial deployment" was confirmed as the device was returned with the stent partially displayed.The exact cause of the events could not be determined during analysis.Although lesion and vessel characteristics are unknown, failure to cross is most commonly related to lesion characteristics including calcification, tortuousity, high degree of stenosis and the profile of the selected device.It is also possible that the operator's interaction with the sds may have contributed to the reported event if the deployment steps as listed in the ifu were not followed correctly.Holding the outer member during deployment may result in the support member pushing the stent forward and compressing the stent.In addition, moving the handle proximally or distally after the stent achieves initial wall apposition may result in stent compression or elongation.Pushing the sds against resistance, which can be encountered during sds advancement through calcified, tortuous or stenotic vasculature, can cause the outer member to compress, thus contributing to premature stent deployment/stent jumping while the locking pin is still in.Neither the device history record (dhr) review nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken.
Event or Problem Description
As reported, the smart control iliac stent 7x100 was unable to cross the lesion.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There were no anomalies noted to the device when it was taken out of the packaging.The device was prepped per the ifu and there were no anomalies during prep.There were no kinks or other damages noted prior to inserting the product into the patient.The procedure was completed successfully.Additional procedural details were requested but are unknown.Additional information was received and the device was returned with the stent partially deployed 4mm.

• Brand Name: SMART CONTROL, ILIAC 7X100
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6850865
• Report Number: 9616099-2017-01403
• Device Sequence Number: 109085
• Product Code: NIO
• UDI-Device Identifier: 20705032023952
• UDI-Public: 20705032023952
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: C07100SL
• Device Lot Number: 17646129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1