MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 7X40ML; STENT, ILIAC

Catalog Number	C07040ML
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The distal end tip of a 7x40ml smart control, iliac stent was inserted and got kinked 90 degrees angle due to inadequate inflation caused by severe calcification.There was a gap noted between the distal tip and the guidewire lumen.The device was removed from the patient and the procedure was completed with the balloon catheter.There was no reported patient injury.The lesion was the superficial femoral artery (sfa) which has severe calcification with stenosis.A contralateral approach was made.The lesion was inflated with a non-cordis balloon catheter (bc) for pre dilation after a non-cordis guidewire crossed the lesion.The patient has no infectious disease.The product was not returned for analysis.A product history record (phr) review of lot 17779706 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip kinked/bent - in patient¿ and ¿catheter tip fractured - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of severe calcification and the procedural factor of inadequate target lesion preparation may have contributed to the reported event.According to the warnings/precautions in the safety information in the instructions for use ¿safety and effectiveness has not been demonstrated in patients with: lesions that are either totally or densely calcified.¿ according to the safety information in the instructions for use ¿the s.M.A.R.T.Control nitinol stent system is indicated for improving luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 4 to 9 mm, and angiographic evidence of a patent profunda or superficial femoral artery.¿ as this device is not indicated for use in the superficial femoral artery this is considered off-label usage.Neither the phr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.
Event or Problem Description
As reported, the distal end tip of a 7x40ml smart control, iliac stent was inserted and got kinked 90 degrees angle due to inadequate inflation caused by severe calcification.There was a gap noted between the distal tip and the guidewire lumen.The device was removed from the patient and the procedure was completed with the balloon catheter.There was no reported patient injury.The lesion was the superficial femoral artery (sfa) which has severe calcification with stenosis.A contralateral approach was made.The lesion was inflated with a non-cordis balloon catheter (bc) for pre dilation after a non-cordis guidewire crossed the lesion.The patient has no infectious disease.The device will not be returned as it was discarded in the hospital.

• Brand Name: SMART CONTROL, ILIAC 7X40ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 9218415
• Report Number: 9616099-2019-03296
• Device Sequence Number: 2183437
• Product Code: NIO
• UDI-Device Identifier: 20705032023792
• UDI-Public: 20705032023792
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2019

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: 04/30/2020
• Device Catalogue Number: C07040ML
• Device Lot Number: 17779706
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/24/2019
• Initial Report FDA Received Date: 10/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1