MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X100; STENT, ILIAC

Model Number	C08100SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
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, a part of the 8 x 100 smart control iliac self-expanding stent (ses) system did not deploy at all.Post dilation (unknown balloon catheter) was performed several times, but recoil occurred.An intravascular ultrasound (ivus) showed that a part of the strut seemed to be broken.¿the stent was implanted as if it covered the strut¿ and the procedure was completed.There was no reported patient injury.The stent was implanted at the iliac artery.The device will not be returned for evaluation since it is implanted in the patient.
Additional Manufacturer Narrative
Part of the 8 x 100 smart control iliac self-expanding stent (ses) system did not deploy at all.Post dilation (unknown balloon catheter) was performed several times, but recoil occurred.An intravascular ultrasound (ivus) showed that a part of the strut seemed to be broken.¿the stent was implanted as if it covered the strut¿ and the procedure was completed.The stent was implanted at the iliac artery.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17922160 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿stent delivery system (sds)-ses- deployment difficulty - partial deployment and stent-ses- fractured - in patient¿ could not be confirmed and the exact root cause could not be determined.Handling and procedural factors such as vessel characteristics (although unknown) may have led to the reported events.According to the instructions for use ¿care should also be taken when deploying the stent as excessive force could, in rare instances, lead to stent deformation and/or fracture.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.¿ stent fractures are a well-known potential complication of this type of procedure and are listed in the ifu as such.Fracture of self-expanding stents placed in the iliac artery occurs in approximately 5% of the cases.Stenting in chronic occlusion represents an increased risk factor for fracture.Fractures of stents placed in iliac arteries rarely affect patency.Neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART CONTROL, ILIAC 8X100
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10416569
• Report Number: 9616099-2020-03847
• Device Sequence Number: 2445765
• Product Code: NIO
• UDI-Device Identifier: 20705032024256
• UDI-Public: 20705032024256
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 12/31/2021
• Device Model Number: C08100SL
• Device Catalogue Number: C08100SL
• Device Lot Number: 17922160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 08/17/2020
• Supplement Report FDA Received Date: 09/03/2020
• 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: UNK BALLOON CATHETER