MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X80ML; STENT, ILIAC

Model Number	C08080ML
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complaint conclusion: a smart control iliac 8x80ml stent was used and attempted to be deployed.The doctor turned its tuning dial; however, the stent was not deployed.Therefore, it was replaced with a new smart control stent and the procedure was completed.The patient had no infectious disease.The lesion was the common iliac artery.A brachial approach was made.The product was returned for analysis and the outer member and support member (inner shaft) of the unit were observed broken/separated.There was no reported patient injury.The device was returned for analysis.One non-sterile smart control, iliac 8x80ml stent delivery system was received for analysis inside a plastic bag.Per visual analysis, the locking pin was detached (not returned for evaluation).The system was not actuated, the stent of the unit was received in place (not deployed), and a severe damage condition found on the shaft of the unit at the id band level.The inner shaft of the unit was observed separated.No other anomalies were seen on the ses smart control unit.Functional analysis (deployment test) could not be performed due to the separated condition of the shaft of the unit the way it was received for evaluation.Dimensional analysis, stroke length (pin-pull sds), not required.Per microscopic analysis, the unit was inspected under the vision system and the inner shaft material presented elongations.Elongations are commonly associated with separations caused by material tensile overload.Thus, it is assumed that the shaft of the unit was induced to a tensile force that exceeded the material yield strength prior to the separation.A product history record (phr) review of lot 17908594 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses- deployment difficulty ¿ unable¿ was not confirmed since the deployment test could not be performed due to the separated inner shaft of the device the way it was received for evaluation.However, "inner shaft - separated" was confirmed.Per the observed damaged condition of the unit the way it was received for analysis, a probable application of a tension force that induced the damage condition on the unit can be considered.Therefore, it is reasonable to consider that the user applied an application of tension force during use of the device resulting in the reported separation.As evidence by the elongations noted on the device during analysis.Additionally, vessels characteristics (although unknown) may have contributed to the damages noted on the device, as received.Analysis results and phr review results do not suggest that the observed condition is related to the manufacturing process.The product manufacturing records indicated that the product met specifications before shipment.Also, the packaging tray the unit is packaged in does not allow the stent delivery system to endure any condition such as separation.According to the instructions for use, ¿introduction of stent delivery system: ensure locking pin is still in place.Note: if the locking pin is not in place, system performance may be compromised, and another system should be used.Advance the stent delivery system over the guidewire through the sheath introducer to the lesion site.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Caution: always use an appropriate size introducer sheath for the implant procedure to protect vessel and access site.¿ neither the phr review nor the product analysis suggests that the events reported are related to the manufacturing process.Therefore, no actions will be taken.
Event or Problem Description
As reported, a smart control iliac 8x80ml stent was used and attempted to be deployed.The doctor turned its tuning dial; however, the stent was not deployed.Therefore, it was replaced with a new smart control stent and the procedure was completed.There was no reported patient injury.The patient had no infectious disease.The lesion was the common iliac artery.A brachial approach was made.The product was returned for analysis and the outer member and support member (inner shaft) of the unit were observed broken/separated.

• Brand Name: SMART CONTROL, ILIAC 8X80ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 12800193
• Report Number: 9616099-2021-05051
• Device Sequence Number: 5644874
• Product Code: NIO
• UDI-Device Identifier: 20705032024171
• UDI-Public: (01)20705032024171(17)211031(10)17908594
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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: 10/31/2021
• Device Model Number: C08080ML
• Device Catalogue Number: C08080ML
• Device Lot Number: 17908594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/11/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown