MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 6X100ML; STENT, ILIAC

Catalog Number	C06100ML
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.
Event or Problem Description
During an interventional endovascular procedure, while advancing/crossing the target lesion with a smart control iliac 6 x 100 stent delivery system (sds), the outer sheath was withdrawn before crossing the lesion and the stent almost released.Therefore, it was removed from the patient and replaced with a smart 6 x 120 stent to complete the procedure successfully.There was no reported patient injury.The target lesion/target lesion characteristic information was not known/provided.
Additional Manufacturer Narrative
Additional information received: the product was returned for inspection.The preliminary inspection indicated that the stent was protruding 0.5 cm.Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Additional information will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Additional information received indicated that premature deployment of the stent was noted to be 0.5 cm.From the distal end of the stent when it crossed the lesion, before it was removed.The procedure was completed successfully without patient injury using the other smart stent reported.A contralateral antegrade approach was made from the common femoral artery.The target lesion for the procedure was the superficial femoral artery (sfa).The lesion was reported to be: a 99% stenosis, moderately calcified, not tortuous and not a chronic total occlusion (cto).No patient information was provided.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.The product was stored properly per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly per the ifu with no problems noted during preparation.No additional information is available.During an interventional endovascular procedure, while advancing/crossing the target lesion with a smart control iliac 6 x 100 stent delivery system (sds), the outer sheath was withdrawn before crossing the lesion and the stent almost released.Therefore, it was removed from the patient and replaced with a smart 6 x 120 stent to complete the procedure successfully.There was no reported patient injury.The premature deployment of the stent was noted to be 0.5 cm from the distal end of the stent when it crossed the lesion, before it was removed.A contralateral antegrade approach was made from the common femoral artery.The target lesion for the procedure is the superficial femoral artery (sfa).The lesion is reported to be: 99% stenotic, moderately calcified, not tortuous and not a chronic total occlusion (cto).There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.The product was stored properly per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly per the ifu with no problems noted during preparation.No additional information is available.The device was returned for analysis.One non-sterile smart control iliac 6 x 100 stent delivery system (sds) was received for analysis inside a plastic bag.No original packaging was returned.The locking pin of the unit was observed in place.Per visual analysis, the stent of the unit was received 0.5 cm pre-deployed.No other anomalies found.Per dimensional analysis, the usable length of unit was found within specification.Two deployment tests were successfully performed, the stent was completely deployed.Neither difficulty nor anomaly (resistance, friction, or incomplete stent deployment) was experienced during the deployment procedure.A product history record (phr) review of lot 17555249 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿stent delivery system (sds)-ses-deployment difficulty - premature/in patient - during advancement¿ was confirmed due to the stent of unit was received 0.5 cm already pre-deployed.However, the cause of the stent pre-deployment could not be conclusively determined during the analysis.Procedural and handling factors, as well as vessel characteristics may have contributed to this event.According to the instructions for use (ifu), which is not intended as a mitigation, during prep ¿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.During use, ensure the locking pin is still in place.Advance the device over the guidewire through the hemostatic valve and sheath introducer.Note: if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.¿ neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SMART CONTROL, ILIAC 6X100ML
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7606482
• Report Number: 9616099-2018-02190
• Device Sequence Number: 13876854
• Product Code: NIO
• UDI-Device Identifier: 20705032023624
• UDI-Public: 20705032023624
• 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: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2018

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: 07/31/2018
• Device Catalogue Number: C06100ML
• Device Lot Number: 17555249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Distributor Facility Aware Date: 05/24/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 06/20/2018; 07/24/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 07/20/2018; 08/01/2018
• 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: DESTINATION (90CM6FR,TERUMO)RADIFOCUS (0.035INCH