MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 7X60; STENT, ILIAC

Catalog Number	C07060SL
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.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, as the smart control iliac 7 x 60 stent delivery system (sds) was advanced towards the target lesion, the outer shaft moved, and the stent was slightly deployed.It is unknown if the sds became caught on the lesion calcification.The product was removed and replaced with a 120 cm.Smart 7 mm/ x 6 cm.Sds to complete the procedure successfully.There was no reported patient injury.The target lesion was the superficial femoral artery (sfa).An ipsilateral approach was made.An unknown guidewire was used to cross the target lesion and the lesion was pre-dilated with an unknown balloon catheter.Additional information received indicated that about one (1) cm.Of the stent was noted to have prematurely deployed.The sds was not advanced through another stent.There was some tracking difficulty noted, as the stent got caught on the target lesion during advancement.There was no attempt made to intentionally deploy the stent.The procedure was completed successfully without patient injury with the other smart stent that was used.The target lesion was reported to be: not tortuous, a 90% stenosis, and the entire lesion circumference was calcified.No patient information was available/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.
Additional Manufacturer Narrative
Additional information received indicated that the product was discarded and is not available for inspection.During an interventional endovascular procedure, as the smart control iliac 80 cm 7 mm x 60 mm stent delivery system (sds) was advanced towards the target lesion, the outer shaft moved, and the stent was slightly deployed.It is unknown if the sds became caught on the lesion calcification.The product was removed and replaced with a 120 cm smart 7 mm x 60 mm sds to complete the procedure successfully without patient injury.About 1 cm of the stent was noted to have prematurely deployed.The target lesion was the superficial femoral artery (sfa).The target lesion was reported to be: not tortuous, 90% stenotic, and the entire lesion circumference was calcified.No patient information was available/provided.An ipsilateral approach was made.An unknown guidewire was used to cross the target lesion and the lesion was pre-dilated with an unknown balloon catheter.The sds was not advanced through another stent.There was some tracking difficulty noted, as the stent got caught on the target lesion during advancement.There was no attempt made to intentionally deploy the stent.There was no other product issue noted.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 not returned for analysis.A review of the manufacturing documentation associated with lot 17624378 was performed and no issues were noted that may be related to the reported complaint.The phr review does not suggest that the failure experienced by the customer could be related to the manufacturing process.The events reported by the customer as ¿stent delivery system (sds)-ses deployment difficulty - premature/in patient - during advancement¿ and ¿stent delivery system (sds)- tracking difficulty¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics of 90% stenosis, and the circumferential calcification of the entire lesion may have contributed to the may have contributed to the reported event.According to the instructions for use, 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 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.

• Brand Name: SMART CONTROL, ILIAC 7X60
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7651892
• Report Number: 9616099-2018-02226
• Device Sequence Number: 2281798
• Product Code: NIO
• UDI-Device Identifier: 20705032023853
• UDI-Public: 20705032023853
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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: 11/30/2018
• Device Catalogue Number: C07060SL
• Device Lot Number: 17624378
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 06/06/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 06/29/2018
• Supplement Report FDA Received Date: 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1