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

Model Number	C08100SL
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17932840 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, after the smart control stent was implanted; however the device got stuck during the removal/withdrawal.The physician strongly pulled and tried to remove several times without success, the smart control, sheath and guidewire were removed.There was no reported injury to the patient.This was a stent graft case.The lesion was the in the right iliac.A non-cordis sheath was inserted through a dry non-cordis sheath.A.035 non-cordis guidewire crossed the lesion.The stent was used due to the dissected lesion.After the device was removed from the patient, the physician pulled the wire out from the distal tip and it came out/off safely.The device will be returned for evaluation.
Additional Manufacturer Narrative
After the 8x100 smart control stent was implanted; however, the device got stuck during the removal/withdrawal.The physician strongly pulled and tried to remove several times without success, the smart control, sheath, and guidewire were removed.This was a stent graft case.The lesion was the in the right iliac.An 8f non-cordis sheath was inserted through a dry 22f non-cordis sheath.A.035 non-cordis guidewire crossed the lesion.The stent was used due to the dissected lesion.After the device was removed from the patient, the physician pulled the wire out from the distal tip, and it came out/off safely.There was no reported injury to the patient.The device was returned for analysis.One non-sterile smart control, iliac 8x100 was received for analysis inside a plastic bag.No original packaging was returned.Locking pin was not returned along the unit.Per visual analysis, the stent of the unit was observed deployed but not returned inside the bag.Also, a kink was observed on the outer sheath of the unit approximately at 5.1 cm from the strain relief.No other anomalies were observed.The (outer diameter) od of the outer sheath was measured at different distances and the results were found within specification.Per functional analysis an insertion/withdrawal test was performed on the unit.The smart control device was inserted into a 6f cordis catheter sheath introducer lab sample.The unit was successfully inserted into the lab sample and successfully withdrawn; neither resistance nor friction was observed during the test.A product history record (phr) review of lot 17932840 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) - withdrawal difficulty - through guide/sheath¿ was not confirmed since no difficulty was observed while withdrawing the device from the catheter sheath introducers, during insertion/withdrawal test.Also, dimensional test was performed on the outer sheath of the unit and the results were found within specification.The cause of the kink observed on the outer sheath could not be conclusively determined during the analysis.However, it is probable the procedural and or handling factors such as vessel characteristics and the user¿s interaction with the device may have led to the reported event.According to the instructions for use ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.¿ 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.
Event or Problem Description
As reported, after the 8x100 smart control stent was implanted; however the device got stuck during the removal/withdrawal.The physician strongly pulled and tried to remove several times without success, the smart control, sheath and guidewire were removed.There was no reported injury to the patient.This was a stent graft case.The lesion was the in the right iliac.A 8f non-cordis sheath was inserted through a dry 22f non-cordis sheath.A.035 non-cordis guidewire crossed the lesion.The stent was used due to the dissected lesion.After the device was removed from the patient, the physician pulled the wire out from the distal tip and it came out/off safely.The device will be returned for evaluation.

• Brand Name: SMART CONTROL, ILIAC 8X100
• 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: 13339247
• Report Number: 9616099-2022-05311
• Device Sequence Number: 19874813
• Product Code: NIO
• UDI-Device Identifier: 20705032024256
• UDI-Public: (01)20705032024256(17)220131(10)17932840
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2022

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: 01/31/2022
• Device Model Number: C08100SL
• Device Catalogue Number: C08100SL
• Device Lot Number: 17932840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 02/05/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2020
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-CORDIS GUIDEWIRE (035*260CM, RADIFOCUS).; NON-CORDIS SHEATH (22F, MDT); NON-CORDIS SHEATH (8F, TERUMO)
• Patient Sex: Unknown