MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 8X100ML; CATHETER, BILIARY, DIAGNOSTIC

Model Number	C08100ML
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A smart control 8 x 100 self-expanding stent (ses) iliac was delivered to the lesion.However, it was spinning around, and the stent could not be deployed when the doctor turned the dial to try to deploy.Therefore, it was replaced with a new smart control stents 8x80 and 10x60 which could be deployed, and the procedure was completed.Additional information obtained from the product analysis states the smart control stent was received partially deployed approximately 18 mm from the unit.This was an endovascular therapy (evt) case.The lesion was the iliac artery which had stenosis.An approach was made from the brachial artery.A non-cordis guiding catheter was used.The device was stored and handled per the instructions for use (ifu).The device was prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was little vessel tortuosity.The lesion had little calcification.The device was not used for a chronic total occlusion (total occlusion >3 months).The percentage of stenosis was 75%.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The smart control locking pin was in place during advancement towards the lesion.The user held the handle of the smart control sds flat and straight outside the patient as per ifu.There was no reported patient injury.The product was returned for analysis.One non-sterile smart control, iliac 8x100ml was received for analysis inside a plastic bag.No original packaging was returned.Locking pin was not returned.Per visual analysis, the stent of the unit was observed deployed approximately 18 mm from the unit.The strain relief was observed bent as received.No damages were observed on the tuning dial.No other anomalies were observed.Per functional analysis, deployment test was performed on the returned unit.Tuning dial was fully rotated.No difficulty was experienced while rotating the tuning dial during the deployment test.Then, the sliding lever was fully pulled, and the stent was released.No anomalies were observed on the stent.A product history record (phr) review of lot 17899159 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported "stent delivery system (sds)-ses~pinsc deployment difficulty - partial deployment" was confirmed since stent was observed partially deployed, as received.Furthermore, no damages were observed on the tuning dial of the unit.Also, the strain relief was observed bent.The cause of the bend observed on strain relief and the stent's partial deployment could not be conclusively determined during the analysis.Handling and or procedure factors such as 75% vessel stenosis may have led to the reported event.According to the precautions in the safety information of the instructions for use, ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to the stent or lumen.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Prior to stent deployment, remove all slack from the catheter delivery system.Neither the phr review nor the product analysis suggests that the reported failure 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, the 8x100 smart control self-expanding stent (ses) iliac was delivered to the lesion.However, it was spinning around, and the stent could not be deployed when the doctor turned the dial to try to deploy.Therefore, it was replaced with a new smart control stents 8x80 and 10x60 which could be deployed, and the procedure was completed.Additional information obtained from the product analysis states the smart control stent was received partially deployed approximately 18 mm from the unit.There was no reported patient injury.This was an endovascular therapy (evt) case.The lesion was the iliac artery which had stenosis.An approach was made from the brachial artery.A non-cordis guiding catheter was used.The device was stored and handled per the instructions for use (ifu).The device was prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was little vessel tortuosity.The lesion had little calcification.The device was not used for a chronic total occlusion (total occlusion >3 months).The percentage of stenosis was 75%.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The smart control locking pin was in place during advancement towards the lesion.The user held the handle of the smart control sds flat and straight outside the patient as per ifu.Other additional patient/procedural details were requested but were not available.The device will be returned for evaluation.

• Brand Name: SMART CONTROL, ILIAC 8X100ML
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10169356
• Report Number: 9616099-2020-03751
• Device Sequence Number: 2152350
• Product Code: FGE
• UDI-Device Identifier: 20705032024225
• UDI-Public: 20705032024225
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K021898
• 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
• Report Date (Section B): 06/18/2020

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: 08/31/2021
• Device Model Number: C08100ML
• Device Catalogue Number: C08100ML
• Device Lot Number: 17899159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/03/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1