MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL 14X80 120; STENT, ILIAC

Model Number C14080MV

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  Injury  

Manufacturer Narrative

Device history record (dhr) review was conducted, and the product met quality requirements for product acceptance.This device was received for analysis, but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a 14mm x 80mm 120 smart control self-expanding stent delivery system was implanted; however, the stent was significantly shortened.Therefore, a new 12mm x 80mm smart stent (unknown) was used to complete the procedure.The patient had iliac vein compression syndrome with ninety percent stenosis.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The smart control product was stored, handled, inspected and prepped according to the instructions for use (ifu); with nothing unusual noted about the stent delivery system prior to use.The device was prepped in the tray.A stopcock was connected to the y-connector of the tuohy borst valve and there were no difficulty encountered flushing the stopcock or the sds.The target lesion vessel diameter is 12~14mm; therefore the diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion vessel length is 6-7cm.The delivery of the sds to the lesion was ipsilateral.A 7f sheath (unknown) was inserted through the left popliteal vein, and a non-cordis guidewire was used.Three powerflex pro balloon catheters (6x8, 10x8, 12x6) were used for pre-expansion to reduce stenosis to fifty percent.The stent delivery system did not pass through any acute bends or previously placed stents.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The device will be returned for evaluation.No other information was provided.

Manufacturer Narrative

A 14mm x 80mm 120 smart control self-expanding stent delivery system was implanted; however, the stent was significantly shortened.Therefore, a new 12mm x 80mm smart stent (unknown) was used to complete the procedure.The patient had iliac vein compression syndrome with ninety percent stenosis.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The smart control product was stored, handled, inspected and prepped according to the instructions for use (ifu); with nothing unusual noted about the stent delivery system prior to use.The device was prepped in the tray.A stopcock was connected to the y-connector of the tuohy borst valve and there was no difficulty encountered flushing the stopcock or the sds.The target lesion vessel diameter is 12~14mm; therefore, the diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion vessel length is 6-7cm.The delivery of the sds to the lesion was ipsilateral.A 7f sheath (unknown) was inserted through the left popliteal vein, and a non-cordis guidewire was used.Three powerflex pro balloon catheters (6x8, 10x8, 12x6) were used for pre-expansion to reduce stenosis to fifty percent.The stent delivery system did not pass through any acute bends or previously placed stents.The sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The device was returned for analysis.A non-sterile ¿smart control 14x80 120¿ was received coiled inside of a clear plastic bag.The device was unpacked and laid on a tray to perform the product evaluation.The device was thoroughly inspected noticing that it is fully deployed, and the stent was not returned for analysis.A kinked/bent condition was observed at 11 and 123 cm from the distal tip.The looking pin was not included at the shipment.No other outstanding details were observed.A product history record (phr) review of lot 17973127 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent-ses ~ incorrect length - too short¿ was not confirmed.The stent which is the component involved in the complaint was not returned to be analyzed.The exact cause of the kink/bent condition observed on the unit could not be conclusive determined during the analysis.It is probable that the damages observed on the device could be related to procedural and or handling factors such as vessel characteristics and the user¿s interaction with the device during use.According to the instructions for use (ifu) ¿verify that the delivery system¿s radiopaque stent markers (leading and trailing ends) are proximal and distal to the target lesion.Ensure that the introducer sheath does not move during deployment.Remove locking pin from handle.Initiate one-handed stent deployment by rotating the tuning dial with thumb and index fingers in a clockwise direction (direction of arrow) while holding the handle in a fixed position.While using fluoroscopy, maintain position of the radiopaque stent markers relative to the targeted lesion site.Watch for the distal radiopaque markers to begin separating.Separation of the distal stent markers signals that the stent is unsheathed.Continue turning the tuning dial until the distal end of the stent obtains full apposition with the vessel wall.Note: only the initial 40 mm of the stent may be unsheathed using the tuning dial.With maintaining a fixed handle position, pull back the deployment lever to unsheathe the remainder of the stent.Note: failure to maintain a fixed handle position or constraining the catheter shaft during deployment may result in stent compression (shortening) or elongation.Note: the stent may be deployed using two hands (¿pin and pull¿ method) by holding the proximal end of the handle stationary with one hand and sliding the deployment lever back towards the stationary hand.Stent deployment is complete when the proximal markers appose to the vessel wall and the outer sheath radiopaque marker is proximal to the inner shaft stent stop.Note: when more than one stent is required to cover the lesion, the more distal stent should be placed first.Efforts should be taken to minimize the stent overlap.¿ neither the product analysis nor the phr review suggests that the event could be related to the manufacturing process; therefore, no corrective action will be taken at this time.

• Brand Name: SMART CONTROL 14X80 120
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 12121784
• MDR Text Key: 260048947
• Report Number: 9616099-2021-04681
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: K021898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: C14080MV
• Device Catalogue Number: C14080MV
• Device Lot Number: 17973127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Initial Date Manufacturer Received: 06/08/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 08/02/2021
• Supplement Dates FDA Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10*8 POWERFLEX PRO BALLOON; 12*6 POWERFLEX PRO BALLOON; 6*8 POWERFLEX PRO BALLOON; GUIDEWIRE OF TERUMO; UNKNOWN 7F SHEATH; 10*8 POWERFLEX PRO BALLOON; 12*6 POWERFLEX PRO BALLOON; 6*8 POWERFLEX PRO BALLOON; GUIDEWIRE OF TERUMO; UNKNOWN 7F SHEATH
• Patient Outcome(s): Required Intervention
• Patient Weight: 55