MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL NITINOL STENT SYSTEM; SELF EXPANDING STENTS (NIO)

Catalog Number C10030SL

Device Problem Unintended Movement (3026)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/08/2015

Event Type  Injury  

Event Description

As reported, the smart control stent migrated to the ascending aorta after release at the left subclavian artery.The migrated stent was retrieved with a guidewire and balloon and implanted in the common iliac artery.Another stent was implanted to stabilize the migrated stent, and the target lesion was treated with another stent.The patient was a male but his age was unknown.The intended procedure was a percutaneous transluminal angioplasty.The target lesion was the left subclavian artery.The lesion was moderately calcified and tortuous.There was 95% stenosis.After lesion was crossed with a non-cordis guidewire, a non-cordis balloon catheter was inflated for pre-dilation.Then, a 10x30mm smart control stent was released.Right then, the stent migrated to the ascending aorta.To treat the migrated stent, the physician inserted a 7f long sheath into the left femoral artery and delivered a non-cordis guidewire into the smart control carefully, and then a non-cordis balloon catheter was inflated in the stent and brought the stent to the right over the bifurcation of the descending aorta.And he drew the stent into the common iliac artery and moved it back and forth.Then, half of the stent was placed in the common iliac artery.For stent stability, another smart control stent was delivered and placed from the contralateral right femoral artery.Finally, the complaint stent was implanted at the common iliac artery and the procedure was finished.The original target lesion of the left subclavian artery was treated with another non-cordis stent.The product was clinically used.And it will not be returned for analysis.

Manufacturer Narrative

Concomitant product and devices: agosal, st.Jude medical guidewire; 6.0*20 senri, terumo balloon catheter; retrieving gw: (radifocus035/300cm, terumo); retrieving bc: (armada12.0/20, abbott); stabilizing stent: smart control (c10040sl) and target lesion stent: (express 8/27mm.(b)(6).(b)(4).The device remains implanted in the patient; therefore it was not available for analysis.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information received: the reference diameter of the target lesion vessel is unknown.There were no damages or anomalies noted to the smart control device or packaging prior to use.The device was handled and prepped according to the ifu.The access site was located in the left femoral artery.It is unknown if there was any difficulty as the stent delivery system (sds) was delivered to the lesion.It is unknown if the locking pin was in place during advancement or if the pin was removed before attempting to deploy.It is unknown if the sds was advanced past the lesion and then withdrawn back into the lesion prior to stent deployment.The handle of the smart control sds was flat and straight outside of the patient.It is unknown if unusual force was applied during deployment of if the sds was easily removed from the patient.It is unknown where the other half of the stent was.The migrated stent had remained intact during the entire procedure.It was stabilized, and then the long sheath was inserted into the contralateral right femoral artery.There were no adverse events or patient consequences.Procedural films were not available.Complaint conclusion: the site reported that a 10 x 30mm smart control iliac stent migrated into the ascending aorta after it had been released in the left subclavian artery.The stent was retrieved on a balloon and implanted in the common iliac artery with no further reported patient injury.The event involved a male patient who was undergoing percutaneous transluminal angioplasty of a target lesion in his left subclavian artery that was described as 95% stenosed, moderately calcified and tortuous.The patient¿s vasculature was accessed from the left femoral artery.The lesion was crossed with a non-cordis guidewire and pre-dilated with a non-cordis balloon catheter.The smart control packaging and device were inspected prior to use and no anomalies were found.The site reported that the device was handled and prepped according to the instructions for use (ifu).They further reported that the stent delivery system had been flat and straight outside of the patient.Immediately upon deploying the 10 x 30mm smart control stent, it migrated to the ascending aorta.The migrated stent was retrieved with the use of a long 7f sheath in the patient¿s pre-existing left femoral artery access.A non-cordis guidewire was carefully passed into the smart control stent followed by the introduction of a non-cordis balloon.The balloon was then inflated to capture the stent in order to withdraw it past the iliac bifurcation.The stent was then drawn into the common iliac artery with some maneuvering and implanted there.The stent was further stabilized in place with the use of another smart control stent from the contralateral right femoral artery.The target lesion was then treated with a non-cordis stent.Procedural films of this event are not available for review.The device could not be returned for analysis.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.Without the return of the device for analysis or films of the event, the reported ¿stent ¿ migration¿ could not be confirmed and no determination of possible contributing factors could be made.According to the product ifu, the device is indicated for improving the luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries.The ifu lists stent migration as a potential adverse event associated with intravascular stent implantation.It further instructs the user to ensure that the locking pin is still in place during the introduction of the device.In addition it instructs the user to advance the device past the lesion site and then withdraw it until the radiopaque stent markers are proximal and distal to the lesion site.The user is to ensure that the sds outside the patient remains flat and straight.Slack in the catheter shaft either outside or inside the patient may result in deploying the stent beyond the lesion site.The user is to ensure that the introducer sheath and that the locking pin should be removed from the handle prior to deployment.Based on the information available for review, there are vessel characteristics (calcification and tortuosity) and procedural factors (use of this device in the subclavian artery) that may have contributed to the reported event.Based on the device history record review, there is no indication that the event is related to the device manufacturing process.Therefore, no corrective actions will be taken at this time.

• Brand Name: SMART CONTROL NITINOL STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIO)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4950327
• MDR Text Key: 15133705
• Report Number: 9616099-2015-00333
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/08/2015

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: 10/31/2016
• Device Catalogue Number: C10030SL
• Device Lot Number: 17123775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/08/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability