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

Catalog Number C10040SL

Device Problem Unintended Movement (3026)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/02/2016

Event Type  Injury  

Manufacturer Narrative

It is unknown if the device was resterilized.It is unknown if there was any resistance/friction experienced as the smart control was inserted into the sheath/guiding catheter or if resistance/friction was met while advancing the device over the guidewire.It is unknown if there was difficulty advancing the sds to the target lesion or crossing the lesion.It is unknown if the sds passed through any acute bends or a previously deployed stent.It is unknown if the smart control locking pin was in place during advancement and if the locking pin was removed before attempting to deploy the stent.It is unknown is the sds was advanced past the lesion and then withdrawn back to the lesion prior to stent deployment.It is unknown if the slack had been removed from the catheter prior to attempting deployment, or if the handle was held straight and flat outside of the patient.The user attempted to place the smart control stent at the target lesion, and it was deployed halfway.However, the stent jumped and flew to the right ventricle from superior vena cava.It is unknown if unusual force was applied during deployment of the stent, or if excessive torquing was used.It is unknown if the tantalum markers opened symmetrically.The physician tried to retrieve the stent with snare and wires, but the stent could not be retrieved from the patient.It is unknown how the free-floating stent was removed from the right ventricle.It is unknown if the sds was removed from the patient without difficulty or if there were any damages/anomalies noted after removal.Therefore, an additional stent (smart10060) was placed at the target lesion, but it is unknown if the stent expanded with good wall apposition.The current health status of the patient is unknown.The product was clinically used and it will not be returned for analysis.A procedural cd is not available.Please note that the gender of the patient is unknown.(b)(6).(b)(4).The device is not available to be returned for analysis.A device history record (dhr) review and additional information are pending and will be submitted within 30 days.

Event Description

As reported, the smart control stent jumped and flew into the right ventricle.The physician attempted to retrieve the stent, but it could not be returned.An additional stent was used to complete the procedure.The device will not be returned for analysis.The patient¿s information was unknown.The target lesion was the subclavian vein.The lesion was not calcified and tortuous.The rate of stenosis was 90%.The vessel angulation was unknown, and it was unknown if there was thrombus present in or near the lesion.It is unknown if the lesion was pre-dilated.For the procedure, a 10x40mm smart control stent delivery system (sds) was opened.There were no damages or anomalies noted to the device after removal from the packaging.There were no anomalies noted with the temperature exposure indicator, and there were no anomalies during prep.

Manufacturer Narrative

Complaint conclusion: a report was received the a 10 x 40mm smart control iliac stent ¿jumped¿ and migrated to the right ventricle when being deployed in the subclavian vein.Attempts to retrieve the stent were unsuccessful.The patient¿s target lesion was successfully treated with the placement of an additional stent with no reported patient injury.The event involved a patient undergoing a percutaneous endovascular intervention of a target lesion in the subclavian vein.This lesion was described as 90% stenosed, non-calcified and tortuous.The site reported that the smart control stent delivery system (sds) was inspected after being removed from its¿ packaging, to the temperature exposure indicator and no anomalies were noted.No issues were experienced while prepping the device.The patient¿s vasculature was accessed and the sds placed across the target lesion.When the user attempted to deploy the stent, they noted that it had only deployed halfway.They further reported that the stent ¿jumped and flew¿ to the right ventricle from the superior vena cava.Attempts to retrieve the migrated stent with a snare and wires were unsuccessful.It is unclear from the report if any further attempts were made to retrieve this stent or the results of these attempts.An additional 10 x 60mm smart stent was deployed to treat the target lesion with no reported patient injury.Attempts to obtain procedural films of this event have been unsuccessful.The product was not returned to the manufacturer 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 customer complaint could not be confirmed and no determination of possible contributing factors could be made.According to the instructions for use (ifu), this product is indicated for improving the luminal diameter in patients with symptomatic atherosclerotic disease of the common and/or external iliac arteries up to 126mm in length with a reference vessel diameter of 4 ¿ 9 mm and angiographic evidence of a patent profunda or superficial femoral artery.The ifu further instructs the user to ensure that the locking pin is still in place during the introduction of the device.It further instructs 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 procedural factors (use of the sds in the subclavian vein) that may have contributed to the reported event.Based on the device history record review, there is no indication that the event was related to the 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: 5457960
• MDR Text Key: 38962023
• Report Number: 9616099-2016-00095
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: C10040SL
• Device Lot Number: 17331379
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability