MAUDE Adverse Event Report: CORDIS CORPORATION SMART CONTROL, ILIAC 7X40ML; SELF EXPANDING STENTS

Model Number N/A

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant products: sheath (6f 90 cm destination, terumo).A guidewire (0.035*300 cm radifocus, terumo).(b)(6).The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During deployment of a 7x60 iliac smart control stent into a thrombotic lesion, the stent was deployed to hold a previous smart control stent (7x40, m shaft) but became caught by the first stent and it could not be delivered.The physician attempted to fix the position, then the outer sheath slipped towards her/him.Therefore, it was replaced with a new stent (8.0 x 60 mm) and it was successfully deployed.A balloon catheter (7.0 x 40 mm) inflated as a post dilatation.The procedure completed successfully.There was no reported patient injury.The product will not be returned for analysis due to the patient¿s infectious disease.The target lesion was the left external iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A left brachial approach was made with a sheath (6f 90 cm destination, terumo).A guidewire (0.035*300 cm radifocus, terumo) crossed the lesion and a balloon catheter (5.0 x 40 mm) inflated for pre-dilatation.A smart stent (7.0 x 40 mm, m shaft) was deployed in the lesion and implanted.It was a thrombotic lesion and required another stent to hold.

Manufacturer Narrative

The lot number was received for this device and therefore sections of the report were updated accordingly.Additional information was received regarding the even that it was a thrombosis case at the external iliac artery.The second stent was needed to hold the first one because there was massive thrombus in the lesion.It was also deployed at the intended site.The devices will not be returned for analysis due to infectious diseases.For each stent, the product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The stent delivery systems did not pass through any acute bends.There was some resistance felt when the second stent go through inside the first stent, but there was no resistance felt before that.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.There was no attempt to deploy the smart control stent.The stent was not delivered to the lesion because there was resistance felt before reaching to the target lesion.The ifu instructs the user to hold the handle of the smart control sds flat and straight outside the patient which was done.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

During deployment of a 7x60 iliac smart control stent into a thrombotic lesion, the stent was deployed to hold a previous smart control stent (7x40, m shaft) but became caught by the first stent and it could not be delivered.The physician attempted to fix the position, then the outer sheath slipped towards her/him.Therefore, it was replaced with a new stent (8.0x60mm) and it was successfully deployed.A balloon catheter (7.0x40mm) inflated as a post dilatation.The procedure completed successfully.There was no reported patient injury.The product will not be returned for analysis due to the patient¿s infectious disease.The target lesion was the left external iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A left brachial approach was made with a sheath (6f 90cm destination, terumo).A guidewire (0.035*300cm radifocus, terumo) crossed the lesion and a balloon catheter (5.0x40mm) inflated for pre-dilatation.A smart stent (7.0x40mm, m shaft) was deployed in the lesion and implanted.It was a thrombotic lesion and required another stent to hold.The product was not returned for analysis.A review of the device history record revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.Incomplete expansion is a known potential product malfunction associated with the use of the smart control stent and is listed in the ifu as such.Per the smart control ifu: if incomplete expansion exists within the stent at any point along the lesion, post deployment balloon dilatation (standard pta technique) can be performed.Note: only areas within the stent length should note: only areas within the stent length should receive post-deployment balloon dilatation.Tracking difficulty and splitting of the outer sheath are known potential product issues associated with the use of this device and may be related to target vessel anatomy as well as user technique.The products were not returned and the dhr could not be completed because the sterile lot number was unavailable.Review of the available information suggests that vessel/lesion characteristics, specifically the thrombus burden within the target vessel, may have contributed to the reported incomplete expansion.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

Manufacturer Narrative

During deployment of a 7x60 iliac smart control stent into a thrombotic lesion, the stent was deployed to hold a previous smart control stent (7x40, m shaft) but became caught by the first stent and it could not be delivered.The physician attempted to fix the position, then the outer sheath slipped towards her/him.Therefore, it was replaced with a new stent (8.0x60mm) and it was successfully deployed.A balloon catheter (7.0x40mm) inflated as a post dilatation.The procedure completed successfully.There was no reported patient injury.The product will not be returned for analysis due to the patient¿s infectious disease.The target lesion was the left external iliac artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A left brachial approach was made with a sheath (6f 90cm destination, terumo).A guidewire (0.035*300cm radifocus, terumo) crossed the lesion and a balloon catheter (5.0x40mm) inflated for pre-dilatation.A smart stent (7.0x40mm, m shaft) was deployed in the lesion and implanted.It was a thrombotic lesion and required another stent to hold.The product was not returned for analysis and the sterile lot number has not been provided; therefore, no device analysis nor device history record review could be performed.Incomplete expansion is a known potential product malfunction associated with the use of the smart control stent and is listed in the ifu as such.Per the smart control ifu: if incomplete expansion exists within the stent at any point along the lesion, post deployment balloon dilatation (standard pta technique) can be performed.Note: only areas within the stent length should note: only areas within the stent length should receive post-deployment balloon dilatation.The product was not returned and the dhr could not be completed because the sterile lot number was unavailable.Review of the available information suggests that vessel/lesion characteristics, specifically the thrombus burden within the target vessel, may have contributed to the reported incomplete expansion.Without procedural films or images for review the reported event(s) could not be confirmed.Given the limited information available for review at this time, there is nothing to suggest that the reported events are related to the design and manufacturing process of the device; therefore, no corrective action will be taken.Should additional information become available, the file will be updated accordingly.

• Brand Name: SMART CONTROL, ILIAC 7X40ML
• Type of Device: SELF EXPANDING STENTS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 32014
• MDR Report Key: 7251473
• MDR Text Key: 99350211
• Report Number: 9616099-2018-01835
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P020036
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: N/A
• Device Catalogue Number: C07040ML
• Device Lot Number: 17639302
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 01/19/2018
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SHEATH (6F 90CM DESTINATION); SHEATH (6F 90CM DESTINATION)
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention