MAUDE Adverse Event Report: CORDIS CORPORATION SES SMART CONTROL 8X40 120; STENT, ILIAC

Catalog Number C08040MV

Device Problems Difficult or Delayed Positioning (1157); Defective Component (2292)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 8x40 120 smart control self-expanding stent (ses) had an unspecified issue.Upon receipt of a letter from the physician, it was further reported that two smart control self-expanding stents (ses) (8x40 mm and 8 x 60mm) were advanced simultaneously.While deploying the stents, the user was unable to see the proximal and distal markers on the stent, resulting in the stents missing the targeted lesions.This was only noted after a post-plasty shoot.Two similar sized stents were deployed to cover the missed lesions and the procedure was successfully completed as the radiopaque markers were visible.The devices were intended to be used in a bilateral iliac artery stenting procedure.The products were stored according to the instructions for use (ifu).There was no noted damage to the product packaging upon inspection prior to use, and there was no difficulty removing the product from the packaging.No kinks or other damages were noted prior to inserting the product into the patient.The product was prepped properly according to the ifu.The bilateral iliac artery at the aorto-iliac junction had moderate calcification, no tortuosity, and had a rate of about 70% stenosis in the left iliac and 85% stenosis in the right iliac.The stents remain deployed in the patient.No attempt was made to remove them.The device systems were discarded after unsuccessful use and will not be returned for analysis.A procedural video will be provided at a later date.

Manufacturer Narrative

The 8x40 120 smart control self-expanding stent (ses) had an unspecified issue.Upon receipt of a letter from the physician, it was further reported that two smart control self-expanding stents (ses) (8x40 mm and 8 x 60mm) were advanced simultaneously.While deploying the stents, the user was unable to see the proximal and distal markers on the stent, resulting in the stents missing the targeted lesions.This was only noted after a post-plasty shoot.Two similar sized smart control stents were deployed to cover the missed lesions and the procedure was successfully completed as the radiopaque markers were visible.The bilateral iliac artery at the aorto-iliac junction had moderate calcification, no tortuosity, and had a rate of about 70% stenosis in the left iliac and 85% stenosis in the right iliac.The devices were intended to be used in a bilateral iliac artery stenting procedure.The products were stored according to the instructions for use (ifu).There was no noted damage to the product packaging upon inspection prior to use, and there was no difficulty removing the product from the packaging.No kinks or other damages were noted prior to inserting the product into the patient.The product was prepped properly according to the ifu.The stents remain deployed in the patient.No attempt was made to remove them.The device systems were discarded after unsuccessful use and will not be returned for analysis.A procedural video was provided.The products were not returned for analysis.Partial procedural imagery was provide for review.A series of moving images were provided for review.All stent markers are visible throughout the procedure.In summary the lesions were not prepared adequately, calcification and disease are considerable and no signs of post dilation or ballooning noted during the procedural images provided.Additional smart control stents were implanted.A product history record (phr) review of lot 17749503 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.A product history record (phr) review of lot 17765877 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses deployment difficulty - inaccurate placement¿ was confirmed by review of the provided procedural imagery.The exact cause of the event could not be determined during analysis.Based on the information available for review, vessel characteristics (moderate calcification, no tortuosity, and had a rate of about 70% stenosis in the left iliac and 85% stenosis in the right iliac) coupled with procedural factors such as inadequate lesion preparation coupled with a failure to post-dilate the residual stenosis may have contributed to the event noted during analysis of the images provided.The reported ¿marker band-ses inadequate radiopacity¿ was not confirmed by review of the provided procedural imagery.The exact cause of the event could not be determined during analysis.Based on the information available for review, the radiopaque markers were visible throughout the images provided for review.According to the safety information in the instructions for use ¿stent positioning about the target lesion is achieved prior to deployment utilizing the distal stent markers and the proximal stent markers.Safety and effectiveness has not been demonstrated in patients with: lesions that are either totally or densely calcified.It is important to use the correct stent size, as recommended in the stent size selection table.The stent may cause a thrombus or distal embolization, or it may migrate from the site of an implant down the arterial lumen.When catheters are in the body, they should be manipulated only under fluoroscopy.Failure to pre-dilate the lesion may impair the ability to remove the stent system after stent deployment.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or vessel.Carefully withdraw the stent system without deploying the stent.If resistance is felt when beginning deployment, do not force deployment.Carefully withdraw the stent system without deploying the stent.The stent is not designed to be lengthened or shortened past its nominal length.Excessive stent lengthening or shortening may increase the risk of stent fracture.Do not attempt to drag or reposition the stent, as this may result in unintentional stent deployment.Once the stent is partially deployed, it cannot be recaptured using the stent delivery system.Do not attempt to recapture the stent once the stent is partially deployed.Note: stent placement is not indicated if the primary angioplasty is not technically successful.A technically successful angioplasty is one in which the guidewire and dilation catheter are passed through the lesion and dilatation of the lesion produces a lumen adequate to accommodate introduction of the stent delivery system.Measure the length of the target lesion to determine the length of stent required.Size the stent length to extend slightly proximal and distal to the lesion.The appropriate stent length should be selected based on covering the entire obstructed segment with a single stent.Note: should more than one stent be required, place the stent most distal from the puncture site first, followed by the placement of the proximal stent in tandem.Caution: slack in the catheter shaft, either outside or inside the patient, may result in deploying the stent beyond the target lesion site.Verify that the delivery system¿s radiopaque stent markers (leading and trailing ends) are proximal and distal to the target lesion.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 receive post-deployment balloon dilatation.¿ neither the phr review nor the procedure films suggest that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: SES SMART CONTROL 8X40 120
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8980117
• MDR Text Key: 161832926
• Report Number: 9616099-2019-03192
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: C08040MV
• Device Lot Number: 17749503
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Weight: 63