MAUDE Adverse Event Report: CORDIS CORPORATION SES SMART CONTROL 6X100 120; STENT, ILIAC

Model Number C06100MV

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 06/17/2021

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.A review of the manufacturing documentation associated with this lot# 17951941 presented no issues during the manufacturing process that can be related to the reported complaint.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the stent of a 6 x 100 x 120 smart control self-expanding stent was shortened after it was released in the patient.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the ifu.There product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The intended procedure/target lesion is superficial femoral artery stenosis.The intended lesion was located at the carotid bifurcation.The target lesion vessel diameter is 5.3mm.A 6f non cordis sheath was used.8f unknown guiding catheter the diameter of the unconstrained stent size was not 1-2 mm larger than the vessel diameter.The target lesion vessel length was 90mm.The % stenosis of the target lesion is 80%.The lesion has moderate calcification and no vessel tortuosity.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was contralateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The thrombus was present proximal to the lesion site.The lesion was pre-dilated prior to stent implantation with a 4,5,6mm with a savylong at 8atm.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The stent did expand fully with good wall apposition.No images are available.There was no reported patient injury.The device will be returned for evaluation.

Manufacturer Narrative

After further reviewed of additional information received the following sections have been updated accordingly :g4,g7,h1,h2,h3 and h6 the stent of a smart control 6 x 100 x 120 self-expanding stent (ses) was shortened after it was released in the patient.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the ifu.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.The intended procedure/target lesion was the superficial femoral artery stenosis.The intended lesion was located at the carotid bifurcation.The target lesion vessel diameter is 5.3mm.A 6f non cordis sheath and an 8f unknown guiding catheter were used.The diameter of the unconstrained stent size was not 1-2 mm larger than the vessel diameter.The target lesion vessel length was 90mm.The target lesion stenosis was 80%.The lesion has moderate calcification and no vessel tortuosity.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was contralateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.The thrombus was present proximal to the lesion site.The lesion was pre-dilated prior to stent implantation with a 4,5,6 mm with a savylong at 8atm.There was no difficulty or resistance noted while crossing the lesion with the stent.The stent delivery system did not have to pass through a previously placed stent.The stent did expand fully with good wall apposition.There was no reported patient injury.The device was returned for analysis.One non-sterile ses smart control 6x100 120 stent delivery system was received for analysis inside a plastic bag.Per visual analysis, the locking pin was received detached from its original position and the stent delivery system was returned actuated.The actual self-expanding stent of the unit involved in the complaint was not received for evaluation.No anomalies observed on the unit.A product history record (phr) review of lot 17951941 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 since the actual self-expanding stent of the unit involved in the complaint was not received for evaluation.The cause of the reported event could not be determined.It should be noted that the customer failed to provide any procedural images or films for evaluation.Per the instructions for use (ifu) ¿select stent size- measure the length of the target lesion to determine the length of stent(s) required.Measure the diameter of the reference vessel (proximal and distal to the lesion).It is necessary to select a stent that has an unconstrained diameter at least 1 mm larger than the largest reference vessel diameter to achieve secure placement according to the following stent size selection table (which is in the instructions for use).¿ per the investigation conducted, the user reported that ¿the diameter of the unconstrained stent size was not 1-2 mm larger than the vessel diameter¿.Therefore, it is reasonable to consider that the operator¿s interaction with the stent delivery system may have contributed to the reported event if the deployment steps as listed in the instructions for use (ifu) were not followed correctly.Furthermore, vessel characteristics of a lesion with 80% stenosis with moderate calcification may have contributed to the reported event.The instructions for use state ¿note: failure to maintain a fixed handle position or constraining the catheter shaft during deployment may result in stent compression (shortening) or elongation.¿ neither the phr review nor the product evaluation suggests that the reported event could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken.

• Brand Name: SES SMART CONTROL 6X100 120
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 12162187
• MDR Text Key: 263414001
• Report Number: 9616099-2021-04708
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: C06100MV
• Device Catalogue Number: C06100MV
• Device Lot Number: 17951941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2021
• Date Manufacturer Received: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4,5,6MM WITH A SAVYLONG; 6F COOK SHEATH; 8F UNKNOWN GUIDING CATH,
• Patient Age: 72 YR
• Patient Weight: 74