MAUDE Adverse Event Report: CORDIS CORPORATION S.M.A.R.T. RADIANZ 6X100MM 190CM; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	SR06100XL
Medical Device Problem Codes	Stretched (1601); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, the stent delivery system of the s.M.A.R.T.Radianz 6x100mm was stuck to the guidewire while trying to remove the system after stent deployment.It was noted that the wire remained in the vessel as the device was removed from the patient over the wire.After removal, it was noted the device did not look right and it looked separated or stretched.There was no reported injury to the patient.The device was stored properly according to the instruction for use (ifu).There were no kinks or other damages noted prior to the insertion into the patient.The device was prepped normally with no difficulty.The intended lesion was in the superficial femoral artery which was noted to have moderate calcification.The vessel did not have any tortuosity.A non-cordis wire was used with the smart device.There was no difficulty noted while advancing the device through the vessel.The device crossed the lesion without difficulty.The catheter was never in an acute bend and was never kinked during use.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18103053 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.This device is available for analysis but has not yet been received.
Event or Problem Description
As reported, the stent delivery system of the s.M.A.R.T.Radianz 6x100mm was stuck to the guidewire while trying to remove the system after stent deployment.It was noted that the wire remained in the vessel as the device was removed from the patient over the wire.After removal, it was noted the device did not look right and it looked separated or stretched.There was no reported injury to the patient.The device was stored properly according to the instruction for use (ifu).There were no kinks or other damages noted prior to the insertion into the patient.The device was prepped normally with no difficulty.The intended lesion was in the superficial femoral artery which was noted to have moderate calcification.The vessel did not have any tortuosity.A non-cordis wire was used with the smart device.There was no difficulty noted while advancing the device through the vessel.The device crossed the lesion without difficulty.The catheter was never in an acute bend and was never kinked during use.The device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
The stent delivery system of the s.M.A.R.T.Radianz 6x100mm was stuck to the guidewire while trying to remove the system after stent deployment.It was noted that the wire remained in the vessel as the device was removed from the patient over the wire.After removal, it was noted the device did not look right and it looked separated or stretched.There was no reported injury to the patient.The device was stored properly according to the instruction for use (ifu).There were no kinks or other damages noted prior to the insertion into the patient.The device was prepped normally with no difficulty.The intended lesion was in the superficial femoral artery which was noted to have moderate calcification.The vessel did not have any tortuosity.A non-cordis wire was used with the smart device.There was no difficulty noted while advancing the device through the vessel.The device crossed the lesion without difficulty.The catheter was never in an acute bend and was never kinked during use.The product was returned for analysis.A non-sterile unit of s.M.A.R.T.Radianz 6x100mm 190cm stent delivery system was received for analysis inside of a plastic bag.The unit was inspected observing the following conditions: the stent is fully deployed and was not returned for analysis.Per visual analysis the distal section of the inner shaft presents a compressed condition.A separation condition on the luer hub was observed.The separated piece of the luer hub was returned inside a plastic container for analysis.No other anomalies were noted.Per functional analysis a lab sample guide wire of the proper size was inserted by the tip to be advanced all the way through the inner shaft of the device.However, due to the compressed/crushed condition of the inner shaft on the distal area the guidewire could not advance further.Also, due to the separated condition of the luer hub it was not possible to insert the guidewire by the proximal entrance.Due to the separation condition of the luer hub the flushing test was not performed.Per microscopic analysis the separated surface presents evidence of plastic deformation and fatigue striations.Plastic deformation and fatigue striations found on the hub material are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the hub material was induced to a tensile force that exceeded the hub material yield strength prior to the separation.The distal area was inspected and confirmed the compressed/crushed condition of the inner shaft.A product history record (phr) review of lot 18103053 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen (inner shaft) ~ resistance/friction - in patient¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis although the insertion/withdrawal test of the guidewire through the wire lumen failed due to the observed compressed/crushed condition located on the distal section of the inner shaft.The reported ¿guidewire lumen (inner shaft) ~ unraveled/stretched - in patient¿ was not confirmed through analysis of the returned device.However, a separation condition was observed on luer hub.The exact cause of the separated condition could not be conclusive determined during the product analysis.Procedural or handling factors might have contributed to this issue.According to the safety information in the instructions for use, ¿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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken.
Event or Problem Description
As reported, the stent delivery system of the s.M.A.R.T.Radianz 6x100mm was stuck to the guidewire while trying to remove the system after stent deployment.It was noted that the wire remained in the vessel as the device was removed from the patient over the wire.After removal, it was noted the device did not look right and it looked separated or stretched.There was no reported injury to the patient.The device was stored properly according to the instruction for use (ifu).There were no kinks or other damages noted prior to the insertion into the patient.The device was prepped normally with no difficulty.The intended lesion was in the superficial femoral artery which was noted to have moderate calcification.The vessel did not have any tortuosity.A non-cordis wire was used with the smart device.There was no difficulty noted while advancing the device through the vessel.The device crossed the lesion without difficulty.The catheter was never in an acute bend and was never kinked during use.The device will be returned for evaluation.

• Brand Name: S.M.A.R.T. RADIANZ 6X100MM 190CM
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15452453
• Report Number: 9616099-2022-05994
• Device Sequence Number: 12482940
• Product Code: NIP
• UDI-Device Identifier: 20705032082386
• UDI-Public: (01)20705032082386(17)240331(10)18103053
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: SR06100XL
• Device Catalogue Number: SR06100XL
• Device Lot Number: 18103053
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 09/15/2022; 10/22/2022
• Initial Report FDA Received Date: 09/19/2022
• Supplement Report FDA Received Date: 10/11/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VAPER WIRE
• Patient Sex: Unknown