MAUDE Adverse Event Report: CORDIS CORPORATION SMART 120 150, SFA - 7X150MM; SELF EXPANDABLE STENTS

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: sheathlesspv st 90cmpowerflex5-40.(b)(6).This device is available for analysis but has not yet been received.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 or Problem Description
During deployment of a 7x150mm smart stent, resistance was felt when crossing the lesion so the physician applied force to push, however the outer sheath slid and the stent was deployed by mistake.Therefore, it was replaced with a new stent which was implanted.The procedure was completed successfully.There was no reported patient injury and the device will be returned for analysis.The physician commented that the y connector valve might have been released.The lesion was the left the common iliac artery with stenosis.An approach was made from the left brachial artery.A smart stent was attempted to be delivered to the lesion when the resistance was felt.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, 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 system did not pass through any acute bends.Additional details were requested but were not provided.
Additional Manufacturer Narrative
During a left common iliac artery stenting procedure, resistance was felt when crossing the lesion with a 7 x 150mm smart stent.The physician applied force to push, however the outer sheath slid and the stent was thought to have been deployed by mistake.Therefore, it was replaced with a new stent which was implanted.The procedure was completed successfully.There was no reported patient injury.The physician commented that the y connector valve might have been released.An approach was made from the left brachial artery.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, 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 system did not pass through any acute bends.Additional details were requested but were not provided.The device was returned for analysis.One non-sterile smart 120 150, sfa ¿ 7 x 150mm device was received coiled inside a plastic bag, the device was received un-deployed.Per visual analysis no damages or anomalies were noted on the returned device.The usable length was measured and was found within specification.A functional test was performed (stent deployment process), and the stent was deployed without difficulty.A product history record (phr) review of lot 17737519 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The event reported as ¿stent delivery system (sds)-ses- deployment difficulty - premature/in patient - during advancement¿ was not confirmed due to the received product condition, since the device was received un-deployed and no anomalies were found during the analysis.Also, a functional test was performed, and the stent was deployed without difficulty.The exact cause of the event reported by the customer could not be conclusively determined.Procedural factors and vessel characteristics may have contributed to the resistance encountered.As cautioned in the instructions for use (ifu), ¿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.¿ neither the phr review nor the product analysis suggests that the events are related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.
Additional Manufacturer Narrative
The device was returned and section d10 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.

• Brand Name: SMART 120 150, SFA - 7X150MM
• Common Device Name: SELF EXPANDABLE STENTS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 33014
• MDR Report Key: 8019497
• Report Number: 9616099-2018-02475
• Device Sequence Number: 13798384
• Product Code: FGE
• UDI-Device Identifier: 20705032063439
• UDI-Public: 20705032063439
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2018

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: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: C07150ML
• Device Lot Number: 17737519
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/06/2018
• Supplement Date Received by Manufacturer: 10/06/2018; 12/03/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 11/13/2018; 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SABERX4-4 CONTINUED IN H10.