MAUDE Adverse Event Report: CORDIS DE MEXICO SMART CONTROL, ILIAC 8X40; STENT, ILIAC

Model Number C08040SL

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

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 07/18/2018

Event Type  Injury  

Manufacturer Narrative

The complaint evaluation is currently in progress.Additional information will be submitted within 30 days of completion of the complaint evaluation.

Event Description

As reported, while attempting to deploy an 8x40 smart control stent, the proximal and distal markers were not seen.Both the doctor and sales rep attempted to locate the markers, but they remained unseen.The stent was deployed, but it was 1-2 mm distal to the chronic stent that was placed, missing the mark.A stent from another manufacturer was placed to bridge the gap.The patient recovered and there were no adverse events.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly.The patient height is (b)(6).Addendum for additional information received: the product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no difficulty removing the product from the packaging and none of the devices used during the procedure were re-sterilized.The device was prepped according to the ifu and there were no anomalies noted during prep.The target lesion was the external iliac.The lesion was severely calcified, had moderate tortuosity and had a forty-five (45) degree angulation.Continuous flush maintained through all devices.It was verified prior to insertion that the stent was contained within the outer sheath/introducer of the system.The guidewire port was flushed as outlined in the ifu prior to loading on the guidewire.During an external iliac stenting procedure, when attempting to deploy an 8x40 smart control stent, the proximal and distal markers were not visual under fluoroscopy.Regardless, the stent was deployed, but it was 1-2 mm distal to the previously implanted stent, missing the lesion.A non-cordis stent was placed to bridge the gap.The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no difficulty removing the product from the packaging and the device was not re-sterilized.The device was prepped according to the ifu and there were no anomalies noted during prep.The lesion is severely calcified and moderately tortuous with forty-five (45) degree angulation.Continuous flush was maintained through the device during the procedure.It was verified prior to insertion that the stent was contained within the outer sheath/introducer of the system.The guidewire port was flushed as outlined in the ifu prior to loading on the guidewire.The device was not returned for analysis.A product history record (phr) review of lot 17711029 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 reported ¿stent inadequate radiopacity - tantalum markers¿ and ¿stent delivery system (sds)-ses deployment difficulty - inaccurate placement¿ could not be confirmed as the device was not returned for analysis and procedural films were not received.The exact cause could not be determined.Vessel characteristics, as well as procedural and handling factors may have contributed to the reported event.According to the instructions for use (ifu), ¿advance the stent delivery system past the lesion site.Pull back the stent delivery system until the radiopaque stent markers (leading and trailing ends) move in position so that they are proximal and distal to the target lesion.Ensure the device outside the patient remains flat and straight.Caution: slack in the catheter shaft, either outside or inside the patient, may result in deploying the stent beyond the target lesion site.¿ the phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SMART CONTROL, ILIAC 8X40
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 7787892
• MDR Text Key: 117574787
• Report Number: 9616099-2018-02313
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: C08040SL
• Device Catalogue Number: C08040SL
• Device Lot Number: 17711029
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BOSTON SCIENTIFIC STENT
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 89 YR
• Patient Weight: 82