MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS (NIM)

Catalog Number PC0940RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2014

Event Type  Injury  

Event Description

The report received from the affiliate indicated that during deployment of a precise 9 x 40 stent, the device was delivered to the target lesion but the stent jumped and was implanted approximately one cm.(1 cm.) distally.An additional precise 10 x 30 stent was deployed to successfully treat the right common carotid artery target lesion.The stents did overlap.There was no reported resistance or difficulty during deployment.The additional stent expanded fully with good wall apposition.The residual stenosis was unknown.There was no thrombus noted post-deployment.The procedure was completed successfully.The procedure was a carotid artery stenting (cas) procedure.There was no reported patient injury.The right common carotid artery target lesion was reported to be: a 90% stenosis, and heavily calcified.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 properly according to the instructions for use (ifu).The product was inspected and prepped properly according to the ifu.There was nothing unusual noted about the stent delivery system (sds) prior to use.The intended target lesion was at the carotid bifurcation.

Manufacturer Narrative

The sds did not pass through any acute bends.There was no difficulty encountered during advancement of the sds towards the target lesion and no unusual force was used at any time during the procedure.No thrombus was noted proximal to, at, or distal to the target lesion site.The target lesion was pre-dilated prior to stent implantation.There was no difficulty or resistance noted crossing the target lesion.The sds did not have to pass through a previously implanted stent.The stent expanded fully with good wall apposition.The device was prepped in the tray.The tuohy borst valve was closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member/sheath.A stopcock was connected to the tuohy borst valve.There was no reported difficulty encountered flushing the stopcock or the sds.No additional information is available.The product is not available for evaluation and testing.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: the report received from the affiliate indicated that during deployment of a precise 9 x 40 stent, the device was delivered to the target lesion but the stent jumped during deployment and was implanted approximately one cm.Distally.An additional precise 10 x 30 stent was deployed overlapping the first to fully cover the lesion.The residual stenosis was unknown.There was no reported patient injury.The right common carotid artery target lesion was reported to be heavily calcified with a 90% stenosis.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 properly according to the instructions for use (ifu).The product was inspected and prepped properly according to the ifu and there was nothing unusual noted.The device was prepped in the tray.The tuohy borst valve was closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member/sheath.A stopcock was connected to the tuohy borst valve.There was no reported difficulty encountered flushing the stopcock or the sds.The sds did not pass through any acute bends, there was no difficulty encountered during advancement of the sds towards the target lesion and no unusual force was used at any time during the procedure.No thrombus was noted proximal to, at, or distal to the target lesion site.The target lesion was pre-dilated prior to stent implantation.There was no difficulty or resistance noted crossing the target lesion.The sds did not have to pass through a previously implanted stent.The stent expanded fully with good wall apposition.No additional information is available.The product was not returned for inspection.Review of lot 15647835 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.It is possible that the operator's interaction with the sds may have contributed to the reported event if the deployment steps as listed in the ifu were not followed correctly.Holding the outer member during deployment may result in the support member pushing the stent forward and compressing the stent.In addition, moving the handle proximally or distally after the stent achieves initial wall apposition may result in stent compression or elongation.Pushing the sds against resistance, which can be encountered during sds advancement through calcified, tortuous or stenotic vasculature, can cause the outer member to compress, thus contributing to premature stent deployment/stent jumping.With the information available and without return of the product for analysis or films of the event it is not possible to draw a clinical conclusion between the device and the reported event.However, vessel characteristics and procedural factors may have contributed to the reported event.The product was not returned for analysis.With review of the device history records, there is no indication that the event is related to the manufacturing process.Based on the lack of information and the inability to assign or determine a root cause no corrective actions will be taken at this time.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIM)
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3800736
• MDR Text Key: 19022799
• Report Number: 9616099-2014-00311
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 15647835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PRECISE 10 X 30 STENT
• Patient Outcome(s): Life Threatening; Required Intervention