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

Catalog Number PC0940RXC

Device Problems Difficult or Delayed Positioning (1157); Therapy Delivered to Incorrect Body Area (1508)

Patient Problem No Information (3190)

Event Date 04/02/2014

Event Type  Injury  

Event Description

The report received from the affiliate indicated that during a carotid stenting procedure from the right common carotid artery to a internal carotid artery, a 9x40mm precise pro rx stent moved forward during deployment requiring placement of a second stent.There was moderate calcification and tortuosity.There was 90% stenosis in the lesion.When the physician deployed the precise stent in the lesion, the stent moved forward and proximal portion of the lesion could not be covered.Therefore, additional 3cm precise was placed to cover the lesion fully.The product will not be returned for analysis.The access site was the femoral.The product was stored, handled, inspected and prepped according to the instructions for use.Nothing unusual was noted about the stent delivery system prior to use.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.There was no thrombus present proximal to, at, or distal to the lesion site.It is not known if the lesion was predilated.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 expanded fully with good wall apposition.It is not known if post dilatation was performed.The user maintained a fixed inner shaft position during deployment.It is not known if an embolic protection device used.The patient did not experience any adverse event.No additional information is available.

Manufacturer Narrative

Lot number provided is 16608441 which is not valid.This device is not available for testing and evaluation.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

The report received from the affiliate indicated that during a carotid stenting procedure from the right common carotid artery to the internal carotid artery, a 9x40mm precise pro rx stent moved forward during deployment leaving the proximal portion of the lesion uncovered.An additional 3cm stent was deployed to fully cover the lesion.The vessel contained moderate calcification and tortuosity with a 90% stenosis.The access site was the femoral artery.The product was stored, handled, inspected and prepped according to the instructions for use.Nothing unusual was noted about the stent delivery system prior to use.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.There was no thrombus present proximal to, at, or distal to the lesion site.It is not known if the lesion was predilated.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 expanded fully with good wall apposition.It is not known if post dilatation was performed.The user maintained a fixed inner shaft position during deployment.It is not known if an embolic protection device used.The patient did not experience any adverse event.No additional information is available.Review of lot 16013666 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.No units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to 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.It is unknown if the delivery system was advanced past the lesion and then pulled back to the deployment site as directed in the ifu.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 while the locking pin is still in.Vessel characteristics and procedural handling may have contributed to the event.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.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 Contact: aaron goodstein ; miami lakes, FL 33014 ; 63136118
• MDR Report Key: 3755936
• MDR Text Key: 4414717
• Report Number: 9616099-2014-00274
• 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
• Type of Report: Initial,Followup
• Report Date: 04/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PC0940RXC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention