MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE PRO RX 9X40; SELF EXPANDING STENT

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

During a carotid artery stenting procedure, a 9x40 precise pro rx stent was delivered for placement at the common carotid artery to the internal carotid artery; however, the stent could not be deployed although the outer sheath was withdrawn.The stent was removed and the physician found that the outer joint part of the monorail lumen was peeled off.Therefore, the stent was replaced with another precise.  the procedure was completed successfully.  there was no reported patient injury.The patient¿s vessel level of tortuousness and calcification is unknown.The rate of stenosis is unknown.  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.  additional procedural details were requested but are unknown.The product was returned for analysis.  one non-sterile unit of a precise pro rx 9x40 stent delivery system was returned.Per visual analysis, the sheath outer member was separated; the stent pre-deployed 3 mm.No other anomalies were noted.Functional and dimensional analysis could not be performed due to the separation of the outer member.Per sem analysis the separated sections of the outer member revealed elongations and frayed edges.The grilamid section revealed split and crushed conditions and evidence of elongations as well as frayed edges at the split section edges.Evidence of grilamid material transfer was noted on the fused area.All the mentioned characteristics are likely a product of an application of a tension force that induced the separation.No other issues were noted.A device history record (dhr) review of lot 17446758 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿outer sheath-separated - in patient¿, ¿stent delivery system (sds)-ses-deployment difficulty ¿ unable¿ and ¿stent delivery system (sds)-ses deployment difficulty - partial deployment¿ were confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, procedural and handling factors may have contributed to the event as evidenced by elongations and frayed edges commensurate with the application of excessive force noted on the device during analysis.According to the instructions for use ¿extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ neither the dhr 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 at this time.

Event Description

During a carotid artery stenting procedure, a 9x40 precise pro rx stent delivered for placement at the common carotid artery to the internal carotid artery, however, the stent could not be deployed although outer sheath was withdrawn.The stent was removed and the physician found that the outer joint part of the monorail lumen was peeled off.Therefore, the stent was replaced with another precise. analysis of the returned device indicated the stent was deployed by 3mm. the procedure was completed successfully.  there was no reported patient injury and it will be returned for analysis.  the patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown. the product stored, handled, inspected and prepped according to the instructions for use.  there was nothing unusual noted about the stent delivery system prior to use.  additional procedural details were requested but are unknown.

• Brand Name: PRECISE PRO RX 9X40
• Type of Device: SELF EXPANDING STENT
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6499823
• MDR Text Key: 73126148
• Report Number: 9616099-2017-01042
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: N/A
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17446758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/10/2017
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1