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

Catalog Number PC0940RXC

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/07/2014

Event Type  malfunction  

Event Description

As reported by the sapphire registry, during a carotid index procedure a 9.0 x 40mm precise stent failed to cross the left proximal internal carotid artery.A non-cordis stent was placed at the target lesion and there was no patient injury.The lesion was 85% stenosed, 20mm in length and severely calcified.The referenced vessel was 6.0 in diameter.There were no prepping/flushing difficulties with the product.Per the preliminary product visual analysis, the outer shaft was received split at distal end.Additional information from the site indicated that the damage occurred during the procedure.The physician predilated the lesion and the precise stent would not cross the lesion, he removed the stent, then again predilated and got the same precise stent to cross the lesion with some difficulty but then he realized the catheter delivery system had been broken while twisting it to cross the lesion so the cordis stent was removed and not used.

Manufacturer Narrative

Complaint conclusion: during a carotid stenting procedure a 9.0 x 40mm precise stent failed to cross the left proximal internal carotid artery.The lesion was 85% stenosed, 20mm in length and severely calcified.The referenced vessel was 6.0 in diameter.A non-cordis stent was placed at the target lesion and there was no patient injury.There were no prepping/flushing difficulties with the product.Per the preliminary product visual analysis, the outer shaft was received split at distal end.Additional information from the site indicated that the damage occurred during the procedure.The physician pre-dilated the lesion and the precise stent would not cross the lesion, he removed the delivery system, then again pre-dilated and got the same precise stent to cross the lesion with some difficulty but then he realized the catheter delivery system had been broken while twisting it to cross the lesion so the delivery system was removed and the stent was not deployed.One non sterile precise pro rx us carotid syst 9x40mm was received coiled inside a plastic bag.Unit was not deployed.The brite tip was received frayed.Outer member was separated at 7cm from id band; it appeared to have been elongated prior the separation.No other discrepancies were found.Sem results showed that the brite tip and body surface presented evidence of elongation at the surrounding areas of the frayed and separation.Elongation is a common characteristic of pieces which were stretched/ pulled until separation.Stretching/ pulling could have been related to these characteristic.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The cause of the "outer member separated" condition found could not be conclusively determined; however it does not appear to be manufacturing related.Controls are in placed at the final assembly and packaging processes to detect this kind of issue.Handling and procedural factors could be contributed to this condition.The failure reported ¿catheter tip - frayed/split/torn¿ by the customer was confirmed; the cause of the failure was not conclusively determined.The failure does not appear to be manufacturing related.Neither the dhr review nor the analysis suggests that the failure is manufacturing process.During manufacturing process there is a control to detect this kind of issue.Therefore no actions were taken.Based on the information provided the cause of the failures could not be conclusively determined but they do not appear to be manufacturing related.However, procedural factors and/or vessel characteristics may have influenced the events.

• 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: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 3766195
• MDR Text Key: 4467277
• Report Number: 9616099-2014-00282
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2015
• Device Catalogue Number: PC0940RXC
• Device Lot Number: 15856328
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 78