MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX CAROTID STENT SYSTEM; SELF EXPANDING STENTS

Catalog Number PC0840XCE

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device was received for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.A device history record (dhr) review and additional information are pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the 8x40mm precise pro rx stent delivery system (sds) could not cross the lesion.It was also reported that the device was not easily removed from the patient.Another precise pro rx sds was used to complete the procedure.There was no patient injury.The patient was admitted to hospital with vomiting and headache.After screening of suspected cerebral sigmoid sinus stenosis, and angiography, the patient was diagnosed with narrow circumstances, needing a stent implantation in the internal carotid artery.The lesion was de novo with no stent previously implanted.There was slight calcification and moderate tortuosity with 60% stenosis.For the procedure, an 8x40mm precise pro rx stent delivery system (sds) was opened.There were no damages or anomalies noted to the device or packaging prior to use.The device was stored, handled and prepped according to the instructions for use with no anomalies noted.After guiding catheter was in place and guidewire was through the lesion with no difficulty, the physician used balloon expansion.There was no difficulty experienced as the device was advanced to the target lesion; however, when, the physician pushed the stent through the lesion, the surgeon felt resistance.The physician tried 3 times, but the precise pro rx sds failed to pass the lesion.The catheter was not ever in an acute bend; and force was required during use.However, it was reported that the device was not easily removed from the patient.There were no kinks noted on the device after removal.The surgeon decided to use another same catalogue product later in order to successful to complete the operation.There was no patient injury.

Manufacturer Narrative

Additional information: additional intervention was not used to remove the device from the patient.The difficulty was noted when removing the device from the lesion.Complaint conclusion: a report was received that a 5fr 8 x 40mm, 135cm precise pro rx ous carotid system failed to cross a carotid lesion and that there was difficulty in removing the stent delivery system (sds).The device was successfully removed and the procedure completed with another precise pro sds with no reported patient injury.The event involved a (b)(6) female patient who initially presented with vomiting and a headache.Diagnostic testing revealed suspected cerebral sigmoid sinus stenosis with a narrowing of the internal carotid artery.This target lesion was described as de novo, 60% stenosed, slightly calcified and moderately tortuous.The patient¿s vasculature was accessed and the lesion successfully crossed with the use of a guiding catheter and guidewire without difficulty.The lesion was then successfully pre-dilated.The site reported that the precise sds had been stored, handled and prepped according to the instructions for use (ifu) and that no damages or anomalies were noted to the device or its¿ packaging prior to use.No difficulty was experienced while advancing the precise sds towards the target lesion.Resistance was encountered in trying to cross the target lesion with the sds and was ultimately unsuccessful despite multiple attempts to do so.The site further reported that the sds had not passed through an acute bend and that force had been used during these maneuvers.Difficulty was experienced when the physician removed the device but it was removed successfully without additional intervention.No kinks were noted on the sds after it was removed.The procedure was successfully completed with another precise pro rx sds of the same size with no reported patient injury.One non-sterile precise pro rx ous carotid system, 5f, 8mm x 40mm, 135 cm catheter was received for analysis inside a plastic bag.Per the visual analysis, the outer member was separated at the joint of clear distal section of catheter.The stent was received un-deployed.The hemostasis valve was received partially opened.Pin pull stroke was received fully inserted into shaft.Blood residues observed on unit.No other anomalies found.Dimensional analysis of the catheter proximal shaft and shaft outer diameter (measured at different distances) were found to be within specification.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿sds ¿ failure to cross¿ and ¿sds ¿ withdrawal difficulty-from vessel¿ events could not be confirmed based on the nature of these events.However the product analysis did reveal a separation of the outer member.The exact cause of this finding could not be conclusively determined.According to the product ifu, the user is instructed that if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Based on the information available for review, there are procedural factors (repeated attempts to cross lesion against resistance) that may have contributed to these events.Neither the device history record review nor the product analysis suggests that the reported event was related to the manufacturing process.Therefore, no corrective actions will be taken at this time.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 5418737
• MDR Text Key: 37735440
• Report Number: 9616099-2016-00064
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17283331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/14/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Weight: 55