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

Catalog Number PC0840RXC

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2015

Event Type  malfunction  

Event Description

The report received from the affiliate indicated that during a carotid case, the 8x40mm precise pro rx product was deployed successfully in the patient.When the precise stent delivery system was being retrieved, and pulled through the 6fr sheath, it was a little difficult to remove and pull through the sheath.After some manipulation of the pin, the catheter was removed safely from the patient.The sds was ultimately removed through the sheath.There was no patient injury reported.The product will be returned for analysis.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored in the hospital, inside the interventional radiology unit.The product was stored, inspected, handled, and prepped according to the instructions for use.There was nothing unusual noted about stent delivery system prior to use.The target lesion was located in the internal carotid artery.The physician stented from the common carotid artery to the internal carotid artery.The diameter was a little over 7mm.The target lesion vessel length was a little over 30mm.The rate of stenosis is unknown.The degree of calcification is unknown.The vessel was not tortuous.A 6f cook shuttle sheath was used.A guiding catheter was not used.The diameter of the unconstrained stent was sized 1-2mm larger than the vessel diameter.The stent delivery system did not have to pass through any acute bends.There was no difficulty advancing/tracking the sds towards the lesion.There was no thrombus present proximal to, at, or distal to the lesion site.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 was delivered safely to the lesion and expanded fully with good wall apposition.It is unknown if the device was prepped in the tray; ¿they might of removed the stent from the packaging¿.The tuohy borst valve was in the open position when received.Following the ifu, the outer sheath was advanced until the outer sheath marker contacted the catheter tip, and the system was withdrawn as one unit.According to the physician "i believe the most pertinent thing to remember here is that the company recommends advancing the sheath back when there is resistance on the withdrawal which is what i ended up doing.I'm curious to know what is catching when you do not do this because you usually don't have to in my experience.".

Manufacturer Narrative

(b)(4).This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.The gender of the patient is unknown.

Manufacturer Narrative

Complaint conclusion.The site reported that after deploying an 8 x 40mm precise pro rx, the stent delivery system (sds) was difficult to pull out through the 6f non-cordis sheath.The sds was removed from the sheath with some manipulation and with no reported patient injury.The event involved a patient undergoing a percutaneous intervention of the internal carotid artery and was described as having a diameter of ¿a little over 7mm¿, with a length of ¿a little over 30mm¿ and non-tortuous.The site reported that the device had been stored within the radiology department and had been inspected and handled according to the instructions for use (ifu).In addition, the temperature exposure indicator on the pouch had been checked to confirm that the black dotted pattern with a grey background was clearly visible.They further reported that there was nothing unusual about the device prior to use.During the intervention, a 6f non-cordis sheath was used without a guide catheter.The diameter of the unconstrained stent was 1-2mm larger than the vessel diameter.No thrombus was noted proximal to, at or distal to the target lesion.The hemostatic valve of the device was in the open position when received.The sds did not have to pass through any acute bends and no difficulty was experienced while advancing/ tracking it to the lesion.The sds did not have to pass through a previously deployed stent and no difficulty or resistance was experienced while crossing the lesion with the sds.The physician deployed the stent in a vessel segment that extended from the common carotid artery to the internal carotid artery with full expansion and good wall apposition.When the physician withdrew the sds, some resistance was noted when pulling through the non-cordis sheath.The physician reported that when resistance was met during withdrawal, he advanced the outer sheath until the outer sheath marker contacted the catheter tip and then withdrew the sds as instructed in the ifu.The device was removed with some manipulation and with no reported patient injury.One non sterile unit of precise pro rx us carotid syst was received coiled inside a plastic bag.The device was received without stent.No anomalies or damages were observed on the received unit.The involved sheath introducer was not received.The outer diameter (od) of the outer shaft was measured and it was found within dimensional specifications.Functional analysis was performed with the use of a lab sample 5f sheath introducer and no resistance was experienced during the insertion/withdrawal.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported "sds - withdrawal difficulty" event was not confirmed since the od was found within specification and the device passed functional testing.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the reported issue.According to the product ifu, the use of the precise pro rx device is contraindicated in patient in whom the guide catheter is unable to be placed.According to the product ifu, users are instructed to advance the outer sheath until the outer sheath marker contacts the catheter tip and then withdraw the system without the guidewire when any resistance is met during the withdrawal of the device.Neither the dhr review nor the product analysis suggests that the failure is related to the manufacturing process.Therefore, no actions will be taken.

• Brand Name: PRECISE PRO RX CAROTID STENT SYSTEM
• Type of Device: SELF EXPANDING STENTS (NIM)
• 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: 4791926
• MDR Text Key: 5858269
• Report Number: 9616099-2015-00213
• 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: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17116937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F SHEATH