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

Catalog Number PC0640XCE

Device Problems Crack (1135); Premature Activation (1484)

Patient Problem Stenosis (2263)

Event Date 09/22/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The device has not yet been returned for analysis, therefore no product analysis has yet been completed.Additional information will be submitted within 30 days of receipt.

Event Description

It was reported by the surgeon that the tip of the 6.0mmx40mm precise pro stent was cracked and that the stent was slightly deployed after opening the packaging and prior to use.There was no patient injury.The surgeon also noted that the stent was deployed continuously when a wire was attempted to be passed through it.They changed to another stent to successfully complete the procedure.The patient had a high rate of stenosis in the "left clavicle." the device was stored and handled according to the ifu.There weren't any anomalies noted to the device or packaging prior to use.There wasn't any difficulty or resistance noted while crossing the lesion with the stent.The sds (stent delivery system) did not pass through a previously placed stent.The product will be returned for analysis.

Manufacturer Narrative

The tip of a 6 x 4mm precise pro rx carotid stent delivery system (sds) was noted to be cracked and the stent was slightly deployed prior to use on a patient.They also reported that the stent became further deployed as they were passing the sds over the guidewire.The device was exchanged and the procedure successfully completed with no reported patient injury.The event involved an (b)(6) year old patient undergoing endovascular treatment of a highly stenosed lesion in his/her ¿left clavicle¿.The site reported that the sds had been stored and handled according to the instructions for use (ifu) and that no anomalies were noted to the device packaging.Prior to use on the patient, the site noted that the tip of the sds was cracked and the stent was slightly deployed.They also reported that the stent was being deployed inadvertently while they passing the sds over the guidewire.The sds was exchanged for another sds and the procedure successfully completed with no reported patient injury.One non-sterile precise pro rx ous carotid system, 5f, 6mm x 40mm, 135 cm was received coiled inside in plastic bag.The stent was received partially deployed (1cm) and the brite tip was received damaged.No other damages could be observed.Functional testing of the deployment process was successful.Sem of the frayed distal tip revealed evidence of elongation at the areas surrounding the fray.Elongation is a common characteristic of pieces which were stretched/ pulled.Stretching/ pulling could have been related to these characteristic.A review of the manufacturing records for this lot of products revealed that it met specification prior to release.The reported ¿catheter tip - frayed/split/torn¿ and ¿sds -deployment difficulty-premature deployment¿ events were confirmed based on the visual analysis.The cause of these events could not be conclusively determined.However, analysis of the product revealed evidence suggestive of pulling and/or stretching.According to the ifu, this device is indicated for use in patients with stenotic lesions of the carotid artery(ies).Users are cautioned that the device is shipped with the hemovalve in the open position.They are further instructed to be careful not to prematurely deploy the stent during preparation.The preparation of the device should be done in the tray with closure of the hemovalve prior to the device¿s removal from the tray.After removing the device from the tray, users are instructed to examine the device for any damage.They are to evaluate the distal end of the catheter to ensure that the stent is contained within the other sheath.They are instructed not to use the device if the stent is partially deployed.If the user suspects that the sterility or performance of the device has been compromised, they are instructed to not use the device.Based on the information available for review, there are procedural factors (evidence of stretching and continued use of the device after damage was noted) that may have contributed to the reported events.Neither the device history record review nor the product analysis suggests that the reported events could be related to the manufacturing process.Therefore, no corrective actions will be taken.

Manufacturer Narrative

The device was returned for analysis, however the engineering evaluation has not yet been completed.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information will be submitted within 30 days of receipt.

• 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: 5147106
• MDR Text Key: 28601116
• Report Number: 9616099-2015-00488
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• 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,Followup
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: PC0640XCE
• Device Lot Number: 17171377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 86 YR