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

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

Concomitant products: 6fr cook shuttle 90cm sheath.(b)(4).The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.

Event Description

Post stenting to the internal carotid artery with a precise, it was reported that initially the stent delivery system (sds) was unable to be removed.After some time with buddy wire and pressure, sds was successfully removed and lesion post dilated without incident.On inspection of sds, the inner member protruded through catheter with pressure pulling back.As a result it was very difficult to get through the sheath.The product was stored and handled according to the ifu.The product was inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.Approach was made with a 6fr cook shuttle 90cm sheath.The stent delivery system did pass through acute bends.The delivery of the sds to the lesion was ipsilateral.There was difficulty encountered while advancing/tracking the sds towards the lesion but it crossed.Pushing the sds was necessary but not excessive.The sds did not have to pass through a previously placed stent.The technique where if resistance is met during delivery system withdrawal the user is to advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit was not followed.The entire stent was deployed successfully.The target lesion was greater than 60% stenosed, calcified and vessel was tortuous.The product is being returned for inspection.

Manufacturer Narrative

Complaint conclusion: a report was received that the site experienced difficulty when attempting to remove an 8 x 40mm precise pro rx carotid system after having deployed the stent.The inner member of the stent delivery system (sds) was noted to be protruding from the catheter making it difficult to get it through the sheath.The device was successfully removed with the use of a buddy wire and the application of some force.The procedure was completed with post-dilation of the stent with no reported patient injury.The event involved a patient undergoing percutaneous intervention of a target lesion located in the internal carotid artery.This lesion was described as greater than 60% stenosed, calcified and tortuous.The patient¿s vasculature was accessed via an ipsilateral approach with a 6fr 90cm non-cordis catheter sheath introducer.The site reported that the precise sds had been stored and handled according to the instructions for use (ifu) and that nothing unusual was noted about the sds prior to use.Difficulty was encountered while advancing and/or tracking the precise sds towards the lesion but the lesion was successfully crossed.The site noted that this advancement was associated with pushing of the sds but reported that it was not excessive.The sds did not have to pass through any acute bends or through a previously deployed stent.Once across the lesion, the stent was successfully deployed.Difficulty was experienced when the physician attempted to remove the sds.It was noted that the inner member of the sds was protruding from the catheter thereby making it difficult to get it through the sheath.The device was successfully removed with the use of a buddy wire and the application of some force.The procedure was completed with post-dilation of the stent with no reported patient injury.A non-sterile unit precise pro rx us carotid syst was received coiled inside of a plastic bag with the outer body separated 21cm from the brite tip.In addition, the pod was noted to be kinked 4cm from the brite tip.The stent of the sds was not returned with the device.No other damages were found on the received unit.Dimensional analysis of the catheter body outer and inner diameters near the area of separation revealed that it was within specification.Sem analysis of the outer member separation revealed evidence of elongation, plastic deformation and frayed edges.These findings suggested an application of tensile force that induced the separation.A review of the manufacturing records could not be performed since the lot number was not provided.The reported ¿outer sheath ¿ damaged-in patient¿ and ¿sds - withdrawal difficulty-from vessel¿ events were confirmed based on the results of the visual analysis.The most likely cause of these events could not be conclusively determined.The cause of kinked condition found in the delivery system could be conclusively determined during the analysis.According to the ifu, users are instructed that if resistance is met during sds introduction, the system should be withdrawn and another system should be used.During withdrawal of the device, the ifu instructs the user to withdraw the entire delivery system while using fluoroscopy as a single unit over the guidewire and out of the body.If any resistance is met during sds withdrawal, users are instructed to advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.They are not to remove the guidewire along with the sds.Based on the information available for review, there are vessel characteristics (calcification and tortuosity) and procedural factors (continued use of device after resistance experienced during sds advancement) that may have contributed to the reported event.A risk assessment has been initiated to address this type of issue.

• 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: 5444798
• MDR Text Key: 38477594
• Report Number: 9616099-2016-00085
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PC0840RXC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2016
• Initial Date FDA Received: 02/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1