MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Model Number PC1040RXC

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but it has not yet been received.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.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, a precise pro rx (us carotid syst) was delivered to the lesion and the physician deployed the stent.Then the physician tried to remove the delivery system, however, the distal tip of the stent delivery system got caught on the stent.A non-cordis guiding catheter was inserted inside the stent to cover the stent delivery system, and it went through the precise pro.The delivery system was removed from the patient and it was confirmed to be separated.The lesion was the right internal carotid artery.There was no reported patient injury.The product was clinically used and will be returned for analysis.There were no anomalies noted prior to or during use of the device.No piece of the stent or the stent delivery system remained in the patient.The physician commented as follows; anatomically there was severe angulation from the right common carotid artery to the right internal carotid artery that was distal from the bifurcation, therefore the distal tip of the stent delivery system might have been caught by the stent.

Manufacturer Narrative

Complaint conclusion: during a carotid artery stenting procedure, a precise pro rx carotid stent system was delivered to the lesion and the stent was deployed.When the physician tried to remove the delivery system, the distal tip got caught on the stent.A non-cordis guiding catheter was inserted inside the stent to cover the stent delivery system, and it went through the precise pro.The delivery system was removed from the patient and it was noted to be separated.The lesion is the right internal carotid artery.There was no reported patient injury.There were no anomalies noted prior to or during use of the device.No piece of the stent or the stent delivery system remained in the patient.Vessel characteristics were reported as severely angulated from the right common carotid artery to the right internal carotid artery that was distal from the bifurcation.The device was returned for analysis.One non-sterile precise pro rx carotid stent system was received coiled inside in plastic bag.Per visual analysis an unraveled/stretched condition was noted on the coil wire and the catheter tip was noted to be separated from the delivery system (the catheter tip was not received).Also, the inner member was separated, and it was not received for analysis.The hemostasis valve was received open.Dimensional analysis could not be performed due to the inner wire lumen and catheter tip not being received for analysis.Per microscopic analysis, evidence of elongations were found, these characteristics suggest that the device was induced to stretching/pulling events that exceeded the material yield strength prior to the separation.No other damages/anomalies were observed.A product history record (phr) review of lot 17719458 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported events.The phr review does not suggest that the events reported by the customer could be related to the manufacturing process.The reported ¿stainless steel coil (inner shaft)- unraveled/stretched¿ ¿catheter tip- separated¿ and ¿stent delivery system (sds)- withdrawal difficulty - snagged/caught on stent¿ were confirmed by the condition of the received device.However, the exact cause of the damages found on device could not be conclusively determined.Vessel characteristics as well as procedural and handling factors may have contributed to the damages found.Per the instructions for use, which is not intended as a mitigation, ¿while using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire and out of the body.Remove the delivery system from the guidewire.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outersheath marker contacts the catheter tip and withdraw the system as one unit.(do not remove guidewire.) using fluoroscopy, visualize the stent to verify full deployment.If incomplete expansion exists within the stent at any point along the lesion, post-deployment balloon dilatation (standard pta technique) can be performed.¿ neither the phr review nor the product analysis suggest that the damages found on device could be related to manufacturing process.Therefore, no corrective or preventive actions will be taken.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information has been provided as the product has been evaluated.Two non-sterile precise pro rx us carotid syst units were received coiled inside in plastic bag.The unit were numbered/identified as unit one to two.Unit#1: per visual analysis a frayed/ripped/split condition was observed on brite tip.Unit was received partially deployed (.5 cm), the hemostasis valve was received open.No other damages/anomalies were observed on the unit.No other damages/anomalies were observed.The outer sheath diameter (od) was measured at different distances and results were found within specification.During the analysis it was concluded that unusual forces/tension was applied on the units.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information was received and identified unit #1 reported under this case (b)(4) corresponds to the reported events under (b)(4) (manufacturer report number: 9616099-2018-02140).The product identified as unit #2 was confirmed to be the correct device corresponding to this case (b)(4).The product analysis is as follows: per visual analysis an unraveled/stretched condition was noted on the coil wire and the catheter tip was observed separated from the delivery system.The hemostasis valve was received open.No other damages/anomalies were observed.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: during a carotid artery stenting procedure, a precise pro rx carotid stent system 10 mm x 40 mm was delivered to the lesion and the stent was deployed.When the physician tried to remove the delivery system, the distal tip got caught on the stent.A non-cordis guiding catheter was inserted inside the stent to cover the stent delivery system, and it went through the precise pro.The delivery system was removed from the patient and it was noted to be separated.The lesion is the right internal carotid artery.There was no reported patient injury.There were no anomalies noted prior to or during use of the device.No piece of the stent or the stent delivery system remained in the patient.Vessel characteristics were reported as severe angulation from the right common carotid artery to the right internal carotid artery that was distal from the bifurcation.The devices were returned for analysis.Two non-sterile precise pro rx carotid stent system 10 mm x 40 mm units were received coiled inside in plastic bag, the devices were numbered/identified as unit one to two.Per visual analysis for unit number one, a frayed/ripped/split condition was noted on the brite tip.The unit was received partially deployed, the hemostasis valve was received open.No other damages/anomalies were observed on the unit.The outer sheath diameter (od) was measured at different distances and results were found within specification.During the analysis it was concluded that unusual forces/tension had been applied on the device.A review of the manufacturing documentation associated with lot 17719458 was performed and no issues were noted that may be related to the reported complaint.The product history report (phr) review does not suggest that the failure experienced by the customer could be related to the manufacturing process.It is unclear based on the event description which device the customer experienced difficulty with.The event reported by the customer as ¿stent delivery system (sds)-ses- withdrawal difficulty - snagged/caught on stent¿ could not be properly evaluated during the analysis due to the nature of the complaint; however, per the condition of the received device it was determined that the exact cause of the reported failure could be related to the damages found.The event reported as ¿stent delivery system (sds)-ses - separated - in patient¿ was not confirmed due to no separations being found on device.The events reported by the customer as ¿catheter tip- frayed/split/torn¿ and ¿stent delivery system (sds)-ses- deployment difficulty - partial deployment¿ were confirmed due to the condition of received the device for analysis.The exact cause of the events reported could not be conclusively determined.Per the instructions for use, which is not intended as a mitigation, ¿while using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire and out of the body.Remove the delivery device from the guidewire.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.(do not remove guidewire.).¿ however, neither the phr review nor the product analyses suggest that the damages found on units could be related to manufacturing process.Procedural factors and handling process may have contributed to the damages found.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 7446569
• MDR Text Key: 106252135
• Report Number: 9616099-2018-02074
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17719458
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATHETER (8F OPTIMO, TOKAI MEDICAL PRODUCTS)