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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17929128 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the precise pro rapid exchange (rx) ses (self-expanding stent) delivery system was used at the lesion from the common carotid artery to internal carotid artery; however, the physician noticed something was there when they attempted to remove an embolic protection tool (non-cordis).The physician attempted to remove it by using a catheter for removing or an inner guiding catheter (non-cordis), but it was difficult.It was replaced with a guiding sheath (8f, non-cordis).It was able to remove the object.It was recognized that it was the tip of the precise pro.It was confirmed that there were no protrusions by a post- intravascular ultrasound (ivus).The patient was discharged from the hospital with no reported patient injury.This was a carotid artery stenting (cas) case.The lesion was not severely calcified there was no vessel tortuosity.There was minimal angulation of the target vessel with a 70-80% stenosis.The device was not re-sterilized.The device was stored, prepped, and used according to the instructions for use (ifu).There were no anomalies noted when removed from the package and no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing the device.There was no excessive torquing required.There was no resistance met while advancing the device over the guidewire.There was no resistance felt at all.Therefore, the physician did not notice that the distal tip had separated.The physician noticed the marker when an ivus was done after the stent was implanted.At that time, the physician noticed that the distal tip came off.A guidewire of the distal embolic protection filter was used as the axis and the distal tip was between ivus catheters, which was lifted from the bottom.The patient had no infectious disease.Other procedural details were requested but are unknown, unavailable, or not applicable.The device is expected to be returned for analysis.

Manufacturer Narrative

Fda recall #z-1257-2021.Complaint conclusion: a precise pro rapid exchange (rx) ses (self-expanding stent) delivery system was used at the lesion from the common carotid artery to internal carotid artery; however, the physician noticed something was there when they attempted to remove an embolic protection tool (non-cordis).The physician attempted to remove it by using a catheter for removing or an inner guiding catheter (non-cordis), but it was difficult.It was replaced with a guiding sheath (8f, non-cordis).It was able to remove the object.It was recognized that it was the tip of the precise pro.It was confirmed that there were no protrusions by a post- intravascular ultrasound (ivus).This was a carotid artery stenting (cas) case.The lesion was not severely calcified.There was no vessel tortuosity.There was minimal angulation of the target vessel with a 70-80% stenosis.The device was not re-sterilized.The device was stored, prepped, and used according to the instructions for use (ifu).There were no anomalies noted when removed from the package and no anomalies noted during prep.The device was not inserted through a stopcock instead of a hemostatic valve.There was no resistance met while advancing the device.There was no excessive torqueing required.There was no resistance met while advancing the device over the guidewire.There was no resistance felt at all.Therefore, the physician did not notice that the distal tip had separated.The physician noticed the marker when an ivus was done after the stent was implanted.At that time, the physician noticed that the distal tip came off.A guidewire of the distal embolic protection filter was used as the axis and the distal tip was between ivus catheters, which was lifted from the bottom.The patient had no infectious disease.The patient was discharged from the hospital with no reported patient injury.The device was returned for analysis.Per picture analysis.One picture related to the reported event was attached by the customer at the complaint file case-2021-00140461-1.As part of the picture analysis, it could be observed, a non-sterile catheter inside of a plastic bag.The tip is separated from the wire lumen and it is mounted into an embolic protection device.No other anomalies on the packaging of the product can be noticed at the attached picture.Per visual analysis, one non-sterile precise pro rx us carotid system was received for analysis inside a plastic bag.No original packaging was returned.A non-cordis embolic protection system was received inside the same bag.The valve of the unit was received closed.Per visual analysis, the stent of the unit was observed deployed but was not received along the unit.The wire lumen was observed separated from the distal tip.Distal tip was observed inserted into the non-cordis embolic protection system received.An acceptable adhesive quantity was observed inside the tip¿s glue port.Nevertheless, due to the condition received of the tip, visual analysis couldn¿t determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.The body/shaft of the unit was observed kinked/bent approximately at 7.4 cm from the strain relief.No other anomalies were observed.A product history record (phr) review of lot 17929128 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip - separated - in patient¿ was confirmed since the distal tip was observed separated from the wire lumen.An acceptable adhesive quantity was observed inside the tip¿s glue port.Nevertheless, due to the condition received of the tip, visual analysis couldn¿t determine if the correct amount of adhesive was applied throughout the entire section between the wire lumen and the tip.After the physical evaluation of the unit, it was determined by the product engineering team (pet) that the tip separation reported was a manufacturing related as the physical evaluation couldn¿t conclusively determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.According to the instructions for use, which is not intended as a mitigation of risk, ¿extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.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.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d9, g3, g6, h1, h2, h3, and h10, this device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

• 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: 11315162
• MDR Text Key: 231442252
• Report Number: 9616099-2021-04259
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17929128
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDING SHEATH (8F FUBUKI, ASAHI INTECC); INNER GUIDING CATHETER (DD6, MEDIKIT); PROTECTION TOOL (SPIDER); GUIDING SHEATH (8F FUBUKI, ASAHI INTECC); INNER GUIDING CATHETER (DD6, MEDIKIT); PROTECTION TOOL (SPIDER)
• Patient Outcome(s): Required Intervention