MAUDE Adverse Event Report: CORDIS US CORP. PRECISE PRO RX OUS; STENT, CAROTID

Catalog Number PC0730XCE

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

As reported, there was resistance felt when pushing a 7mm x 30mm precise pro rx ous carotid stent delivery system (sds) into the unknown guide catheter.The sds was pushed until it reached the head end of the catheter, at which point the sds was unable to go through the catheter.The device had initially been flushed and the plan was to deliver the stent to the lesion with the guidewire.The operator withdrew the sds and found a split at the tip of the sheath, so a new 7mm x 40mm precise stent was implanted into the lesion.The procedure was completed by replacing with another stent system.There were no reports of patient injury.The procedure was a percutaneous puncture carotid artery stent placement case.After an 8f short sheath was placed into the femoral artery, an unknown guidewire and an unknown angiographic catheter were placed to obtain a view of the aortic arch and the left carotid artery respectively.It showed stenosis of the beginning segment of the internal carotid artery.A 7f mpa guiding catheter was replaced, a cerebral protection device was placed in the distal internal carotid artery, and a 7 mm diameter and 30 mm length precise carotid stent was attempted to be implanted before it was exchanged for a 7mm x 40mm precise stent.The postoperative angiogram showed smooth blood flow, and the patient was returned to the ward after withdrawal of the instruments and an unknown 7f blocker was used to seal the puncture site.The intended lesion was located at the carotid artery.The target vessel was moderately calcified, mildly tortuous with no acute angulation, no bifurcation, and no chronic total occlusion.There was 70% stenosis.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was made via a contralateral approach.A little more force was added when the guiding catheter could not be pushed out.The sds was used in conjunction with a 7f mpa guide catheter.There was no thrombus was present.The lesion was pre-dilated prior to stent implantation.A 4-30 carotid artery balloon was used and was inflated to 10 atm.There was 30% stenosis after pre-dilation.The device will be returned for evaluation.

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18020573 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, there was resistance felt when pushing a 7mm x 30mm precise pro rx ous carotid stent delivery system (sds) into the unknown guide catheter.The sds was pushed until it reached the head end of the catheter, at which point the sds was unable to go through the catheter.The device had initially been flushed and the plan was to deliver the stent to the lesion with the guidewire.The operator withdrew the sds and found a split at the tip of the sheath, so a new 7mm x 40mm precise stent was implanted into the lesion.The procedure was completed by replacing with another stent system.There were no reports of patient injury.The procedure was a percutaneous puncture carotid artery stent placement case.After an 8f short sheath was placed into the femoral artery, an unknown guidewire and an unknown angiographic catheter were placed to obtain a view of the aortic arch and the left carotid artery respectively.It showed stenosis of the beginning segment of the internal carotid artery.A 7f mpa guiding catheter was replaced, a cerebral protection device was placed in the distal internal carotid artery, and a 7 mm diameter and 30 mm length precise carotid stent was attempted to be implanted before it was exchanged for a 7mm x 40mm precise stent.The postoperative angiogram showed smooth blood flow, and the patient was returned to the ward after withdrawal of the instruments and an unknown 7f blocker was used to seal the puncture site.The intended lesion was located at the carotid artery.The target vessel was moderately calcified, mildly tortuous with no acute angulation, no bifurcation, and no chronic total occlusion.There was 70% stenosis.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was made via a contralateral approach.A little more force was added when the guiding catheter could not be pushed out.The sds was used in conjunction with a 7f mpa guide catheter.There was no thrombus was present.The lesion was pre-dilated prior to stent implantation.A 4-30 carotid artery balloon was used and was inflated to 10 atm.There was 30% stenosis after pre-dilation.The device was not returned for evaluation.

Manufacturer Narrative

Complaint conclusion: there was resistance felt when pushing a 7mm x 30mm precise pro rx ous carotid stent delivery system (sds) into the unknown guide catheter.The sds was pushed until it reached the head end of the catheter, at which point the sds was unable to go through the catheter.The device had initially been flushed and the plan was to deliver the stent to the lesion with the guidewire.The operator withdrew the sds and found a split at the tip of the sheath, so a new 7mm x 40mm precise stent was implanted into the lesion.The procedure was completed by replacing with another stent system.The procedure was a percutaneous puncture carotid artery stent placement case.After an 8f short sheath was placed into the femoral artery, an unknown guidewire and an unknown angiographic catheter were placed to obtain a view of the aortic arch and the left carotid artery respectively.It showed stenosis of the beginning segment of the internal carotid artery.A 7f mpa guiding catheter was replaced, a cerebral protection device was placed in the distal internal carotid artery, and a 7 mm diameter and 30 mm length precise carotid stent was attempted to be implanted before it was exchanged for a 7mm x 40mm precise stent.The postoperative angiogram showed smooth blood flow, and the patient was returned to the ward after withdrawal of the instruments and an unknown 7f blocker was used to seal the puncture site.The intended lesion was located at the carotid artery.The target vessel was moderately calcified, mildly tortuous with no acute angulation, no bifurcation, and no chronic total occlusion.There was 70% stenosis.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was made via a contralateral approach.A little more force was added when the guiding catheter could not be pushed out.The sds was used in conjunction with a 7f mpa guide catheter.There was no thrombus was present.The lesion was pre-dilated prior to stent implantation.A 4-30 carotid artery balloon was used and was inflated to 10 atm.There was 30% stenosis after pre-dilation.There were no reports of patient injury.The device was not returned for analysis.Instead, one picture related to the reported event was attached by the customer at the complaint file (b)(4).As part of the picture, it could be observed the distal section of the precise catheter.Blood residues can be observed at the distal tip and inner catheter.The brite tip can be noticed torn/damaged.No other anomalies of the product can be noticed at the attached picture.A product history record (phr) review of lot 18020573 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis the reported ¿sds/ impeded¿ was not confirmed as part of the picture analysis since no functional or dimensional analysis could be performed.The reported ¿catheter tip/frayed/split/torn¿ was confirmed due to brite tip damage noticed during picture evaluation.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, it is probable that procedural and or handling factors such as the user¿s interaction with the device during use may have contributed to the reported event.According to the instructions for use (ifu) ¿preparation of stent delivery system: caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.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 root cause of the events reported by the customer could not conclusively determined as part of the picture evaluation; therefore, it is not possible to establish whether it is related to the manufacturing process of the product.No corrective or preventive actions will be taken at this time until the product is received to proceed with a complete evaluation.

Manufacturer Narrative

D2 type of device corrected.After further review of additional information received the following sections have been updated accordingly: d2, g1, g3, g6, h1, h2, h3, h6, and h10 there was resistance felt when pushing a 7mm x 30mm precise pro rx ous carotid stent delivery system (sds) into the unknown guide catheter.The sds was pushed until it reached the head end of the catheter, at which point the sds was unable to go through the catheter.The device had initially been flushed and the plan was to deliver the stent to the lesion with the guidewire.The operator withdrew the sds and found a split at the tip of the sheath, so a new 7mm x 40mm precise stent was implanted into the lesion.The procedure was completed by replacing with another stent system.The procedure was a percutaneous puncture carotid artery stent placement case.After an 8f short sheath was placed into the femoral artery, an unknown guidewire and an unknown angiographic catheter were placed to obtain a view of the aortic arch and the left carotid artery respectively.It showed stenosis of the beginning segment of the internal carotid artery.A 7f mpa guiding catheter was replaced, a cerebral protection device was placed in the distal internal carotid artery, and a 7 mm diameter and 30 mm length precise carotid stent was attempted to be implanted before it was exchanged for a 7mm x 40mm precise stent.The postoperative angiogram showed smooth blood flow, and the patient was returned to the ward after withdrawal of the instruments and an unknown 7f blocker was used to seal the puncture site.The intended lesion was located at the carotid artery.The target vessel was moderately calcified, mildly tortuous with no acute angulation, no bifurcation, and no chronic total occlusion.There was 70% stenosis.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was made via a contralateral approach.A little more force was added when the guiding catheter could not be pushed out.The sds was used in conjunction with a 7f mpa guide catheter.There was no thrombus was present.The lesion was pre-dilated prior to stent implantation.A 4-30 carotid artery balloon was used and was inflated to 10 atm.There was 30% stenosis after pre-dilation.There were no reports of patient injury.The device was returned for analysis.A non-sterile unit of ¿precise pro rx ous carotid sys¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed at one metallic tray to be inspected.A thorough inspection was performed observing that the unit is fully deployed, and the stent was included in the shipment.The stent does not present any damages or anomalies and is expanded as expected.The hemostasis valve was returned opened.The distal brite tip presents a frayed condition.No other outstanding details were observed.Dimensional analysis was performed to verify the correct od of the stent crossing profile.Measurements were taken at three different places and results and were found within specification.Functional test was performed to determine if any impeded condition is noticed on the returned device.The unit was inserted into one lab sample csi french 5.Then the device was withdrawn completely from the catheter.No impeded condition was noticed.The insertion/withdrawn of the unit into the lab sample csi was performed successfully.The brite distal tip was inspected using a vision system to obtain a magnified image confirming the frayed condition.A product history record (phr) review of lot 18020573 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds) ~ impeded¿ was no confirmed.No anomalies were found neither on the functional test nor in the dimensional analysis.The reported ¿catheter tip ~ frayed/split/torn¿ was confirmed, the distal brite tip present a frayed condition.The exact cause of the frayed distal tip condition observed on the device could not be conclusively determined during the analysis.Procedural and/or handling factors might have contributed to this issue.According to the instructions for use (ifu) ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.If resistance is felt during retraction of the outer sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿¿¿ neither the phr review nor the information available suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, there was resistance felt when pushing a 7mm x 30mm precise pro rx ous carotid stent delivery system (sds) into the unknown guide catheter.The sds was pushed until it reached the head end of the catheter, at which point the sds was unable to go through the catheter.The device had initially been flushed and the plan was to deliver the stent to the lesion with the guidewire.The operator withdrew the sds and found a split at the tip of the sheath, so a new 7mm x 40mm precise stent was implanted into the lesion.The procedure was completed by replacing with another stent system.There were no reports of patient injury.The procedure was a percutaneous puncture carotid artery stent placement case.After an 8f short sheath was placed into the femoral artery, an unknown guidewire and an unknown angiographic catheter were placed to obtain a view of the aortic arch and the left carotid artery respectively.It showed stenosis of the beginning segment of the internal carotid artery.A 7f mpa guiding catheter was replaced, a cerebral protection device was placed in the distal internal carotid artery, and a 7 mm diameter and 30 mm length precise carotid stent was attempted to be implanted before it was exchanged for a 7mm x 40mm precise stent.The postoperative angiogram showed smooth blood flow, and the patient was returned to the ward after withdrawal of the instruments and an unknown 7f blocker was used to seal the puncture site.The intended lesion was located at the carotid artery.The target vessel was moderately calcified, mildly tortuous with no acute angulation, no bifurcation, and no chronic total occlusion.There was 70% stenosis.There were no damages or anomalies noted to the device or packaging prior to use in the patient.The stent delivery system did not pass through any acute bends.The delivery of the sds to the lesion was made via a contralateral approach.A little more force was added when the guiding catheter could not be pushed out.The sds was used in conjunction with a 7f mpa guide catheter.There was no thrombus was present.The lesion was pre-dilated prior to stent implantation.A 4-30 carotid artery balloon was used and was inflated to 10 atm.There was 30% stenosis after pre-dilation.The device was returned for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d9, g3, g6, h2, h3, h6, 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 OUS
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 16811342
• MDR Text Key: 313964353
• Report Number: 9616099-2023-06476
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062388
• UDI-Public: (01)20705032062388(17)230430(10)18020573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K914007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: PC0730XCE
• Device Lot Number: 18020573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7F EXOSEAL OCCLUDER; 8F PUNCTURE SHEATH KIT; BOSTON: 7F MPA GUIDE TUBE; CORDIS: 5F MPA CONTRAST CATHETER; MEDTRONIC: SPIDER UMBRELLA; PRECISE CAROTID STENT; TERUMO 0.035 GUIDEWIRE