MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X30; STENT, CAROTID

Catalog Number PC0830XCE

Device Problems Partial Blockage (1065); Detachment of Device or Device Component (2907)

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

Event Date 06/27/2022

Event Type  malfunction  

Event Description

As reported, after the implantation of a 7mm x 40mm precise self-expanding stent (ses), an 8mm x 30m 135cm precise pro rx self-expanding stent (ses) delivery system was to be used as an additional stent when a non-cordis.014 guidewire was unable to enter the stent release section of the device.An attempt to insert the guidewire from the rapid exchange port of the device was made but was still unsuccessful.After multiple attempts to insert the guidewire, it was believed that the stent was causing the issue and it was reported that the lumen was blocked with possibly injectable material.Therefore, a new 8mm x 40mm precise pro ses was used and implanted in place of the initial 8mm x 30m 135cm precise pro rx ses.There was no reported injury to the patient.This was during a procedure to treat a 70% stenosis in the carotid artery in which an 8f avanti plus catheter sheath introducer (csi) was used for access in the femoral artery.It was reported that there was no stenosis of the femoral artery.The target lesion was not calcified; however, there was mild tortuosity to the target vessel.After femoral access was obtained, an 8f 90cm multipurpose (mpa) vista brite tip guiding catheter was used along with a non-cordis.035 guidewire; however, due to vessel tortuosity, the 8f mpa guiding catheter could only reach the common carotid opening.A 4f 125cm mpa tempo diagnostic catheter was then inserted and advanced to the internal carotid occlusion segment, followed by the use of a 2.7f 130cm non-cordis microcatheter to exchange the non-cordis.035 guidewire with a non-cordis.014 guidewire.The non-cordis.014 guidewire was then advanced through the diseased segment to the upper segment of the perforating process of the internal carotid artery.The 4f mpa catheter was then removed, and an unknown embolic protection device was inserted and placed below the petrous segment of the internal carotid artery.A 5mm x 30mm non-cordis balloon catheter was then used to pre-dilate the lesion but no access was found.The lesion was measured by using the 4f mpa catheter, and a 7mm x 40mm precise ses was implanted.Due to the length of the lesion, a second stent was required and the 8mm x 30m 135cm precise pro rx ses was then chosen for use, which is when the guidewire loading difficulty occurred.The device was stored and prepped per the instruction for use (ifu) and there was nothing unusual about the delivery system prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was no difficulty encountered flushing the stopcock or the delivery system itself, and the delivery system did not become kinked and any point.There was no reported damage to the distal tip of the precise pro.It was reported that the precise pro was able to be removed easily from the patient, the stent was still attached to the delivery system, and the device remained in one piece during its removal.The device will be returned for evaluation.Addendum: 3 pictures were provided for the 8mm x 30m 135cm precise pro rx ses.One picture displays a distal tip separation.Per the sales rep, the distal tip separation was observed as the sds was being inserted into the patient.

Manufacturer Narrative

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

Event Description

As reported, after the implantation of a 7mm x 40mm precise self-expanding stent (ses), an 8mm x 30m 135cm precise pro rx self-expanding stent (ses) delivery system was to be used as an additional stent when a non-cordis.014 guidewire was unable to enter the stent release section of the device.An attempt to insert the guidewire from the rapid exchange port of the device was made but was still unsuccessful.After multiple attempts to insert the guidewire, it was believed that the stent was causing the issue and it was reported that the lumen was blocked with possibly injectable material.Therefore, a new 8mm x 40mm precise pro ses was used and implanted in place of the initial 8mm x 30m 135cm precise pro rx ses.There was no reported injury to the patient.This was during a procedure to treat a 70% stenosis in the carotid artery in which an 8f avanti plus catheter sheath introducer (csi) was used for access in the femoral artery.It was reported that there was no stenosis of the femoral artery.The target lesion was not calcified; however, there was mild tortuosity to the target vessel.After femoral access was obtained, an 8f 90cm multipurpose (mpa) vista brite tip guiding catheter was used along with a non-cordis.035 guidewire; however, due to vessel tortuosity, the 8f mpa guiding catheter could only reach the common carotid opening.A 4f 125cm mpa tempo diagnostic catheter was then inserted and advanced to the internal carotid occlusion segment, followed by the use of a 2.7f 130cm non-cordis microcatheter to exchange the non-cordis.035 guidewire with a non-cordis.014 guidewire.The non-cordis.014 guidewire was then advanced through the diseased segment to the upper segment of the perforating process of the internal carotid artery.The 4f mpa catheter was then removed, and an unknown embolic protection device was inserted and placed below the petrous segment of the internal carotid artery.A 5mm x 30mm non-cordis balloon catheter was then used to pre-dilate the lesion but no access was found.The lesion was measured by using the 4f mpa catheter, and a 7mm x 40mm precise ses was implanted.Due to the length of the lesion, a second stent was required and the 8mm x 30m 135cm precise pro rx ses was then chosen for use, which is when the guidewire loading difficulty occurred.The device was stored and prepped per the instruction for use (ifu) and there was nothing unusual about the delivery system prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was no difficulty encountered flushing the stopcock or the delivery system itself, and the delivery system did not become kinked and any point.There was no reported damage to the distal tip of the precise pro.It was reported that the precise pro was able to be removed easily from the patient, the stent was still attached to the delivery system, and the device remained in one piece during its removal.The device will be returned for evaluation.Addendum: 3 pictures were provided for the 8mm x 30m 135cm precise pro rx ses.One picture displays a distal tip separation.Per the sales rep, the distal tip separation was observed as the sds was being inserted into the patient.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b3, d4, d8, d9, g3, g4, g6, h1, h2, h3, h6, and h10.A review of the manufacturing documentation associated with lot 18061159 presented no issues during the manufacturing process that can be related to the reported event.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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g4, g6, h1, h2, h3, h6, and h10.Complaint conclusion: after the implantation of a 7mm x 40mm precise self-expanding stent (ses), an 8mm x 30mm 135cm precise pro rx self-expanding stent (ses) delivery system was to be used as an additional stent when a non-cordis.014 guidewire was unable to enter the stent release section of the device.An attempt to insert the guidewire from the rapid exchange port of the device was made but was still unsuccessful.After multiple attempts to insert the guidewire, it was believed that the stent was causing the issue and it was reported that the lumen was blocked with possibly injectable material.Therefore, a new 8mm x 40mm precise pro ses was used and implanted in place of the initial 8mm x 30m 135cm precise pro rx ses.There was no reported injury to the patient.This was during a procedure to treat a 70% stenosis in the carotid artery in which an 8f avanti plus catheter sheath introducer (csi) was used for access in the femoral artery.It was reported that there was no stenosis of the femoral artery.The target lesion was not calcified; however, there was mild tortuosity to the target vessel.After femoral access was obtained, an 8f 90cm multipurpose (mpa) vista brite tip guiding catheter was used along with a non-cordis.035 guidewire; however, due to vessel tortuosity, the 8f mpa guiding catheter could only reach the common carotid opening.A 4f 125cm mpa tempo diagnostic catheter was then inserted and advanced to the internal carotid occlusion segment, followed by the use of a 2.7f 130cm non-cordis microcatheter to exchange the non-cordis.035 guidewire with a non-cordis.014 guidewire.The non-cordis.014 guidewire was then advanced through the diseased segment to the upper segment of the perforating process of the internal carotid artery.The 4f mpa catheter was then removed, and an unknown embolic protection device was inserted and placed below the petrous segment of the internal carotid artery.A 5mm x 30mm non-cordis balloon catheter was then used to pre-dilate the lesion but no access was found.The lesion was measured by using the 4f mpa catheter, and a 7mm x 40mm precise ses was implanted.Due to the length of the lesion, a second stent was required and the 8mm x 30m 135cm precise pro rx ses was then chosen for use, which is when the guidewire loading difficulty occurred.The device was stored and prepped per the instruction for use (ifu) and there was nothing unusual about the delivery system prior to use.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.There was no difficulty encountered flushing the stopcock or the delivery system itself, and the delivery system did not become kinked and any point.There was no reported damage to the distal tip of the precise pro.It was reported that the precise pro was able to be removed easily from the patient, the stent was still attached to the delivery system, and the device remained in one piece during its removal.Addendum: 3 pictures were provided for the 8mm x 30m 135cm precise pro rx ses.One picture displays a distal tip separation.Per the sales rep, the distal tip separation was observed as the sds (stent delivery system) was being inserted into the patient.The product was returned for analysis.A non-sterile unit of precise pro rx 8x30mm sds was received for analysis coiled inside of a clear plastic bag.The stent is not deployed still mounted on the device.Per visual analysis several kinks were observed located approximately at 13 cm from the proximal end on the hypotube, another at approximately at 22.5 cm from the proximal end, and other two kinks located approximately at 20 cm and 28.5 cm from the distal tip.The hemostasis valve was received tightly closed.No other damages or anomalies were observed.Dimensional analysis was not performed due to the kinks observed on the returned unit.Per functional analysis positive pressure was applied by the distal tip with a syringe full of water.The water wept from the guidewire exit port, and neither resistance to the water flow nor loose material was observed during the flushing procedure.One lab sample guidewire of the appropriate size was inserted by the distal tip.Despite the kink, the device was advanced over the guidewire until the end of the guidewire got out by the exit port.Resistance was felt only where the kink is located.The unit was straightened up as much as possible.The hemostasis valve was unlocked of the stent delivery system.The stent deployment functionality test was initiated by retracting the outer sheath while holding the inner shaft in a fixed position.Despite the observed kinks the push rod traveled toward the distal tip as expected and the stent was deployed.The stent expands normally presenting no damages or anomalies.Per picture analysis picture one shows an unknown guidewire inserted into the precise catheter.As part of the picture it could be observed the distal section of the catheter.The brite tip can be observed; however, the distal tip cannot be noticed since the image is blurry.The second picture shows the inner label of a precise product, and the following information can be read: lot # 18061159, catalogue# pc0830xce and use by date 2023-09-30.As part of picture number 3 it can be observed an unknown guidewire catheter introduced into distal end of the precise catheter.Distal tip can be noticed.A product history record (phr) review of lot 18061159 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¿ and ¿inner shaft~ obstructed - in patient¿ were not confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.The flushing test and the insertion/withdrawal test of the guidewire into the inner shaft were performed successfully.Based on the information available for review, procedural factors may have contributed to the event as evidenced by kinks noted on the device during analysis.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: PRECISE PRO RX 8X30
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15065154
• MDR Text Key: 300888705
• Report Number: 9616099-2022-05834
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062418
• UDI-Public: (01)20705032062418(17)230930(10)18061159
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 09/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Catalogue Number: PC0830XCE
• Device Lot Number: 18061159
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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: 0.14 BOSTON SCIENTIFIC GUIDE WIRE.; 0.35 TERUMO GUIDE WIRE.; 2.7F 130CM NON-CORDIS MICROCATHETER.; 4F 125CM MPA TEMPO DIAGNOSTIC CATHETER.; 8F 90CM MPA VISTA BRITE TIP GUIDING CATHETER.; 8F AVANTI PLUS SHEATH/402-608X.; AVAT BALLOON 5MM X 30MM.; PRECISE 7MM X 40MM SES.; PRECISE 8MM X 40MM SES.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 90 KG