MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X40; STENT, CAROTID

Model Number PC0840XCE

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2018

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: during a carotid artery bifurcation stenting procedure, a precise pro stent delivery system (rx 8x40) was found to be fractured prior to deploying the stent.There was no patient injury reported.It is unknown how the procedure was completed.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the instructions for use (ifu).The product was inspected and prepped according to the ifu.Nothing unusual was noted about the stent delivery system (sds) prior to use.The target lesion vessel diameter was 6.5mm.The sheath introducer used was a 6f non-cordis device.The guiding catheter used was a non-cordis long sheath.The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.The target lesion was a little tortuous and moderately calcified with 75% stenosis.The sds passed through a type 3 arch.Delivery of the sds to the lesion was ipsilateral.The device did not arrive at the lesion.No unusual force was used at any time during the procedure.Thrombus was not present proximal to, at, or distal to the lesion site.The lesion was pre-dilated prior to stent implantation using a non-cordis device.The percentage of stenosis after pre-dilation was 65%.The type of contrast used was visipaque mixed 1:1 with saline.The sds did not have to pass through a previously placed stent.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in the open position when received.The tuohy borst valve was closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member/sheath.A stopcock was connected to the y-connector of the tuohy borst valve.No difficulty was encountered while flushing the stopcock.No difficulty was encountered flushing the sds.The device did not separate into 2 or more pieces.No other information was reported.The device was not returned for analysis.Three device pictures were received for review.One picture is of the device outer box label, showing the device name, size, lot number, and expiration date.The other two pictures show the device in a clear plastic bag, it is not possible to make a clear analysis of the device based on the quality of pictures.A product history record (phr) review of lot 17736188 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The reported ¿stent delivery system (sds)-ses cracked¿ could not be confirmed as the device was not returned for analysis and device photographs do not clearly show damage.The exact cause of the reported damage could not be clearly determined.Vessel characteristics, such as tortuosity and moderate calcification with 75% stenosis, as well as procedural and handling factors may have contributed to the reported event.Per the instructions for use, which is not intended as a mitigation, ¿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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.If resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.¿ the phr review does not suggest that the event experienced by the customer could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

As reported, a precise pro stent delivery system (rx 8x40) was found to be fractured.There was no patient injury reported.The device was clinically used and will not be returned for analysis.The device has been discarded.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the ifu.The product was inspected and prepped according to the instructions for use.Nothing unusual was noted about the stent delivery system prior to use.The target lesion was the carotid artery.The intended lesion was located at the carotid bifurcation.The target lesion vessel diameter was 6.5mm.The sheath introducer used was a 6f non-cordis device.The guiding catheter used was a non-cordis long sheath.The diameter of the unconstrained stent was sized 1-2 mm larger than the vessel diameter.The target lesion was a little tortuous and moderately calcified with 75% stenosis.The stent delivery system passed through a type 3 arch.Delivery of the sds to the lesion was ipsilateral.The device did not arrive at the lesion.No unusual force was used at any time during the procedure.Thrombus was not present proximal to, at, or distal to the lesion site.The lesion was pre-dilated prior to stent implantation using a non-cordis device.The percentage of stenosis after pre-dilation was 65%.The type of contrast used was visipaque mixed 1:1 with saline.The sds did not have to pass through a previously placed stent.The lesion was not post-dilated after stent implantation.The user thinks that the event was related to the stent.The user does not think that the event was related to the procedure.The device was prepped in the tray.The tuohy borst (hemostasis) valve was in the open position when received.The tuohy borst valve was closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member/sheath.A stopcock was connected to the y-connector of the tuohy borst valve.No difficulty was encountered while flushing the stopcock.No difficulty was encountered flushing the sds.The fracture was noted prior to insertion in the patient.The device did not separate into 2 or more pieces.

• Brand Name: PRECISE PRO RX 8X40
• 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 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 8256414
• MDR Text Key: 133356089
• Report Number: 9616099-2019-02641
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 17736188
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/16/2017
• 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