MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 10X40; STENT, CAROTID

Model Number PC1040XCE

Device Problems Fracture (1260); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

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.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the tip of the inner shaft of the 10 x 40 precise pro rapid exchange (rx) self-expanding stent (ses) delivery system got detached and the inner shaft got stuck to the angioguard wire.The tip was detached from its original position but was still holding to some inner material and it came out as the delivery system was removed.The delivery catheter was removed but with lot of force.No piece of the stent delivery system remained in the patient.There was no reported patient injury.Meanwhile, the stent was successfully deployed and expanded fully with good wall apposition.The devices were opened in sterile field.The intended procedure was a carotid angioplasty.The intended lesion was located at the carotid bifurcation.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is 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.There was nothing unusual noted about the stent delivery system prior to use.The target lesion vessel diameter was 6.5mm in ica and 8.5mm in cca.A brite tip 6f, 90cm catheter sheath introducer (csi) was used.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion vessel length was around 25mm.The fibrotic lesion was moderately calcified.There was little vessel tortuosity.The percentage of stenosis was 90%.The stent delivery system passed through acute bends.Delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The lesion was pre-dilated prior to stent implantation.The percent stenosis after pre-dilation was 50%.Omnipaque contrast was used.The contrast was mixed with normal saline.The ratio of contrast to fluid was 50:50.There was no difficulty nor resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The lesion was post-dilated after stent implantation with a non-cordis balloon catheter at 10-12 atmospheres.The percent stenosis after post-dilation was 20%.There was no thrombus noted post deployment.The precise pro rx will be returned for analysis.Angioguard will not be returned for analysis.

Manufacturer Narrative

The tip of the inner shaft of the 10 x 40 precise pro rapid exchange (rx) self-expanding stent (ses) delivery system got detached and the inner shaft got stuck to the angioguard wire.The tip was detached from its original position but was still holding to some inner material and it came out as the delivery system was removed.The delivery catheter was removed but with lot of force.No piece of the stent delivery system remained in the patient.Meanwhile, the stent was successfully deployed and expanded fully with good wall apposition.The devices were opened in sterile field.The intended procedure was a carotid angioplasty.The intended lesion was located at the carotid bifurcation.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is 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.There was nothing unusual noted about the stent delivery system prior to use.The target lesion vessel diameter was 6.5mm in ica and 8.5mm in cca.A brite tip 6f, 90cm catheter sheath introducer (csi) was used.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion vessel length was around 25mm.The fibrotic lesion was moderately calcified.There was little vessel tortuosity.The percentage of stenosis was 90%.The stent delivery system passed through acute bends.Delivery of the sds to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The lesion was pre-dilated prior to stent implantation.The percent stenosis after pre-dilation was 50%.Omnipaque contrast was used.The contrast was mixed with normal saline.The ratio of contrast to fluid was 50:50.There was no difficulty nor resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The lesion was post-dilated after stent implantation with a non-cordis balloon catheter at 10-12 atmospheres.The percent stenosis after post-dilation was 20%.There was no thrombus noted post deployment.There was no reported patient injury.One non-sterile precise pro rx 10x40 was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received unlocked.Per visual analysis, the stent was observed deployed from the unit and not returned for its analysis.Blood residues were observed inside the distal tip.The distal tip was observed intact and fixed to the wire lumen.Six kinks were observed on the body/shaft of the unit approximately at 3.5 cm, 16.8 cm, 49.1 cm, 49.6 cm, 99.9 cm and 100.4 cm from the strain relief.Also, the strain relief was observed bent and the wire lumen was observed kinked approximately at 2.1 cm from the distal tip.The guidewire lumen was not observed separated from the unit.No other anomalies were observed.The outer diameter (od) of the unit was measured at different distances and the results were found within specification.Additionally, the distal tip was pulled by hand to verify that the tip was properly fixed to the wire lumen.Distal tip was observed fixed and didn¿t come off during the pulling test.A product history record (phr) review of lot 17855147 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿guidewire lumen (inner shaft) - separated - remains on wire¿ was not confirmed since the guidewire lumen was observed intact, the guidewire lumen was not observed separated from the unit.The reported ¿catheter tip - fractured - in patient¿ was not confirmed since the distal tip was observed intact and fixed to wire lumen.Also, the distal tip was pulled by hand to verify that the tip was properly fixed to the wire lumen.Distal tip was observed fixed and didn¿t come off during the pulling test.The reported ¿stent delivery system (sds)-ses - withdrawal difficulty - from vessel¿ couldn¿t be properly evaluated due to the nature of the complaint.Nevertheless, the reported ¿stent delivery system (sds)-ses - withdrawal difficulty¿ was not confirmed since a dimensional test was performed on the outer member of the unit and the results were observed within specification.The cause of the bend observed on the strain relief and the kinks observed on the body/shaft and the wire lumen of the unit could not be conclusively determined during the analysis.However, it is probable that procedure and handling factors such as the user¿s interaction with the device and vessel characteristics (moderately calcified lesion with 50% stenosis post dilation) may had contributed to the reported events.

• Brand Name: PRECISE PRO RX 10X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11669790
• MDR Text Key: 247753042
• Report Number: 9616099-2021-04410
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: PC1040XCE
• Device Catalogue Number: PC1040XCE
• Device Lot Number: 17855147
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/22/2021
• Initial Date FDA Received: 04/15/2021
• Supplement Dates Manufacturer Received: 07/02/2021
• Supplement Dates FDA Received: 07/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1