MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X30; STENT, CAROTID

Model Number PC0930XCE

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/02/2021

Event Type  Injury  

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 whole process was smooth, however; after a 9mm x 30mm precise pro rapid exchange (rx) self-expanding stent delivery system was successfully implanted and released, when the system was ready to be recovered; the head end of the stent system (transparent segment) suddenly fell off for an unknown reason and flowed to the distal end with the blood flow.Therefore, using a catheter suction under x-ray, the detached head end was recovered successfully.The device was used for a percutaneous subclavian stent implantation.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 8.3mm.An unknown 8f sheath introducer and guiding catheter were used.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion vessel length was 23mm.The lesion was not calcified.There was no vessel tortuosity.The percentage of stenosis was 60%.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.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.Normal contrast solution was used.The contrast was mixed with saline.The ratio of contrast to fluid was regular.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 stent expanded fully with good wall apposition.No piece of the stent or the stent delivery system remained in the patient.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: the whole process was smooth.However, after a precise pro 9mm x 30mm rapid exchange (rx) self-expanding stent delivery system was successfully implanted and released, when the system was ready to be recovered; the head end of the stent system (transparent segment) suddenly fell off for an unknown reason and flowed to the distal end with the blood flow.Therefore, using a catheter suction under x-ray, the detached head end was recovered successfully.The device was used for a percutaneous subclavian stent implantation.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 8.3mm.An unknown 8f sheath introducer and guiding catheter were used.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion vessel length was 23mm.The lesion was not calcified.There was no vessel tortuosity.The percentage of stenosis was 60%.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.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.Normal contrast solution was used.The contrast was mixed with saline.The ratio of contrast to fluid was regular.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 stent expanded fully with good wall apposition.No piece of the stent or the stent delivery system remained in the patient.The device was not returned for analysis.A product history record (phr) review of lot 17932849 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 and based on the information provided, the reported ¿catheter tip- separated- in patient¿ could not be confirmed.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 and vessel characteristics of 60% stenosis may have led to the reported event.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.¿ based on the information available and provided, a manufacturing related cause could not be conclusively determined.However, a risk assessment has been initiated for further investigation.

Manufacturer Narrative

Complaint conclusion: the whole process was smooth.However, after a precise pro 9mm x 30mm rapid exchange (rx) self-expanding stent delivery system was successfully implanted and released, when the system was ready to be recovered; the head end of the stent system (transparent segment) suddenly fell off for an unknown reason and flowed to the distal end with the blood flow.Therefore, using a catheter suction under x-ray, the detached head end was recovered successfully.The device was used for a percutaneous subclavian stent implantation.The device was returned for analysis.One non-sterile precise pro rx 9x30 was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received opened.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 not received.Since the distal tip was not received, visual analysis couldn¿t determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.No other anomalies were observed.A product history record (phr) review of lot 17932849 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 as the distal tip was noted to be separated from the wire lumen during device analysis.Due to the condition of the device received and the distal tip not being returned, visual analysis could not determine if the correct amount of adhesive was applied throughout the entire section between the wire lumen and the tip.Therefore, it was determined by the pet team that the tip separation failure may potentially be manufacturing related as the physical analysis could not 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 risk assessment has been initiated for further investigation.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

• Brand Name: PRECISE PRO RX 9X30
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11399900
• MDR Text Key: 234285571
• Report Number: 9616099-2021-04310
• 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,Followup,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PC0930XCE
• Device Catalogue Number: PC0930XCE
• Device Lot Number: 17932849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK.
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 68