MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X40; STENT, CAROTID

Catalog Number PC0940XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/29/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17900178) 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, while using a 9 x 40 precise pro rapid exchange (rx) for carotid artery stenting (cas) surgery, the surgeon found that the stent was released external of the patient's body.The device damaged was noted during preparation (flushing).There was no patient injury reported.The target lesion was the proximal tip of internal carotid artery.The vessel level of calcification is severe.The vessel level of angulation and tortuosity is none.The vessel percentage of stenosis is 70%.The device was stored and handled per the instructions for use (ifu).The device was opened in sterile field.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.The device was prepped according to instructions for use (ifu).There was an anomaly noted while device was prepped as the stent was partially deployed.There was no unusual force used at any time during the procedure.The device was not used in patient.The device will be returned for analysis.

Manufacturer Narrative

While using a precise pro 9mm x 40mm rapid exchange (rx) for carotid artery stenting (cas) surgery, the surgeon found that the stent was released external of the patient's body.The device damage was noted during preparation (flushing).The target lesion was the proximal tip of internal carotid artery.The vessel level of calcification is severe.The vessel level of angulation and tortuosity is none.The vessel percentage of stenosis is 70%.The device was stored and handled per the instructions for use (ifu).The device was opened in sterile field.There was no difficulty removing the stylet or any of the sterile packaging components.There was no difficulty removing the product from the hoop.The device was prepped according to instructions for use (ifu).There was an anomaly noted while device was prepped as the stent was partially deployed.There was no unusual force used at any time during the procedure.The device was not used in patient.There was no patient injury reported.The product was returned for analysis.One non-sterile precise pro rx 9x40 stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received partially locked.Per visual analysis, stent was observed deployed from the unit approximately 4 mm.No other anomalies were observed.Per functional analysis, deployment test was performed successfully; neither resistance nor any anomalies were observed during the test.No damages were observed on the stent.A product history record (phr) review of lot 17900178 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)-ses - deployment difficulty - premature/during prep¿ was confirmed since the stent was observed deployed approximately 4 mm from the unit, as received.However, deployment test was performed successfully; neither resistance nor any anomalies were observed during the test.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¿.The hemovalve of the precise pro rx is shipped in the open position.If the prepping instructions are not properly followed and the valve is not closed prior to removal from the tray it is possible to pre-maturely deploy the stent or to start stent deployment while still in the tray or during removal from the tray.It is possible that the operator's interaction with the sds may have contributed to the reported event if these steps were not followed correctly.Rough shipping/handling conditions may also have had an impact on the event.Nevertheless, the cause of the premature deployment observed on the unit, could not be conclusively determined.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 9X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10323928
• MDR Text Key: 200380536
• Report Number: 9616099-2020-03803
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

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: 09/30/2021
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17900178
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 07/28/2020
• Supplement Dates FDA Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1