MAUDE Adverse Event Report: CORDIS US. CORP PRECISE PRO RX OUS; STENT, CAROTID

Catalog Number PC0940XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, the stent of a 9mm x 40mm 135cm precise pro rx carotid self-expanding stent (ses) delivery system was unable to be opened.The device was able to be removed easily from the patient and remained in one piece during its removal.The stent was still attached to the delivery system upon removal.A 9mm x 40mm non-cordis stent was then used as a replacement to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat an 85% stenosis of the right internal carotid (ic) artery which had moderate calcification and moderate tortuosity.A non-cordis embolic protection device was used during this procedure.The patient was sterilely draped and the ¿channel is established¿ with a non-cordis catheter sheath introducer (csi).A non-cordis balloon catheter was used to pre-dilate the ic lesion after placement of the embolic protection device.The device was stored, handled, and prepped per the instructions for use (ifu).The user maintained a fixed inner shaft position during the attempted deployment.The surgeon was trained and had extensive experience.The device will be returned for evaluation.Addendum: the device was returned with the stent partially deployed on the delivery system.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b4, d4, g3, g6, h1, h2, h3, h6, and h10 complaint conclusion: the stent of a 9mm x 40mm 135cm precise pro rx carotid self-expanding stent (ses) delivery system was unable to be opened.The device was able to be removed easily from the patient and remained in one piece during its removal.The stent was still attached to the delivery system upon removal.A 9mm x 40mm non-cordis stent was then used as a replacement to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat an 85% stenosis of the right internal carotid (ic) artery which had moderate calcification and moderate tortuosity.A non-cordis embolic protection device was used during this procedure.The patient was sterilely draped and the ¿channel is established¿ with a non-cordis catheter sheath introducer (csi).A non-cordis balloon catheter was used to pre-dilate the ic lesion after placement of the embolic protection device.The device was stored, handled, and prepped per the instructions for use (ifu).The user maintained a fixed inner shaft position during the attempted deployment.The surgeon was trained and had extensive experience.The device will be returned for evaluation.The device was returned for analysis.A non-sterile unit of ¿precise pro rx us carotid syst¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and placed at one metallic tray to be inspected.A thorough inspection was performed on the unit observing the following conditions: the device is partially deployed.The hemostasis valve was returned closed.Several kinks were observed located approximately on 27, 41, 84, 99 and 139 cm from the brite tip.Also, the hypotube steel presents a kinked condition located approximately on 12.5 cm form the proximal end.No other outstanding details were observed.The usable length was not measured due to the kinked condition.Due to the severe damages observed on the device the functional analysis was not performed to determine if the stent can be deployed as expected.A product history record (phr) review of lot 18050610 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)~deployment difficulty-partial deployment¿ was confirmed, a partial stent deployed was observed.Due to the severe damages observed on the returned device the functional test was not performed.The exact cause of these damages observed on the device could not be conclusively determined during the analysis.Procedural and/or handling factors might have contributed to this issue.According to the instructions for use (ifu) ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ the product analysis does not suggest that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX OUS
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 17560459
• MDR Text Key: 321438937
• Report Number: 9616099-2023-06577
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062456
• UDI-Public: (01)20705032062456(17)230831(10)18050610
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 18050610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/03/2021
• 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: ABBOTT'S CAROTID ARTERY DILATATION BALLOON; CORDIS CONTRAST CATHETER; MEDTRONIC'S UMBRELLA SPIDER; TERUMO VASCULAR SHEATH; UNK GUIDING CATHETER
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 26 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian