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

Catalog Number	PC0730XCE
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18189178 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 or Problem Description
As reported, after inserting a 7mm x 30mm precise pro rx carotid self-expanding stent (ses) delivery system into an unknown 8f guiding sheath, the device was unable to advance past the proximal portion of the guiding sheath.Upon removal of the stent, the stent opened by itself, outside of the patient.As a result, an 8mm x 30mm precise pro rx ses delivery system was used as a replacement to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a carotid artery lesion detected via angiography.The device was stored and prepped per the instructions for use (ifu), and there was no resistance experienced while removing the device.The device will be returned for evaluation.
Event or Problem Description
As reported, after inserting a 7mm x 30mm precise pro rx carotid self-expanding stent (ses) delivery system into an unknown 8f guiding sheath, the device was unable to advance past the proximal portion of the guiding sheath.Upon removal of the stent, the stent opened by itself, outside of the patient.As a result, an 8mm x 30mm precise pro rx ses delivery system was used as a replacement to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a carotid artery lesion detected via angiography.The device was stored and prepped per the instructions for use (ifu), and there was no resistance experienced while removing the device.The device has now been returned.
Additional 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.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Complaint conclusion: as reported, after inserting a 7mm x 30mm precise pro rx carotid self-expanding stent (ses) delivery system into an unknown 8f guiding sheath, the device was unable to advance past the proximal portion of the guiding sheath.Upon removal of the stent, the stent opened by itself, outside of the patient.As a result, an 8mm x 30mm precise pro rx ses delivery system was used as a replacement to complete the procedure.There was no reported injury to the patient.This was during a procedure to treat a carotid artery lesion detected via angiography.The device was stored and prepped per the instructions for use (ifu), and there was no resistance experienced while removing the device.The device has now been returned.The device was returned for analysis.One non-sterile units of product ¿precise pro rx ous carotid sys¿ was received coiled inside of a clear plastic bag.The device was unpacked to proceed with the product evaluation.The unit was thoroughly inspected, and several kinks were found at the system.No other anomalies were noted.In addition, the hemostasis valve was closed.The device was received partially deployed.The stroke length was measured, and dimension analysis result were found within specification.Functional test was not performed, since the device was received kinked.This condition did not allow to complete the deployment.A product history record (phr) review of lot 18189178 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, since the device was received partially deployed.During the functional test, the device could not be completely deployed.In addition, several kinks were found at the catheter, it is possible that this condition could have contributed to the reported issue.The reported ¿stent delivery system (sds)-resistance/friction¿ was not confirmed.Since it was not possible to determine the failure cause due to the device returned condition.However.It is possible that the kinks found on the system may have caused the reported issue.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.¿ neither the product analysis nor the phr review suggests that the reported issue could be related to the manufacturing process; therefore, no corrective action will be taken at this time.

• Brand Name: PRECISE PRO RX OUS
• Common Device Name: 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: 17555538
• Report Number: 9616099-2023-06576
• Device Sequence Number: 12023294
• Product Code: NIM
• UDI-Device Identifier: 20705032062388
• UDI-Public: (01)20705032062388(17)250131(10)18189178
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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 Expiration Date: 01/31/2025
• Device Catalogue Number: PC0730XCE
• Device Lot Number: 18189178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2023
• Supplement Date Received by Manufacturer: 08/18/2023; 11/08/2023
• Initial Report FDA Received Date: 08/16/2023
• Supplement Report FDA Received Date: 09/12/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK 8F GUIDING
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 62 KG
• Patient Ethnicity: Non Hispanic