MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During a carotid artery stenting (cas) case, an 8x40mm precise pro rxself expanding stent was implanted but an unknown filter wire got stuck on the strut of the stent.It was unable to cover the lesion therefore, a non-cordis stent was implanted, ¿covering the strut part.¿ the procedure completed.There was no reported patient injury.The sales rep cannot visit the hospital because of the covid-19.Therefore, additional information cannot be obtained.The device will not be returned because it was implanted.
Additional Manufacturer Narrative
During a carotid artery stenting (cas) case, an 8x40mm precise pro rx self expanding stent was implanted but an unknown filter wire got stuck on the strut of the stent.It was unable to cover the lesion therefore, a non-cordis stent was implanted, ¿covering the strut part.¿ the procedure completed.The sales rep cannot visit the hospital because of the covid-19.Therefore, additional information cannot be obtained.There was no reported patient injury.The device was not returned because it was implanted.A product history record (phr) review of lot 18042555 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 ¿stent-ses~ migration¿ was not confirmed.It is difficult to draw a clinical conclusion between the device and the event based on the information available.However, it is probable to consider that the user¿s interaction with the device and the ¿unknown filter wire¿ as well as vessel characteristics (although unknown) may have contributed to the reported event.According to the instructions for use (ifu) ¿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.(do not remove guidewire.) neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13541475
• Report Number: 9616099-2022-05349
• Device Sequence Number: 17073772
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: (01)20705032036495(17)230731(10)18042555
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: N/A
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 18042555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/16/2022
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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 FILTER WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown