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

Model Number	PC1030RXC
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, a 10mm x 30mm precise pro rx carotid self-expanding stent (ses) delivery system was being used to treat a carotid lesion but did not deploy normally.As a result, the patient was sent to surgery.The delivery system will be returned without the stent attached.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17976284 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.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b3, d8, d9, g3, g4, g6, h1, h2, h3, h6, and h10.A review of the manufacturing documentation associated with lot 17976284 presented no issues during the manufacturing process that can be related to the reported event.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.
Event or Problem Description
As reported, a 10mm x 30mm precise pro rx carotid self-expanding stent (ses) delivery system was being used to treat a carotid lesion but did not deploy normally.As a result, the patient was sent to surgery.Additional information was requested but was not provided.The delivery system will be returned without the stent attached.
Additional Manufacturer Narrative
This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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: a 10mm x 30mm precise pro rx carotid self-expanding stent (ses) delivery system was being used to treat a carotid lesion but did not deploy normally.As a result, the patient was sent to surgery.Additional information was requested but was not provided.The product was returned for analysis.A non-sterile unit of precise pro rx us carotid system was received for analysis coiled inside of a clear plastic bag.Per visual analysis the stent was fully deployed and was not returned.Kinks were noted on the distal tip.A segment of unknown material which are not used on the manufacturing process was also found inside the bag.It was not possible to identify the unknown material.The hemostasis valve was received tightly closed.No other damages or anomalies were noted.Per dimensional analysis the stroke length of the stent delivery system was measured and verified to be within specification.Functional analysis was not performed due to the unit was returned fully deployed.However, the deploying mechanism was manually actuated, and no anomalies were noted.The unknown material was analyzed with a ft-ir equipment and compared with a lab sample control with the following results.Ftir analysis conclusion: the pieces are made from different materials; the inner section of the outer member is composed of ptfe and the transparent piece is composed of polyamide.A product history record (phr) review of lot 17976284 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¿ was not confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.The stent was fully deployed and was not returned for analysis.However, a kinked condition was observed close to the distal tip.The pieces of plastic returned with the device were not part of the precise pro device returned.The exact cause of these damages could not be conclusively determined during the analysis.Procedural and/or handling factors might have contributed to this issue due to the presence of a kink on the device.According to the instructions for use, which are 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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• 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: 15128484
• Report Number: 9616099-2022-05855
• Device Sequence Number: 6603695
• Product Code: NIM
• UDI-Device Identifier: 20705032036549
• UDI-Public: (01)20705032036549(17)220831(10)17976284
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 10/19/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: PC1030RXC
• Device Catalogue Number: PC1030RXC
• Device Lot Number: 17976284
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2022
• Supplement Date Received by Manufacturer: 08/02/2022; 09/04/2022; 10/10/2022
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/26/2022; 09/30/2022; 10/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2020
• 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: UNKNOWN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown