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

Catalog Number PC0840RXC

Device Problem Fracture (1260)

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

Event Date 08/30/2023

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18212752 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, after deploying the stent of an 8mm x 40mm precise pro rx carotid self-expanding stent (ses) delivery system in the right internal carotid artery, an attempt to post dilate the stent with a non-cordis 5.5mm x 20mm balloon catheter was made.However, the balloon catheter could not advance through the implanted stent and a stent fracture was observed.The fractured stent did not appear to be completely separated.The procedure ended after unsuccessfully crossing with the non-cordis balloon.There were no reported injuries to the patient.A 7f rain catheter sheath introducer (csi) was used for access, and a 7f non-cordis guiding catheter was used.The device will not be returned for evaluation.

Manufacturer Narrative

Compliant conclusion: after deploying the stent of an 8mm x 40mm precise pro rx carotid self-expanding stent (ses) delivery system in the right internal carotid artery, an attempt to post dilate the stent with a non-cordis 5.5mm x 20mm balloon catheter was made.However, the balloon catheter could not advance through the implanted stent and a stent fracture was observed.The fractured stent did not appear to be completely separated.The procedure ended after unsuccessfully crossing with the non-cordis balloon.There were no reported injuries to the patient.A 7f rain catheter sheath introducer (csi) was used for access, and a 7f non-cordis guiding catheter was used.The product was not returned for analysis.However, pictures were provided for analysis which indicated an unevenness in the deployed stents profile.A product history record (phr) review of lot 18212752 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent fractured¿ could not be confirmed as the device was not returned for analysis as thew stent remains implanted in the patient.The exact cause could not be determined.Procedural or handling factors or vessel characteristics (although unknown) may have contributed to the reported event.However still images provided of the procedure are suggestive of an unevenness in the deployed stent¿s profile.According to the safety information in the instructions for use, ¿recrossing a deployed stent with adjunct devices must be performed with caution.¿ according to the safety information in the instructions for use, ¿recrossing a deployed stent with adjunct devices must be performed with caution.¿ neither the phr review nor the procedural images nor the limited information provided 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
• 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: 17807163
• MDR Text Key: 324129323
• Report Number: 9616099-2023-06598
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: (01)20705032036495(17)250430(10)18212752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 18212752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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: BMX GUIDE CATHETER 7FR PENUMBRA; RAIN 7FR RADIAL SHEATH; VIATRAC 5.5 X 20M BALLOON
• Patient Age: 68 YR