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

Catalog Number PC1030RXC

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2018

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.A review of the manufacturing documentation associated with lot 17732301 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, precise pro rx was attempted to be removed after implantation, however there was resistance felt.When the precise pro was removed it was observed that the shaft of the complaint precise pro was separated.There were no reported patient injuries.This was a carotid artery stenting (cas) case.A pre dilation was performed with a non- cordis sheath, a non-cordis filter wire (3.5-5.0mm) and an aviator (4.5*30mm).A post dilation was attempted to be performed with an aviator (5.0*30mm) but it could not because there was strong resistance felt between the filter wire.So, the filter wire was removed with a non-cordis catheter because a non-cordis guide extension catheter could not be inserted.It was confirmed that the distal end of the complaint precise pro was removed with the filter wire.The physician confirmed that no fragments remained inside the patient body.The procedure was completed after hemostasis was achieved by using a non-cordis hemostasis device.

Manufacturer Narrative

During a carotid artery stenting procedure, precise pro rx stent delivery system was attempted to be removed after stent implantation, however there was resistance felt.When the precise pro was removed it was noted that the shaft of the precise pro was separated.There were no reported patient injuries.A pre-dilation was performed with a non- cordis sheath, a non-cordis filter wire (3.5-5.0mm) and an aviator (4.5*30mm).A post dilation was attempted to be performed with an aviator (5.0*30mm) but it could not because there was strong resistance felt between the filter wire.So, the filter wire was removed with a non-cordis catheter because a non-cordis guide extension catheter could not be inserted.It was confirmed that the distal end of the complaint precise pro was removed with the filter wire.The physician confirmed that no fragments remained inside the patient body.The procedure was completed after hemostasis was achieved by using a non-cordis hemostasis device.No other information was reported.The device was returned for analysis.One non-sterile precise pro rx us carotid syst along with an unknown snare wire were received for analysis inside a plastic bag.Per visual analysis, the inner shaft of the device was received separated / trapped inside the unknown snare wire.Elongations and frayed edges were noted on the separated inner shaft of the device.The stent of the device was not received, and the hemostasis valve was received closed.One kink was found on the shaft of the device at 3.0cm from the tip of the outer member.No other anomalies found.Per microscopic analysis, the separated section of the precise inner shaft presented with evidence of elongations, ductile dimples and a plastic deformation that led to the material separation.The available evidence can suggest a tensile overload or an application of stress that exceeded the material yield strength prior to the separation.Also, ductile dimples and reverse bending, as well the material thickness reduction are related to stretching/pulling events.No other anomalies were found during the sem analysis.A product history record (phr) review of lot 17732301 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The event reported by the customer as¿ stent delivery system (sds)-ses-withdrawal difficulty - from vessel ¿was not confirmed since it could not be evaluated due to the nature of the complaint itself.However, the event reported by the customer as ¿inner shaft-separated - in patient ¿was confirmed due to the separated condition of the inner shaft as received.Nonetheless, the exact cause of the separated condition of the inner shaft of the unit could not be conclusively determined during the product analysis.Vessel characteristics (while unknown), as well as procedural/handling factors may have contributed to the reported events.Per the instructions for use, which is not intended as a mitigation, ¿while using fluoroscopy, withdraw the entire delivery system as one unit, over the guidewire and out of the body.Remove the delivery device from the guidewire.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.(do not remove guidewire.).Neither the phr review nor the product analysis suggest that the reported event could be related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8244084
• MDR Text Key: 132934987
• Report Number: 9616099-2019-02634
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036549
• UDI-Public: 20705032036549
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

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 Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: PC1030RXC
• Device Lot Number: 17732301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Manufacturer Received: 12/17/2018
• Initial Date FDA Received: 01/14/2019
• Supplement Dates Manufacturer Received: 02/22/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (6F GUIDE PLUS, NIPRO); (7F GUIDELINER, JAPAN LIFELINE); (ANGIO-SEAL, TERUMO).; 6F DESTINATION, TERUMO; AVIATOR (4.5*30MM); FILTER WIRE (3.5-5.0MM); (6F GUIDE PLUS, NIPRO); (7F GUIDELINER, JAPAN LIFELINE); (ANGIO-SEAL, TERUMO).; 6F DESTINATION, TERUMO; AVIATOR (4.5*30MM); FILTER WIRE (3.5-5.0MM)