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

Model Number PC0540RXC

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/03/2019

Event Type  Injury  

Manufacturer Narrative

The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

During use, the shaft of the precise self expanding stent (ses) came apart as they were attempting to deliver it to the carotid.There was no patient injury.Device was stored as per instruction for use (ifu).

Manufacturer Narrative

Additional information was received and the description of the event and patient code was updated: the carotid was dissected there was no other issues.The precise ses was removed normally.Device was stored as per instruction for use (ifu).The pouch indicator was fine when opened.The device was prepped correctly and nothing unusual was seen.There was no issues tracking the device.Therefore, carotid artery dissection was added to the patient code.

Manufacturer Narrative

During use, the shaft of the precise self-expanding stent (ses) came apart as they were attempting to deliver it to the carotid.The carotid was dissected.There were no other issues.The precise ses was removed normally.Device was stored as per instruction for use (ifu).The pouch indicator was fine when opened.The device was prepped correctly and nothing unusual was seen.There was no issues tracking the device.The product was not returned for analysis.A product history record (phr) review of lot 17784884 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) separated - in patient¿ and ¿carotid artery dissection¿ could not be confirmed as the device was not returned for analysis nor were procedural images provided for review.The exact cause could not be determined.Procedural factors may have contributed to the reported event.According to the instructions for use, which is 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 nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

During use, the shaft of the precise self-expanding stent (ses) came apart as they were attempting to deliver it to the carotid.The carotid was dissected there was no other issues.The precise ses was removed normally.Device was stored as per instruction for use (ifu).The pouch indicator was fine when opened.The device was prepped correctly and nothing unusual was seen.There was no issues tracking the device.The product was returned for analysis.One non-sterile precise pro rx us carotid system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received partially locked/closed.Per visual analysis, the stent was not deployed from the device.The body of the catheter was observed separated.No other anomalies were observed.Per sem analysis the separated condition revealed irregular edges at the inner body distal tip separation.Also, the separated sections of the inner body areas revealed evidence of elongations.Elongations is a common characteristic of pieces which have been stretched or pulled until separation.The braid wires revealed plastic deformations, with twisting and diameter reductions commonly associated with ductile separations caused by material tensile overload.The available evidence may suggest an application of stress that exceeds the material yield strength or a tensile overload that led to the material separation.No other anomalies were noted.A product history record (phr) review of lot 17784884 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) - separated - in patient¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the event as evidenced by elongations and deformations noted on the device during analysis.The available evidence may suggest an application of stress that exceeds the material yield strength or a tensile overload that led to the material separation.The reported ¿carotid artery dissection¿ was not confirmed as procedural images were not provided for review.The exact cause of the event could not be determined during analysis.According to the instructions for use, which is 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
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8678239
• MDR Text Key: 147319539
• Report Number: 9616099-2019-02997
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036402
• UDI-Public: 20705032036402
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/10/2019

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: 05/31/2020
• Device Model Number: PC0540RXC
• Device Catalogue Number: PC0540RXC
• Device Lot Number: 17784884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 06/10/2019; 07/15/2019; 09/12/2019
• Supplement Dates FDA Received: 07/05/2019; 07/18/2019; 10/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 99