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

Catalog Number PC0830RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  Injury  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.  the product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during an interventional endovascular procedure, after deployment the precise pro rx 8 x 30 stent was reported to not cover the target lesion fully due to jumping.Another stent was deployed successfully to fully cover the target lesion.There was no reported patient injury.The product will be returned for inspection.

Manufacturer Narrative

During an interventional endovascular procedure, after deployment the precise pro rx 8 x 30 stent was reported to not cover the target lesion fully due to ¿jumping¿.A second stent was deployed successfully to fully cover the target lesion.There was no reported patient injury.Multiple attempts were made to obtain additional information and have the product returned for inspection; however, they were unsuccessful.No additional information is available.The product was not returned for analysis.A device history record (dhr) review of lot 17620064 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-deployment difficulty-inaccurate placement¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics are unknown.According to the instructions for use ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.Under fluoroscopic guidance, position the distal stent markers distal to the target lesion and proximal placement marker proximal to the target lesion.Straighten the proximal part of the delivery system as much as possible and keep the handle in a stable position.The tuohy borst valve on the handle must be loosened to allow free movement of the pusher tube.Deploy the stent.Stent deployment must be performed under fluoroscopic guidance.Grip the outer sheath and handle with one hand and the pusher tube with the other.Move the outer sheath proximally relative to the pusher tube, while holding the pusher tube in a fixed position.The position of the delivery system may need to be adjusted to keep the distal stent markers at the appropriate location.Once the distal end of the stent starts to deploy continue to retract the proximal outer sheath and handle while holding the pusher tube still until the stent is fully deployed and the proximal stent markers have expanded.Note: the proximal placement marker may move during the stent deployment and may not coincide with the location of the proximal stent markers after deployment.If resistance is felt during retraction of the outer sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ neither the dhr not the information available suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

Complaint conclusion amended: during an interventional endovascular procedure, after deployment the precise pro rx 8 x 30 stent was reported to not cover the target lesion fully due to ¿jumping¿.A second stent was deployed successfully to fully cover the target lesion.There was no reported patient injury.Multiple attempts were made to obtain additional information and have the product returned for inspection; however, they were unsuccessful.No additional information is available.One non-sterile precise pro rx us carotid syst catheter was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received open.Per visual analysis, neither a kink nor compression that could cause a deployment difficulty was observed.The unit was received already deployed.The stent was not returned for analysis.No anomalies found.The precise pro rx us carotid syst usable length was measured per drawing (b)(4) rev: 2 and results were found within specification.Functional test was not performed due to the already deployed condition of unit received.A device history record (dhr) review of lot 17620064 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system-deployment difficulty-inaccurate placement¿ could not be confirmed through analysis of the returned device as the unit was received with the stent deployed.The exact cause could not be determined.Vessel characteristics are unknown.Patient factors such as vessel tortuosity or calcification and possibly handling factors may have contributed to the reported event.According to the instructions for use ¿advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.Under fluoroscopic guidance, position the distal stent markers distal to the target lesion and proximal placement marker proximal to the target lesion.Straighten the proximal part of the delivery system as much as possible and keep the handle in a stable position.The tuohy borst valve on the handle must be loosened to allow free movement of the pusher tube.Deploy the stent.Stent deployment must be performed under fluoroscopic guidance.Grip the outer sheath and handle with one hand and the pusher tube with the other.Move the outer sheath proximally relative to the pusher tube, while holding the pusher tube in a fixed position.The position of the delivery system may need to be adjusted to keep the distal stent markers at the appropriate location.Once the distal end of the stent starts to deploy continue to retract the proximal outer sheath and handle while holding the pusher tube still until the stent is fully deployed and the proximal stent markers have expanded.Note: the proximal placement marker may move during the stent deployment and may not coincide with the location of the proximal stent markers after deployment.If resistance is felt during retraction of the outer sheath, do not force deployment.Carefully withdraw the stent system without deploying the stent.Neither the dhr nor the analysis of the device suggest a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

Manufacturer Narrative

Additional information: the product was returned for inspection.Additional information will be submitted within 30 days upon receipt.

Event Description

As reported, during an interventional endovascular procedure, after deployment the precise pro rx 8 x 30 stent was reported to not cover the target lesion fully due to jumping.Another stent was deployed successfully to fully cover the target lesion.There was no reported patient injury.Multiple attempts to obtain additional information were unsuccessful.No additional information is available.Addendum: the product was returned for inspection.

• 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
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6721664
• MDR Text Key: 80308044
• Report Number: 9616099-2017-01252
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/29/2017

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: 10/31/2018
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 17236183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/27/2017
• Initial Date Manufacturer Received: 06/27/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 08/02/2017; 08/21/2017; 09/13/2017
• Supplement Dates FDA Received: 08/02/2017; 09/01/2017; 09/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2016
• 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
• Patient Outcome(s): Life Threatening; Required Intervention