MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 7X40; STENT, CAROTID

Catalog Number PC0740XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2019

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 17725765 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, when the package of the precise pro rx 7*40 was opened, it was found to be prematurely released.There were no reported patient injuries.The patient was diagnosed with carotid stenosis by preoperative angiography.When the user removed the product from the packaging, it was found that it was half released.After that, the surgeon tried to withdraw the stent into the release sheath without success, and completely released the stent in vitro.Additional procedural details were requested but are unknown.

Manufacturer Narrative

Addendum for additional information received:the device was stored in the cath lab according to the instructions for use (ifu).The device was stored for less than three months.The device was stored, handled and prepped per the instructions for use.There was no difficulty experienced in prepping the device.The stent was partially released prior to inserting into the patient.The stent was partially released after removing the package.There was no unusual force used at any time.There was no difficulty removing the device from the sterile packaging.None of the stent was pre-maturely deployed.The target lesion was the left internal carotid artery.The lesion was a little calcified and was a little tortuous.There was fifty percent stenosis.The device was not used for a chronic total occlusion (cto).The procedure was completed by using another stent.As reported, when the package of the precise pro rx 7*40 was opened the stent was found to be prematurely released.There were no reported patient injuries.The patient was diagnosed with carotid stenosis by preoperative angiography.When the user removed the device from the packaging, it was found that the stent was half released.After that, the surgeon tried to withdraw the stent into the release sheath without success, and completely released the stent in vitro.The device was stored in the cath lab according to the instructions for use (ifu).The device was stored for less than three months.The device was stored, handled and prepped per ifu.There was no difficulty experienced in prepping the device.The stent was partially released prior to inserting into the patient.The stent was partially released after removing the package.There was no unusual force used at any time.There was no difficulty removing the device from the sterile packaging.The target lesion was the left internal carotid artery.The lesion was a little calcified and was a little tortuous.There was fifty percent stenosis.The device was not used for a chronic total occlusion (cto).The procedure was completed by using another stent.The device was returned for analysis.A non-sterile precise pro rx 7x40 was received inside of a clear plastic bag.Per visual inspection, the stent of the device was already deployed, and the hemostasis valve was tightly closed.The stent was not received for analysis.No damages or anomalies were noted.Functional analysis could not be carried out due to the condition in which the device was received; the product was returned with the stent already deployed.A product history record (phr) review of lot 17725765 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 reported ¿stent delivery system- deployment difficulty premature deployment¿ could not be evaluated during analysis due to the condition of the device as it was received.The product was returned with the stent already deployed.The exact cause of the reported event could not be conclusively determined during the product analysis.Procedural and handling factors may have contributed to the event reported.Per the instructions for use, which is not intended as a mitigation, ¿precise® pro rx nitinol stent system is shipped with the tuohy borst valve in the open position.Care should be taken not to pre-deploy the stent.The device should be prepped in the tray.After prep, 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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.¿ 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 7X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8320193
• MDR Text Key: 135540486
• Report Number: 9616099-2019-02696
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• 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: 09/30/2019
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 17725765
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 02/12/2019
• Supplement Dates FDA Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1