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

Model Number PC0740XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 09/16/2021

Event Type  malfunction  

Event Description

During a carotid stent implantation, a 7mm x 40mm precise pro rapid exchange (rx) self-expanding stent delivery system could not be released after reaching the lesion.The procedure was completed using another unknown product.There was no reported patient injury.The patient had a history of hypertension and hyperlipidemia.Blood routine examination was normal and physical examination was acceptable.The ultrasound and the ct showed that part of the left internal carotid artery was severely stenosed.An cordis 8f short sheath, a common and hard unknown loach guidewire, an unknown 5f pigtail catheter, an unknown sim 1 contrast catheter, a non-cordis guidewire, and an unknown 8f guide catheter were used in the procedure.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the instructions for use (ifu).The user is trained with the device.The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use along with an 8f unknown guiding catheter.The intended lesion was at the carotid bifurcation.The internal carotid artery (ica) was 32mm long and 5.5mm in diameter, and the diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion had 85% stenosis with moderate calcification and mild tortuosity.The stent delivery system did not pass through any acute bends.A contralateral approach was used.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was pre-dilated prior to stent implantation with a cordis 4mmx4cm balloon catheter, inflated to 10 atmospheres.The lesion was 65% stenosed after pre-dilation.A 1:1 contrast to heparinized saline ratio was used.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The user maintained a fixed inner shaft position during deployment.The procedure was completed using another unknown product.The device was later returned for evaluation.Addendum: visual analysis during product evaluation revealed the stent of the unit was observed deployed approximately 2.1 cm.

Manufacturer Narrative

The product history review is expected but has not been completed.This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Complaint conclusion: during a carotid stent implantation, a 7mm x 40mm precise pro rapid exchange (rx) self-expanding stent delivery system could not be released after reaching the lesion.The procedure was completed using another unknown product.The patient had a history of hypertension and hyperlipidemia.Blood routine examination was normal and physical examination was acceptable.The ultrasound and the ct showed that part of the left internal carotid artery was severely stenosed.A cordis 8f short sheath, a common and hard unknown loach guidewire, an unknown 5f pigtail catheter, an unknown sim 1 contrast catheter, a non-cordis guidewire, and an unknown 8f guide catheter were used in the procedure.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored and handled according to the instructions for use (ifu).The user is trained with the device.The product was inspected and prepped according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.Along with an 8f unknown guiding catheter.The intended lesion was at the carotid bifurcation.The internal carotid artery (ica) was 32mm long and 5.5mm in diameter, and the diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion had 85% stenosis with moderate calcification and mild tortuosity.The stent delivery system did not pass through any acute bends.A contralateral approach was used.There was no difficulty encountered while advancing/tracking the sds towards the lesion.There was no unusual force used at any time during the procedure.There was no thrombus present proximal to, at, or distal to the lesion site.The lesion was pre-dilated prior to stent implantation with a cordis 4mmx4cm balloon catheter, inflated to 10 atmospheres.The lesion was 65% stenosed after pre-dilation.A 1:1 contrast to heparinized saline ratio was used.There was no difficulty or resistance noted while crossing the lesion with the stent.The sds did not have to pass through a previously placed stent.The user maintained a fixed inner shaft position during deployment.The procedure was completed using another unknown product.Addendum: visual analysis during product evaluation revealed the stent of the unit was observed deployed approximately 2.1 cm.There was no reported patient injury.The device was returned for analysis.One non-sterile precise pro rx 7x40 was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received closed.Per visual analysis, the stent of the unit was observed deployed approximately 2.1 cm.The hypo tube rod of the unit was observed slightly bent, as received.No other anomalies were observed.Per dimensional analysis, the stroke length of the stent delivery system was measured against the precise pro rx packaging assembly specification and the results were found within specification.Per functional analysis, deployment test of the stent was performed successfully; neither resistance nor any anomalies were observed during the test.No damages were observed on the stent.A product history record (phr) review of lot 17925700 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)-ses - deployment difficulty ¿ unable¿ was not confirmed since deployment test of the stent was performed successfully; neither resistance nor any anomalies were observed during the test.Stroke length dimensional analysis was performed, and the results were found within specification.The reported "stent delivery system (sds)-ses - deployment difficulty - partial deployment" was confirmed since the unit was received deployed approximately 2.1 cm.However, the cause of the partially deployed unit and the bent hypo tube rod observed on the unit as received, could not be conclusively determined.Per the instructions for use (ifu) ¿preparation of stent delivery system- caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.¿ procedural and or handling factors such as the user¿s interaction with the device during use as well as vessel characteristics may had led to the reported events.Additionally, the hemostasis valve was returned tightly closed, per analysis.Indicating that the end user manipulated the device.Neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX 7X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13061024
• MDR Text Key: 290277372
• Report Number: 9616099-2021-05220
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: PC0740XCE
• Device Catalogue Number: PC0740XCE
• Device Lot Number: 17925700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2020
• 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: A COMMON AND HARD UNKNOWN LOACH GUIDEWIRE; A CORDIS 8F SHORT SHEATH,; A NON-CORDIS GUIDEWIRE; AN 8F UNKNOWN GUIDE CATHETER; AN UNKNOWN 5F PIGTAIL CATHETER; AN UNKNOWN SIM 1 CONTRAST CATHETER; CORDIS AVIATOR BALLOON, 4MMX4CM; HEPARINIZED SALINE; IODIXANOL CONTRAST; OTHER UNKNOWN PRODUCT
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 60 KG