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

Model Number PC1040RXC

Device Problems Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

The product is being returned for analysis, however has not yet been received.A device history record (dhr) review of revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.

Event Description

During a carotid artery stenting (cas) procedure, a guiding catheter was delivered to the common carotid artery, and a pre-dilatation was done.A precise pro rx us carotid system (9 mm*40 mm precise pro) was deployed proximal at the bifurcation lesion of the left common carotid artery to the inner carotid artery without any issue.Another precise pro was delivered distal to the common carotid artery and the inner carotid artery through the newly deployed stent.However, when the stent was deployed a couple of centimeters, an outer sheath separation occurred and it could not be deployed further.According to the physician, there was resistance when releasing the stent and it was harder than usual.The physician attempted to advance the guiding catheter over the precise pro in order to cover up the partially deployed stent and remove the whole stent delivery system together with the guiding catheter; however, it could not be retracted.A snare catheter was inserted so that it could hold the outer sheath and deploy the rest of the stent, but it was too slippery to capture the outer sheath.After an hour and half of attempt, the snare catheter captured the outer sheath and the stent was deployed.No dissection occurred.The target lesion was not covered by the stent, therefore, a non-cordis (protege, covidien) stent was deployed in the target lesion.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The patient¿s information was unknown.The target lesion was from the left common carotid artery to the inner carotid artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.

Manufacturer Narrative

Complaint conclusion: during a carotid artery stenting (cas) procedure, a guiding catheter was delivered to the common carotid artery, and a pre-dilatation was done.A precise pro rx us (9mmx40mm) carotid system was deployed proximal at the bifurcation lesion of the left common carotid artery to the inner carotid artery without any issue.Another precise pro rx (10mmx40mm) was delivered distal to the common carotid artery and the inner carotid artery through the newly deployed stent.However, when the stent was deployed a couple of centimeters, an outer sheath separation occurred and it could not be deployed further.There was no reported patient injury.According to the physician, there was resistance when releasing the stent and it was harder than usual.The physician attempted to advance the guiding catheter over the precise pro in to cover up the partially deployed stent and remove the whole stent delivery system together with the guiding catheter; however, it could not be retracted.A snare catheter was inserted so that it could hold the outer sheath and deploy the rest of the stent, but it was too slippery to capture the outer sheath.After an hour and half of attempt, the snare catheter captured the outer sheath and the stent was deployed.No dissection occurred.The target lesion was not covered by the stent, therefore, a non-cordis stent was deployed in the target lesion.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The patient¿s information was unknown.The target lesion was from the left common carotid artery to the inner carotid artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A non-sterile unit of a precise pro rx 10x40 was received for analysis along with a snare system coiled inside a plastic bag.Per visual analysis, the snare system was observed kinked, twisted and accordioned all over its length.The precise pro rx 10x40 was received in three separated pieces with the snare system attached to the distal outer member section of unit.The brite distal tip was found frayed/ split/ torn.The unit was observed deployed (no stent returned) and the hemostasis valve was received open.Also, it could be observed that the hub of unit was cut from the hypo tube as well as the outer member was torn/separated approximately 10 cm from id band.The precise proximal outer member was found separated at 22.0 cm from brite tip.The separated proximal outer member was not returned for analysis, precisely, the polyamide proximal component that fuses with pod and grilamid was missing.Process machinery maintenance and calibration verification records were reviewed and no anomalies were found during manufacturing process of lot 17453660.Pull test outcomes were revised during the dhr review and all results were found as ¿pass¿ for lot 17453660.Pull test fpi/lpi results & parameters were reviewed and found to pass for lot 17453660.Per microscopic analysis, the separated sections of unit were reviewed under vision system.Evidence of elongations and plastic deformation on frayed edges found.These characteristics are evident of application of a tension force that induced the separation.No other issues were noted during microscopic analysis.A device history record (dhr) review of lot 17453660 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.It is concluded that the root cause related to the observed event condition cannot be associated to the manufacturing process of the involved unit.The events reported by the customer as ¿stent delivery system (sds)-ses- withdrawal difficulty - from vessel¿, ¿outer sheath- separated - in patient¿ and ¿stent delivery system (sds)-ses- deployment difficulty - partial deployment¿ were confirmed due to the precise separated condition as received.The exact cause of the separated condition of unit could not be conclusively determined during the analysis.Based on the information available for review, procedural or handling factors may have contributed to the separation as evidenced by elongations and frayed edges noted on the outer member during analysis which are indicative of excessive force being applied to the device.The product information for safety warns that during use, once the stent is already deployed, even at the minimum length, it cannot be retracted, otherwise the device is subject to suffer damage.If excessive force causing stretching continues, separation of the device may occur.Neither the dhr 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.

Manufacturer Narrative

Corrected section brand name and product code per additional information received.Complaint conclusion: during a carotid artery stenting (cas) procedure, a guiding catheter was delivered to the common carotid artery, and a pre-dilatation was done.A precise pro rx us carotid system (9 mm*40mm precise pro) was deployed proximal at the bifurcation lesion of the left common carotid artery to the inner carotid artery without any issue.Another precise pro was delivered distal to the common carotid artery and the inner carotid artery through the newly deployed stent.However, when the stent was deployed a couple of centimeters, an outer sheath separation occurred and it could not be deployed further.According to the physician, there was resistance when releasing the stent and it was harder than usual.The physician attempted to advance the guiding catheter over the precise pro in order to cover up the partially deployed stent and remove the whole stent delivery system together with the guiding catheter; however, it could not be retracted.A snare catheter was inserted so that it could hold the outer sheath and deploy the rest of the stent, but it was too slippery to capture the outer sheath.After an hour and half of attempt, the snare catheter captured the outer sheath and the stent was deployed.No dissection occurred.The target lesion was not covered by the stent, therefore, a non-cordis (protege, covidien) stent was deployed in the target lesion.There was no reported patient injury.The product was clinically used and it will be returned for analysis.The patient¿s information was unknown.The target lesion was from the left common carotid artery to the inner carotid artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.A non-sterile unit of a precise pro rx carotid system was received for analysis along with a snare system coiled inside a plastic bag.Per visual analysis, the snare system was observed kinked, twisted and accordioned all over its length.The precise pro rx carotid was received in three separated pieces with the snare system attached to the distal outer member section of unit.The brite distal tip was found frayed/ split/ torn.The unit was observed deployed (no stent returned) and the hemostasis valve was received open.Also, it could be observed that the hub of unit was cut from the hypo tube as well as the outer member was torn/separated approximately 10 cm from id band.The precise proximal outer member was found separated at 22.0 cm from brite tip.The separated proximal outer member was not returned for analysis, precisely, the polyamide proximal component that fuses with pod and grilamid was missing.Process machinery maintenance and calibration verification records were reviewed and no anomalies were found during manufacturing process of lot 17453660.Pull test outcomes were revised during the dhr review and all results were found as ¿pass¿ for lot 17453660.Pull test fpi/lpi results & parameters were reviewed and found to pass for lot 17453660.Per microscopic analysis, the separated sections of unit were reviewed under vision system.Evidence of elongations and plastic deformation on frayed edges found.These characteristics are evident of application of a tension force that induced the separation.No other issues were noted during microscopic analysis.A device history record (dhr) review of lot 17453660 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.It is concluded that the root cause related to the observed event condition cannot be associated to the manufacturing process of the involved unit.The events reported by the customer as ¿stent delivery system (sds)-ses- withdrawal difficulty - from vessel¿, ¿outer sheath- separated - in patient¿ and ¿stent delivery system (sds)-ses- deployment difficulty - partial deployment¿ were confirmed due to the precise separated condition as received.The exact cause of the separated condition of unit could not be conclusively determined during the analysis.Based on the information available for review, procedural or handling factors may have contributed to the separation as evidenced by elongations and frayed edges noted on the outer member during analysis which are indicative of excessive force being applied to the device.The product information for safety warns that during use, once the stent is already deployed, even at the minimum length, it cannot be retracted, otherwise the device is subject to suffer damage.If excessive force causing stretching continues, separation of the device may occur.Neither the dhr 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 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 60th ave; miami lakes, FL 33014
• MDR Report Key: 6767017
• MDR Text Key: 81820616
• Report Number: 9616099-2017-01294
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2018

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: 02/28/2018
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17453660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2017
• Initial Date FDA Received: 08/04/2017
• Supplement Dates Manufacturer Received: 07/12/2017; 09/14/2017
• Supplement Dates FDA Received: 08/30/2017; 01/31/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• 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
• Treatment: UNKNOWN SNARE CATHETER