MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISEPRO RX US CAROTID SYSTE; STENT, CAROTID

Model Number PC0730RXC

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2017

Event Type  malfunction  

Manufacturer Narrative

During deployment of the precise pro rx us carotid system stent, there was significant resistance and the stent delivery system broke (the delivery system cracked) while attempting to appropriately deliver the stent to the proper location.A different precise pro system was used to complete the procedure.During deployment the physician felt resistance and then felt none.The stent was not deployed but the part pinned was at the rotating hemostatic valve (rhv).Out of an abundance of caution, the physician removed the device and discovered that the delivery system had broken (cracked).The physician took a different precise pro carotid stent and completed the case without incident.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).The device was prepped appropriately.The physician is familiar with the device and performed all prep task appropriately.There wasn't anything unusual noted about the stent delivery system prior to use.The intended procedure/target lesion was the carotid artery; however the lesion characteristics are unknown.When removed from the tray, the stent was still constrained within the outer member/sheath.The following information is unknown: if the tuohy borst (hemostasis) valve was in the open or closed position when received; if the temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible; the sheath introducer brand and size, the guiding catheter brand and size; if the stent delivery system (sds) pass through any acute bends; if the delivery of the sds to the lesion ipsilateral or contralateral; if any unusual force used at any time during the procedure; if the sds have to pass through a previously placed stent; if there was any difficulty advancing the sds over the guidewire or the embolic protection device; the location where the difficulty occurred.The product was returned for analysis.One non-sterile units of precise pro rx us carotid system was returned.Per visual analysis the hemovalve was returned opened.The stent was not deployed and the outer body was found separated at 21.9cm from the outer member brite tip.A kink or bent condition was found on the device at 12.8cm from the outer member brite tip.No other damages were noted.Functional analysis was not performed due to the separated condition found on the outer body of the device.Per dimensional analysis the od and id were measured adjacent to the separated condition and results were found within specification.The stroke length could not be measured due to the separated condition on the outer body.Per sem analysis of the separated section of the proximal outer member (polyamide), the distal section of the outer member shows a twisted or ripped condition that indicates elongation at the point of material rupture.Elongation is a common characteristic of pieces which were stretched or pulled until separation.There was also evidence of adhered or transferred material at the fused area found in some separated areas of polyamide.The available evidence may suggest that the catheter proximal outer member was fused to the catheter distal section at a certain time.A device history record (dhr) review of lot 17449576 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) - resistance/friction-outer sheath - in patient¿ and ¿stent delivery system (sds)-cracked - in patient¿ was confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) or procedural factors may have contributed to the event as evidenced by the description of resistance, the kink noted on the device and the elongations noted on the outer surface during analysis which are associated with the application of excessive force.According to the instructions for use ¿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 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.

Event Description

During deployment of the precise pro rx us carotid system stent, there was significant resistance and the stent delivery system broke (the delivery system cracked) while attempting to appropriately deliver the stent to the proper location.A different precise pro system was used to complete the procedure.During deployment the physician felt resistance and then felt none.The stent was not deployed but the part pinned was at the rotating hemostatic valve (rhv).Out an abundance of caution, the physician removed the device and discover that the delivery system had broken (cracked).The physician took a different precise pro carotid stent and completed the case without incident.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).The device was prepped appropriately.The physician is familiar with the device and performed all prep task appropriately.There wasn't anything unusual noted about the stent delivery system prior to use.The intended procedure/target lesion was the carotid artery, however the lesion characteristics are unknown.When removed from the tray, the stent was still constrained within the outer member/sheath.The following information is unknown: if the tuohy borst (hemostasis) valve was in the open or closed position when received; if the temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible; the sheath introducer brand and size, the guiding catheter brand and size; if the stent delivery system (sds) pass through any acute bends; if the delivery of the sds to the lesion ipsilateral or contralateral; if any unusual force used at any time during the procedure; if the sds have to pass through a previously placed stent; if there was any difficulty advancing the sds over the guidewire or the embolic protection device; the location where the difficulty occurred.

Manufacturer Narrative

During deployment of the precise pro rx us carotid system stent, there was significant resistance and the stent delivery system broke (the delivery system cracked) while attempting to appropriately deliver the stent to the proper location.A different precise pro system was used to complete the procedure.During deployment the physician felt resistance and then felt none.The stent was not deployed but the part pinned was at the rotating hemostatic valve (rhv).Out of an abundance of caution, the physician removed the device and discovered that the delivery system had broken (cracked).The physician took a different precise pro carotid stent and completed the case without incident.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).The device was prepped appropriately.The physician is familiar with the device and performed all prep task appropriately.There wasn¿t anything unusual noted about the stent delivery system prior to use.The intended procedure/target lesion was the carotid artery; however the lesion characteristics are unknown.When removed from the tray, the stent was still constrained within the outer member/sheath.The following information is unknown: if the tuohy borst (hemostasis) valve was in the open or closed position when received; if the temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible; the sheath introducer brand and size, the guiding catheter brand and size; if the stent delivery system (sds) pass through any acute bends; if the delivery of the sds to the lesion ipsilateral or contralateral; if any unusual force used at any time during the procedure; if the sds have to pass through a previously placed stent; if there was any difficulty advancing the sds over the guidewire or the embolic protection device; the location where the difficulty occurred.The product was returned for analysis.One non-sterile units of precise pro rx us carotid system was returned.Per visual analysis the hemovalve was returned opened.The stent was not deployed and the outer body was found separated at 21.9cm from the outer member brite tip.A kink or bent condition was found on the device at 12.8cm from the outer member brite tip.No other damages were noted.Functional analysis was not performed due to the separated condition found on the outer body of the device.Per dimensional analysis the od and id were measured adjacent to the separated condition and results were found within specification.The stroke length could not be measured due to the separated condition on the outer body.Per sem analysis of the separated section of the proximal outer member (polyamide), the distal section of the outer member shows a twisted or ripped condition that indicates elongation at the point of material rupture.Elongation is a common characteristic of pieces which were stretched or pulled until separation.There was also evidence of adhered or transferred material at the fused area found in some separated areas of polyamide.The available evidence may suggest that the catheter proximal outer member was fused to the catheter distal section at a certain time.A device history record (dhr) review of lot 17449576 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) - resistance/friction-outer sheath - in patient¿ and ¿stent delivery system (sds)-cracked - in patient¿ was confirmed through analysis of the returned device.The exact cause of the events could not be determined during analysis.Based on the information available for review, vessel characteristics (although unknown) or procedural factors may have contributed to the event as evidenced by the description of resistance, the kink noted on the device and the elongations noted on the outer surface during analysis which are associated with the application of excessive force.According to the instructions for use ¿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 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: PRECISEPRO RX US CAROTID SYSTE
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014
• MDR Report Key: 6446843
• MDR Text Key: 71337115
• Report Number: 9616099-2017-01009
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036457
• UDI-Public: 20705032036457
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030047
• 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
• Report Date: 04/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2017
• 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: PC0730RXC
• Device Catalogue Number: PC0730RXC
• Device Lot Number: 17449576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/15/2017
• Date Manufacturer Received: 03/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2016
• 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