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

Model Number PC1040RXC

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing documentation associated with lot 17591134 was performed and it was found that no defective units were rejected during the final assembly of this lot.No other issues were noted that were considered potentially related to the reported complaint.Device evaluation anticipated, but not yet begun.Additional information will be submitted within 30 days of receipt.

Event Description

During a stenting procedure to an unknown lesion, it was reported that a precise pro us carotid system was delivered to the lesion and the physician attempted to deploy the stent.However, the delivery system was stiff and could not deploy the stent.So, the user applied some force to deploy the stent.Then the junction separated.Therefore, the system and the separated part were all removed from the patient.Another non-cordis stent was inserted but failed to cross the lesion.Therefore, the procedure was completed with plain old balloon angioplasty (poba).The procedure was completed successfully.There was no reported patient injury.The product will be returned for analysis.The patient¿s vessel level of calcification was unknown.The lesion was heavily tortuous.The rate of stenosis was unknown.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.No procedural cd or films are available for review.No additional information is available.

Manufacturer Narrative

The sections were updated on this report.During a stenting procedure to an unknown lesion, it was reported that a precise pro rx carotid system was delivered to the lesion and the physician attempted to deploy the stent.However, the delivery system was stiff and could not deploy the stent.The user then applied some force to deploy the stent.The junction separated.Therefore, the system and the separated part were all removed from the patient.Another non-cordis stent was inserted but failed to cross the lesion.Therefore, the procedure was completed with plain old balloon angioplasty (poba).The procedure was completed successfully.There was no reported patient injury.The product will be returned for analysis.The patient¿s vessel level of calcification was unknown.The lesion was heavily tortuous.The rate of stenosis was unknown.There were no anomalies noted when removed from the package.There were no anomalies noted during prep.No procedural cd or films are available for review.No additional information is available.One non-sterile unit of an precise pro rx carotid system was received for analysis coiled inside a plastic bag.Per visual analysis, the outer member was received separated at 21 cm from distal end.The stent was received inside the unit (not deployed).A kink was observed at 6 cm from the precise distal end, just at the proximal end of the stent location.Dried blood residues were observed on the unit.No other anomalies were found.Functional analysis could not be performed due to the condition the device was received in (outer member separation).The unit was sent to sem analysis; results showed that the outer body as well as guide wire lumen separated sections presented evidence of plastic deformation, elongations and frayed edges.These characteristics suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.A meeting was held with the pet and after unit analysis it was concluded that the reported complaint is not related to the manufacturing process.A device history record (dhr) review of lot 17591134 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿stent delivery system (sds)-ses - deployment difficulty - unable and ¿stent delivery system (sds)-ses- separated - in patient¿ were confirmed as the product was received.The cause of the stent deployment difficulty was related to the kink located on the stent distal section which might prevent the stent deployment.The cause of the stent delivery system separated - in patient might be related to an excess force applied during the stent deployment attempt as per sem results.The exact cause of the device kinked condition could not be conclusively determined; however, it appears to be related to the procedural\handling factors as per failure mode test findings.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: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6992730
• MDR Text Key: 91228399
• Report Number: 9616099-2017-01540
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17591134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/06/2017
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2016
• 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