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

Model Number	PC1040RXC
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 17603341 presented no issues during the manufacturing process that can be related to the reported event.   this device is available for analysis but has not yet been received.  additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
It was reported that a precise stent was attempted to be deployed after pre-dilatation, however it was unable to be deployed under fluoroscopy even though the outer sheath was withdrawn and the inner shaft was fixed.There was no reported patient injury.The patient¿s information was unknown.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification were unknown.The rate of stenosis was unknown.The device was stored and handled according to the instructions for use (ifu).There were no anomalies noted when removed from the package.The device was prepped per the ifu and there were no anomalies noted during prep.When the system was removed from the patient, it was confirmed that the stent shaft was separated.The device was replaced with another one of a smaller size and the procedure was completed successfully.The product was clinically used and will be returned for analysis.Additional procedural details were requested but are unknown.
Additional Manufacturer Narrative
A precise stent was attempted to be deployed after pre-dilatation; however it was unable to be deployed under fluoroscopy even though the outer sheath was withdrawn and the inner shaft was fixed.There was no reported patient injury.The patient¿s information is unknown.The target lesion is unknown.The patient¿s vessel level of tortuosity and calcification are unknown.The rate of stenosis is unknown.The device was stored and handled according to the instructions for use (ifu).There were no anomalies noted when removed from the package.The device was prepped per the ifu and there were no anomalies noted during prep.When the system was removed from the patient, it was confirmed that the stent shaft was separated.The device was replaced with another one of a smaller size and the procedure was completed successfully.Additional procedural details were requested but are unknown.The product was not returned for analysis.A device history record (dhr) review of lot 17603341 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¿ and ¿stent delivery system (sds)-ses separated - in patient¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Vessel characteristics, although unknown, may have contributed to the reported event as calcification and tortuosity may damage the devices or encourage the use of excessive force to deliver them to the target lesion.According to the instructions for use ¿slack removal.Advance the stent delivery system past the lesion site.Pull back the stent delivery system until the radiopaque inner shaft markers (leading and trailing ends) move in position so that they are proximal and distal to the target lesion.Ensure the device outside the patient remains flat and straight.Caution: slack in the catheter shaft either outside or inside the patient may result in deploying the stent beyond the lesion site.Stent deployment.Note: when ready to proceed with stent deployment, heparin may be administered per standard hospital practice or as prescribed by a physician.Heparin may be continued following stent deployment if so indicated by a physician or hospital protocol.A.Verify that the delivery system's radiopaque inner shaft markers (leading and trailing ends) are proximal and distal to the target lesion.Unlock the tuohy borst valve connecting the inner shaft and outer sheath of the delivery system.Ensure that the access sheath or guiding catheter does not move during deployment.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.Note: the mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6404847
• Report Number: 9616099-2017-00968
• Device Sequence Number: 913816
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17603341
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/17/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1