MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; PRECISE PRO RX (NIM)

Model Number	PC0840RXC
Medical Device Problem Code	Failure To Adhere Or Bond (1031)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is not available for analysis.The lot number has been updated, and the device history report is pending.Additional information is pending and will be submitted within 30 days.
Event or Problem Description
As reported, the precise pro rx stent bunched at the distal end.Deployment resistance was average.Additional information has been requested.
Additional Manufacturer Narrative
Complaint conclusion-the precise pro rx stent bunched at the distal end.Deployment resistance was average.There was no other product issue noted either at the account, after the procedure, or prior to shipping for inspection.There was no patient injury.The procedure was completed with the product in question.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.This was a non-stenotic vessel; it was stenting for non-stenosis vulnerable plaque.The size sheath introducer used was 6 fr.The diameter of the unconstrained stent size was 1-2 mm larger than the vessel diameter.The target lesion vessel length was approximately 30 mm.Stenosis of the target lesion was less than 30%.The lesion was not calcified and not tortuous.The stent delivery system passed through acute bends.The delivery of the sds (stent delivery system) to the lesion was ipsilateral.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The product was not returned for analysis.A device history record (dhr) review of lot 17555265 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent-ses incomplete expansion¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Procedural factors such as the correct positioning of the stent delivery system before and during stent deployment may have contributed to the reported event.According to the instructions for use ¿slack removal a.Advance the stent delivery system past the lesion site.B.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.C.Ensure that the stent delivery system 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.5.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.B.Unlock the tuohy borst valve connecting the inner shaft and outer sheath of the delivery system.C.Ensure that the access sheath or guiding catheter does not move during deployment.D.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 (often referred to as the ¿pin-and-pull¿ method).¿ 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.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Common Device Name: PRECISE PRO RX (NIM)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 6050528
• Report Number: 9616099-2016-00670
• Device Sequence Number: 10782391
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2016

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: 07/31/2018
• Device Model Number: PC0840RXC
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17555265
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/30/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/30/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2016
• Supplement Report FDA Received Date: 12/16/2016
• Patient Sequence Number: 1