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

Catalog Number	PC0520RXC
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, customer mentioned that information presented in website is outdated and does not align with a letter/other more updated mri information in a different ifu.There was no reported patient injury.Initially, the customer called the service number on the document previously sent by sales rep and also emailed the instructions for use.Unfortunately, they state 1.5 tesla, with a spatial gradient limit of 3 t/m (300 g/cm).The spatial gradient is not the same as field strength.Although the document states some stents were tested on a 3 tesla magnet, is does not state the spatial gradient of those systems and/or any other conditions for use.Per customer ¿they can really only safely scan devices and implants while following the specific fda approved guidelines published in the instructions for use for manufacturer guidelines for implants rated conditional 5.The cordis precise stents are rated conditional 5, but from what i can tell the instructions for use state 1.5 tesla only, with a very low spatial gradient limit¿.The device will not be returned for analysis.
Additional Manufacturer Narrative
The customer mentioned that information presented in the website is outdated and does not align with a letter/other more updated mri information in a different ifu (instructions for use).There was no reported patient injury.Initially, the customer called the service number on the document previously sent by a sales rep and also emailed the ifu.Unfortunately, they state 1.5 tesla, with a spatial gradient limit of 3 t/m (300 g/cm).The spatial gradient is not the same as field strength.Although the document states some stents were tested on a 3 tesla magnet, it does not state the spatial gradient of those systems and/or any other conditions for use.Per customer ¿they can really only safely scan devices and implants while following the specific fda approved guidelines published in the instructions for use for manufacturer guidelines for implants rated conditional 5.The cordis precise stents are rated conditional 5, but from what i can tell the instructions for use state 1.5 tesla only, with a very low spatial gradient limit¿.The product was not returned for analysis.No lot number was provided therefore a product history record (phr) review could not be generated.The reported ¿packaging/pouch/box labeling incorrect¿ was confirmed as there are differences in the information provided.The exact cause could not be determined.Vessel characteristics are unknown.As no lot number was supplied a phr could not be completed.According to the safety information in the instructions for use ¿mri compatibility through non-clinical testing, the cordis precise nitinol stent has been shown to be mri conditional at field strengths of 3 tesla or less and a maximum whole body averaged specific absorption rate (sar) of 0.8w/kg for 20:00 minutes of mri.The precise stent should not migrate in this mri environment.Non-clinical testing has not been performed to rule out the possibility of stent migration at field strengths higher than 3 tesla.In this testing, the stent produced a temperature rise of 0.5 degrees c at a maximum whole body averaged sar of 0.8w/kg for 20:00 minutes of mri.Mr image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the stent.The effect of heating in the mri environment for overlapping stents or stents with fractured struts is not known.¿ a risk assessment has already been opened to further investigate this issue.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014 ; MX 33014
• MDR Report Key: 8864166
• Report Number: 9616099-2019-03123
• Device Sequence Number: 2078770
• Product Code: NIM
• UDI-Device Identifier: 20705032036389
• UDI-Public: 20705032036389
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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 Catalogue Number: PC0520RXC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1