ONYX FRONTIER
Report
- Report Number
- 9612164-2024-00217
- Event Type
- Malfunction
- Date Received
- January 12, 2024
- Date of Event
- December 15, 2023
- Report Date
- February 13, 2024
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- UDI-DI
- 00763000511814
- PMA / PMN Number
- P160043
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ANALYSIS: THE DEVICE WAS RECEIVED FOR ANALYSIS. A KINK WAS EVIDENT IMMEDIATELY DISTAL TO THE LUER. THE STENT HAD DISPLACED PROXIMALLY ON THE BALLOON AND WAS NOT POSITIONED ON THE BALLOON BETWEEN THE MARKERBANDS AS PER SPECIFICATIONS. THE PROXIMAL STENT WRAPS WERE POSITIONED OVER THE PROXIMAL MARKERBAND. THE STENT WAS NOT POSITIONED AGAINST THE DISTAL PILLOW AS PER SPECIFICATION. CRIMP IMPRESSIONS WERE VISIBLE ON THE EXPOSED BALLOON SURFACE. DEFORMATION WAS EVIDENT TO THE PROXIMAL AND DISTAL STENT WRAP WITH STRUTS RAISED AND BUNCHED. THE INNER LUMEN PATENCY WAS VERIFIED WITH A 0.015-INCH MANDREL. NO OTHER DAMAGE EVIDENT TO THE REMAINDER OF THE DEVICE. IMAGE ANALYSIS: FLUOROSCOPIC IMAGES SHOW THE PRESENCE OF A TIGHT LESION IN THE PROXIMAL RCA. THE LESION WAS PRE-DILATED WITH PARTIAL BUT NOT FULL RESOLUTION OF THE STENOSIS. NO IMAGES WERE PROVIDED SHOWING THE ATTEMPTED BUT UNSUCCESSFUL DELIVERY OF THE STENT THROUGH THE GUIDE CATHETER AND GUIDE EXTENSION CATHETER. ONLY IMAGES OF THE VASCULATURE WERE PROVIDED AND IT WAS REPORTED THAT THE STENT DID NOT ENTER THE VASCULATURE. A NON-MEDTRONIC STENT WAS DELIVERED AND DEPLOYED ACROSS THE LESION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION: A PULL WAS FELT WHILE ADVANCING THE STENT THROUGH THE GUIDE AND THE TELESCOPE GUIDE EXTENSION CATHETER. IT WAS STATED THAT THE DISLODGEMENT OCCURRED IN THE GUIDE AND THAT THE STENT NEVER MADE IT TO THE CORONARY ARTERIES. THE SYSTEM WAS PULLED BACK BEFORE ADVANCING ANY FURTHER WITHOUT ANY ADDITIONAL ISSUES. THE DISLODGED STENT WAS REMOVED BY PULLING THE STENT DELIVERY SYSTEM BACK OUT THROUGH THE GUIDE. RESISTANCE WAS NOT NOTED DURING WITHDRAWAL OF THE DEVICE AND EXCESSIVE FORCE WAS NOT USED. THERE WAS NO DEFORMATION NOTED TO THE TELESCOPE DEVICE AND THE REPLACEMENT STENT PASSED WITH NO ISSUES. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION: ANNEX D CODE ADDED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
THE PATIENT PRESENTED TO HOSPITAL WITH DECLINING LEFT VENTRICULAR FUNCTION AND SHORTNESS OF BREATH (ANGINA), FOR DIAGNOSTIC CARDIAC CATHETERIZATION. INDICATION FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS ANGINA AND CONGESTIVE HEART FAILURE. AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER CORONARY DRUG ELUTING STENT (DES) TO TREAT A MODERATELY TORTUOUS, MODERATELY CALCIFIED LESION WITH 80% STENOSIS IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA). THE DEVICE WAS INSPECTED WITH NO ISSUES. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED WITH A 4.0X12MM BALLOON TO 14ATM. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS NOTED WHILE ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT WAS REPORTED THAT STENT DEFORMATION OCCURRED IN VIVO DURING POSITIONING/ADVANCEMENT. THE RCA WAS ENGAGED WITH A 6F GUIDE CATHETER. A 300CM 0.014 NON-MEDTRONIC (MDT) GUIDEWIRE WAS ADVANCED BEYOND THE CULPRIT LESION, DISTALLY IN THE VESSEL, WITHOUT COMPLICATION. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED WITH A NON-MDT DEVICE. DIFFICULTY WAS NOTED DURING ADVANCEMENT OF THE ONYX FRONTIER DEVICE THROUGH A TELESCOPE GUIDE EXTENSION CATHETER BEFORE IT REACHED THE VESSEL. THE STENT SYSTEM WAS PULLED BACK, AND THE STENT WAS DEFORMED AND PARTIALLY DISLODGED OFF THE BALLOON. A 5.0X18MM NON-MDT STENT WAS THEN USED, AND THERE WERE NO ISSUES WHEN USING THIS DEVICE AND THE SAME TELESCOPE DEVICE. THE LESION WAS STENTED WITH THE5.0X18MM NON-MDT DES TO 12ATM. THE PATIENT IS ALIVE WITH NO INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1707036 | ONYX FRONTIER | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | ONYXNG50022UX | 0011049800 | 00763000511814 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Female |