ONYX FRONTIER
Report
- Report Number
- 9612164-2023-02254
- Event Type
- Injury
- Date Received
- May 26, 2023
- Date of Event
- November 7, 2022
- Report Date
- July 25, 2023
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- UDI-DI
- 00763000511463
- PMA / PMN Number
- P160043
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: ANNEX D CODES. CORRECTION: IN ORDER TO SUPPORT ROOT CAUSE DETERMINATION A MEDICAL SAFETY ASSESSMENT WAS PERFORMED BY A MEDTRONIC MEDICAL SAFETY SPECIALIST. SPECIALIST REVIEW DETERMINED THAT THERE IS ANGIOGRAPHIC EVIDENCE OF SEVERE CALCIFICATION, PRIOR STENTING AND INDEED A TORTUOUS PATHWAY TO THE PROXIMAL / MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, WHERE PRE-DILATION WAS COMPLETED WITH KISSING BALLOON (KB). H.1. TYPE OF REPORTABLE EVENT - SERIOUS INJURY. 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.
IMAGE ANALYSIS: IMAGES CONFIRM THE VESSEL MORPHOLOGY AS REPORTED, WITH TORTUOUS VESSEL LEADING INTO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY LESION. LESIONS WERE EVIDENT IN THE RIGHT CORONARY ARTERY (RCA) AND THE LEFT CIRCUMFLEX (LCX) ARTERY. THE LCX LESION WAS PRE-DILATED PRIOR TO ATTEMPTED TREATMENT OF THE LAD. THE TIMESTAMP ON THE IMAGES WAS STATIC THEREFORE IT WAS NOT POSSIBLE TO OBSERVE A TIMELINE ON THE IMAGES. ATTEMPTED POSITIONING OF THE STENT WAS OBSERVED ON THE IMAGES AND THE NEXT IMAGE CONFIRMED THE STENT DISLODGMENT IN THE VESSEL. HOWEVER, THE MECHANISM OF THE STENT DISLODGEMENT WAS NOT CAPTURED ON THE IMAGES PROVIDED. THE VESSEL FLOW APPEARED UNOBSTRUCTED POST STENT DISLODGEMENT. THEREFORE, THE IMPACT OF THE STENT DISLODGEMENT ON THE REPORTED PATIENT DEATH CANNOT BE ASSESSED BASED ON THE IMAGES PROVIDED. 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.
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. 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: THE 2.0X12MM COMPLIANT BALLOON THAT WAS BACKLOADED AND INFLATED SUCCESSFULLY WAS A EUPHORA DEVICE. THE 3.0X12MM NON COMPLIANT BALLOON USED TO DILATE THE CALCIFIED STENOSIS WAS AN NC EUPHORA DEVICE. THE 3.5X12MM MEDTRONIC STENT UNABLE TO PASS THE ANGULATED LESION INTO THE LAD DUE TO SEVERE TORTUOSITY WAS AN ONYX FRONTIER STENT. A 1.5X12MM EUPHORA BALLOON WERE ADVANCED BUT DID NOT ADVANCE THROUGH THE STENT. THERE WAS NO EVIDENCE OF RESTENOSIS OR THROMBOSIS. THERE WERE NO ISSUES WITH THE TELESCOPE GEC. A 1.25X15MM SPRINTER LEGEND BALLOON, A 2.5X10MM EUPHORA BALLOON, AND ANOTHER 1.5X2MM EUPHORA BALLOON WERE ALSO USED DURING THE PROCEDURE. A NON-MEDTRONIC GEC WAS ALSO USED DURING THE PROCEDURE. NONE OF THE WIRES OR SNARES USED WERE MEDTRONIC DEVICES. IT WAS LATER REPORTED THAT THE PATIENT DID NOT PASS AWAY. THE PATIENT IS STILL ALIVE. PAST MEDICAL HISTORY UPDATED. 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: THE 3.5 EBU GUIDE CATHETER USED WAS A LAUNCHER DEVICE. THERE IS NO COMPLAINT AGAINST THIS DEVICE. THERE IS NO COMPLAINT AGAINST THE OTHER MEDTRONIC DEVICE USED DURING THE PROCEDURE. 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.
A PATIENT PRESENTED WITH PROGRESSIVE DYSPNEA, SHORTNESS OF BREATH, CHEST PAIN AND POSSIBLE ANGINA. THE PATIENT UNDERWENT A CARDIAC PET SCAN THAT SHOWED SIGNIFICANT ISCHEMIA IN THE ANTERIOR ANTEROAPICAL TERRITORY WHICH WAS TREATED USING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA). AN ATTEMPT WAS MADE TO USE ONE ONYX FRONTIER RX CORONARY DRUG ELUTING STENT TO TREAT A SEVERELY TORTUOUS, SEVERELY CALCIFIED LESION WITH 99% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DEVICE WAS INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS NOT PERFORMED. THE LESION WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT WAS REPORTED THAT STENT DISLODGEMENT OCCURRED DURING REMOVAL FOLLOWING FAILED DELIVERY. IT WAS DETAILED THAT A 3.5 EBU GUIDE CATHETER AND A NON-MEDTRONIC WIRE WERE ADVANCED INTO THE DISTAL LAD. IT WAS NOTED AS BEING VERY DIFFICULT DUE TO THE SEVERE CALCIFICATION AND ALSO BECAUSE OF AN ANGULATED LESION AT PREVIOUSLY PLACED STENTS. A 2.0X12MM COMPLIANT BALLOON WAS BACKLOADED AND INFLATED SUCCESSFULLY. A 2.5X12MM NON-C OMPLIANT BALLOON WAS USED AT 14 ATM AND A 3.0X12MM NON-COMPLIANT BALLOON WAS USED TO DILATE THE CALCIFIED STENOSIS. A 3.5X12MM MEDTRONIC STENT WAS USED HOWEVER IT WAS UNABLE TO PASS THE ANGULATED LESION INTO THE LAD DUE TO SEVERE TORTUOSITY. A TELESCOPE GUIDE CATHETER WAS ALSO USED HOWEVER THE STENT STILL FAILED TO CROSS THE ANGULATED LESION. THE STENT WAS SWITCHED TO A 3.0X12MM ONYX FRONTIER STENT AND WITH THE TELESCOPE, THE STENT WAS ADVANCED WITH DIFFICULTY OVERLAPPING WITH THE PRIOR STENT. THE STENT LENGTH APPEARED TO BE BIG AS THE PROXIMAL STRUTS APPEARED TO BE IN THE DISTAL LEFT MAIN. IT WAS DECIDED TO SWITCH TO A SMALLER STENT. AN ATTEMPT WAS MADE TO PULL BACK THE UNDELIVERED STENT HOWEVER, THE STENT DISLODGED FROM THE BALLOON AND WAS IN THE DISTAL LEFT MAIN INTO THE LAD. NO SIGNIFICANT FORCE WAS USED TO PULL THE STENT BACK. A 1.0MM NON-MEDTRONIC AND 1.5MM BALLOON WERE ADVANCED BUT DID NOT ADVANCED THROUGH STENT. A WIRE WAS ATTEMPTED TO PARALLEL WIRE WITH THE STENT HOWEVER, THE STENT APPEARED TO BE JAILED ACROSS THE OSTIUM OF LAD. NO WIRE WAS ABLE TO ADVANCE PARALLEL TO THE STENT WHICH APPEARED TO BE WITHIN THE STENT STRUTS. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE A SMALL BALLOON TO INFLATE DISTAL TO THE UNDEPLOYED STENT AND RETRIEVE THE STENT BACK HOWEVER, IT WAS UNABLE TO CROSS THE STENT. A SMALL PROFILE NON-MEDTRONIC MICROCATHETER WAS ATTEMPTED TO CROSS THE UNDEPLOYED STENT WITH NO SUCCESS. MULTIPLE ATTEMPTS WERE MADE TO USE A 1.0X6MM BALLOON TO ADVANCE THROUGH THE STENT STRUTS. EVENTUALLY IT CROSSED INTO THE PROXIMAL EDGE OF THE STENT. THE BALLOON WAS INFLATED TO 12 ATM IN AN ATTEMPT TO PUSH THE BALLOON THROUGH THE STENT HOWEVER, THIS WAS UNSUCCESSFUL. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE STENT HOWEVER THE STENT APPEARED TO BE WEDGED INTO THE PROXIMAL LAD, LEFT MAIN. A FINAL ATTEMPT WAS MADE WITH A SMALLER SNARE HOWEVER, AFTER MULTIPLE ATTEMPTS THE STENT APPEARED WEDGED IN THE VESSEL. THE PROCEDURE WAS TERMINATED TO AVOID PERFORATING THE CORONARY VESSELS. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE WHOLE PROCEDURE. THE PATIENT VITAL SIGNS WERE ALL STABLE. THE PATIENT HAD 600MG PLAVIR PRIOR TO PROCEDURE. THE DISLODGED STENT WAS NOT REMOVED. THE PATIENT WAS PLANNED FOR BYPASS SURGERY. THE SURGERY DID NOT OCCUR. THE PATIENT DECEASED A WEEK LATER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1728543 | ONYX FRONTIER | CORONARY DRUG-ELUTING STENT | NIQ | MEDTRONIC IRELAND | ONYXNG30012UX | 0011315083 | 00763000511463 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Male | Required Intervention| D |