NC EUPHORA RX
Report
- Report Number
- 9612164-2024-03922
- Event Type
- Injury
- Date Received
- August 28, 2024
- Date of Event
- July 31, 2024
- Report Date
- October 23, 2024
- Manufacturer
- MEDTRONIC MEXICO
- Product Code
- LOX
- UDI-DI
- 00643169395862
- PMA / PMN Number
- K141090
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ADDITIONAL INFORMATION: THE NC EUPHORA CORONARY BALLOON WAS BEING USED IN A HIGHLY CALCIFIED LESION WITH 90-95% STENOSIS IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) ARTERY. THERE WAS DELAYED FILLING TO THE LAD WITH TIMI II, AND FRACTIONAL FLOW RESERVE (FFR) WAS POSITIVE. RIGHT RADIAL ACCESS WAS OBTAINED. MULTIPLE RUNS OF ATHERECTOMY WERE REQUIRED FROM THE PROXIMAL TO MID LAD. A NON-MEDTRONIC (MDT) GUIDE EXTENSION CATHETER (GEC) AND A NON-MDT SINGLE GUIDEWIRE THROUGH THE LAD (MID TO PROXIMAL) WERE USED IN THE PROCEDURE. THE PROXIMAL LAD WAS PRE-DILATED WITH A 3.0X15MM BALLOON TO 10 ATM FOR 10 SECONDS. A 2.5X10MM NON-MDT CUTTING BALLOON COULD NOT PASS WITH THE GEC. FURTHER PRE-DILATION DONE WITH A 3.0X15MM EUPHORA BALLOON TO 10 ATM FOR 13 SECONDS WITH MULTIPLE INFLATIONS. IT WAS THEN POSSIBLE TO DELIVER THE CUTTING BALLOON WHICH WAS INFLATED TO 13 ATM FOR 20 SECONDS. INTRAVASCULAR ULTRASOUND (IVUS) COULD NOT BE ADVANCED TO THE MID LAD, THEREFORE, PRE-DILATION CONTINUED WITH A 2.5X8MM NC EUPHORA BALLOON TO 16 ATM FOR 14 SECONDS, MULTIPLE TIMES. SHOCKWAVE LITHOTRIPSY WAS THEN PERFORMED. AFTER, THE MID LAD WAS PRE-DILATED WITH A 3.0X10MM EUPHORA BALLOON. USING THE GEC, A 2.5X38MM ONYX FRONTIER STENT WAS DELIVERED AND DEPLOYED AT 11 ATM FOR 12 SECONDS. AN ATTEMPT WAS MADE TO DELIVER A 3.0X15MM ONYX FRONTIER STENT FROM PROXIMAL-OSTIAL LAD, BUT THE STENT WOULD NOT CROSS. THERE APPEARED TO BE A CALCIFIED SEGMENT IN THE PROXIMAL LAD PREVENTING THE GEC OR STENT TO PASS. MULTIPLE NON-MDT BALLOONS, MICROCATHETER AND WIRES COULD NOT CROSS. DUE TO POOR GUIDE SUPPORT A FEMORAL APPROACH WAS THEN USED. A 3.0X15MM BALLOON WAS USED IN THE PROXIMAL LAD. THE 3.5X15MM ONYX FRONTIER STENT WAS DELIVERED THROUGH THE GEC AND POSITIONED IN AN OVERLAP FASHION TO THE PREVIOUS STENT AND WAS DEPLOYED IN THE PROXIMAL-OSTIAL LAD AT 12 ATM FOR 10 SECONDS, WITH NO COMPLEXITIES. THE 3.5X12MM NC EUPHORA BALLOON WAS DELIVERED IN THE LAD STENT FOR POST-DILATION. FIRST IN THE DISTAL STENT SECTION AT 17-18 ATM, THEN MOVED TO THE MID-SECTION TO 18 ATM WITH NO ISSUES. INFLATION WAS APPLIED FOR 10 SECONDS. ON THE THIRD AND LAST INFLATION THE BALLOON WAS PULLED BACK TO THE PROXIMAL SECTION AND INFLATED AT 18 ATM FOR 8 SECONDS, THE BALLOON RUPTURED AND PRESSURE ON THE INDEFLATOR DROPPED. NO TORQUE WAS NEEDED WHEN DELIVERING CATHETER. NO TENSION WAS FELT IN THE SHAFT OF THE BALLOON CATHETER. NO SLOWDOWN IN DEFLATION WAS NOTED. DISTAL AND MID POST-DILATIONS WERE GOOD. FOLLOWING THE THIRD POST-DILATION, WHILE REMOVING THE DEVICE FROM THE LESION, IT DID NOT FEEL NORMAL, AND IT WAS OBSERVED ONCE THE DEVICE WAS REMOVED THAT THE TIP WAS MISSING. UNDER FLUOROSCOPY AND ANGIOGRAM, THE BALLOON WAS SEEN FLOATING IN THE LEFT MAIN (LM). A 3.5X12MM EUPHORA BALLOON WAS PASSED TO THE LAD AND INFLATED TO 6 ATM. AN ATTEMPT WAS MADE TO PULL THE BALLOON BACK TO THE GEC TO CAPTURE THE FRACTURED TIP, BUT THIS WAS UNSUCCESSFUL. FLOW IMPROVED TO THE LM. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE DETACHED PORTION OF THE BALLOON WITH A 3F 4.0MMX175CM GOOSENECK SNARE, HOWEVER, THIS WAS UNSUCCESSFUL AND THE BALLOON FRAGMENT MIGRATED/EMBOLIZED TO THE POPLITEAL ARTERY TRIFURCATION. ENDOVASCULAR SURGEON WAS CALLED AND MANAGED TO SUCCESSFULLY RETRIEVE THE PORTION OF THE BALLOON ENDOVASCULARLY USING A 4MM SNARE. REPEAT ANGIOGRAM SHOWED NORMAL FLOW TO THE LEFT LOWER EXTREMITY. IVUS OF THE LAD AND LM SHOWED GOOD STENT APPOSITION AND EXPANSION. THERE WAS NO DISSECTION TO THE LM. THERE WAS TIMI III FLOW TO THE LAD AND ALL BRANCHES. LAD STENOSIS WAS REDUCED TO 0%. THE PATIENT REMAINED HEMODYNAMICALLY STABLE. THE PATIENT DID NOT NEED TO GO FOR SURGERY. PATIENT WENT HOME THE NEXT DAY AND IS DOING REALLY WELL. SECTIONS A. PATIENT INFORMATION (&) B7.RELEVANT HISTORY UPDATED. IMAGE ANALYSIS: PROCEDURAL IMAGES CONFIRM THAT THE LAD IS TORTUOUS IN THE MID TO DISTAL SECTION. THE LEFT MAIN IS SEVERELY CALCIFIED AS IS THE LCX. PROCEDURAL WIRES ARE DELIVERED TO THE LEFT MAIN AND THE PROXIMAL TO MID LAD ARE REPEATEDLY DILATED. THE BURST OF THE BALLOON WAS NOT CAPTURED ON THE IMAGES, BUT DETACHED MATERIAL AND THE MARKER BANDS FROM THE DELIVERY SYSTEM CAN BE SEEN IN THE PROXIMAL LAD/LEFT MAIN. THE MATERIAL APPEARS TO HAVE MIGRATED TO THE PERIPHERAL VESSEL FROM WHERE RETRIEVAL WAS ATTEMPTED. TO SUPPORT ROOT CAUSE DETERMINATION ADDITIONAL IMAGE REVIEW WAS PERFORMED BY A MEDTRONIC MEDICAL SAFETY CLINICIAN. CLINICIAN REVIEW DETERMINED THAT THE ANGIOGRAM REVEALS SEVERE CALCIFICATION IN THE LM EXTENDING FROM THE DISTAL LM INTO THE LAD AND LCX. RUNS 4 AND 5 DEMONSTRATE A PARTIALLY INFLATED BALLOON. RUN 7 SHOWS A GUIDE EXTENSION CATHETER DELIVERED INTO THE LAD WITH A BALLOON THAT APPEARS MOSTLY INFLATED, POTENTIALLY LESS INFLATED ON THE PROXIMAL END. RUN 11 APPEARS TO BE AN ATTEMPT AT ADVANCING AN IVUS CATHETER. RUNS 12-14 SHOW A SMALLER BALLOON (POTENTIALLY THE CUTTING BALLOON) PASSED WITH MULTIPLE INFLATIONS PERFORMED. RUN 59 SHOWS SNARING ATTEMPTS IN THE PERIPHERAL ARTERIES. OVERALL, THE REVIEW OF THE ANGIOGRAM IS NOT DEMONSTRATING AN EXCLUSIVE CAUSE FOR THE BALLOON RUPTURE, EXPECT FOR CONFIRMING THE INITIALLY NOTED SEVERE CALCIFICATION WHICH WAS MANAGED BY ATHERECTOMY (NOT SHOWN) AS WELL AS INTRAVASCULAR LITHOTRIPSY IN ADDITION TO THE USE OF A CUTTING BALLOON. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
PRODUCT ANALYSIS: THE DEVICE WAS RETURNED FOR ANALYSIS. THE DEVICE RETURNED WITH A COMPLETE RADIAL DETACHMENT OF THE BALLOON AT THE PROXIMAL BOND, EXPOSING THE INNER MEMBER. A COMPLETE RADIAL BURST OCCURRED AT THE PROXIMAL END OF THE BALLOON. IT APPEARED THAT THE BALLOON BOND EXPANDED LEADING TO THE BURST. THE BALLOON MATERIAL WAS JAGGED AND UNEVEN AT THE BURST SITE. BOTH PROXIMAL AND DISTAL MARKER BANDS WERE NOT POSITIONED ON THE INNER MEMBER. NO DEFORMATION WAS EVIDENT TO THE DISTAL TIP. NO OTHER DAMAGE EVIDENT TO THE REMAINDER OF THE DEVICE. ADDITIONAL INFORMATION: THE PATIENT WENT FOR SURGERY. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
IMAGE ANALYSIS: TWO STILL IMAGES WERE RECEIVED FOR ANALYSIS. THE FIRST STILL IMAGE PROVIDED DOES NOT PROVIDE SUFFICIENT DETAIL TO CONFIRM THE REPORTED EVENT OR TO DETERMINE A CAUSE. IT IS POSSIBLE THAT THE SECOND IMAGE IS SHOWING A SMALL SECTION OF DETACHED BALLOON, HOWEVER THIS IS NOT POSSIBLE TO DETERMINE BASED ON THE IMAGE PROVIDED. CINE IMAGE ANALYSIS: TWO STILL FLUOROSCOPY IMAGES WERE PROVIDED BUT IMAGES DO NOT SHOW THE DELIVERY OF THE BALLOON OR THE BURST AND DETACHMENT OF THE BALLOON MATERIAL. THE STILL IMAGES WERE NOT OF THE CORONARY ARTERIES. THEREFORE, THE IMAGES DO NOT SUPPORT DETERMINATION OF ROOT CAUSE. CORRECTION: INITIAL REPORTER NAME AND PHONE NUMBER. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
AN ATTEMPT WAS MADE TO USE ONE NC EUPHORIA CORONARY BALLOON DURING A PROCEDURE TO TREAT A LESION. IT WAS REPORTED THAT A BALLOON BURS T/RUPTURE OCCURRED DURING BALLOON INFLATION BELOW THE RATED BURST PRESSURE (RBP). IT WAS ALSO REPORTED THAT THE BALLOON HAD A COMPLETE DISARTICULATION FROM THE WIRE CAUSING THE BALLOON TO EMBOLIZE. NO FURTHER PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 181037 | NC EUPHORA RX | CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, | LOX | MEDTRONIC MEXICO | NCEUP3012X | 228897132 | 00643169395862 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Male | Other |