NanoCross EliteRecalls & reported problems across all models
Ev3, Inc · 63 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 206
- Deaths reported
- 1
- Injuries reported
- 63
- Recalls
- 0
We found 63 models of NanoCross Elite by Ev3, Inc in the FDA's device registry (GUDID). Together they are named in 206 adverse event reports in the FDA's MAUDE database, received between Mar 8, 2017 and Jan 23, 2026 — classified as 1 death, 63 injuries, 142 malfunctions.
The most frequently reported specific device problem is “Burst Container or Vessel” (120 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NanoCross Elite problems
Device problems
- Burst Container or Vessel120
- Detachment of Device or Device Component44
- Deflation Problem39
- Difficult to Remove36
- Leak/Splash19
- Inflation Problem14
- Material Twisted/Bent9
- Difficult to Advance6
Patient problems
- No Clinical Signs, Symptoms or Conditions116
- No Consequences Or Impact To Patient43
- Insufficient Information14
- Device Embedded In Tissue or Plaque8
- Patient Problem/Medical Problem8
- Unspecified Tissue Injury8
- Injury4
- Obstruction/Occlusion4
NanoCross Elite models
63 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NanoCross™ Elite AB14W025210150Catheter, angioplasty, peripheral, transluminal1 death16 reports
- NanoCross™ Elite AB14W060200150Catheter, angioplasty, peripheral, transluminal15 reports
- NanoCross™ Elite AB14W050200150Catheter, angioplasty, peripheral, transluminal11 reports
- NanoCross™ Elite AB14W030210150Catheter, angioplasty, peripheral, transluminal10 reports
- NanoCross™ Elite AB14W040150150Catheter, percutaneous8 reports
- NanoCross™ Elite AB14W020210150Catheter, angioplasty, peripheral, transluminal7 reports
- NanoCross™ Elite AB14W040210150Catheter, percutaneous7 reports
- NanoCross™ Elite AB14W050120150Catheter, angioplasty, peripheral, transluminal7 reports
- NanoCross™ Elite AB14W050150150Catheter, angioplasty, peripheral, transluminal7 reports
- NanoCross™ Elite AB14W060040150Catheter, angioplasty, peripheral, transluminal6 reports
- NanoCross™ Elite AB14W060120150Catheter, angioplasty, peripheral, transluminal6 reports
- NanoCross™ Elite AB14W035210150Catheter, percutaneous5 reports
- NanoCross™ Elite AB14W025150150Catheter, angioplasty, peripheral, transluminal4 reports
- NanoCross™ Elite AB14W050060150Catheter, angioplasty, peripheral, transluminal4 reports
- NanoCross™ Elite AB14W050100150Catheter, angioplasty, peripheral, transluminal4 reports
- NanoCross™ Elite AB14W030210150Catheter, angioplasty, peripheral, transluminal4 reports
- NanoCross™ Elite AB14W060150150Catheter, angioplasty, peripheral, transluminal4 reports
- NanoCross™ Elite AB14W025040150Catheter, angioplasty, peripheral, transluminal3 reports
- NanoCross™ Elite AB14W025120150Catheter, angioplasty, peripheral, transluminal3 reports
- NanoCross™ Elite AB14W030150150Catheter, percutaneous3 reports
- NanoCross™ Elite AB14W040080150Catheter, percutaneous3 reports
- NanoCross™ Elite AB14W050040150Catheter, angioplasty, peripheral, transluminal3 reports
- NanoCross™ Elite AB14W050080150Catheter, angioplasty, peripheral, transluminal3 reports
- NanoCross™ Elite AB14W060060150Catheter, angioplasty, peripheral, transluminal3 reports
- NanoCross™ Elite AB14W060150150Catheter, angioplasty, peripheral, transluminal3 reports
- NanoCross™ Elite AB14W030150150CATHETER, PERCUTANEOUS3 reports
- NanoCross™ Elite AB14W040080150Catheter, angioplasty, peripheral, transluminal3 reports
- NanoCross™ Elite AB14W020080150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W020100150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W030100150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W030120150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W035040150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W035080150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W060100150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W020080150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W020210150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W025150150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W025210150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W030040150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W050120150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W060040150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W060100150Catheter, angioplasty, peripheral, transluminal2 reports
- NanoCross™ Elite AB14W020040150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W020060150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W020120150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W020150150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W030040150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W030080150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W035150150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W040120150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W060080150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W060120090Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W060150090Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W020040150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W020120150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W025040150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W030080150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W030100150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W030120150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W040100150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W040150150CATHETER, PERCUTANEOUS1 report
- NanoCross™ Elite AB14W050200150Catheter, angioplasty, peripheral, transluminal1 report
- NanoCross™ Elite AB14W060200150Catheter, angioplasty, peripheral, transluminal1 report
Recent NanoCross Elite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 23, 2026Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE INVOLVING THE ANTERIOR TIBIAL ARTERY AT THE DISTAL LOCATION WITH A CALCIFIED TARGET LESION, THE NANOCROSS 014 BALLOON RUPTURED BEFORE REACHING THE RATED BURST PRESSURE DURING INFLATION. ALL FRAGMENTS OF THE BALLOON WERE RETRIEVED. SUBSEQUENTLY, A NANOCROSS ELITE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY BALLOON WAS USED, BUT THE BALLOON DID NOT EXPAND SUFFICIENTLY, RESULTING IN BALLOON INFLATION DIFFICULTIES DURING INFLATION. BOTH DEVICES WERE PREPPED PER THE INSTRUCTIONS FOR USE WITH NO ISSUES IDENTIFIED, AND NO DAMAGE WAS NOTED TO THE PACKAGING OR DURING DEVICE REMOVAL. EMBOLIC PROTECTION WAS NOT USED, AND THE INFLATION DEVICE ID-40S WAS UTILIZED FOR BOTH BALLOONS. THE PROCEDURE WAS COMPLETED BY OPENING AND USING ANOTHER BALLOON. NO ABNORMALITIES WERE REPORTED IN RELATION TO ANATOMY. THE PATIENT WAS REPORTED TO BE ALIVE WITH NO INJURY. IT WAS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT OR COMPLICATIONS AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24161058 ↗MalfunctionAug 7, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON CATHETER DEVICE FOR PATIENT TREATMENT IN THE ANTERIOR TIBIAL ARTERY. NO ABNORMALITIES REPORTED IN RELATION TO ANATOMY. IT WAS REPORTED THAT THERE WAS A BALLOON TWIST NOTED DURING THE PROCEDURE. A NEW MEDTRONIC DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. NO PATIENT INJURY REPORTED FOR THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22737904 ↗MalfunctionJun 27, 2025Deflation Problem; Deflation Problem
IT WAS REPORTED THAT DURING TREATMENT IN THE PATIENTS RIGHT MID TIBIAL/POPLITEAL TRUNK USING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AB14W030120150 NANOCROSS 014 BALLOON, THERE WERE DEFLATION DIFFICULTIES. THERE WAS NO DAMAGE NOTED TO THE BALLOON CATHETER. THERE WERE NO ISSUES NOTED DURING INFLATION. THE BALLOON TOOK 5 MINUTES TO FULLY DEFLATE. THE PROCEDURE INVOLVED USE OF A 6FR X45 NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE, WITH INFLATION PERFORMED USING A NON-MEDTRONIC INFLATION DEVICE AND 50/50 CONTRAST FLUID. THE BALLOON WAS DEFLATED USING NEGATIVE PRESSURE WITH A 60 CC SYRINGE. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22344036 ↗MalfunctionJun 19, 2025Burst Container or Vessel; Burst Container or Vessel
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING THE NANOCROSS 014 BALLOON, THE BALLOON BURST ON THE FIRST INFLATION IN THE MID RIGHT ANTERIOR TIBIAL ARTERY, WHICH HAD A MODERATE CALCIFIED LESION MEASURING 130MM IN LENGTH AND 2.0MM IN DIAMETER. THE SHEATH USED WAS A 6F NON-MEDTRONIC, AND 50/50 CONTRAST WAS USED AS THE INFLATION FLUID. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE DEVICE, AND THE INSTRUCTIONS FOR USE WERE FOLLOWED WITHOUT ISSUE. THE DEVICE WAS SAFELY REMOVED FROMTHE PATIENT, AND THE PROCEDURE WAS COMPLETED USING A NEW DEVICE. NO HEALTH CONSEQUENCES OR IMPACT WERE REPORTED, AND THE PATIENT WAS ALIVE WITH NO INJURY. .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22289025 ↗MalfunctionJun 16, 2025Deflation Problem; Deflation Problem
LIMITED INFORMATION REPORTED THAT THERE WERE DEFLATION DIFFICULTIES WITH THE NANOCROSS ELITE 5 MM X 80 MM X 150 CM BALLOON, SPECIFICALLY THAT THE BALLOON WOULD NOT DEFLATE PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22210236 ↗InjuryJun 3, 2025Deflation Problem; Difficult to Remove; Deflation Problem; Difficult to Remove
IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY NANOCROSS BALLOON, THERE WAS A DELAY IN SURGERY OF 10 MINUTES DUE TO DIFFICULTIES WITH BALLOON DEFLATION. THE BALLOON WOULD NOT DEFLATE AS INTENDED, RESULTING IN REMOVAL DIFFICULTIES. THE BALLOON WAS ULTIMATELY DEFLATED BY INTENTIONALLY PUNCTURING IT WITH A PUNCTURE WIRE TO FACILITATE REMOVAL. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Insufficient Information
MAUDE report 22132909 ↗MalfunctionFeb 18, 2025Burst Container or Vessel; Inflation Problem; Burst Container or Vessel; Inflation Problem
A PHYSICIAN WAS ATTEMPTING TO USE A NANOCROSS PTA BALLOON WAS INTENDED TO BE USE USED FOR THE TREATMENT OF A FIBROUS/PLAQUE LESION WITH 70% STENOSIS IN THE MID/DISTAL REGION OF THE LEFT PERONEAL ARTERY. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. THE BALLOON WAS INFLATED WITH A SYRINGE, INFLATION FLUID WAS USED. NO LEAKS NOTED ON THE DEVICE. IT WAS REPORTED DURING BALLOON INFLATION AT 12ATM BALLOON INFLATION DIFFICULTIES WERE MET, BALLOON COULD NOT BE INFLATED. THE DEVICE HAD NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT AND NO RESISTANCE WAS MET WHEN ADVANCING THE DEVICE. ANOTHER BALLOON OF THE SAME MODEL WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY. WHEN THE DEVICE WAS RECEIVED FOR EVALUATION, IT WAS NOTED THAT THE THERE WAS A LEAK IN THE BALLOON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21400068 ↗MalfunctionFeb 11, 2025Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE USING A NANOCROSS 014 BALLOON TO TREAT A 70% LESION STENOSIS IN THE ANTERIOR TIBIAL ARTERY, BALLOON INFLATION DIFFICULTIES WERE OBSERVED. A LEAK WAS NOTED ON THE DEVICE. THE BALLOON BODY HAD AIR LEAKAGE. THE LESION WAS LOCATED DISTALLY IN THE ARTERY AND WAS DESCRIBED AS HAVING LITTLE CALCIFICATION AND TORTUOSITY. THE BALLOON WAS INFLATED USING A SYRINGE, AND INFLATION DIFFICULTIES WERE NOTED AT AN INFLATION PRESSURE OF 6 ATM. THE PROCEDURE WAS COMPLETED BY REPLACING THE BALLOON WITH THE SAME MODEL FOR DILATATION. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21354967 ↗InjuryFeb 7, 2025Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component; Burst Container or Vessel; Difficult to Remove; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A TRANSCATHETER ARTERIALIZATION OF DEEP VEINS (TADV) WITH AV CONNECTION PROCEDURE TO TREAT A 200MM CALCIFIED LESION IN THE MID RIGHT PERONEAL ARTERY USING A NANOCROSS ELITE BALLOON, THE BALLOON BURST AT 24 ATM, WHICH WAS ABOVE THE RATED BURST PRESSURE. THE BURST OCCURRED ON THE SECOND INFLATION. THE BURST WAS CIRCUMFERENTIAL/RADIAL, AND THE BALLOON DETACHED DURING THE EVENT. INTERVENTION WAS REQUIRED TO REMOVE THE BALLOON FRAGMENTS. THE BALLOON SHAFT AND PROXIMAL ONE-THIRD OF THE BALLOON WERE REMOVED THROUGH THE ANTEGRADE SHEATH, WHILE THE DISTAL TWO-THIRDS AND REMAINING SHAFT WERE REMOVED THROUGH A 6F SHEATH IN THE LATERAL PLANTAR VEIN. ARTERY DIAMETER REPORTED AS 5MM. A 7X45 NON-MEDTRONIC SHEATH AND A .014 NITREX GUIDEWIRE WERE USED. 50/50 CONTRAST INFLATION FLUID WAS USED. PHYSICIAN WAS ABLE TO MAINTAIN WIRE CONTROL (WIRE WAS FLOSSED). THE PROCEDURE WAS COMPLETED USING A NEW MEDTRONIC DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21332014 ↗InjuryJan 20, 2025Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE INVOLVING THE PERONEAL ARTERY, A NANOCROSS 014 BALLOON WAS USED, AND A BALLOON TWIST OCCURRED. THE BALLOON WAS INFLATED WITH AN INFLATION DEVICE. THE DEVICE WAS REMOVED WITH A SNARE. SUCCESSFULLY FROM THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A NEW MEDTRONIC DEVICE. THE PATIENT OUTCOME WAS REPORTED AS ALIVE WITH NO FURTHER INJURY REPORTED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 21191387 ↗InjuryOct 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
A NANOCROSS PTA BALLOON WAS BEING USED FOR TREATMENT OF A 60MM CALCIFIED LESION WITH 100% STENOSIS IN THE MID RIGHT SUPERFICIAL FEMORAL ARTERY. THE ARTERY WAS 6MM IN DIAMETER WITH SEVERE CALCIFICATION AND MINIMAL TORTUOSITY. CHRONIC TOTAL OCCLUSION SUB-INTIMAL. A 7FR NON MEDTRONIC SHEATH WITH A 0.014" NON MEDTRONIC GUIDEWIRE WERE USED. THE IFU WAS FOLLOWED. THE VESSEL WAS PRE-DILATED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. SEVERE RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT OF THE DEVICE. EXCESSIVE FORCE WAS NOT USED. IT IS NOT KNOWN HOW THE BALLOON WAS INFLATED, 50/50 CONTRAST INFLATION FLUID WAS USED. IT WAS REPORTED AT THE TARGET LESION THE BALLOON TIP BROKE OFF IN THE VESSEL, THE DETACHED COMPONENT WAS NOT REMOVED IT WAS TACKED TO THE VESSEL WALL. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS ABORTED.
Patient problems: Insufficient Information
MAUDE report 20567934 ↗MalfunctionOct 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 5FR NON-MEDTRONIC (COOK) SHEATH AND A .014 NON-MEDTRONIC (ASHAI GLADIUS) GUIDEWIRE DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENTS LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. TORTUOUS ILIAC BIFURCATION WITH SIGNIFICANT DISEASE AND CALCIFICATION MADE IT DIFFICULT TO TRACK SHEATH UP AND OVER. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A BALLOON BURST WAS REPORTED ON FIRST INFLATION AT 8ATMS DURING PROCEDURE. DEFLATION DIFFICULTIES WERE ALSO REPORTED. THE BALLOON
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20408330 ↗MalfunctionAug 23, 2024Burst Container or Vessel; Burst Container or Vessel
A NANOCROSS PTA BALLOON WAS INTENDED TO BE USED. THE DEVICE WAS PREPPED AS PER THE IFU WITH NO ISSUES IDENTIFIED. IT WAS REPORTED BALLOON BURST AT AN UNKNOWN PRESSURE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20056398 ↗InjuryAug 8, 2024Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component; Burst Container or Vessel; Deflation Problem; Detachment of Device or Device Component
PHYSICIAN ATTEMPTED TO USE A NANOCROSS ELITE PTA BALLOON WITH A 5FR NON-MEDTRONIC SHEATH AND A .014 NON-MEDTRONIC GUIDEWIRE DURING TREATMENT OF A 150MM CALCIFIED LESION IN THE PATIENTS LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). SEVERE VESSEL TORTUOSITY AND SEVERE VESSEL CALCIFICATION WERE REPORTED. LESION EXHIBITED 80% STENOSIS. ARTERY DIAMETER REPORTED AS 6MM. THERE WERE ABNORMALITIES REPORTED IN RELATION TO ANATOMY. TORTUOUS ILIAC BIFURCATION WITH SIGNIFICANT DISEASE AND CALCIFICATION MADE IT DIFFICULT TO TRACK SHEATH UP AND OVER. THERE WAS NO DAMAGE NOTED TO PACKAGING, I.E. SHELF CARTON, HOOP/TRAY. NO ISSUES WERE NOTED WHEN REMOVING THE DEVICE FROM THE HOOP/TRAY. THE IFU (INSTRUCTION FOR USE) WAS FOLLOWED DURING PREPARATION, PROCEDURE, POST-PROCEDURE WITHOUT ISSUE. EMBOLIC PROTECTION WAS NOT USED. THE VESSEL WAS NOT PRE OR POST DILATED. AN INFLATION DEVICE WAS USED. 50/50 CONTRAST INFLATION FLUID WAS USED. THE DEVICE WAS NOT PASSED THROUGH A PREVIOUSLY DEPLOYED STENT. NO RESISTANCE WAS NOTED DURING ADVANCEMENT OF THE DEVICE. A BALLOON BURST WAS REPORTED ON FIRST INFLATION AT 8ATMS DURING PROCEDURE. DEFLATION DIFFICULTIES WERE ALSO REPORTED. THE BALLOON WOULD NOT FULLY DEFLATE
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19937511 ↗MalfunctionJul 22, 2024Burst Container or Vessel; Burst Container or Vessel
A NANOCROSS ELITE PTA BALLOON WAS BEING USED FOR TREATMENT OF A 150MM CALCIFIED LESION WITH 100% STENOSIS IN THE PROXIMAL REGION OF THE RIGHT POSTERIOR TIBIAL ARTERY. THE ARTERY WAS 2.5MM IN DIAMETER WITH MINIMAL TORTUOSITY AND SEVERE CALCIFICATION. A 6FR NON MEDTRONIC SHEATH AND A 0.014" NON MEDTRONIC GUIDEWIRE WAS USED. THE VESSEL WAS NOT PRE-DILATED. THE IFU WAS FOLLOWED. THERE WAS NO ISSUES NOTED WHEN REMOVING THE DEVICE FROM PACKAGING. MODERATE RESISTANCE WAS MED WHEN ADVANCING THE DEVICE. A NON MEDTRONIC INFLATION DEVICE WITH 50/50 CONTRAST WAS USED FOR INFLATION. IT WAS REPORTED ON THE FIRST INFLATION THE BALLOON BURST AT 10 ATM. THE BALLOON DID NOT DETACH. THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. ANOTHER NANOCROSS WAS USED WAS USED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19792604 ↗
Other Ev3, Inc products
All Ev3, Inc devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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