LUTONIX® Drug Coated Balloon LX351306120Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00801741088728), received between Dec 2, 2015 and Apr 24, 2019 — classified as 22 injuries.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT POPLITEAL ARTERY. APPROXIMATELY 28 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA AND POPLITEAL VESSELS WERE REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 8546873 ↗
• InjuryDec 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. A REVASCULARIZATION WAS PERFORMED AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES OR PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2018-00281.

  Patient problems: Reocclusion

  MAUDE report 8144105 ↗
• InjuryOct 17, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE IN-STENT TARGET LESION LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND PROXIMAL POPLITEAL ARTERY. APPROXIMATELY 15 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT DISTAL SFA AND PROXIMAL POPLITEAL VASCULATURE BECAME REPORTEDLY OCCLUDED THROUGH A DUPLEX ULTRASOUND EVALUATION ON 08-MAR-2017. A REVASCULARIZATION WAS PERFORMED ON (B)(6) 2017, INVOLVING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND AN ADDITIONAL LUTONIX DCB. THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2018-00227.

  Patient problems: Reocclusion

  MAUDE report 7974471 ↗
• InjuryMar 5, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT POPLITEAL ARTERY. APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSELS CONTAINING THE TARGET LESION WAS REPORTEDLY REOCCLUDED. THE REGISTRY'S INDEPENDENT EVALUATOR'S DETERMINED THE PATIENT'S VESSELS CONTAINING THE TARGET LESION WAS PATENT AT THIS TIME. APPROXIMATELY 22 MONTHS AFTER THE INDEX PROCEDURE, A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7314234 ↗
• InjuryDec 27, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 16 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. AN INCORRECT LUTONIX DCB LOT NUMBER WAS PROVIDED. THROUGH INVESTIGATION, IT WAS FOUND THERE ARE TWO POTENTIAL LOT NUMBERS LUZE0006 AND LUZE0022. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7149026 ↗
• InjuryNov 1, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 2 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBER IS 3006513822-2017-00266.

  Patient problems: Reocclusion

  MAUDE report 6995397 ↗
• InjuryApr 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S MID-DISTAL SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00064.

  Patient problems: Reocclusion

  MAUDE report 6499817 ↗
• InjuryJan 18, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 16 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA STENTED AREA WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2017-00003.

  Patient problems: Reocclusion

  MAUDE report 6261891 ↗
• InjuryNov 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 15 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT PROXIMAL SFA STENTED VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2016-00207.

  Patient problems: Reocclusion

  MAUDE report 6110906 ↗
• InjuryNov 10, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 14 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S LEFT DISTAL SFA STENTED AREA WAS REPORTEDLY REOCCLUDED. IT WAS ALSO REPORTED THE LIFESTENT WAS DISLOCATED AND TORQUED WHICH PROVIDES EVIDENCE THAT IT IS BREAKING. A REVASCULARIZATION WAS PERFORMED WHICH WAS UNSUCCESSFUL, BUT BASED ON THE GOOD FORMATION OF COLLATERAL VESSELS DURING THE FIRST INTENSIVE WALK TRAINING NO ADDITIONAL MEDICATION OR INTERVENTION WAS PLANNED. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT DEFINITELY RELATED TO THE PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2016-00201.

  Patient problems: Reocclusion

  MAUDE report 6092334 ↗
• InjuryOct 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. APPROXIMATELY 17 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA AND POPLITEAL VESSELS WERE REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2016-00191.

  Patient problems: No Consequences Or Impact To Patient; Reocclusion

  MAUDE report 6034460 ↗
• InjuryAug 16, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A GRADE E FLOW LIMITING DISSECTION WAS ALLEGEDLY PRESENT AFTER TREATMENT WITH TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER. THE HEALTH CARE PROFESSIONAL (HCP) GAINED ACCESS TO TREAT THE MILDLY CALCIFIED MID DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP PERFORMED A SUCCESSFUL PREDILATION OF THE ARTERY. THE HCP PREPARED THE LUTONIX DCB'S IN THE NORMAL FASHION AND TREATED THE TARGET LESION, WHICH RESULTED IN A GRADE E FLOW LIMITING DISSECTION. THE HCP USED A SUPRA BARE METAL STENT TO TREAT THE GRADE E FLOW LIMITING DISSECTION, RESULTING IN RESIDUAL STENOSIS OF LESS THAN 10%. THE INVESTIGATOR ASSESSED THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. THE LUTONIX DCB'S WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR RETURN. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER IS 3006513822-2016-00160.

  Patient problems: Intimal Dissection

  MAUDE report 5878863 ↗
• InjuryJul 29, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA AREA PROXIMAL TO THE STENT WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED ON (B)(6) 2016, WHICH INVOLVED A ROTAREX THROMBECTOMY, AN ADDITIONAL DRUG COATED BALLOON AND STENT PLACEMENT. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, BUT NOT RELATED TO THE PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NOTE, THE LUTONIX 035 DRUG COATED BALLOON PTA CATHETER IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AFTER PRE-DILATATION OF DE NOVO OR RESTENOTIC LESIONS UP TO 150 MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 4-7 MM. THESE LUTONIX DCB'S WERE USED TO TREAT THE STENTED LESION PER THE STUDY REQUIREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCI

  Patient problems: Reocclusion

  MAUDE report 5833077 ↗
• InjuryJul 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA AREA PROXIMAL TO THE STENT WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED ON (B)(6) 2016, WHICH INVOLVED A ROTAREX THROMBECTOMY, AN ADDITIONAL DRUG COATED BALLOON AND STENT PLACEMENT. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, BUT NOT RELATED TO THE PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NOTE, THE LUTONIX 035 DRUG COATED BALLOON PTA CATHETER IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AFTER PRE-DILATATION OF DE NOVO OR RESTENOTIC LESIONS UP TO 150 MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 4-7 MM. THESE LUTONIX DCB'S WERE USED TO TREAT THE STENTED LESION PER THE STUDY REQUIREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCI

  Patient problems: Reocclusion

  MAUDE report 5831918 ↗
• InjuryJun 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 15 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S LEFT SFA STENTED AREA AND ASSOCIATED VESSELS WERE REPORTEDLY REOCCLUDED. A HIGH GRADE REOCCLUSION OF THE LEFT COMMON FEMORAL, SFA, AND PROFUNDUS ARTERIES WAS PRESENT. THE PATIENT HAD A SUCCESSFUL THROMBO-ENDARTERECTOMY PERFORMED ON (B)(6) 2015. EVEN THOUGH IMPROVED BLOOD FLOW WAS EVIDENT, THE PATIENT COMPLAINS OF STRONG LEG PAIN; THEREFORE, A MINOR AMPUTATION OF DIGIT II AND III OF THE LEFT FOOT WAS PERFORMED. THE FOREFOOT AND ULTIMATELY THE LOWER LEFT LEG WAS AMPUTATED ON (B)(6) 2016. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 5709804 ↗
• InjuryMay 9, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT HAS EXPERIENCED LIFESTYLE LIMITING CLAUDICATION 2 MONTHS AFTER THE INDEX PROCEDURE AND APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE LEFT SFA STENTED AREA WAS REPORTEDLY OCCLUDED. THE FIRST REVASCULARIZATION WAS UNSUCCESSFUL, BUT THE HCP PERFORMED A SECOND ATTEMPT ON (B)(6) 2016 AND IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NOTE, THE LUTONIX 035 DRUG COATED BALLOON PTA CATHETER IS INDICATED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AFTER PRE-DILATATION OF DE NOVO OR RESTENOTIC LESIONS UP TO 150 MM IN LENGTH IN THE NATIVE SUPERFICIAL FEMORAL OR POPLITEAL ARTERIES WITH REFERENCE VESSEL DIAMETERS OF 4-7 MM. THESE LUTONIX DCB'S WERE USED TO TREAT THE STENTED LESION PER THE STUDY REQUIREMENTS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPO

  Patient problems: Claudication; Reocclusion

  MAUDE report 5640291 ↗
• InjuryMar 18, 2016Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT AFTER TREATING THE SUPERFICIAL FEMORAL ARTERY WITH AN LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED ANGIOPLASTY BALLOON, THE BALLOON ALLEGEDLY COULD NOT BE DEFLATED FROM EIGHT ATMOSPHERES AFTER SEVERAL ATTEMPTS WHEN USING AN INDEFLATOR. THE HEALTH CARE PROFESSIONAL ALLEGEDLY UTILIZED A NEEDLE TO PUNCTURE THE BALLOON THROUGH THE SKIN. AFTER THE BALLOON WAS DEFLATED, THE CATHETER COULD BE REMOVED WITHOUT DIFFICULTIES. THE HEALTH CARE PROVIDER INDICATED THE PATIENT'S STATUS WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5511308 ↗
• InjuryMar 17, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 14 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICE, DRUG OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 5509107 ↗
• InjuryFeb 12, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER TREATMENT WITH TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, ALLEGEDLY A GRADE D DISSECTION OCCURRED. THE HEALTH CARE PROFESSIONAL (HCP) TREATED THE GRADE D DISSECTION WITH AN INTACT VASCULAR TACK ENDOVASCULAR SYSTEM. THE FACILITY IS UNAWARE OF THE SAMPLE DISPOSITION, THUS THE SAMPLE IS UNLIKELY TO BE RETURNED. THE PATIENT WAS DISCHARGED THE SAME DAY, WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2016-00005.

  Patient problems: Intimal Dissection

  MAUDE report 5435353 ↗
• InjuryDec 21, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE, THE PHYSICIAN USED TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS TO TREAT THE TARGET LESION LOCATED IN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) OF THE RIGHT LEG. APPROXIMATELY 16 MONTHS LATER, THE HCP PERFORMED AN ANGIOPLASTY WITH NORMAL PTA AND PLACEMENT OF 2 STENTS, MANUFACTURER UNKNOWN, TO SUCCESSFULLY RESOLVE THE REOCCLUSION OF THE PATIENT'S ORIGINAL TARGET LESION. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND DIAGNOSTIC IMAGES HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 5313427 ↗
• InjuryDec 16, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER TREATMENT WITH A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, ALLEGEDLY A GRADE D DISSECTION OCCURRED. THE HEALTH CARE PROFESSIONAL (HCP) TREATED THE GRADE D DISSECTION WITH AN INTACT VASCULAR TACK ENDOVASCULAR SYSTEM. THE PATIENT WAS DISCHARGED THE SAME DAY, WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT AND ARE ASSOCIATED MANUFACTURERS REPORT NUMBERS 3006513822-2015-00067.

  Patient problems: Intimal Dissection

  MAUDE report 5301994 ↗
• InjuryDec 2, 2015Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, AFTER TREATMENT WITH A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, A GRADE D DISSECTION ALLEGEDLY OCCURRED. THE HEALTH CARE PROFESSIONAL (HCP) TREATED THE DISSECTION WITH AN INTACT VASCULAR TACK ENDOVASCULAR SYSTEM. THE PATIENT WAS DISCHARGED THE SAME DAY WITH NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 5262345 ↗