LUTONIX® Drug Coated Balloon LX351305120Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 00801741088711), received between Oct 28, 2015 and Jan 23, 2019 — classified as 32 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESIONS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT POPLITEAL ARTERY. APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT DISTAL SFA, TARGET LESION 2, WAS REPORTEDLY 50-99% REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. NO ADDITIONAL INTERVENTION WAS PERFORMED AT THAT TIME. APPROXIMATELY 33 MONTHS AFTER THE INDEX PROCEDURE, A REVASCULARIZATION WAS PERFORMED ON BOTH TARGET LESIONS 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 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 3006513822-2018-00303.

  Patient problems: Reocclusion

  MAUDE report 8270326 ↗
• InjuryJan 23, 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESIONS LOCATED IN THE LEFT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT POPLITEAL ARTERY. APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT DISTAL SFA, TARGET LESION 2, WAS REPORTEDLY 50-99% REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. NO ADDITIONAL INTERVENTION WAS PERFORMED AT THAT TIME. APPROXIMATELY 33 MONTHS AFTER THE INDEX PROCEDURE, A REVASCULARIZATION WAS PERFORMED ON BOTH TARGET LESIONS 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 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 3006513822-2018-00304.

  Patient problems: Reocclusion

  MAUDE report 8270263 ↗
• InjuryNov 20, 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 DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 13 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT DISTAL SFA VESSEL WAS REPORTEDLY 50-99% OCCLUDED VIA ANALYSIS OF DUPLEX ULTRASOUND (DUS) IMAGING BY AN INDEPENDENT EVALUATOR ON (B)(6) 2016. APPROXIMATELY 32 MONTHS AFTER THE INDEX PROCEDURE, A REVASCULARIZATION WAS PERFORMED ON THE ENTIRE TARGET LESION 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 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 3006513822-2018-00270.

  Patient problems: Reocclusion

  MAUDE report 8091452 ↗
• InjuryApr 8, 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 RIGHT MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 30 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 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 7405985 ↗
• InjuryMar 16, 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 DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 14 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA 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.

  Patient problems: Reocclusion

  MAUDE report 7344745 ↗
• InjuryNov 2, 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, THREE 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 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT 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 SAMPLES WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS IS ONE OF THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2017-00274 AND 3006513822-2017-00276.

  Patient problems: Reocclusion

  MAUDE report 6995567 ↗
• 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 12 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 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 3006513822-2017-00273.

  Patient problems: Reocclusion

  MAUDE report 6995536 ↗
• 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 6 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 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 3006513822-2017-00271.

  Patient problems: Reocclusion

  MAUDE report 6995526 ↗
• 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 5 DAYS 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 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 3006513822-2017-00269.

  Patient problems: Reocclusion

  MAUDE report 6995522 ↗
• 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 5 DAYS 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 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 3006513822-2017-00268.

  Patient problems: Reocclusion

  MAUDE report 6995521 ↗
• 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 1 MONTH 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 3006513822-2017-00264.

  Patient problems: Reocclusion

  MAUDE report 6995142 ↗
• 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT 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 3006513822-2017-00263.

  Patient problems: Reocclusion

  MAUDE report 6995106 ↗
• 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS 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.

  Patient problems: Reocclusion

  MAUDE report 6994936 ↗
• 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 10 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.

  Patient problems: Reocclusion

  MAUDE report 6993543 ↗
• 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 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.

  Patient problems: Reocclusion

  MAUDE report 6993497 ↗
• InjuryJul 26, 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 MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT MID 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. 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 6743160 ↗
• InjuryJun 6, 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 RIGHT MID DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT MID DISTAL SFA 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 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 3006513822-2017-00116.

  Patient problems: Reocclusion

  MAUDE report 6614073 ↗
• InjuryMar 2, 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 PROXIMAL -MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 17 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LIFESTENT'S REPORTEDLY FRACTURED RESULTING IN REOCCLUSION OF THE LEFT PROXIMAL-MID SFA VESSEL. A REVASCULARIZATION WAS PERFORMED INVOLVING THROMBECTOMY AND STENT GRAFT IN-STENT IMPLANTATION AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE, BUT POSSIBLY 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 3006513822-2017-00041.

  Patient problems: Reocclusion

  MAUDE report 6371606 ↗
• InjuryFeb 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 LESIONS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND RIGHT POPLITEAL ARTERY. APPROXIMATELY 5 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA AND POPLITEAL VESSELS WERE 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 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 3006513822-2017-00012.

  Patient problems: Reocclusion

  MAUDE report 6295084 ↗
• InjuryOct 6, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A NORMAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) DURING A CLINICAL REGISTRY STUDY PRIOR TO THE USE OF ANY LUTONIX . THE PATIENT'S VESSEL BECAME REOCCLUDED AND WAS TREATED ON (B)(6) 2014 WITH TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS. THE TARGET LESION WAS LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 21 MONTHS AFTER THE PROCEDURE, THE PATIENT'S RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING NORMAL PTA 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 3006513822-2016-00190.

  Patient problems: Reocclusion

  MAUDE report 6002585 ↗
• InjurySep 30, 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, THREE 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 7 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 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 THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER ARE 3006513822-2016-00186 AND 3006513822-2016-00187.

  Patient problems: Reocclusion

  MAUDE report 5989969 ↗
• InjurySep 29, 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, THREE 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 7 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 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 THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBER ARE 3006513822-2016-00186 AND 3006513822-2016-00188.

  Patient problems: Reocclusion

  MAUDE report 5988994 ↗
• InjuryJun 23, 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 CATHETER WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA STENTED AREA WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH AN ANGIOSCULPT BALLOON 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. 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 ASSOCIATED MANUFACTURERS REPORT NUMBERS ARE

  Patient problems: Reocclusion

  MAUDE report 5746725 ↗
• InjuryJun 23, 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 CATHETER WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA STENTED AREA WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH AN ANGIOSCULPT BALLOON 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. 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 ASSOCIATED MANUFACTURERS REPORT NUMBERS ARE

  Patient problems: Reocclusion

  MAUDE report 5746688 ↗
• InjuryMay 24, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) DURING A (B)(6) STUDY PROCEDURE. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT PRESENTED WITH COMPLAINTS OF CLAUDICATION. DIAGNOSTIC TESTING REVEALED THE RIGHT SFA STENTED AREA WAS REPORTEDLY REOCCLUDED. A FEMORAL BYPASS PROCEDURE WAS PERFORMED AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE BUT WAS DEFINITELY RELATED TO THE INDEX 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 THREE PRODUCTS INVOLVED WITH THE REPORTED EVEN

  Patient problems: Reocclusion

  MAUDE report 5675639 ↗