LUTONIX® Drug Coated Balloon LX351305150Recalls & reported problems

Summary

The FDA's MAUDE database contains 117 adverse event reports that list this exact device (DI 00801741088759), received between Aug 28, 2015 and Dec 21, 2020 — classified as 113 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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, 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 117 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 21, 2020Deflation Problem; Retraction Problem; Device-Device Incompatibility; Deflation Problem; Retraction Problem; Device-Device Incompatibility

  IT WAS REPORTED DURING AN ANGIOPLASTY PROCEDURE, THE DRUG COATED BALLOON ALLEGEDLY HAD A DEFLATION ISSUE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11044964 ↗
• InjuryMay 3, 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 LESION LOCATED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT PROXIMAL SFA VESSEL WAS REPORTEDLY REOCCLUDED. NO ADDITIONAL INTERVENTION WAS PERFORMED AT THAT TIME. ON (B)(6) 2018, APPROXIMATELY 25 MONTHS FROM THE INDEX PROCEDURE, A REINTERVENTION WAS PERFORMED. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICES OR PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS 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 3006513822-2019-00068.

  Patient problems: Reocclusion

  MAUDE report 8579951 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LITERATURE ARTICLE THAT DURING THE INDEX PROCEDURE, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS RE-EXAMINED DUE TO RIGHT CALF CLAUDICATION AFTER WALKING 100 METERS. A NEW DUPLEX ULTRASOUND (DUS) REVEALED GREATER THAN 75% REOCCLUSION JUST PROXIMAL TO THE ELUVIA STENT WHICH WAS PLACED DUE TO A DISSECTION OCCURRING AFTER THE USE OF LUTONIX DCB'S DURING THE INDEX PROCEDURE. THE HEALTH CARE PROFESSIONAL (HCP) PRESUMED THE REOCCLUSION WAS A RESULT OF NEOINTIMAL HYPERPLASIA FROM BALLOON TRAUMA, GIVEN THAT THERE WAS NO CLINICAL OR BIOCHEMICAL EVIDENCE OF AN ACUTE INFLAMMATORY FLARE OF GIANT CELL ARTERITIS (GCA). IN THE OPINION OF THE INVESTIGATOR, THE OCCURRENCE OF REOCCLUSION IS POSSIBLY RELATED TO THE LUTONIX DCB. THE REMAINDER OF THE SFA AND STENT APPEARED WIDELY PATENT WITH NO SIGNIFICANT STENOSIS. AN ANGIOPLASTY PROCEDURE IS PLANNED INVOLVING THE USE OF DCB'S. THE LUTONIX DCB'S WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR RETURN. NO ADVER

  Patient problems: Claudication; Reocclusion

  MAUDE report 8388658 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LITERATURE ARTICLE THAT DURING THE INDEX PROCEDURE, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. APPROXIMATELY 6 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT WAS RE-EXAMINED DUE TO RIGHT CALF CLAUDICATION AFTER WALKING 100 METERS. A NEW DUPLEX ULTRASOUND (DUS) REVEALED GREATER THAN 75% REOCCLUSION JUST PROXIMAL TO THE ELUVIA STENT WHICH WAS PLACED DUE TO A DISSECTION OCCURRING AFTER THE USE OF LUTONIX DCB'S DURING THE INDEX PROCEDURE. THE HEALTH CARE PROFESSIONAL (HCP) PRESUMED THE REOCCLUSION WAS A RESULT OF NEOINTIMAL HYPERPLASIA FROM BALLOON TRAUMA, GIVEN THAT THERE WAS NO CLINICAL OR BIOCHEMICAL EVIDENCE OF AN ACUTE INFLAMMATORY FLARE OF GIANT CELL ARTERITIS (GCA). IN THE OPINION OF THE INVESTIGATOR, THE OCCURRENCE OF REOCCLUSION IS POSSIBLY RELATED TO THE LUTONIX DCB. THE REMAINDER OF THE SFA AND STENT APPEARED WIDELY PATENT WITH NO SIGNIFICANT STENOSIS. AN ANGIOPLASTY PROCEDURE IS PLANNED INVOLVING THE USE OF DCB'S. THE LUTONIX DCB'S WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR RETURN. NO ADVER

  Patient problems: Claudication; Reocclusion

  MAUDE report 8388649 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LITERATURE ARTICLE THAT DURING THE INDEX PROCEDURE, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. AFTER SYSTEMIC ANTICOAGULATION WITH HEPARIN, THE LESION WAS CROSSED INTRALUMINALLY WITH A V-18 CONTROL WIRE GUIDEWIRE (BOSTON SCIENTIFIC, MARLBOROUGH, MASS) AND A SPIDER EMBOLIC PROTECTION DEVICE (MEDTRONIC, MARLBOROUGH MINN) WAS DEPLOYED IN THE DISTAL POPLITEAL ARTERY. A DISTAL FILTER WAS USED BECAUSE MULTIPLE FILLING DEFECTS SEEN ON DUPLEX ULTRASOUND (DUS) PRESENTED A POTENTIAL EMBOLIC SOURCE. SFA AND POPLITEAL ARTERY WERE PRE-DILATED WITH AN ARMADA 0.018-INCH 3MM X 200MM BALLOON AND AN ARMADA 0.018-INCH 5MM X 200MM BALLOON (ABBOTT VASCULAR, ABBOTT PARK III). THEN, THE LESIONS WERE TREATED WITH THREE LUTONIX DCB'S (C.R. BARD, MURRAY HILL, NJ). THE LENGTHS OF THE BALLOONS WERE 5MM X 150MM, 5MM X 150MM, AND 8MM X 50MM. DIGITAL SUBTRACTION ANGIOGRAPHY DEMONSTRATED A NEW FLOW-LIMITING DISSECTION IN DISTAL SFA AFTER ANGIOPLASTY. A 6MM X 80MM ELUVIA DRUG-ELUTING STENT (BOSTON SCIENTIFIC) WAS PLACED TO COVER THE DISSECTION WITH

  Patient problems: Intimal Dissection

  MAUDE report 8387884 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A LITERATURE ARTICLE THAT DURING THE INDEX PROCEDURE, THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY. AFTER SYSTEMIC ANTICOAGULATION WITH HEPARIN, THE LESION WAS CROSSED INTRALUMINALLY WITH A V-18 CONTROL WIRE GUIDEWIRE (BOSTON SCIENTIFIC, MARLBOROUGH, MASS) AND A SPIDER EMBOLIC PROTECTION DEVICE (MEDTRONIC, MARLBOROUGH MINN) WAS DEPLOYED IN THE DISTAL POPLITEAL ARTERY. A DISTAL FILTER WAS USED BECAUSE MULTIPLE FILLING DEFECTS SEEN ON DUPLEX ULTRASOUND (DUS) PRESENTED A POTENTIAL EMBOLIC SOURCE. SFA AND POPLITEAL ARTERY WERE PRE-DILATED WITH AN ARMADA 0.018-INCH 3MM X 200MM BALLOON AND AN ARMADA 0.018-INCH 5MM X 200MM BALLOON (ABBOTT VASCULAR, ABBOTT PARK III). THEN, THE LESIONS WERE TREATED WITH THREE LUTONIX DCB'S (C.R. BARD, MURRAY HILL, NJ). THE LENGTHS OF THE BALLOONS WERE 5MM X 150MM, 5MM X 150MM, AND 8MM X 50MM. DIGITAL SUBTRACTION ANGIOGRAPHY DEMONSTRATED A NEW FLOW-LIMITING DISSECTION IN DISTAL SFA AFTER ANGIOPLASTY. A 6MM X 80MM ELUVIA DRUG-ELUTING STENT (BOSTON SCIENTIFIC) WAS PLACED TO COVER THE DISSECTION WITH

  Patient problems: Intimal Dissection

  MAUDE report 8387883 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A CLINICAL REGISTRY, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT POPLITEAL ARTERY. APPROXIMATELY 30 MONTHS AFTER THE INDEX PROCEDURE, 80% OF THE TARGET LESION WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED. THE HEALTHCARE 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 8253146 ↗
• InjuryDec 1, 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) AND POPITEAL ARTERY. THE HEALTH CARE PROFESSIONAL (HCP) PREDILATED THE TARGET LESION WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND A NON-FLOW LIMITING DISSECTION, GRADE B, WAS EVIDENT. THE HCP THEN TREATED THE TARGET LESION WITH THE LUTONIX DCB, WHICH RESULTED IN THE DISSECTION WORSENING TO A FLOW LIMITING DISSECTION, GRADE D. THE HCP SUCCESSFULLY STENTED THE TARGET LESION DISSECTION, WHICH SUCCESSFULLY RE-ESTABLISHED UNOBSTRUCTED BLOOD FLOW. THE INVESTIGATOR ASSESSED THAT THE DISSECTION EVENT WAS NOT RELATED TO THE STUDY DEVICE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Intimal Dissection

  MAUDE report 8121941 ↗
• InjuryNov 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, TWO LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS WERE USED TO TREAT THE TARGET LESIONS LOCATED IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY (SFA) AND LEFT MID POPLITEAL ARTERY. APPROXIMATELY 13 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S TARGET LESIONS WERE REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. THE REGISTRY'S INDEPENDENT EVALUATOR ASSESSED THAT BOTH TARGET LESIONS WERE PATENT AT THIS TIME. APPROXIMATELY 28 MONTHS AFTER THE INDEX PROCEDURE, A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED ON TARGET LESION 2, LEFT MID SFA . APPROXIMATELY ONE MONTH AFTER THE REVASCULARIZATION ON LEFT MID SFA, A REVASCULARIZATION WAS PERFORMED ON LEFT MID POPLITEAL ARTERY, TARGET LESION 1. THE HEALTH CARE PROFESSIONAL (HCP) DEEMED BOTH REVASCULARIZATIONS WERE 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 ASS

  Patient problems: Reocclusion

  MAUDE report 8081953 ↗
• InjuryNov 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 RIGHT MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S TARGET LESION WAS REPORTEDLY REOCCLUDED VIA DUPLEX ULTRASOUND (DUS) IMAGING. HOWEVER, THE REGISTRY'S INDEPENDENT EVALUATORS DETERMINED THE SAME DUS IMAGING RESULTING IN THE PATIENT¿S RIGHT MID SFA WAS PATENT. APPROXIMATELY 26 MONTHS AFTER THE INDEX PROCEDURE, A CLINICALLY DRIVEN 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 8081944 ↗
• InjuryOct 22, 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 POPLITEAL ARTERY FOLLOWED BY A BARE METAL STENT. APPROXIMATELY 3 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT POPLITEAL VESSEL WAS REPORTEDLY OCCLUDED. 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 7993757 ↗
• InjuryJul 6, 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 SUPERFICIAL FEMORAL ARTERY (SFA) . APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VESSEL WAS REPORTEDLY REOCCLUDED. APPROXIMATELY 14 MONTHS AFTER THE INDEX PROCEDURE, THE HCP ATTEMPTED A REVASCULARIZATION ON THE TARGET LIMB, BUT IS WAS DEEMED UNSUCCESSFUL.. ONE MONTH LATER, THE HCP PERFORMED A SUBSEQUENT REVASCULARIZATION AND IT WAS DEEMED 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 FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7666135 ↗
• InjuryJun 26, 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 PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 13 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED, APPROXIMATELY 16 MONTHS AFTER THE INDEX PROCEDURE, 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 FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7638471 ↗
• InjuryJun 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, 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). APPROXIMATELY 23 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. 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 7608545 ↗
• InjuryMay 30, 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 SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT MID SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED, APPROXIMATELY 15 MONTHS AFTER THE INDEX PROCEDURE, 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 FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7553703 ↗
• InjuryMay 24, 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 ENTIRE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). AFTER TREATMENT WITH THE LUTONIX DEVICES, THE PATIENT HAD A GRADE A DISSECTION PRESENT. THE HCP PERFORMED POST-DILATION WITH ONE OF THE ALREADY USED LUTONIX DCB'S AND PLACED A BAILOUT STENT. THE HCP DEEMED THE MEDICAL INTERVENTION SUCCESSFUL. 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 3006513822-2018-00131.

  Patient problems: Intimal Dissection

  MAUDE report 7543021 ↗
• InjuryMay 24, 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 ENTIRE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). AFTER TREATMENT WITH THE LUTONIX DEVICES, THE PATIENT HAD A GRADE A DISSECTION PRESENT. THE HCP PERFORMED POST-DILATION WITH ONE OF THE ALREADY USED LUTONIX DCB'S AND PLACED A BAILOUT STENT. THE HCP DEEMED THE MEDICAL INTERVENTION SUCCESSFUL. 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 3006513822-2018-00132.

  Patient problems: Intimal Dissection

  MAUDE report 7542923 ↗
• InjuryMay 23, 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 ENTIRE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 31 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 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 3006513822-2018-00127.

  Patient problems: Reocclusion

  MAUDE report 7537421 ↗
• InjuryMay 23, 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 ENTIRE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 31 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 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 3006513822-2018-00126.

  Patient problems: Reocclusion

  MAUDE report 7537419 ↗
• InjuryMay 22, 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 SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VASCULATURE WAS REPORTEDLY REOCCLUDED. APPROXIMATELY 14 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 7533609 ↗
• InjuryMay 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT POPLITEAL ARTERY. APPROXIMATELY 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT POPLITEAL VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS ATTEMPTED WITH AN UNKNOWN DEVICE AND THE HEALTH CARE PROFESSIONAL (HCP) DEEMED IT WAS NOT SUCCESSFUL. APPROXIMATELY 27 MONTHS AFTER THE INDEX PROCEDURE, THE HCP PERFORMED A REVASCULARIZATION AND IT WAS DEEMED 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 7521767 ↗
• MalfunctionMar 8, 2018Difficult to Remove; Material Rupture; Difficult to Remove; Material Rupture

  IT WAS REPORTED A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER ALLEGEDLY HAD A MATERIAL RUPTURE OCCUR AFTER TREATING THE TARGET LESION. THE HEALTH CARE PROFESSIONAL (HCP) USED A CONTRALATERAL APPROACH TO GAIN PATIENT ACCESS AND THE TARGET LESION WAS SUCCESSFULLY PREDILATED. THE HCP ADVANCED THE LUTONIX DCB TO THE TARGET LESION AND INFLATED THE BALLOON TO TREAT THE TARGET LESION SUCCESSFULLY. THE SPECIFIC INFLATION PRESSURE OF THE BALLOON IS UNKNOWN, BUT THE BALLOON WAS NOT INFLATED GREATER THAN RATE BURST PRESSURE (RBP). AS THE HCP ATTEMPTED TO REMOVE THE LUTONIX DCB, IT BECAME STUCK IN THE INTRODUCER SHEATH, THUS THE ENTIRE CATHETER AND THE INTRODUCER SHEATH WERE REMOVED AS A SINGLE UNIT. ALTHOUGH REQUESTED, IT IS UNKNOWN IF NEGATIVE PRESSURE WAS APPLIED PRIOR TO THE REMOVAL OF THE LUTONIX DCB. FURTHERMORE, THE HCP DOES NOT BELIEVE THAT PATIENT ANATOMY OR CALCIFICATION OF THE VESSEL IS RELATED TO THE NATURE OF THE REPORTED MATERIAL RUPTURE. NO ADVERSE PATIENT OUTCOMES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7325770 ↗
• InjuryMar 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER TREATMENT WITH FOUR LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETERS REPORTEDLY THE PATIENT EXPERIENCED HYPERTENSION, AND AN ITCHY RED RASH. THE HEALTH CARE PROFESSIONAL (HCP) ADMINISTERED HYDROCHLORIDE AND EPINEPHRINE. AT THE CONCLUSION OF THE PROCEDURE, THE PATIENT WAS ASYMPTOMATIC. NO FURTHER ADVERSE PATIENT OUTCOMES WERE REPORTED. THE LUTONIX DCB'S WERE DISCARDED BY THE USER FACILITY AND ARE NOT AVAILABLE FOR EVALUATION. THIS IS ONE OF FOUR PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURER¿S REPORT NUMBERS ARE 3006513822-2018-00034, 3006513822-2018-00036, AND 3006513822-2018-00037.

  Patient problems: High Blood Pressure/ Hypertension; Hypersensitivity/Allergic reaction; Rash

  MAUDE report 7309318 ↗
• InjuryFeb 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, A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER WAS USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT MID TO DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 16 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT MID TO DISTAL SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED AND THE HCP DEEMED IT 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 FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7282171 ↗
• InjuryFeb 13, 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 WERE USED TO TREAT THE TARGET LESION LOCATED IN THE RIGHT PROXIMAL AND MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 20 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT PROXIMAL AND MID 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 TO THE PROCEDURE. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Reocclusion

  MAUDE report 7269071 ↗