Lutonix® Drug Coated Balloon LX35130580Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00801741088636), received between Mar 17, 2016 and Nov 20, 2018 — classified as 19 injuries.

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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• 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 3006513822-2018-00269.

  Patient problems: Reocclusion

  MAUDE report 8091541 ↗
• InjuryOct 25, 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 ENTIRE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND THE RIGHT POPLITEAL ARTERY. APPROXIMATELY 33 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSELS CONTAINING THE TARGET LESIONS WERE REPORTEDLY 50-99% OCCLUDED VIA A DUPLEX ULTRASOUND ON (B)(6) 2018. AN INDEPENDENT EVALUATOR SUGGESTED THAT THE DISTAL SFA WAS 50-99% OCCLUDED DURING A PREVIOUS DUPLEX ULTRASOUND, WHICH THE PRINCIPLE INVESTIGATOR (PI) DEEMED PATENT. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED ON THE 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 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 3006513822-2018-00241.

  Patient problems: Reocclusion

  MAUDE report 8006095 ↗
• InjuryOct 25, 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 ENTIRE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND THE RIGHT POPLITEAL ARTERY. APPROXIMATELY 33 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S VESSELS CONTAINING THE TARGET LESIONS WERE REPORTEDLY 50-99% OCCLUDED VIA A DUPLEX ULTRASOUND ON (B)(6) 2018. AN INDEPENDENT EVALUATOR SUGGESTED THAT THE DISTAL SFA WAS 50-99% OCCLUDED DURING A PREVIOUS DUPLEX ULTRASOUND, WHICH THE PRINCIPLE INVESTIGATOR (PI) DEEMED PATENT. A CLINICALLY DRIVEN REVASCULARIZATION WAS PERFORMED ON THE 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 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 3006513822-2018-00242.

  Patient problems: Reocclusion

  MAUDE report 8006006 ↗
• InjuryNov 22, 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 THIRD OF THE SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 13 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VESSEL WAS REPORTEDLY 50-99% REOCCLUDED. THE HCP TOOK A CONSERVATIVE APPROACH AND WAITED TO TREAT THE TARGET LESION. A REVASCULARIZATION WAS PERFORMED 12 MONTHS AFTER THE DUS IMAGING ALLEGEDLY REPORTED A 50-99% REOCCLUSION 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 7054337 ↗
• InjuryNov 21, 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 PROXIMAL THIRD OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S LEFT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED ON (B)(6) 2016 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 7051388 ↗
• InjuryNov 8, 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 PROXIMAL AND DISTAL PORTIONS OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 13 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT PROXIMAL AND DISTAL SFA VASCULATURES WERE REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED ON (B)(6) 2017 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 3006513822-2017-00285.

  Patient problems: Reocclusion

  MAUDE report 7009423 ↗
• InjuryOct 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 9 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.

  Patient problems: Reocclusion

  MAUDE report 6981981 ↗
• InjuryOct 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 RIGHT PROMIXAL SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 9 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT PROMIXAL 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 6980149 ↗
• InjuryAug 15, 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 PROXIMAL AND DISTAL THIRDS OF THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 12 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S PROXIMAL AND DISTAL THIRDS OF THE LEFT SFA VESSEL WERE REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED A FEW MONTHS LATER ON (B)(6) 2017 AND THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE PATIENT PASSED AWAY FROM LUNG CANCER ON (B)(6) 2017. 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 3006513822-2017-00158.

  Patient problems: Reocclusion

  MAUDE report 6794009 ↗
• InjuryJul 21, 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 27 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED CLAUDICATION IN THEIR RIGHT LEG. IT WAS DISCOVERED THE PATIENTS RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING THE USE OF AN ABBOTT ARMADA PTA BALLOON AND THE PLACEMENT OF TWO STENTS. THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE CEC HAS ADJUDICATED THE REOCCLUSION TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. APPROXIMATELY 4 MONTHS AFTER THE REVASCULARIZATION, THE PATIENTS RIGHT SFA HAD A THROMBOSIS. THE PI ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT THE CEC ADJUDICATED THE THROMBOSIS TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. UPON FURTHER EVALUATION, IT SHOULD BE NOTED THAT THE THROMBOSIS OCCURRED AFTER THE FIRST REVASCULARIZATION INVOLVING ADJUNCTIVE TREATMENTS. FURTHERMORE, ONE

  Patient problems: Claudication; Reocclusion; Thrombosis

  MAUDE report 6733929 ↗
• InjuryJul 21, 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 27 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT DEVELOPED CLAUDICATION IN THEIR RIGHT LEG. IT WAS DISCOVERED THE PATIENTS RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING THE USE OF AN ABBOTT ARMADA PTA BALLOON AND THE PLACEMENT OF TWO STENTS. THE HCP DEEMED IT WAS SUCCESSFUL. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE. THE CEC HAS ADJUDICATED THE REOCCLUSION TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. APPROXIMATELY 4 MONTHS AFTER THE REVASCULARIZATION, THE PATIENTS RIGHT SFA HAD A THROMBOSIS. THE PI ASSESSED THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR PROCEDURE, BUT THE CEC ADJUDICATED THE THROMBOSIS TO BE POSSIBLY RELATED TO THE STUDY DEVICE AND PROCEDURE. UPON FURTHER EVALUATION, IT SHOULD BE NOTED THAT THE THROMBOSIS OCCURRED AFTER THE FIRST REVASCULARIZATION INVOLVING ADJUNCTIVE TREATMENTS. FURTHERMORE, O

  Patient problems: Claudication; Reocclusion; Thrombosis

  MAUDE report 6733819 ↗
• InjuryJun 14, 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 RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 11 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT¿S RIGHT SFA VESSEL WAS REPORTEDLY REOCCLUDED. NO ADDITIONAL INTERVENTION HAS BEEN PERFORMED AT THIS TIME. THE REGISTRY'S INDEPENDENT EVALUATOR'S HAVE DETERMINED THE PATIENT DEVELOPED REOCCLUSION IN APPROXIMATELY 11 MONTHS AFTER INDEX PROCEDURE. THE INVESTIGATOR ORIGINAL ASSESSED THE PATIENT'S TARGET LESION WAS PATENT BUT AFTER THE INDEPENDENT EVALUATION WAS PROVIDED, THE SITE CHANGED THEIR ASSESSMENT TO REOCCLUDED. THE SAMPLE WAS DISCARDED BY THE USER FACILITY AND NOT AVAILABLE FOR FURTHER EVALUATION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. DURING FURTHER FOLLOW-UP, IT WAS DISCOVERED THE PATIENT UNDERWENT A REINTERVENTION.

  Patient problems: Reocclusion

  MAUDE report 6642588 ↗
• InjuryMar 24, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTEDLY AFTER THE TREATMENT OF THE TARGET LESION WITH A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, A FLOW LIMITING THROMBUS OCCURRED. THE HEALTH CARE PROFESSIONAL (HCP) USED A 4MM ANGIOPLASTY BALLOON TO PREDILATE THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND THE POPLITEAL ARTERY. THE LUTONIX DCB WAS USED TO TREAT THE TARGET LESION AND AFTER TREATMENT, A THROMBUS OCCURRED. THE TIMEFRAME FROM THE THROMBUS OCCURRENCE TO THROMBECTOMY TREATMENT BY THE HCP IS UNKNOWN. REPORTEDLY, THE PATIENT'S SKIN WAS DISCOLORED. THE LUTONIX DCB WAS REQUESTED TO BE RETURNED FOR EVALUATION, BUT IS UNAVAILABLE. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Skin Discoloration; Thrombosis

  MAUDE report 6434066 ↗
• InjurySep 21, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN A CLINICAL REGISTRY 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 MID SUPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 10 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT MID SFA VESSEL WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION WAS PERFORMED INVOLVING STENT PLACEMENT 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.

  Patient problems: Reocclusion

  MAUDE report 5965620 ↗
• InjuryJul 28, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A GRADE D FLOW LIMITING DISSECTION WAS ALLEGEDLY PRESENT AFTER TREATMENT WITH THREE LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER. THE HEALTH CARE PROFESSIONAL (HCP) GAINED ACCESS TO TREAT THE MODERATELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE HCP PERFORMED AN ATHERECTOMY WITH A CROSSER CTO AND THEN PREDILATED THE TARGET LESION WITH A VASCUTRAK DILATION CATHETER. THE HCP THEN TREATED THE TARGET LESION WITH THREE LUTONIX DCB'S, WHICH RESULTED IN A GRADE D FLOW LIMITING DISSECTION. THE HCP USED AN ABBOTT STENT AND A BARD LIFESTENT TO SUCCESSFULLY TREAT THE GRADE D DISSECTION. 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 THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBERS ARE 3006513822-2016-00150 AND 3006513822-2016-00151.

  Patient problems: Intimal Dissection

  MAUDE report 5831886 ↗
• 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, THREE 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 7 MONTHS AFTER THE INDEX PROCEDURE, THE PATIENT'S RIGHT SFA STENTED AREA WAS REPORTEDLY REOCCLUDED. A REVASCULARIZATION INVOLVING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH LUMINOR CATHETER 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 THREE PRODUCTS INVOLVED WITH THE REPORTED EVENT AND THE ASSOCIATED MANUFACTURERS REPORT NUMBERS ARE 3

  Patient problems: Reocclusion

  MAUDE report 5746636 ↗
• InjuryJun 8, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 30 DAYS AFTER TREATMENT WITH A LUTONIX PERCUTANEOUS TRANSLUMINAL DRUG COATED BALLOON (DCB) DILATATION CATHETER, THE PATIENT ALLEGEDLY EXPERIENCED ONGOING LEG PAIN. THE PATIENT REPORTS THE LEG PAIN BEGAN THE DAY AFTER THE STUDY PROCEDURE. PER THE INVESTIGATOR, THE ETIOLOGY IS UNKNOWN, BUT MAY POSSIBLY BE RELATED TO LUTONIX DCB AND/OR THE STUDY PROCEDURE. THE INVESTIGATOR PERFORMED A DIFFERENTIAL DIAGNOSES WHICH INCLUDES POSSIBLE CAUSES FROM PLAVIX, PACLITAXEL, POLYMYALGIA RHEUMATICA, OR OTHER SYSTEMIC PROCESSES, BECAUSE THE RELATIONSHIP TO THE DEVICE OR PROCEDURE CANNOT BE RULED OUT. THE LUTONIX DCB WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR FURTHER EVALUATION. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Claudication

  MAUDE report 5706026 ↗
• 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 LEFT SUPPERFICIAL FEMORAL ARTERY (SFA). APPROXIMATELY 13 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, 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 5508894 ↗
• 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 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 THAT THE EVENT WAS NOT 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 5507761 ↗