Lotus™ Introducer Set H749NTR200Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 05391526210116), received between Jan 24, 2019 and Sep 3, 2020 — classified as 1 death, 23 injuries.

The most frequently reported specific device problem is “Difficult to Insert” (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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL; EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: INITIALLY INSERTED INTO PATIENTS FEMORAL ARTERY, FOLLOWED BY A 23MM LOTUS EDGE VALVE. PHYSICIANS CONVEYED SIGNIFICANT RESISTANCE IN DELIVERING THE VALVE THRU THE SHEATH, AND AFTER CONSIDERABLE EFFORT THE DECISION WAS MADE TO REMOVE THE ISLEEVE SHEATH AND CONVERT TO THE LIS SHEATH INSTEAD. THIS PROVED TO WORK WELL, AND ALLOWED THE 23MM VALVE TO PASS THRU UNINHIBITED. FOLLOWING THE SUCCESSFUL DEPLOYMENT OF THE VALVE AND REMOVAL OF THE SHEATH, IT WAS RECOGNIZED THAT THE EXTERNAL ILIAC ARTERY HAS A SLIGHT DISSECTION. PHYSICIAN DECIDED TO BALLOON AND THEN STENT THE DISSECTION. SUCCESSFUL RESULT AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. EVENT DATE: (B)(6) 2020

  Patient problems: Vascular Dissection

  MAUDE report 10486769 ↗
• InjuryAug 26, 2020Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL; EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: IT WAS PLANNED TO PERFORM TAVR ON THE PATIENT FOR SEVERE AORTIC VALVE STENOSIS. CALCIFICATION FOLLOWING LVOT WAS OBSERVED, SO TAVR BY LOTUS EDGE WAS JUDGED TO BE APPROPRIATE. ANNULUS WAS WITHIN THE TREATMENT RANGE OF 23 MM VALVE, BUT THE POSITION OF LVOT -4 MM WAS SLIGHTLY SMALLER THAN THE 23 MM RANGE, BUT IT WAS JUDGED THAT IT COULD BE TREATED BY PLACING IT HIGHER TO MINIMIZE PVL WHILE TAKING PMI RISK. REGARDING ACCESS, THERE WAS POSSIBILITY THAT IT MIGHT BE DIFFICULT TO INSERT THE LIS BECAUSE THERE WAS SEVERE CALCIFICATION IN BOTH SIDES EIA AND CIA. THE PHYSICIAN INSTRUCTED TO START PREPARING THE LOTUS VALVE AFTER THE LIS HAD PASSED THROUGH. DURING THE PROCEDURE, THE FIRST SURGEON FELT RESISTANCE WHEN TRYING TO PASS THE SHEATH TIP TO THE RIGHT EIA, SO THE PROCEDURE WAS TEMPORARILY INTERRUPTED AND DISCUSSIONS WERE HELD WITH OTHER PHYSICIANS AS TO WHETHER OR NOT TO CONTINUE. AFTER THAT, WHEN THE SECOND SURGEON TRIED TO INSERT THE LIS AGAIN, THE SHEATH PASSED THROUGH THE EIA AND THE TIP COULD BE ADVANCED INTO THE ABDOMINAL AORTA, EVEN THOUGH SLIGHT RESISTANCE

  Patient problems: Blood Loss; Hemostasis; Perforation of Vessels

  MAUDE report 10453407 ↗
• InjuryJul 23, 2020Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL; EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: LEFT FEMORAL ACCESS WAS ATTEMPTED VIA STANDARD TECHNIQUE. PHYSICIAN WAS UNABLE TO ADVANCE LOTUS INTRODUCER SHEATH MORE THAN A FEW CENTIMETERS. ATTEMPTED TO DILATE UP THE ARTERIOTOMY USING MULTIPLE DILATORS THAT GRADUALLY INCREASED IN SIZE. WE WERE STILL UNABLE TO ADVANCE THE LOTUS SHEATH. ATTEMPTED A 24F GORE SHEATH AND WAS UNABLE TO INTRODUCE THAT AS WELL. MOVED TO THE RIGHT FEMORAL AND ATTEMPTED ACCESS THERE. JUST LIKE THE LEFT, UNABLE TO OBTAIN ACCESS DESPITE SAME ATTEMPTS AT UPSIZING DILATOR AND ATTEMPTING GORE SHEATH. IT WAS DECIDED TO ABORT THE PROCEDURE ALTOGETHER DUE TO ACCESS ISSUES. PATIENT WAS STABLE THROUGHOUT AND NO ADVERSE EVENTS WERE ENCOUNTERED. THE PATIENT DEVELOPED A LARGE HEMATOMA IN THE RIGHT GROIN POST PROCEDURE. VASCULAR SURGERY ASSESSED THE PATIENT AND IT WAS DETERMINED THE PATIENT A RT. FEMORAL ARTERIAL? TEAR?. REPAIRED BY VASCULAR SURGEON. UNABLE TO DETERMINE WHICH SHEATH (LIS OR GORE) THAT CAUSED THE TEAR. PATIENT REPORTED STABLE POST OP. EVENT DATE: (B)(6) 2020.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 10314018 ↗
• InjuryJun 18, 2020Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT (B)(6); EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: SHEATH WAS IN LEFT GROIN, ON CT, SIZE SHOWED 5.6/5.7; SUGGESTED RT GROIN ACCESS BUT WENT WITH LEFT WITH IDEA OF NO TORTUOUS NOTED; THEY SLOWLY DILATED THE VESSEL BEFORE ADVANCING LIS SHEATH TO LT GROIN, WAS NOT MENTION OF DIFFICULTIES ADVANCING THE SHEATH. AFTER THE VALVE DEPLOYED, DELIVERY SYSTEM CAME OUT WITHOUT ANY ISSUES. TRYING TO REMOVE THE LIS SHEATH, UNABLE TO; AFTER MUCH ATTEMPT, PART OF THE LIS SHEATH BROKE OFF, HAD TO CONVERT TO CUTDOWN AND REMOVED THE REMAKING LIS SHEATH AND PT RECEIVED BYPASS GRAFT FROM EXTERNAL ILIAC TO COMMON FEMORAL. EVENT DATE: (B)(6) 2020.

  Patient problems: No Information

  MAUDE report 10169363 ↗
• InjuryJun 3, 2020Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL; EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: (B)(6) 2020 AFTER SUCCESSFUL TAVI PROCEDURE, RT EIA TEAR WAS CONFIRMED DURING DEVICE SHEATH REMOVAL. RT EIA OCCLUSION AND STENTING WERE PERFORMED BY PTA, TEARS WERE HEMOSTATIC, BUT PUNCTURE SITE BLEEDING OF THE RT FEMORAL HEAD INFERIOR BORDER CONTINUED, AND RT IIA & CFA BLEEDING CONTROL SURGERY WAS PERFORMED. AFTER THAT, THE BP DROP SHOWED RBC 1UNIT TRANSFUSION AND NE SUPPORT, AND THE CONDITION IMPROVED. AFTER TREATMENT, THE CONDITION IMPROVED AND SHE WAS DISCHARGED ON (B)(6). THE RT EIA TEAR WAS DEFINITELY RELATED TO STUDY PROCEDURE AND REPORTED BY SAE. EVENT DATE: (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED 07-MAY-2020 WHAT BSC DEVICE CAUSED THE RT EIA TEAR? -> LOTUS INTRODUCER SET LARGE. WAS ANY RESISTANCE ENCOUNTERED WHEN INSERTING OR WITHDRAWING THE SHEATH? -> YES, WHEN WITHDRAWING THE SHEATH. IF YES, PLEASE EXPLAIN: -> THE OPERATOR SLOWLY AND CAREFULLY TRIED TO REMOVED THE SHEATH BUT HE FELT RESISTANCE AS HE WAS DOING SO AND REALIZED THERE WAS A TEAR. WAS ANY RESISTANCE ENCOUNTERED WHEN INSERTING THE LOTUS EDGE VALVE SYSTEM INTO THE SHEATH? -> NO. WAS

  Patient problems: Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 10114533 ↗
• InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL; EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: QUALITY EVENT YES PATIENT OUTCOME SUCCESSFUL MAJOR VASCULAR COMPLICATIONS YES PVL GRADE NONE QUALITY EVENT DESCRIPTION: ILIAC PERFORATION REQUIRING SURGICAL REPAIR. SHEATH WAS ADVANCED WITHOUT ISSUE. 25 LOTUS WAS IMPLANTED SUCCESSFULLY. WHEN TAKING OUT THE LIS, THE ILIAC VESSEL TORE REQUIRING SURGICAL REPAIR. ADDITIONAL INFORMATION RECEIVED. THE DOCTOR SAID IT WAS A LITTLE TIGHT BUT VERY SMOOTH ADVANCING THE SHEATH. THERE WAS RESISTANCE WITHDRAWING THE SHEATH. THE VALVE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WHEN THE ILIAC TORN. THE CAUSED THE PERFORATION WAS THE VESSEL ADHERING TO THE SHEATH. THE PHYSICIAN STATES THE PATIENT IS DOING WELL. AS PER THE CNF THE DEVICE WAS DISCARDED POST PROCEDURE AND SO WILL NOT BE RETURNING. THE INCIDENT HAD NOTHING TO DO WITH THE VALVE. THE PHYSICIAN REITERATED THAT IT WAS A LITTLE TIGHT PUTTING IN THE SHEATH BUT WENT SMOOTHLY. THE EVENT DESCRIPTION STATES IT WAS A '6.0MM VESSEL WITH NO CALCIUM' THERE WAS NO TORTUOSITY OR CALCIFICATION. AN ILIAC CONDUIT WAS PLACED.

  Patient problems: Perforation of Vessels

  MAUDE report 10023943 ↗
• DeathApr 2, 2020Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: PER CNF, IT WAS REPORTED THAT: LOTUS 23MM VALVE SUCCESSFULLY IMPLANTED WITH NO PVL. WHEN THE PHYSICIAN ATTEMPTED TO TAKE OUT THE LIS, IT WAS FROZEN IN THE VESSEL. VASOSPASM SUSPECTED. SHEATH WAS PARTIALLY REMOVED BUT EVIDENCE OF VESSEL DISRUPTION WAS APPARENT. VIABAHN COVERED STENTS WERE PLACED IN THE EXTERNAL AND COMMON ILIAC ARTERIES. PATIENT CONTINUED TO BLEED. PATIENT MOVED TO THE OR FOR SURGICAL REPAIR OF THE ILIACS WHERE PATIENT EXPIRED. EVENT DATE: (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED FROM DISTRIBUTOR ON 12TH OF MARCH 2020: OPERATOR 2 WAS RUSSELL STAHL. LOTUS INTRODUCER LOT NUMBER: 0000012694. WAS THERE DIFFICULTY ADVANCING THE LOTUS EDGE? NO. WAS THERE DIFFICULTY REMOVING THE LOTUS EDGE? NO. WAS THE LOTUS EDGE ABLE TO BE REMOVED THROUGH THE LOTUS INTRODUCER? YES. WAS LOTUS EDGE REMOVED BEFORE THE VASOSPASM? YES. WHERE WAS THE SPASM? LEFT ILIACS. CAN YOU FURTHER DESCRIBE THE ''VESSEL DISRUPTION'? (PERFORATION, DISSECTION): APPEARED TO BE EVULSION OF THE ILIACS. WAS THE 'VESSEL DISRUPTION' A RESULT OF THE VASOSPASM AROUND THE LOTUS INTRODUCER SHEATH? WE BELIEVE, A PHYSICIAN WILL NEED TO COMMENT ON THAT. DID THE LOTUS EDGE VALVE CAUSE OR CONTRIBUTE T

  Patient problems: Death; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 9917757 ↗
• InjuryMar 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: LATER IT WAS DECIDED TO PERFORM INTERVENTION DUE TO VASCULAR INJURY TO RIGHT ILIAC AND/OR COMMON FEMORAL ARTERY. AS PER SOURCE THERE WAS POSSIBLE VASCULAR COMPLICATION DUE TO TAVR ACCESS SHEATH. WARFARIN WAS RECOMMENDED TO DISCONTINUE. PER EDC, SURGERY WAS PERFORMED TO TREAT THE EVENT (RIGHT COMMON FEMORAL ENDARTERECTOMY WITH PATCH ANGIOPLASTY. STENT PLACEMENT TO COVER DISSECTION OF RIGHT COMMON FEMORAL AND EXTERNAL ILIAC ARTERIES). ON (B)(6) 2020, THE EVENT WAS CONSIDERED TO BE RECOVERED. PER CTSENR, IT WAS REPORTED THAT: REPRISE IV 0784R42002 (ECG "SINUS PAUSES" ; NEW LEFT BUNDLE BRANCH BLOCK) EVENT DESCRIPTION: NEW LEFT BUNDLE BRANCH BLOCK (002- ADE)/ ECG "SINUS PAUSES" (003- NEW PERMANENT PACEMAKER IMPLANTATION RESULTING FROM NEW OR WORSENED CONDUCTION DISTURBANCES): ON (B)(6) 2020, SAME DAY OF THE INDEX PROCEDURE, POST TAVR, THE SUBJECT DEVELOPED NEW LEFT BUNDLE BRANCH BLOCK. OF NOTE, BALLOON VALVULOPLASTY WAS NOT PERFORMED. PER EDC NO DIAGNOSTIC TESTS WERE PERFORMED AND NO ACTION WAS TAKEN TO TREAT THE EVENT. ON (B)(6) 2020, 1 DAY POST INDEX PROCEDURE, THE SUBJECT DEVELOPED ECG "SINUS PAUSES". THE EVENT WAS INITIALLY TREATED

  Patient problems: Ischemia; Vascular Dissection

  MAUDE report 9903241 ↗
• InjuryFeb 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: IT WAS REPORTED THAT: TRANSFEMORAL ACCESS WITHOUT PROBLEMS WITH LIS, INSERTING BALLOON WITHOUT PROBLEMS, INSERTING LOTUS EDGE WITHOUT PROBLEMS, REMOVING LOTUS EDGE WITHOUT PROBLEMS, ANGIO ILLIACA COMMUNIS AFTER REMOVE LIS, DISSECTION ILLIACA COMMUNIS RIGHT, SUPPLYING THE DISSECTION WITH STENT, THEN CONTROL ANGIO, NO MORE DISSECTION SMALL VIDEO RECORDED WAS BAV PERFORMED? YES ASSOCIATED WITH LABELED USE? YES PATIENT STATUS POST PROCEDURE/EVENT: FINE. EVENT DATE: (B)(6) 2020.

  Patient problems: Vascular Dissection

  MAUDE report 9706164 ↗
• InjuryFeb 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL; PER EMAIL, IT WAS REPORTED THAT: PLEASE NOTE THAT, PER EDC, MULTIPLE PER CLOSURE DEVICES ATTEMPTED WITH BALLOON ANGIOPLASTY ACROSS FEMORAL PERFORATION TO TREAT THE EVENT AND THE EVENT WAS RESOLVED WITH MANUAL COMPRESSION AND TR BAND. PER CTSENR, IT WAS REPORTED THAT: (B)(6) 0110R4204 (NEW COMPLETE HEART BLOCK) EVENT DESCRIPTION: NEW COMPLETE HEART BLOCK (002- NEW PERMANENT PACEMAKER IMPLANTATION RESULTING FROM NEW OR WORSENED CONDUCTION DISTURBANCES): ON (B)(6) 2019, 3 DAYS OF POST INDEX PROCEDURE, THE SUBJECT DEVELOPED NEW COMPLETE HEART BLOCK. OF NOTE, NO CONDUCTION DISTURBANCE WAS NOTED POST BAV. -ELECTROPHYSIOLOGY STUDY WAS PERFORMED AND A NEW PERMANENT PACEMAKER WAS RECOMMENDED DUE TO THE COMPLETE HEART BLOCK. -SUBJECT WAS UNDER PROLONGED HOSPITALIZATION -ON AN UNKNOWN DAY, A NEW PERMANENT PACEMAKER WAS IMPLANTED. ON (B)(6) 2019, THE EVENT WAS CONSIDERED RECOVERED/RESOLVED WITH SEQUELAE. ON (B)(6) 2019, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS MOMENT, HOWEVER SITE HAS BEEN QUERIED FOR SOURCE DOCUMENT AND BLANK RELATIONSHIP TO STUDY DEVICE AND

  Patient problems: Perforation of Vessels

  MAUDE report 9681131 ↗
• InjuryJan 30, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING COMPLAINT EVENT DESCRIPTION WAS RECEIVED AT CREGANNA MEDICAL; IT WAS REPORTED THAT: PT HAD TO HAVE A FEM FEM BYPASS TO THE LEFT ILIAC. CONVERTED TO SURGERY. PACEMAKER IMPLANTED. PRE-DIL PERFORMED. EVENT DATE: (B)(6) 2019. WHY WAS THE FEM-FEM BYPASS IT PERFORMED? - PATIENT HAD A FEM FEM ON LEFT LEG, NOT SURE IF CLOSURE WAS THE CAUSE, LARGE PERFORATION IN THE ILIAC, WHEN WAS IT PERFORMED? IT WAS PERFORMED AFTER PATIENT WAS STABILIZED AND VALVE DEPLOYED. THE LOTUS INTRODUCER WAS USED DURING THE PROCEDURE. THE PATIENT PASSED AWAY ON (B)(6). THE PATIENT'S ANATOMY WAS MILD TO MOD CALCIFICATION, TORTUOUS. PATIENT WENT INTO CHB. IT IS UNKNOWN WHETHER THE PATIENT HAD ANY PRIOR CONDUCTION ISSUES. THE PERFORATION OCCURRED PAST INTRODUCER SHEATH OR WITHIN SHEATH RANGE/LENGTH. THE PERFORATION WAS IN THE LEFT ILIAC. 3 MENSIO DETAILS WERE SENT TO CREGANNA. USER EXPERIENCED A HARD TIME LOCKING THE VALVE, IT TOOK MULTIPLE TRIES AND OVER AN HOUR TO LOCK. THE REASON FOR THE DIFFICULTY LOCKING THE VALVE WAS THAT THE USER(S) COULD NOT FIND THE TWISTED POST AND HAD A HARD TIME LOCKING BUT EVENTUALLY DID LOCK. THERE WAS ONE FULL RE SHEATH DONE AND NUMEROUS PARTIAL RE-SHEATHING. USER NOT SUR

  Patient problems: Death; Perforation of Vessels

  MAUDE report 9647006 ↗
• InjuryJan 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: EVENT DESCRIPTION: PER UPDATE RECEIVED ON CNF, IT WAS REPORTED THAT: UNABLE TO LOCK VALVE AND THEN UNABLE TO RESHEATH VALVE FULLY. REMOVED PARTIALLY FLOWERED DEVICE AND SHEATH AT THE SAME TIME. ILIAC PERFORATION AND EXTRAVASATION. ACCESS ROUTE TF LOCATION RIGHT TF ACCESS PERCUTANEOUS GUIDEWIRE USED SAFARI2 (XS) OTHER WIRE LUNDRQUIST SHEATH USED LIS OTHER SHEATH EMBOLIC PROTECTION USED NONE. PER EMAIL, IT WAS REPORTED THAT: SUMMARY: DIFFICULTY LOCKING AND RESHEATHING DEVICE. PATIENT DEATH. VALVE WAS PREPPED WITHOUT ISSUE AS PER DFU. PATIENT ANATOMY WAS CALCIFIED AND EXTREMELY TORTUOUS. STANDARD TAVR PROCEDURE. LOTUS LIS SHEATH IN RIGHT COMMON FEMORAL ARTERY. CONTRALATERAL ACCESS FOR LUNDERQUIST BUDDY WIRE TO FACILITATE DEVICE TRACKING THROUGH TORTUOSITY. DEVICE WAS DELIVERED TO AORTIC ANNULUS. CONSIDERABLE TORQUE WAS REQUIRED TO DELIVER THROUGH ANATOMY. DEPLOYMENT OF DEVICE: ? FIRST RESULT WAS HIGH, ASYMMETRIC UNSHEATHING? SECOND DEPLOYMENT WAS ATTEMPTED WITH LOWER STARTING POINT. PRIOR TO LOCKING, TWISTED POST WAS IDENTIFIED, RESHEATHING ATTEMPTED TO FIX. ? THIRD DEPLOYMENT TWISTED POST WAS AGAIN NOTICED. PHYSICIAN C

  Patient problems: Death; Perforation of Vessels

  MAUDE report 9622424 ↗
• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT EVENT RECEIVED AS FOLLOWS; 'IT WAS REPORTED THAT: STUDY ID: (B)(6) PATIENT CURRENT CONDITION: STABLE DETAILS: PATIENT (B)(6) REQUIRED STENTING OF THE EXTERNAL ILIAC (7 X 110 GORE) WHICH WAS SOMEWHAT EXPECTED. THEY BALLOONED THE EXTERNAL ILIAC PRIOR TO THE STENT AND THEN PLACED THE STENT THEREAFTER. THE ACCESS VESSELS WERE SMALL IN BOTH LEGS, SO THERE WAS A HIGHER LIKELIHOOD THAT THIS WOULD HAPPEN. BOTH THE PROCTOR AND MYSELF SET THE EXPECTATION THAT VESSEL ACCESS WOULD BE CHALLENGING, BUT DOCTOR WANTED TO PROCEED WITH THE PROCEDURE. PRIOR TO IMPLANT, THE TEAM GAINED CONTRALATERAL ACCESS IN THE EVENT THERE WAS A VASCULAR COMPLICATION. THERE WAS A DISSECTION NOTED FOLLOWING THE IMPLANT. THE DISSECTION WAS CONTROLLED (VERY LITTLE BLEEDING), THE TEAM BALLOONED AND STENTED THE LEFT EXTERNAL ILIAC AND THE PATIENT WAS STABLE THROUGHOUT THE ENTIRE PROCESS.' ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR CONFIRMING THAT THE LOTUS INTRODUCER WAS THOUGHT TO HAVE BEEN INVOLVED IN THE DISSECTION. FURTHER DISCUSSIONS WERE HELD WITH THE DISTRIBUTOR ON 20-JAN-2020 AND ADDITIONAL INFORMATION RECEIVED (FOUND IN THE ATTACHMENT OF THIS FOLLOW UP MDR REPORT) WAS DISCUSSED AND SHARED. TH

  Patient problems: Vascular Dissection

  MAUDE report 9400061 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION: IT WAS REPORTED THAT: DELIVERY SYSTEM KINKED DUE TO OVERLY TORTUOUS AORTIC ANATOMY. KINK OBSERVED UNDER FLUOROSCOPY ELECTED TO WITHDRAW SYSTEM. KINK CAUSED CHANGE IN DELIVERY SYSTEM PROFILE AND RESULTED IN INCREASED FRICTION WHILST WITHDRAWING THROUGH LARGE LOTUS INTRODUCER SHEATH (LIS). HAEMOSTATIC CAP ON LIS DETACHED DUE TO FRICTION. TEMPORARY EXSANGUINATION THROUGH SHEATH RESULTING IN HYPOTENSION. PATIENT STABILISED. LOTUS EDGE VALVE NOT IMPLANTED. BSC CONTACT PERSON SUPPORTING THE CASE (ALEX MONCADA) PATIENT STATUS/CONDITION: STABLE WHEN DID THE PROBLEM OCCUR? DURING TRACKING OF LOTUS EDGE DELIVERY SYSTEM THROUGH AORTA AND WITHDRAWAL OF DELIVERY SYSTEM FROM INTRODUCER SHEATH PROCEDURE OUTCOME WAS IT COMPLETED WITH THIS DEVICE? ANOTHER SAME? NO. NO DEVICE IMPLANTED. WHERE DID THE PROBLEM OCCUR? INSIDE THE PATIENT ANY OTHER INFO: PHOTOS AVAILABLE AS DEVICE DISPOSED OF. EVENT DATE: (B)(6) 2019. AS OF 13-NOV-2019, THE ADDITIONAL INFORMATION WAS RECEIVED. THE KINK WAS THE LOTUS EDGE. FLUID CHALLENGE WAS GIVEN TO COMPENSATE FOR THE HYPOVOLEMIA/VAGAL RESPONSE TO BLEEDING OUT THROUGH THE LIS. BLOOD WAS SOUGHT IMMEDIATELY AND TRANSFUSION WAS GIVEN. INTRODUCER SHEATH W

  Patient problems: Exsanguination

  MAUDE report 9340164 ↗
• InjuryNov 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EVENT DESCRIPTION RECEIVED ON 10 SEP 2019: THE SUBJECT WAS ENROLLED INTO THE (B)(6) STUDY ON (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 25 MM LOTUS EDGE VALVE. BALLOON VALVULOPLASTY WAS NOT PERFORMED. THERE WAS CORRECT POSITIONING OF THE PROSTHETIC HEART VALVE INTO THE PROPER ANATOMICAL LOCATION AND NEITHER REPOSITIONING NOR RETRIEVAL WAS ATTEMPTED. FAILURE OF PERCUTANEOUS CLOSURE DEVICE ON LEFT FEMORAL ARTERY (001 CEC VASCULAR COMPLICATIONS): ON (B)(6) 2019, DURING THE INDEX PROCEDURE, THE SUBJECT WAS NOTED TO HAVE LEFT COMMON FEMORAL ARTERY INJURY AT THE ACCESS SITE THAT LED TO PROLONGED HOSPITALIZATION OF THE SUBJECT. PER EDC, ULTRASOUND WAS PERFORMED AS DIAGNOSTIC FOR THE EVENT. DECISION WAS MADE TO PERFORM EXPOSURE AND EXPLORATION OF LEFT FEMORAL ARTERY AND LIMITED ENDARTERECTOMY WITH PATCH ANGIOPLASTY FOLLOWED BY PLACEMENT PREVENA VAC. PER VASCULAR COMPLICATION FROM, THE TYPE OF INJURY WAS "PERCUTANEOUS CLOSURE DEVICE FAILURE," "ACCESS SITE OR ACCESS RELATED VASCULAR INJURY LEADING TO MAJOR COMPLICATION" AND "UNPLANNED ENDOVASCULAR OR SURGICAL INTERVENTION ASSOCIAT

  Patient problems: No Code Available

  MAUDE report 9315617 ↗
• InjurySep 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "(B)(6), DR. (B)(6), TREATED HIS PATIENT USING A LOTUS EDGE, 25MM AND USED THE LOTUS INTRODUCER-L ACCESS SHEATH. THE DEVICE IMPLANT WAS STRAIGHTFORWARD AND AFTER THE LOTUS EDGE VALVE WAS DEPLOYED, THE DELIVERY SYSTEM WAS SUBSEQUENTLY REMOVED WITHOUT ISSUE. AS PER NORMAL PRACTICE, THEY REMOVED THE LOTUS INTRODUCER-L SHEATH AND CLOSED THE GROIN WITH A PERCLOSE. DR. (B)(6) ASSESSED THE PULSE IN THE LEFT FEMORAL ARTERY THEREAFTER AND THERE WAS NO PALPABLE PULSE. DR. (B)(6) THEN PERFORMED AN ARTERIOGRAM AND NOTICED A THROMBUS IN THE LEFT COMMON ILIAC. DR. (B)(6), THE SURGEON FOR THIS IMPLANT BELIEVES THAT THERE MUST HAVE BEEN THROMBUS ON THE SHEATH AND WHEN THEY REMOVED THE IT, THAT?S WHEN THE THROMBUS/OCCLUSION OCCURRED. IT SHOULD BE NOTED THAT THE PATIENT WAS HEPARINIZED AFTER SHEATH INSERTION. THE TREATMENT PLAN WAS TO DRIP TPA OVERNIGHT, AND IF THE THROMBUS WAS UNRESOLVED, THEY WOULD POTENTIALLY USE AN ANGIOJET TO REMOVE THE THROMBUS. I JUST WANT TO MAKE IT CLEAR THAT THE IMPLANTING PHYSICIANS, PROCTOR AND MYSELF DO NOT BELIEVE THIS WAS A LOTUS EDGE VALVE RELATED COMPLAINT. THE VALVE BEHAVED IN TYPICAL FASHION WITHOUT

  Patient problems: Thrombosis

  MAUDE report 9129014 ↗
• InjurySep 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "THEY USED THE SHEATH. THEY IMPLANTED A 25MM LOTUS EDGE VALVE SUCCESSFULLY. AT THE END OF THE CASE WHEN THE SHEATH WAS REMOVED, THEY NOTICED THERE WAS A VASCULAR COMPLICATION. THE SHEATH WAS REMOVED, THE VASCULAR COMPLICATION WAS TAKEN CARE OFF. THERE WAS NO OTHER COMPLAINT, THE PATIENT WAS FINE. THEY USED BALLOONS AND COVERED STENT FOR THE INTERVENTION." ON10-SEP-2019, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED : 'THE DEVICE INSERTED AND REMOVED FROM THIS ARTERY WAS THE LOTUS EDGE LIS SHEATH, SO IT WOULD BE PERCEIVED THAT THE SHEATH WAS THE POTENTIAL CAUSE. THERE WAS A DISSECTION IN THE ARTERIAL WALL THE DAMAGE OCCURED ON THE EXTERNAL ILIAC NO MEDIA HAS BEEN PROVIDED FOR THIS CASE'.

  Patient problems: Vascular Dissection

  MAUDE report 9006469 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "EVENT DESCRIPTION: PER GFE RESPONSE, IT WAS REPORTED THAT: THE DISSECTION WAS CAUSED BY THE LOTUS INTRODUCER SHEATH (LIS) WHICH COMES WITH THE LOTUS VAVLE AS A BUNDLE. IT WAS REPORTED THAT: THE DEVICE WAS WELL AND GREAT. COMING OUT, THE PATIENT DID HAD A VASCULAR COMPLICATION. DISSECTION OF THE ILIAC. EVENT DATE: (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED ON 6TH OF AUGUST 2019 IS AS FOLLOWS: 1. WHAT IS THE CAUSE OF THE ILIAC DISSECTION? CALCIFIED SMALL VESSEL SHEATH DISSECTION 2. HOW WAS THE ILIAC DISSECTION TREATED? THEY STENTED THE VESSEL 3. WHAT IS THE NAME OF THE 2ND PHYSICIAN INVOLVED IN THE CASE? (B)(6). 4. IS THERE MEDIA AVAILABLE THAT CAPTURES THE EVENT? YES 5. WHAT IS THE PATIENT'S CURRENT CONDITION AND PROGNOSIS? DISCHARGED HOME THE HOSPITAL. (B)(6) 2019 PHONE CONVERSATION WITH SALES REP: LIS - L LOT # IS 526318. MEDIA HAS NOT YET BEEN OBTAINED. PHYSICIAN IS CURRENTLY OUT OF THE COUNTRY UNTIL NEXT WEEK. POST STENTING, THERE WAS STILL A PROXIMAL DISSECTION THAT DID NOT STOP BLEEDING. THE PATIENT WENT TO SURGERY. THE PATIENT (SHE) WAS ABLE TO BE DISCHARGED ON AN UNSPECIFIED DATE. THE PATIENT RETURNED ON AN

  Patient problems: Vascular Dissection

  MAUDE report 8965545 ↗
• InjuryJul 30, 2019Difficult to Insert; Difficult to Advance; Difficult to Insert; Difficult to Advance

  INITIAL COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: EVENT DESCRIPTION: IT WAS REPORTED THAT: THE PHYSICIAN COULDN'T INSERT THE SHEET INTO THE RIGHT A. FEMORAL/ILEAC. AFTER MULTIPLE INSERTION ATTEMPTS HE TRIED TO INSERT THE SHEET INTO THE LEFT A. FEMORAL/ILEAC WERE IT A STUCK AS WELL. AFTER MULTIPLE ATTEMPTS ON THE LEFT SIDE THE PHYSICIAN RECOGNIZED A DISSECTION IN THE LEFT A. FEMORAL/ILEAC. THE DISSECTION WAS TREADED UNSUCCESSFULLY WITH MULTIPLE STENTS THEREFOR THE DECISION WAS MADE TO TREAT THE PATIENT SURGICALLY. ASSOCIATED WITH LABELLED USE: YES ACTION TAKEN TO RESOLVE: SURGERY PATIENT COMPLICATIONS: SURGERY EVENT DATE: (B)(6) 2019 AS OF THE (B)(6) 2019 THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED; THERE WERE 3 DEVICES USED IN THIS PROCEDURE. TWO MORE COMPLAINTS WERE OPEN FOR THE OTHER 2 DEVICES ASSOCIATED WITH THIS CASE; (B)(4). THE INITIAL TWO INTRODUCERS COULDN'T PASS THE RIGHT FEMORAL ACCESS. IT WAS THE THIRD INTRODUCER WHICH LEAD TO THE EVENT (THE LEFT FEMORAL ACCESS). AS OF THE (B)(6) 2019 THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED; BOSTON SCIENTIFIC COMPLAINT NUMBERS (BSC TW#S) ADDED TO EACH CREGANNA MEDICAL COMPLAINT CASE. (B)(4). (B)(4)

  Patient problems: Vascular Dissection

  MAUDE report 8840714 ↗
• InjuryJul 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: EVENT DESCRIPTION: IT WAS REPORTED THAT: UPON SUCCESSFUL COMPLETION OF THE TAVI PROCEDURE AND DURING REMOVAL OF INTRODUCER AND USE OF CLOSURE DEVICES, COMPLICATION WITH FEMORAL (POSSIBLE DISSECTION) AND NEEDED STENT INSERTED TO RESOLVE. ADDL INFO: CONTACT METHOD: I WAS ONSITE IN LAB DURING PROCEDURE. WAS THE PROBLEM ASSOCIATED WITH LABELED USE? YES. EVENT RESOLVED? YES. PHYSICIAN ASSESSMENT OF THE RELATIONSHIP OF THE EVENT TO THE DEVICE: RELATED. OTHER POSSIBLE CONTRIBUTING FACTORS TO THE EVENT: PROCEDURE. DOES PATIENT HAVE KNOWN ALLERGY TO STAINLESS STEEL? NO. DOES PATIENT HAVE KNOWN SENSITIVITY TO ANY DRUGS? NO. SIGNIFICANT PAST MEDICAL HISTORY/ PATIENT COMORBIDITIES: CORONARY DISEASE, AORTIC VALVE DISEASE. DOES PATIENT HAVE A CONTRAINDICATION TO ANTI-PLATELET OR ANTICOAGULATION THERAPY? NO.

  Patient problems: Vascular Dissection

  MAUDE report 8820885 ↗
• InjuryJul 18, 2019Difficult to Advance; Difficult to Advance

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: EVENT DESCRIPTION: PER EMAIL, IT WAS REPORTED THAT: THE LIS SHEATH WAS INSERTED INTO THE RFA INITIALLY. IT WOULD NOT PASS THROUGH THE ILIO/AORTIC BIFURCATION SO THE PHYSICIAN (OPERATOR 1) REMOVED IT. NO DISSECTION WAS OBSERVED. A 16F EDWARDS ESHEATH WAS THEN INSERTED. THE LOTUS 25MM VALVE WAS INSERTED AND IMPLANTED SUCCESSFULLY. WHEN THE ESHEATH WAS REMOVED THERE WAS EVIDENCE OF A DISSECTION. THE PHYSICIAN BALLOONED IT AND STENTED IT. EVENT DATE: (B)(6) 2019.

  Patient problems: Vascular Dissection

  MAUDE report 8802386 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: EVENT DESCRIPTION: PER CTSENR, IT WAS REPORTED THAT: REPRISE IV (B)(4) (ACUTE RETROPERITONEAL BLEED FROM RIGHT COMMON FEMORAL ARTERY, 1ST DEGREE A-V BLOCK) EVENT DESCRIPTION: 1ST DEGREE A-V BLOCK (002- AE)/ LEFT GROIN HEMATOMA (001- MAJOR VASCULAR COMPLICATION)/ ACUTE RETROPERITONEAL BLEED FROM RIGHT COMMON FEMORAL ARTERY (003- REPEAT PROCEDURE FOR VALVE-RELATED DYSFUNCTION): ON (B)(6) 2019, SAME DAY OF THE INDEX PROCEDURE, SUBJECT DEVELOPED 1ST DEGREE AV BLOCK (002), LEFT GROIN HEMATOMA AND ACUTE RETROPERITONEAL BLEED. NO ADDITIONAL DIAGNOSTICS OR ACTIONS WERE TAKEN WITH REGARDS TO AE 002. PER EDC, ULTRASOUND AND ANGIOGRAM WERE PERFORMED AND THE SUBJECT WAS DIAGNOSED WITH MAJOR VASCULAR COMPLICATION (001). TYPE OF VASCULAR COMPLICATION: PERCUTANEOUS CLOSURE DEVICE FAILURE (SITE HAS BEEN QUERIED TO CONFIRM THE TYPE OF VASCULAR COMPLICATION) -THE EVENT# 001 WAS MEDICALLY TREATED AND ANGIOPLASTY TO LEFT SFA UNDER ULTRASOUND GUIDANCE WAS PERFORMED. PER EDC, CT SCAN, LAB TESTS AND ULTRASOUND WERE PERFORMED AS DIAGNOSTICS FOR EVENT # 003 AND THE EVENT LED TO PROLONGATION OF INDEX HOSPITALIZATION AND WAS MEDICALLY TREATED.

  Patient problems: Hematoma; Vascular Dissection

  MAUDE report 8797074 ↗
• InjuryMar 11, 2019Adverse Event Without Identified Device or Use Problem

  COMPLAINT DESCRIPTION RECEIVED AT CREGANNA MEDICAL IS AS FOLLOWS: "IT WAS REPORTED THAT: FEMORAL ARTERY DISSECTION DURING A LOTUS EDGE IMPLANT. THE DEVICE WAS FINE IT IS JUST THAT THE PATIENT JUST HAD DISSECTION AT THE FEMORAL ARTERY WHERE THE SHEATH GOES IN TO THE PATIENT AND THEN THEY HAD TO USE A COVERED STENT TO FIX THE DISSECTION. THEY USED A VIABAHN 10MM X 4CM COVERED STENT TO ACHIEVE HEMOSTASIS. THIS HAPPENED TOWARDS THE END OF THE PROCEDURE, INSIDE THE PATIENT'S BODY. THE PATIENT IS FINE." ON 26-FEB-2019, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED; 'IT WAS REPORTED THAT THE PATIENT RECEIVED 2 UNITS OF BLOOD AND HAS BEEN ADMITTED IN THE HOSPITAL. THE PATIENT IS UNDER SEPSIS WATCH.'

  Patient problems: Blood Loss; Vascular Dissection

  MAUDE report 8408780 ↗
• InjuryJan 24, 2019Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash

  COMPLAINT DESCRIPTION RECEIVED AT (B)(6) MEDICAL IS AS FOLLOWS: "PER CTSENR, IT WAS REPORTED THAT REPRISE (B)(4) (BLEEDING FROM THE HAEMOSTATIC VALVE OF THE INTRODUCER THROUGHOUT THE PROCEDURE APPROXIMATELY 500 MLS TOTAL BLOOD LOSS WITH THIS COMPLAINT) EVENT(S) DESCRIPTION: BLEEDING FROM THE HAEMOOSTATIC VALVE OF THE INTRODUCER THROUGHOUT THE PROCEDURE APPROXIMATELY 500MLS TOTAL BLOOD LOSS WITH THIS COMPLAINT. DURING CLOSURE THE LIS - KL WAS CLAMPED WITH FORCEPS BELOW THE HUB AND THAT THIS WAS NOT THE CAUSE OF THE BLOOD LOSS AS IT WAS ONLY CLAMPED DURING VASCULAR CLOSURE."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 8274699 ↗