R2P MISAGO SXR06150RRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04987350727749), received between Sep 22, 2020 and Jul 5, 2025 — classified as 13 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 5, 2025Malposition of Device; Malposition of Device

  THE USER FACILITY REPORTED THAT POST-DEPLOYMENT OF TWO MISAGO STENTS (6X150 UNITS) IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE PROXIMAL STENT WAS CONSIDERED TO BE CRIMPED, WITH THE EDGES OF THE STENT APPEARING INWARD. THE DISTAL STENT, ALSO 6X150 (SAME LOT NUMBER), WAS FORESHORTENED UPON DEPLOYMENT. AFTER DEPLOYMENT OF BOTH STENTS, THERE WAS NO FLOW THROUGH THE STENTS, AND THE PATIENT BEGAN TO SHOW CLOTS THROUGHOUT THE LEG. THE PHYSICIAN HAD DIFFICULTY CANNULATING THE PROXIMAL STENT DUE TO THE EDGES APPEARING CRIMPED. THE TYPE OF PROCEDURE PERFORMED WAS AN SFA PERIPHERAL ANGIOGRAM. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND REQUIRED MEDICAL OR SURGICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVELY. ESTIMATED BLOOD LOSS WAS NONE. THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR POSSIBLE CLOT ASPIRATION OR BYPASS. ADDITIONAL INFORMATION RECEIVED ON 10 JUN 2025: INDICATED THAT IN ADDITIONAL SURGICAL/MEDICAL PROCEDURES PERFORMED AFTER THE STENT SHRINKAGE, THE LYSIS CATHETER WAS INSERTED IN A SUBSEQUENT PROCEDURE. THE PATIENT IS STABLE AND DOING WELL ACCORDING TO THE PHYSICIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22408210 ↗
• InjuryJul 2, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT POST-DEPLOYMENT OF TWO MISAGO STENTS (6X150 UNITS) IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE PROXIMAL STENT WAS CONSIDERED TO BE CRIMPED, WITH THE EDGES OF THE STENT APPEARING INWARD. THE DISTAL STENT, ALSO 6X150 (SAME LOT NUMBER), WAS FORESHORTENED UPON DEPLOYMENT. AFTER DEPLOYMENT OF BOTH STENTS, THERE WAS NO FLOW THROUGH THE STENTS, AND THE PATIENT BEGAN TO SHOW CLOTS THROUGHOUT THE LEG. THE PHYSICIAN HAD DIFFICULTY CANNULATING THE PROXIMAL STENT DUE TO THE EDGES APPEARING CRIMPED. THE TYPE OF PROCEDURE PERFORMED WAS AN SFA PERIPHERAL ANGIOGRAM. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND REQUIRED MEDICAL OR SURGICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVELY. ESTIMATED BLOOD LOSS WAS NONE. THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR POSSIBLE CLOT ASPIRATION OR BYPASS. ADDITIONAL INFORMATION RECEIVED ON 10 JUN 2025: INDICATED THAT IN ADDITIONAL SURGICAL/MEDICAL PROCEDURES PERFORMED AFTER THE STENT SHRINKAGE, THE LYSIS CATHETER WAS INSERTED IN A SUBSEQUENT PROCEDURE. THE PATIENT IS STABLE AND DOING WELL ACCORDING TO THE PHYSICIAN.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 22391639 ↗
• InjuryJul 2, 2025Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  THE USER FACILITY REPORTED THAT POST-DEPLOYMENT OF TWO MISAGO STENTS (6X150 UNITS) IN THE SUPERFICIAL FEMORAL ARTERY (SFA), THE PROXIMAL STENT WAS CONSIDERED TO BE CRIMPED, WITH THE EDGES OF THE STENT APPEARING INWARD. THE DISTAL STENT, ALSO 6X150 (SAME LOT NUMBER), WAS FORESHORTENED UPON DEPLOYMENT. AFTER DEPLOYMENT OF BOTH STENTS, THERE WAS NO FLOW THROUGH THE STENTS, AND THE PATIENT BEGAN TO SHOW CLOTS THROUGHOUT THE LEG. THE PHYSICIAN HAD DIFFICULTY CANNULATING THE PROXIMAL STENT DUE TO THE EDGES APPEARING CRIMPED. THE TYPE OF PROCEDURE PERFORMED WAS AN SFA PERIPHERAL ANGIOGRAM. THERE WAS NO BLOOD LOSS. THE REPORTED EVENT DID RESULT IN PATIENT INJURY AND REQUIRED MEDICAL OR SURGICAL INTERVENTION. THE EVENT OCCURRED INTRA-OPERATIVELY. ESTIMATED BLOOD LOSS WAS NONE. THE PATIENT WAS ADMITTED TO THE OPERATING ROOM FOR POSSIBLE CLOT ASPIRATION OR BYPASS. ADDITIONAL INFORMATION RECEIVED ON 10 JUN 2025: INDICATED THAT IN ADDITIONAL SURGICAL/MEDICAL PROCEDURES PERFORMED AFTER THE STENT SHRINKAGE, THE LYSIS CATHETER WAS INSERTED IN A SUBSEQUENT PROCEDURE. THE PATIENT IS STABLE AND DOING WELL ACCORDING TO THE PHYSICIAN.

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 22391638 ↗
• InjuryJun 2, 2025Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS TREATING AN OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA) STENT IN THE RIGHT SFA VIA LEFT COMMON FEMORAL ACCESS. A 7FR DESTINATION SHEATH WAS USED. TO TREAT THE OCCLUDED STENT, THE PHYSICIAN PLACED A 6MM SPIDERFX WIRE INTO THE POPLITEAL ARTERY AND USED JETSTREAM. AFTER PLASTYING THE ARTERY, IT WAS DECIDED TO EXTEND THE EXISTING STENTS INTO THE DISTAL SFA WITH A 6MM X 150CM MISAGO STENT. THIS WAS DONE OVER THE SPIDER WIRE DUE TO SOME CLOT SEEN IN THE ARTERY. THE MISAGO STENT WAS SUCCESSFULLY DEPLOYED AND PLASTIED WITH A 6MM CROSSTELLA BALLOON. THE PHYSICIAN DECIDED TO USE A 5FR X 100CM GLIDECATH TO TRY AND RE-CAPTURE THE SPIDER FILTER WIRE BECAUSE OF THE DEBRIS AND CLOT BELIEVED TO BE IN THE BASKET. THE PHYSICIAN WAS UNABLE TO COMPLETELY CAPTURE THE SPIDER WIRE BASKET WITHIN THE GLIDECATH AND ATTEMPTED TO PULL THE SYSTEM THROUGH THE STENTS PARTIALLY UNCAPTURED. IT IS BELIEVED THAT THE SPIDER WIRE FILTER BASKET CAUGHT THE MISAGO STENT STRUTS IN TWO DIFFERENT PLACES, CAUSING THE MISAGO STENT TO BUNCH UP AND FOLD ON ITSELF. THE PHYSICIAN WAS ABLE TO PASS A 0.035 NAVICROSS PAST BOTH MANGLED PARTS OF THE MISAGO AND STENT OPEN THE MISAGO WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129206 ↗
• InjuryJun 2, 2025Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  THE USER FACILITY REPORTED THAT THE PHYSICIAN WAS TREATING AN OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA) STENT IN THE RIGHT SFA VIA LEFT COMMON FEMORAL ACCESS. A 7FR DESTINATION SHEATH WAS USED. TO TREAT THE OCCLUDED STENT, THE PHYSICIAN PLACED A 6MM SPIDERFX WIRE INTO THE POPLITEAL ARTERY AND USED JETSTREAM. AFTER PLASTYING THE ARTERY, IT WAS DECIDED TO EXTEND THE EXISTING STENTS INTO THE DISTAL SFA WITH A 6MM X 150CM MISAGO STENT. THIS WAS DONE OVER THE SPIDER WIRE DUE TO SOME CLOT SEEN IN THE ARTERY. THE MISAGO STENT WAS SUCCESSFULLY DEPLOYED AND PLASTIED WITH A 6MM CROSSTELLA BALLOON. THE PHYSICIAN DECIDED TO USE A 5FR X 100CM GLIDECATH TO TRY AND RE-CAPTURE THE SPIDER FILTER WIRE BECAUSE OF THE DEBRIS AND CLOT BELIEVED TO BE IN THE BASKET. THE PHYSICIAN WAS UNABLE TO COMPLETELY CAPTURE THE SPIDER WIRE BASKET WITHIN THE GLIDECATH AND ATTEMPTED TO PULL THE SYSTEM THROUGH THE STENTS PARTIALLY UNCAPTURED. IT IS BELIEVED THAT THE SPIDER WIRE FILTER BASKET CAUGHT THE MISAGO STENT STRUTS IN TWO DIFFERENT PLACES, CAUSING THE MISAGO STENT TO BUNCH UP AND FOLD ON ITSELF. THE PHYSICIAN WAS ABLE TO PASS A 0.035 NAVICROSS PAST BOTH MANGLED PARTS OF THE MISAGO AND STENT OPEN THE MISAGO WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22129205 ↗
• InjuryOct 25, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PATIENT NEEDED A RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) TO MILD POPLITEAL INTERVENTION. AN ATHERECTOMY WAS DONE WITH A DRUG COATED BALLOON (DCB) TO MID POP TO DISTAL RIGHT SFA, AND STENT FROM MID TO DISTAL SFA. THE ACCESS WAS A CUT DOWN TO THE RIGHT PROXIMAL SFA WITH A SHORT 7 FRENCH SHEATH ANTEGRADE POSITIONED. THE VESSEL WAS 6 MM IN DIAMETER AND 150 MM IN LENGTH WAS NEEDED. WHEN THE STENT WAS DEPLOYED, THE STENT DID NOT ELONGATE. AFTER DEPLOYMENT, IT SHORTENED. THE STENT LENGTH WAS NOT ENOUGH, AND ANOTHER MISAGO STENT WAS PLACED PROXIMALLY. HOWEVER, IT WAS FORESHORTENED ALSO. THE STENT LENGTH WAS 100 MM. THE DOCTOR USED A THIRD STENT TO COVER THE LENGTH TO THE MID SFA. THE STENT WAS A ZILVER BALLOON EXPANDING STENT. THE PATIENT'S VESSEL WAS FULLY OPPOSED, AND FLOW WAS NOT LIMITED. PRIOR TO THE INTERVENTION THE VESSEL WAS A CHRONIC TOTAL OCCLUSION (CTO). THE CASE WAS SUCCESSFUL. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS A SUCCESSFUL INTERVENTION OF RIGHT SFA. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE LESION TREATMENT HISTORY WAS DE NOVO. THE RIGHT LIMB WAS DISEASED. THE CALCIFICATION WAS MODERATE. TORT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668057 ↗
• InjuryOct 25, 2022Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE PATIENT NEEDED A RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) TO MILD POPLITEAL INTERVENTION. AN ATHERECTOMY WAS DONE WITH A DRUG COATED BALLOON (DCB) TO MID POP TO DISTAL RIGHT SFA, AND STENT FROM MID TO DISTAL SFA. THE ACCESS WAS A CUT DOWN TO THE RIGHT PROXIMAL SFA WITH A SHORT 7 FRENCH SHEATH ANTEGRADE POSITIONED. THE VESSEL WAS 6MM IN DIAMETER AND 150MM IN LENGTH WAS NEEDED. WHEN THE STENT WAS DEPLOYED, THE STENT DID NOT ELONGATE. AFTER DEPLOYMENT, IT SHORTENED. THE STENT LENGTH WAS NOT ENOUGH, AND ANOTHER MISAGO STENT WAS PLACED PROXIMALLY. HOWEVER, IT WAS FORESHORTENED ALSO. THE STENT LENGTH WAS 100MM. THE DOCTOR USED A THIRD STENT TO COVER THE LENGTH TO THE MID SFA. THE STENT WAS A ZILVER BALLOON EXPANDING STENT. THE PATIENT'S VESSEL WAS FULLY OPPOSED, AND FLOW WAS NOT LIMITED. PRIOR TO THE INTERVENTION THE VESSEL WAS A CHRONIC TOTAL OCCLUSION (CTO). THE CASE WAS SUCCESSFUL. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS A SUCCESSFUL INTERVENTION OF RIGHT SFA. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. THE LESION TREATMENT HISTORY WAS DE NOVO. THE RIGHT LIMB WAS DISEASED. THE CALCIFICATION WAS MODERATE. TORTUOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15667867 ↗
• InjuryOct 20, 2022Stretched; Stretched

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD ANTEGRADE ACCESS ON THE LEFT FEMORAL ARTERY WITH A 6 FRENCH 10 CENTIMETER PINNACLE SHEATH WHEN HE ATTEMPTED TO STENT THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH A MISAGO DEVICE INVOLVED. THE PHYSICIAN ROLLED THE WHEEL ON THE DELIVERY SYSTEM; HOWEVER, THE STENT WAS NOT DEPLOYING. AFTER MANIPULATION OF THE SYSTEM FORWARD AND BACKWARDS IT STARTED TO DEPLOY. THE STENT STARTED TO SCRUNCH UP; THEREFORE, SLIGHT TENSION WAS PULLED ON THE DELIVERY SYSTEM AS THE STENT DEPLOYED. THIS CAUSED THE STENT TO ELONGATE ABOUT 20-30 MILLIMETERS. THE ENTIRE SFA WAS HEAVILY CALCIFIED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 05 OCT 2022: ANOTHER STENT WAS PLACED IN ADDITION (WITHIN) TO THE ELONGATED STENT.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 15638612 ↗
• InjuryOct 20, 2022Stretched; Stretched

  THE USER FACILITY REPORTED THAT THE DOCTOR HAD ANTEGRADE ACCESS ON THE LEFT FEMORAL ARTERY WITH A 6 FRENCH 10 CENTIMETER PINNACLE SHEATH WHEN HE ATTEMPTED TO STENT THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) WITH A MISAGO DEVICE INVOLVED. THE PHYSICIAN ROLLED THE WHEEL ON THE DELIVERY SYSTEM; HOWEVER, THE STENT WAS NOT DEPLOYING. AFTER MANIPULATION OF THE SYSTEM FORWARD AND BACKWARDS IT STARTED TO DEPLOY. THE STENT STARTED TO SCRUNCH UP; THEREFORE, SLIGHT TENSION WAS PULLED ON THE DELIVERY SYSTEM AS THE STENT DEPLOYED. THIS CAUSED THE STENT TO ELONGATE ABOUT 20-30 MILLIMETERS. THE ENTIRE SFA WAS HEAVILY CALCIFIED. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE WAS SUCCESSFUL. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: ANOTHER STENT WAS PLACED IN ADDITION (WITHIN) TO THE ELONGATED STENT.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 15638522 ↗
• InjuryAug 9, 2022Fracture; Stretched; Fracture; Stretched

  THE USER FACILITY REPORTED THAT WHILE DEPLOYING THE MISAGO STENT IN THE MID TO PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), THE STENT STRETCHED OUT AND FRACTURED IN THE MIDDLE. THE STENT ALSO WENT BACK INTO THE SHEATH AND THE DOCTOR HAD TO PUSH IT BACK OUT. THIS CAUSED THE STENT TO STRETCH OUT FROM THE SFA THROUGH THE COMMON FEMORAL. THE STENT DID FRACTURE IN THE MID-SECTION. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: THE STENT WAS FRACTURED IN THE MID-SECTION AND REMAINED IN THE PATIENT'S BODY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15191294 ↗
• InjuryJun 24, 2022Fracture; Stretched; Fracture; Stretched

  THE USER FACILITY REPORTED THAT WHILE DEPLOYING THE MISAGO STENT IN THE MID TO PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), THE STENT STRETCHED OUT AND FRACTURED IN THE MIDDLE. THE STENT ALSO WENT BACK INTO THE SHEATH AND THE DOCTOR HAD TO PUSH IT BACK OUT. THIS CAUSED THE STENT TO STRETCH OUT FROM THE SFA THROUGH THE COMMON FEMORAL. THE STENT DID FRACTURE IN THE MID-SECTION. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE EVENT OCCURRED INTRA-OPERATIVE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14800237 ↗
• InjuryApr 6, 2021Collapse; Collapse

  ADDITIONAL INFORMATION WAS RECEIVED ON 13APR2021. THE DOCTOR STATED THAT IT WAS NOT ANYTHING WITH THE TERUMO SHEATH, HE WAS TRYING TO USE A LOW-PROFILE SHEATH AND IT WAS HIS DECISION. THE MISAGO, DID NOT COMPLETELY COLLAPSE, IT BUCKLED AT THE PROXIMAL END; THE DOCTOR SAID HE SHOULD HAVE USED A LARGER SIZE. ADDITIONAL INFORMATION WAS RECEIVED ON 16APR2021. THERE IS NO ALLEGATION AGAINST THE REPORTED PRODUCT CURRENTLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618819 ↗
• InjuryApr 6, 2021Collapse; Collapse

  THE USER FACILITY REPORTED THAT THE 6MM MISAGO STENT COLLAPSED IN THE COMMON ILIAC. THEY WERE UNDER THE IMPRESSION THE DOCTOR WAS PLACING IN THE SFA. THE PHYSICIAN HAD TO PUT A VBX STENT IN ITS PLACE. THEY DID A CUT DOWN ON THE LEFT GROIN AND RESTENT. THE PROCEDURE WAS SUCCESSFUL. THE PATIENT'S CONDITION WAS STABLE, AND THEY WENT HOME. THE ARTERY OF THE LOWER EXTREMITY WAS NOT PREVIOUSLY TREATED. LESION: LEFT DISEASED LIMB; LOCATION SFA POPLITEAL OTHER CIA. CALCIFICATION WAS MODERATE. TORTUOUSNESS WAS MILD. VESSEL DIAMETER APPROXIMATELY (6 MM). ACCESS SITE: OTHER AXILLARY. LESION TREATMENT HISTORY: POST-DILATATION: YES; PRE-DILATION: NO. ADDITIONAL INFORMATION WAS RECEIVED ON 19MAR2021. IT WAS A R2P CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618818 ↗
• MalfunctionMar 22, 2021Material Deformation; Material Deformation

  ADDITIONAL INFORMATION WAS RECEIVED ON 06APR2021. THE LESION WAS IN THE SFA. ACCESS WAS GAINED IN CONTRA LATERAL FEMORAL ARTERY. A 6 X 45 DESTINATION WAS USED UP AND OVER. IT WAS CROSSED WITH AN .035 NAVICROSS AND .035 GWA. THE LESION WAS MODERATELY CALCIFIED. A VIPER WIRE WAS EXCHANGED AND CSI ATHERECTOMY WAS PERFORMED. AND ANGIOPLASTY FOLLOWED WITH A CROSSTELLA RX BALLOON. THE MISAGO WAS BEING DEPLOYED IN THE SFA. THE RENAMING SHAFT OUTSIDE OF THE BODY WAS BEING VISUALIZED WHILE BEING DEPLOYED. THAT PART OF THE SHAFT WAS "CORKSCREWING" WHEN THE STENT WAS BEING DEPLOYED. THEY DID NOT SEE THE BLUE PORTION OF THE CATHETER DURING DEPLOYMENT. THE CATHETER WAS NOT STUCK IN THE DESTINATION. THE OUTER CATHETER OF THE MISAGO STOPPED MOVING BEFORE THE ENTIRE STENT WAS DEPLOYED. THE STENT WAS DEPLOYED 3/4 OF THE WAY AND THE CATHETER STOPPED MOVING BACK. THE PHYSICIAN WAS ABLE TO BEND THE EXPOSED WIRE BACK INTO PLACE AND THE CATHETER THEN MOVED ALL THE WAY AND RELEASED THE REMAINING PART OF THE MISAGO STENT. HE DID NOT REALLY PULL AND WIRE, HE JUST BENT IT BACK INTO PLACE WHICH RELEASED THE TENSION ON EVERYTHING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11540688 ↗
• MalfunctionSep 22, 2020Material Deformation; Material Deformation

  THE USER FACILITY REPORTED THAT THE INVOLVED R2P MISAGO WAS USED DURING THE PROCEDURE. THE DOCTOR WAS PERFORMING A RIGHT SFA INTERVENTION VIA RIGHT POPLITEAL ACCESS. HE GAINED ACCESS UNDER ULTRASOUND WITH A 6FR PRECISION SHEATH. THE DOCTOR PERFORMED CSI ATHERECTOMY OVER THE .014 VIPER WIRE. HE THEN BALLOONED WITH AN .018 CROSSTELLA 5 X 200 BALLOON OVER VIPER WIRE. HE DID MANIPULATE THE SHEATH IN AND OUT SO HE COULD BALLOON AS CLOSE TO THE ACCESS SITE AS POSSIBLE. AFTER BALLOONING, HE EXCHANGED FOR A .035 GWA THROUGH A .035 NAVICROSS. HE THEN DELIVERED A 6 X 150 MISAGO STENT OVER THE .035 GWA. THE RT DID A GOOD JOB OF PREPPING THE STENT. THE DOCTOR WAS INSTRUCTED TO WATCH THE BLUE PORTION OF THE CATHETER AND NOT TO TOUCH IT DURING DEPLOYMENT. HE MOVED THE STENT PAST THE LESION AND DRAGGED IT BACK INTO PLACE. HE DID HOLD ONTO THE SHEATH DURING DEPLOYMENT. AFTER THE STENT FLOWERED, HE SAID THAT HE DID NOT THINK THE REMAINDER WAS DEPLOYING. THE CATHETER LOOKED AS IF TENSION WAS BUILT UP AND WAS STARTING TO CORKSCREW. THE DOCTOR WAS INSTRUCTED TO STRAIGHTEN OUT THE CATHETER AND TO BE CAREFUL NOT TO TOUCH THE BLUE PORTION. HE THEN ROLLED BACK ON THE WHEEL AGAIN THE PROXIMAL MARKER WAS SE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10566112 ↗