Stealth PRD-SC30-200 (REF 7-10059-04)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10850000491295), received between Jul 21, 2020 and Sep 3, 2025 — classified as 24 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (7 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Device Contaminated at the User Facility; Device Contaminated at the User Facility

  IT WAS REPORTED A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR THREE TOTAL TREATMENTS ON MEDIUM AND HIGH SPEED ON A PROXIMAL PERONEAL ARTERY. IT WAS INDICATED TISSUE GOT WRAPPED ON THE OAD AND CLOTS FORMED DISTAL TO THE TREATMENT AREA POST ORBITAL ATHERECTOMY TREATMENT. THERE WERE NO ABNORMAL DEVICE SYMPTOMS OR BEHAVIORS PRIOR TO THE ADVERSE EVENT. THE PATIENT WAS APPROPRIATELY HEPARINIZED IN PREPARATION FOR THE PROCEDURE. PROLONGED ANTICOAGULATION MEDICATION AND THROMBOLYTICS WERE ADMINISTERED. THE PATIENT HAD A DISTAL EMBOLI AT THE END OF THE PROCEDURE. THE PATIENT WAS DISCHARGED.

  Patient problems: Embolism/Embolus; Thrombosis/Thrombus

  MAUDE report 22956599 ↗
• InjuryJul 26, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE 2.0 SOLID STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SUCCESSFULLY USED FOR TREATMENT OF MODERATELY CALCIFIED, NON-TORTUOUS LESION IN SUPERFICIAL FEMORAL ARTERY (SFA) THROUGH PEDAL ACCESS OF THE POSTERIOR TIBIAL ARTERY (PT) WITH 6F SHEATH. DURING OAD REMOVAL RESISTANCE WAS FELT AND PERFORATION WAS OBSERVED. A FOAM SEALANT AGENT WAS USED TO CONTROL THE BLEEDING AND THE PATIENT WAS TRANSFERRED TO ACUTE CARE FOR SURGICAL INTERVENTION. SURGICAL REPAIR WAS COMPLETED WITHOUT COMPLICATION. AS OF (B)(6) 2025 THE PATIENT REMAINED IN INPATIENT STATUS, IN STABLE CONDITION. IN THE PHYSICIAN'S OPINION, THE SHEATH WAS THE CAUSE OF THE EVENT.

  Patient problems: Perforation of Vessels

  MAUDE report 22621527 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEALTH 360 ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) ON LOW SPEED. FOLLOW TREATMENT, NO FLOW WAS OBSERVED AT THE PROXIMAL SFA DUE TO DISTAL EMBOLIZATION. THE EMBOLIZATION WAS DUE TO GRINDED CALCIUM PARTICLES. THE OAD WAS REMOVED. AN ASPIRATION CATHETER AND PLAIN OLD BALLOON ANGIOPLASTY WERE USED TO RESTORE FLOW. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 22072231 ↗
• InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING TREATMENT OF HEAVILY CALCIFIED, VERY DIFFUSE, DISEASED LESION IN POPLITEAL SUPERFICIAL FEMORAL ARTERY (SFA) TWO LOW-SPEED TREATMENTS WERE PERFORMED WITH 2.0 SOLID STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY (OAD). THE VESSEL SIZE WAS 6.0-5.0MM. FOLLOWING BALLOON ANGIOPLASTY WITH UNSPECIFIED BALLOON, IT WAS OBSERVED THE ANTERIOR TIBIAL VESSEL SHUT DOWN. A 5.5MM ABBOTT SUPERA STENT WAS DEPLOYED IN THE POPLITEAL (SFA). THE ANTERIOR TIBIAL WAS WIRED AND DILATED WITH UNSPECIFIED BALLOON TO SEE IF THEY CAN OPEN THE VESSEL BUT IT WAS UNSUCCESSFUL. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR LYSIS AND THROMBECTOMY. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 14APRIL2025 INDICATING PER PHYSICIAN, THE CAUSE OF EMBOLISM WAS ORIGINALLY THOUGHT TO BE ORBITING OAD CROWN/ATHERECTOMY BUT IT ALSO MAY HAVE BEEN RELATED TO HEPARIN. THE TYPE OF EMBOLISM IS BIOLOGICAL MATTER WHICH WAS ORIGINALLY SMALL PARTICULATE FROM SEVERELY CALCIFIED SFA. THE PATIENT WAS SENT TO LOCAL HOSPITAL FOR TAP INFUSION THERAPY AND THROMBECTOMY TO BE FOLLOWED BY FASCIOTOMY THE NEXT DAY. THROMBECTOMY WAS PERFORMED ON (B)(6) 2025. ON (B)(6) 2025 PATIENT WAS STABLE AWAI

  Patient problems: Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 21928108 ↗
• InjuryMar 25, 2025Difficult to Remove; Material Separation; Failure to Advance; Difficult to Remove; Material Separation; Failure to Advance

  IT WAS REPORTED THAT A 2.00 SOLID STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS ATTEMPTED TO BE USED FOR TREATMENT OF HEAVILY CALCIFIED, 100% STENOSED, NON-TORTUOUS LESION IN RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). ACCESS WAS GAINED THROUGH THE LEFT FEMORAL ARTERY UP-AND-OVER THE ILIAC BIFURCATION. A 6F X 70 CM NON-ABBOTT GUIDING SHEATH WAS IN USE. THE .014 VIPERWIRE ADVANCE GUIDE WIRE CROSSED THROUGH THE LESION. THE OAD WAS ADVANCED TWICE USING THE CONTROL KNOB BUT FAILED TO CROSS THE ILIAC AND BECAME STUCK AT THE TOP DURING THE SECOND ATTEMPT. WHEN THE OAD WAS PULLED INSIDE THE SHEATH TO REMOVE IT, THERE WAS DIFFICULTY. THE OAD WAS REMOVED THEN RE-ADVANCED TO THE LESION; HOWEVER, THE CROWN COULD NOT BE SEEN ON FLUOROSCOPY. THE OAD WAS REMOVED, AND THE CROWN WAS MISSING. THE PHYSICIAN SUSPECTED THE FRACTURED COMPONENT WAS INSIDE THE 6F SHEATH AS IT WAS NOT VISIBLE IN VIVO. IT IS UNKNOWN IF THE CROWN DETACHED OR THE DRIVESHAFT FRACTURED. THE SIZE OF THE FRACTURED COMPONENT IS UNKNOWN. THE 6F SHEATH WAS REMOVED AND A NEW SHEATH WAS LOADED OVER THE SAME VIPERWIRE GUIDEWIRE. THE PHYSICIAN DECIDED TO REPLACE THE VIPERWIRE GUIDEWIRE WITH A NEW ONE. THERE IS NO ALLEGATION O

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

  MAUDE report 21691049 ↗
• InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A MILDLY CALCIFIED, MILDLY TORTUOUS, 100% STENOSED PROXIMAL TO MID SUPERFICIAL FEMORAL ARTERY (SFA) IN THE LEFT LEG THROUGH AN UP AND OVER APPROACH. ONE LOW SPEED TREATMENT, ONE MEDIUM SPEED TREATMENT, AND ONE HIGH SPEED TREATMENT WERE PERFORMED. IT WAS NOTED A DISSECTION WAS OBSERVED AT THE PROXIMAL SFA POST ORBITAL ATHERECTOMY. A NON-ABBOTT STENT WAS PLACED AT THE SITE OF THE DISSECTION. THE PATIENT WAS IN STABLE CONDITION.

  Patient problems: Vascular Dissection

  MAUDE report 21504467 ↗
• InjuryDec 9, 2024Material Separation; Material Separation

  IT WAS REPORTED THE DIAMONDBACK 360 ORBITAL ATHERECTOMY DEVICE (OAD) AND SALINE PUMP WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU) FOR AN ILLIAC ARTERY PROCEDURE. THREE TREATMENTS WERE PERFORMED SUCCESSFULLY. DURING THE FOURTH TREATMENT, THERE WAS A VARIATION OF SOUND WITH THE DEVICE AND IT WAS OBSERVED THERE WAS AN OAD DRIVESHAFT FRACTURE. AFTER MULTIPLE SNARE ATTEMPTS, THE PHYSICIAN WAS ABLE TO RETRIEVE THE FRACTURED COMPONENT. ANGIOGRAPHIC IMAGING WAS OBSERVED AND NO PATIENT COMPLICATIONS WERE NOTED. BALLOON ANGIOPLASTY WAS USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20879836 ↗
• InjuryAug 23, 2024Break; Material Separation; Insufficient Flow or Under Infusion; Failure to Advance; Break; Material Separation; Insufficient Flow or Under Infusion; Failure to Advance

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF HEAVILY CALCIFIED, OVER 90% STENOSED LESIONS IN COMMON FEMORAL ARTERY (CFA) AND SUPERFICIAL FEMORAL ARTERY (SFA) VIA FEMORAL UP-AND-OVER APPROACH. INTRAVASCULAR ULTRASOUND (IVUS) INDICATED THAT THE VESSEL DIAMETER WAS 7.2 - 7.9MM. FOLLOWING A PROXIMAL-TO-DISTAL TREATMENT OF THE CFA, A SECOND TREATMENT ON LOW SPEED WAS ATTEMPTED, BUT THE OAD COULD NOT BE ADVANCED AND SEEMED TO BE STUCK ON THE VIPERWIRE ADVANCE PERIPHERAL GUIDE WIRE. ANGIOGRAPHIC IMAGING OBSERVED THAT THE OAD CROWN WAS NOT STUCK ON THE VIPERWIRE AS SUSPECTED. BLOOD WAS NOTICED BACKING UP INTO THE OAD SALINE SHEATH AT THE TIP OF THE OAD HANDLE AND THE OAD SALINE SHEATH WAS FOUND DAMAGED. THE NOSECONE OF THE ORBITAL ATHERECTOMY SYSTEM (OAS) WAS DAMAGED, WHICH STOPPED SALINE FLOW FROM CONTINUING THROUGH THE OAS SHEATH. THE PHYSICIAN HAD THE OAD HANDLE LAYING ON THE TABLE AND THERE WAS A STEP-UP FROM ITS LOCATION TO WHERE THE PATIENT WAS LYING DOWN. THE PHYSICIAN INADVERTENTLY PUSHED THE OAD HANDLE ON THE STEP DURING TREATMENT BREAKING THE SHEATH AT THE 90-DEGREE ANGLE WHERE THE OAD HANDLE, AND DRIVESHAFT MEET. THE OAD WAS FREED FROM THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055361 ↗
• InjuryJun 20, 2024Difficult to Remove; Unexpected Shutdown; Difficult to Remove; Unexpected Shutdown

  ATHERECTOMY WAS PERFORMED IN A CHRONIC TOTAL OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) ADVANCING TO HUNTER'S CANAL USING THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE. TREATMENTS WERE PERFORMED A THE PROXIMAL AND MID SFA ON LOW, MEDIUM, AND HIGH SPEEDS. DURING THE FINAL TREATMENT IN THE DISTAL SFA TO POPLITEAL ARTERY, ON MEDIUM SPEED, THE OAD BECAME LOCKED ON THE WIRE, AND THE OAD STALLED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE BY PIN AND PULLING, HOWEVER, THE CROWN WAS UNABLE TO BE ADVANCED PAST THE SFA. MANUAL PRESSURE WAS THEN APPLIED TO THE GROIN UNTIL HEMOSTASIS WAS ACHIEVED AND THE OAD WAS SUCCESSFULLY REMOVED WITH THE VIPERWIRE ADVANCE GUIDE WIRE AND SHEATH. THE PATIENT WAS STABLE AND HEMODYNAMICS WERE UNCHANGED. THE PROCEDURE WAS ABORTED AND WAS TO BE SCHEDULED FOR A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19575016 ↗
• InjuryAug 11, 2023Material Separation; Material Separation

  A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY. DURING OAD REMOVAL, IT WAS OBSERVED THAT THE DRIVESHAFT FRACTURED. AN ATTEMPT WAS MADE TO RETRIEVE THE FRACTURED DRIVESHAFT, HOWEVER, THE FRACTURED COMPONENT WAS PUSHED FURTHER INTO THE LOWER LEG. ADDITIONAL SURGERY WAS PERFORMED TO REMOVE THE COMPONENT. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 17509535 ↗
• MalfunctionMay 5, 2023Material Separation; Material Separation

  THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A COMMON FEMORAL PORFUNDA. DURING ADVANCEMENT OF THE OAD, IT WAS NOTED THERE WAS A VERY SHARP TURN IN THE VESSEL DUE TO THE CALCIFIED LESION. THE OAD STOPPED ADVANCING ABRUPTLY AFTER 5 TO 7 MILLIMETERS. UPON REMOVAL OF THE OAD, MATERIAL WAS OBSERVED ON THE OAD AFTER REMOVAL OF THE DEVICE. BALLOON ANGIOPLASTY WAS PERFORMED TO COMPLETE THE PROCEDURE. CSI RETURN DEVICE ANALYSIS OF THE OAD DETERMINED THE MATERIAL ATTACHED TO THE OAD WAS FROM THE DRIVESHAFT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16880979 ↗
• InjuryJul 20, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  THE STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED IN CALCIFIED ANASTOMOSES OF THE FEMORAL - FEMORAL GRAFT. THE OAD BECAME STUCK ALONG WITH THE VIPERWIRE ADVANCE GUIDE WIRE. THE OAD AND WIRE WERE SUCCESSFULLY REMOVED BY PULLING OUT THE SHEATH WITH THE DEVICE. THE TIP HAD FRACTURED AND WAS SUCCESSFULLY SNARED. ALL COMPONENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT WAS STABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 15067783 ↗
• InjuryJul 6, 2022Entrapment of Device; Entrapment of Device

  FOLLOWING A TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY USING A STEALTH 360 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD), A STENT WAS PLACED. ANOTHER TREATMENT WAS PERFORMED DISTAL TO THE NEWLY PLACED STENT. WHEN ATTEMPTING TO REMOVE THE OAD, IT BECAME STUCK ON THE STENT. THE OAD COULD BE ADVANCED DISTALLY BUT COULD NOT BE ADVANCED PROXIMALLY. THE PHYSICIAN CUT THE DRIVESHAFT, LEAVING A PORTION IN VIVO. THE PATIENT WAS SENT TO THE HOSPITAL FOR A FEMORAL POPLITEAL BYPASS SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 14937318 ↗
• InjuryMar 17, 2022Entrapment of Device; Entrapment of Device

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT VIA GROIN ACCESS. THE TARGET LESION WAS IN THE ANTERIOR TIBIAL ARTERY. IVUS SHOWED THAT THE VESSEL DIAMETER WAS 2.0-2.4MM. DURING TREATMENT, THE OAD BECAME ENTRAPPED IN THE VESSEL. THE PATIENT WAS SENT TO THE HOSPITAL FOR SURGERY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 13794528 ↗
• InjuryDec 16, 2021Mechanical Problem; Mechanical Problem

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF A 90% STENOSED LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA). MULTIPLE TREATMENT PASSES WERE PERFORMED ON ALL SPEEDS. DURING PULLBACK TO THE RESTING POSITION, THE OAD SLOWED AND STALLED. SOME RESISTANCE WAS ENCOUNTERED DURING REMOVAL OF THE OAD. THIS WAS ATTRIBUTED TO THE 2MM CROWN SIZE AND BIFURCATION CHARACTERISTICS. ANGIOGRAPHY THEN SHOWED FLOW WAS SLUGGISH, AND THERE WAS NO FLOW THROUGH THE TREATED SEGMENT. ANGIOPLASTY WAS APPLIED, BUT A SIGNIFICANT DISSECTION WAS NOTED. A STENT WAS DEPLOYED OVER THE TREATMENT AREA, AND FLOW WAS BRISK THEREAFTER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Vascular Dissection

  MAUDE report 13022648 ↗
• InjuryDec 9, 2021Entrapment of Device; Entrapment of Device

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WITH A 2.0MM CROWN WAS USED TO TREAT HEAVILY CALCIFIED LESIONS IN THE TIBIOPERONEAL TRUNK (TPT) AND THE PROXIMAL PERONEAL. TREATMENT BEGAN ON LOW SPEED IN THE 3.0MM VESSEL AND WAS INCREASED TO MEDIUM SPEED. THE OAD STOPPED SPINNING DUE TO BEING STUCK IN THE VESSEL. THE CONTROL KNOB WAS MANIPULATED TO RELEASE THE OAD FROM THE VESSEL AND THE CROWN SPUN FREELY, HOWEVER IT WAS THEN DETERMINED TO BE STUCK ON THE VIPERWIRE GUIDE WIRE. THE OAD WAS FREED FROM THE WIRE, HOWEVER DURING REMOVAL FROM THE PATIENT IT BECAME STUCK ON THE WIRE AGAIN. THE WIRE AND OAD WERE REMOVED TOGETHER AND TISSUE WAS VISIBLE ON THE CROWN AND DRIVESHAFT. A NON-CSI WIRE WAS INSERTED BUT WAS UNABLE TO CROSS THE TPT AND PERONEAL. IMAGING WAS PERFORMED AND REVEALED A PERFORATION IN THE PROXIMAL PERONEAL WHERE THE OAD HAD BECOME STUCK. TIBIAL ACCESS WAS GAINED AND A WIRE WAS INSERTED INTO THE POSTERIOR TIBIAL ARTERY. BALLOON ANGIOPLASTY WAS PERFORMED IN THE DISEASED TIBIAL REGIONS AND A STENT WAS PLACED IN THE TPT AND PT, JAILING THE PERONEAL, WHICH GREATLY REDUCED THE PERFORATION EXTRAVASATION. A NON-FLOW LIMITING DISSECTION WAS THEN NOTED NEAR THE AREA OF OAD TR

  Patient problems: Device Embedded In Tissue or Plaque; Perforation of Vessels; Vascular Dissection

  MAUDE report 12970588 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TREATMENT WITH A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE WAS PERFORMED ON LOW, MEDIUM AND HIGH SPEED TO A 7MM, 80% STENOSED AND HEAVILY CALCIFIED SUPERFICIAL FEMORAL LESION. AN ULTRASOUND REVEALED THAT AN EMBOLI OF CALCIUM HAD MIGRATED TO THE DISTAL DORSALIS PEDIS (DP) ARTERY. VASODILATORS WERE ADMINISTERED AND ADDITIONAL BALLOON ANGIOPLASTY TO THE TIBIAL AND DP ARTERIES WERE PERFORMED. THE PROCEDURE WAS COMPLETED AND THE PATIENT EXPERIENCED NO ADDITIONAL PAIN OR DISCOMFORT.

  Patient problems: Embolism/Embolus

  MAUDE report 12968495 ↗
• MalfunctionNov 30, 2021Entrapment of Device; Entrapment of Device

  A STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS ADVANCED INTO THE SUPERFICIAL FEMORAL ARTERY FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION. AS THE CROWN WAS ADVANCED NEAR THE PROXIMAL PORTION OF THE LESION, THE CROWN BECAME ENTRAPPED IN THE VESSEL AND STOPPED SPINNING. THIS ISSUE RECURRED THREE TIMES, AND ATHERECTOMY WAS ABORTED. THE OAD BECAME STUCK ON THE GUIDE WIRE, AND THE WIRE AND OAD WERE REMOVED TOGETHER. THE PROCEDURE WAS THEN ABORTED SINCE THE LESION COULD THEN NOT BE CROSSED WITH ANOTHER GUIDE WIRE. THE PATIENT WAS MOVED TO RECOVERY. THE PHYSICIAN PLANS TO BRING THE PATIENT BACK IN THREE WEEKS FOR ANOTHER INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12893837 ↗
• InjuryNov 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED ON LOW AND MEDIUM SPEED FOR TWO TREATMENT PASSES EACH. THE OAD STOPPED SPINNING ABRUPTLY WHEN OPERATED ON HIGH SPEED. THE OAD WAS REMOVED, AND A TYPE D DISSECTION WAS OBSERVED. BALLOON ANGIOPLASTY WAS PERFORMED TO RESOLVE THE DISSECTION. A SECOND OAD WAS USED TO COMPLETE TREATMENT TO THE DISTAL AREA OF THE LESION. THE PATIENT WAS DISCHARGED WITHOUT ADDITIONAL COMPLICATIONS.

  Patient problems: Vascular Dissection

  MAUDE report 12852003 ↗
• InjuryJul 8, 2021Material Separation; Material Separation

  THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) COULD NOT BE ADVANCED OVER THE ILIAC BIFURCATION. THE BIFURCATION HAD A NARROW DIAMETER AND WAS HEAVILY CALCIFIED. FOLLOWING SEVERAL ATTEMPTS (PULLING BACK THEN ADVANCING), THE SHEATH OF THE OAD WAS ABLE TO PASS THE BIFURCATION. THE OAD WAS THEN ADVANCED TO THE TREATMENT AREA AT THE OSTIAL SUPERFICIAL FEMORAL ARTERY. THE DEVICE WAS ADVANCED FARTHER FOLLOWING TREATMENTS ON LOW, MEDIUM, AND HIGH SPEEDS, AND THE NOSE OF THE DRIVESHAFT APPEARED FRACTURED ON IMAGING. THE OAD WAS REMOVED. THE NOSE REMAINED ON THE WIRE AND WAS RETRIEVED WITH THE AID OF A SNARE. THE PROCEDURE WAS COMPLETED WITH ANGIOPLASTY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12133859 ↗
• InjuryApr 20, 2021Entrapment of Device; Entrapment of Device

  ANGIOPLASTY WAS PERFORMED VIA PEDAL ACCESS AND CONTRALATERAL APPROACH IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PRIOR TO INSERTION OF A VIPERWIRE AND STEALTH GEN 2 PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD). THE OAD STALLED AND BECAME STUCK IN THE VESSEL FOLLOWING A FEW TREATMENTS. TREATMENT WAS ACTIVATED SEVERAL TIMES, AND EVENTUALLY THE OAD WOULD NO LONGER SPIN. RADIAL ACCESS WAS OBTAINED, AND ANGIOPLASTY WAS PERFORMED NEAR THE AREA OF THE OAD CROWN. THE OAD WAS THEN PULLED, AND IT WAS FREED FROM THE VESSEL. A DISSECTION WAS PRESENT IN THE AREA WHERE THE CROWN HAD BECOME STUCK. A STENT WAS DEPLOYED TO RESOLVE THE DISSECTION. IMAGING THEN SHOWED A WIDELY PATENT SFA WITH GOOD RUNOFF FLOW. THE PATIENT WAS WELL FOLLOWING THE PROCEDURE.

  Patient problems: Vascular Dissection

  MAUDE report 11693153 ↗
• InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEALTH ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF HEAVILY CALCIFIED AREAS IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), POPLITEAL ARTERY, AND TIBIAL ARTERY VIA CONTRALATERAL APPROACH. THE SFA WAS DIFFUSELY DISEASED, THE AT WAS PATENT, AND THE PERONEAL ARTERY WAS OPEN, BUT FLOW DIMINISHED AT MID-THIGH. INTRAVENOUS ULTRASOUND (IVUS) VERIFIED HEAVY CALCIFICATION IN THE SFA AND POPLITEAL. THE PHYSICIAN DETERMINED THAT TREATMENT OF THE IN FLOW AREAS WOULD BE MOST BENEFICIAL; TREATMENT OF THE TIBIAL VESSELS WAS NOT PLANNED. IVUS VERIFIED THAT THE VESSEL SIZING IN THE TREATMENT AREAS WAS GREATER THAN 6MM. AN INITIAL BOLUS OF 7,000 UNITS OF HEPARIN WAS ADMINISTERED. TREATMENTS IN THE SFA WERE PERFORMED ON LOW, MEDIUM, AND HIGH SPEED. TREATMENT IN THE POPLITEAL WAS PERFORMED ON LOW AND MEDIUM SPEED. TREATMENT WAS TERMINATED AT THE LEVEL OF THE PATELLA, PROXIMAL TO THE TIBIAL VESSELS AS PLANNED. TO CONSERVE CONTRAST, IMAGING WAS NOT PERFORMED. TISSUE WAS NOTED ON THE DRIVESHAFT UPON REMOVAL OF THE OAD. ANGIOGRAM THEN SHOWED OCCLUSION OF THE TIBIAL VESSELS. ANGIOPLASTY WAS PERFORMED MULTIPLE TIMES IN THE AT AND PERONEAL WITH SOME IMPROVEMENT. AFTER ADDITIONAL ANGIOPLASTY B

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11344348 ↗
• InjuryOct 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORBITAL ATHERECTOMY(OA) FOLLOWED BY BALLOON ANGIOPLASTY WAS SUCCESSFULLY COMPLETED IN A CALCIFIED SUPERFICIAL FEMORAL ARTERY. OA TREATMENT WAS CONTINUED IN A CALCIFIED PROFUNDA ARTERY. ON THE THIRD TREATMENT PASS ON HIGH SPEED THE STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) STOPPED SPINNING AND THE CROWN WAS ANGLED OUTSIDE OF THE VESSEL. AN ANGIOGRAM WAS PERFORMED AND REVEALED A VESSEL RUPTURE HAD OCCURRED DURING TREATMENT AND THAT AN ANEURYSM WAS PRESENT NEAR THE CROWN OF THE OAD. THE OAD AND VIPERWIRE GUIDE WIRE WERE REMOVED. COILING WAS PERFORMED TO RESOLVE THE ANEURYSM. THE REMAINING VESSELS OF THE PROFUNDA ARTERY WERE INTACT, WITH NO OTHER COMPLICATIONS OBSERVED. THE PATIENT CONDITION WAS REPORTED AS FINE. PER THE OPINION OF THE PHYSICIAN, THE CSI DEVICE CONTRIBUTED TO THE ANEURYSM EVENT. THE CAUSE OF THE VESSEL RUPTURE WAS UNKNOWN.

  Patient problems: Aneurysm; Rupture

  MAUDE report 10648121 ↗
• InjurySep 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STEALTH PLUTO ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A HEAVILY CALCIFIED COMMON FEMORAL STENOSIS WITH OSTIAL SUPERFICIAL FEMORAL ARTERY CHRONIC TOTAL OCCLUSION VIA LEFT COMMON FEMORAL ANTEGRADE ACCESS. FOLLOWING SEVERAL TREATMENTS IN THE PROXIMAL LESION AND ONE DISTAL TREATMENT, THE OAD STALLED. WHEN TESTED EX VIVO, THE DEVICE OPERATED AS INTENDED. DURING THE SECOND ATTEMPT AT DISTAL TREATMENT, THE ISSUE RECURRED. A DISSECTION WAS NOTED ON ANGIOGRAM AFTER THE OAD WAS REMOVED FROM THE PATIENT AND AFTER ANGIOGRAPHY HAD BEEN PERFORMED. THE DISSECTION FLAP OCCLUDED THE VESSEL. A STENT WAS PLACED, AND THE DISSECTION WAS RESOLVED. THE PROCEDURE CONCLUDED WITH ANGIOPLASTY AND STENT PLACEMENT WITH NO FURTHER INDICATION OF DISSECTION OR PERFORATION.

  Patient problems: Vascular Dissection

  MAUDE report 10502605 ↗
• InjuryJul 29, 2020Difficult to Advance; Difficult to Advance

  A STEALTH PERIPHERAL ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A PROFUSELY DISEASED SUPERFICIAL FEMORAL ARTERY (SFA), WITH A CALCIFIED BYPASS GRAFT ANASTOMOSIS IN THE DISTAL SECTION OF THE SFA. THE VESSEL WAS TORTUOUS, 5MM IN LENGTH, SEVERELY CALCIFIED AND HAD MULTIPLE 99% FOCAL LESIONS. THE OAD WAS ADVANCED ACROSS THE SFA BUT WAS UNABLE TO CROSS THE DISTAL END OF THE ANASTOMOSIS SECTION, AND IT WAS DETERMINED THAT THE OAD WOULD NOT ADVANCE THROUGH THE TORTUOUS ANATOMY. THE PROCEDURE WAS ABORTED, AND AS OF (B)(6) 2020 THERE WAS NO FOLLOW-UP PROCEDURE PLANNED. THERE WERE NO PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339739 ↗