Diamondback Coronary DBEC-125 (REF 7-10060-01)Recalls & reported problems

Summary

The FDA's MAUDE database contains 127 adverse event reports that list this exact device (DI 10850000491356), received between Jul 9, 2020 and May 1, 2025 — classified as 21 deaths, 80 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Material Separation” (29 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 127 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) - PRIOR TO THE PROCEDURE A TEMPORARY PACEMAKER WAS PLACED AS A PROPHYLACTIC DEVICE AND WAS ACTIVATED. THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED ON LOW SPEED AND TREATED SEVERELY CALCIFIED LESIONS IN THE RIGHT CORONARY ARTERY. DURING THE PROCEDURE, SLOW FLOW IN THE POSTEROLATERAL ARTERY WAS OBSERVED, ALONG WITH A MICROVASCULAR INJURY AND ELEVATED CREATINE KINASE (CK) LEVELS. DIAGNOSTIC TESTING CONFIRMED THAT ALL TREATED AREAS HAD A TIMI FLOW OF 3 FOLLOWING THE PROCEDURE. PER THE PHYSICIAN, THE SLOW FLOW WAS SUGGESTIVE OF DEBRIS LIKELY FROM THE OAD AND WAS LIKELY THE CAUSE OF THE MICROVASCULAR INJURY AND SUBSEQUENT ELEVATED CREATINE KINASE (CK) ELEVATION. THE PATIENT REMAINED OVERNIGHT DUE TO STANDARD CARE OF THE HOSPITAL AND WAS DISCHARGED THE FOLLOWING DAY. ADDITIONAL INFORMATION RECEIVED INDICATED THE CLINICAL EVENT COMMITTEE REVIEWED IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED TO A MYOCARDIAL INFARCTION.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 21945347 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ECL-014-028 - IT WAS REPORTED A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 70% STENOSED, HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THREE LOW SPEED TREATMENTS WERE PERFORMED. THERE WERE NO DEVICE MALFUNCTIONS OR PATIENT COMPLICATIONS IDENTIFIED POST ORBITAL ATHERECTOMY TREATMENT. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED TO A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 21945120 ↗
• DeathMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY VIA FEMORAL ACCESS. THE SEVERELY CALCIFIED LESION WAS 12MM IN LENGTH WITH A VESSEL DIAMETER OF 2.5MM. AFTER ONE TREATMENT ON LOW SPEED, A TYPE D DISSECTION OCCURRED. THE OAD WAS REMOVED, AND BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED. THE VESSEL LOOKED DECENT FOLLOWING STENT DEPLOYMENT. THE PATIENT BECAME HYPOTENSIVE. DOPAMINE, EPINEPHRINE AND LEVOPHED WERE ADMINISTERED. AN IMPELLA HEART PUMP WAS INSERTED. THE HEART PUMP WAS THEN REMOVED. THE PATIENT ALSO EXPERIENCED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE DURING STENT POSITIONING AND DEPLOYMENT. AMIODARONE WAS ADMINISTERED BUT DID NOT CONVERT THE ARRHYTHMIA. CARDIOVERSION WAS PERFORMED, AND THE CARDIOVERSION WAS SUCCESSFUL IN RETURNING THE PATIENT TO A NORMAL SINUS RHYTHM. THE OPINION OF THE PHYSICIAN WAS THAT THE DISSECTION LED TO THE HYPOTENSION AND ARRYTHMIA. THE PATIENT WAS IN CRITICAL CONDITION AND WAS ADMITTED TO THE INTENSIVE CARE UNIT. THE PATIENT REMAINED HEMODYNAMICALLY UNSTABLE AND EXPERIENCED WORSENING BRADYCARDIA AND PULSELESS ELECTRICAL ACTIVITY. A TEMPORARY PACEMAKE

  Patient problems: Arrhythmia; Myocardial Infarction; Vascular Dissection

  MAUDE report 21944696 ↗
• InjuryMar 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS IDENTIFIED THAT DURING AN ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A PERFORATION OCCURRED. THIS WAS IDENTIFIED DURING AN ANGIOGRAPHIC IMAGE REVIEW FOLLOWING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: Perforation of Vessels

  MAUDE report 18851417 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING PRE-DILATATION, ANGIOGRAPHIC IMAGING OBSERVED A MAJOR DISSECTION IN THE PROXIMAL RIGHT CORONARY ARTERY. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18497486 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING PRE-DILATATION, ANGIOGRAPHIC IMAGING OBSERVED A MAJOR DISSECTION IN THE RIGHT POSTERIOR DESCENDING ARTERY. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Vascular Dissection

  MAUDE report 18493539 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED ABRUPT CLOSURE AND TYPE F DISSECTION IN THE LEFT MAIN CORONARY ARTERY (LMCA). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED.

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

  MAUDE report 18493532 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED A PERFORATION IN THE RAMUS. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 18493528 ↗
• InjuryMay 29, 2022Material Separation; Material Separation

  DURING TREATMENT IN THE OSTIAL CIRCUMFLEX ARTERY, WHICH WAS HEAVILY CALCIFIED, THE DRIVESHAFT OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE FRACTURED ON THE PROXIMAL SIDE OF THE CROWN. SEVERAL TREATMENTS HAD BEEN PERFORMED PRIOR TO THE FRACTURE. THE FRAGMENT WAS SNARED WITHOUT DIFFICULTY. THE PATIENT WAS WELL FOLLOWING ANGIOPLASTY AND STENT PLACEMENT; THERE WAS NO INJURY. THE OA TREATMENT WAS SUCCESSFUL DESPITE THE FRACTURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14538809 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT EXPERIENCED SLOW FLOW IN THE RIGHT CORONARY ARTERY (RCA) FOLLOWING THREE ATHERECTOMY TREATMENTS WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE. THE RCA WAS HIGHLY CALCIFIED. THE PATIENT ALSO EXPERIENCED HEART BLOCK AND HYPOTENSION. THE PATIENT WAS INTUBATED AND WAS STABLE. THE PATIENT RECOVERED AND WAS DISCHARGED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Heart Block; Low Blood Pressure/ Hypotension

  MAUDE report 12907522 ↗
• InjuryOct 15, 2021Material Integrity Problem; Material Integrity Problem

  DISTAL TO PROXIMAL TREATMENT WITH A DIAMONDBACK GEN 2 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS PERFORMED IN THE MID CIRCUMFLEX (CX) ARTERY. A SECOND TREATMENT WAS INITIATED, BUT THE OAD STALLED. THE DRIVESHAFT FRACTURED ON THE PROXIMAL SIDE OF THE CROWN. THE GUIDE WIRE ALSO FRACTURED. THE OAD FRAGMENT WAS LODGED IN THE DISTAL LEFT MAIN AND PROXIMAL CX. A TRIPLE WIRE SNARE TECHNIQUE WAS USED IN AN ATTEMPT TO DISLODGE THE FRAGMENT. HOWEVER, THE FRAGMENT COULD NOT BE RETRIEVED AND WAS NOT VISIBLE ON IMAGING AT THE CONCLUSION OF THE PROCEDURE. THE PATIENT WAS AGITATED AT THE CONCLUSION OF THE PROCEDURE, AND THE REASON FOR THE AGITATION WAS BELIEVED TO BE FROM A RESPONSE TO ANESTHETIC. THE RESULTS OF THE PROCEDURE WERE OTHERWISE DESCRIBED AS "EXCELLENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 12639783 ↗
• InjurySep 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE WAS SELECTED FOR TREATMENT OF A CHRONIC TOTAL OCCLUSION (CTO). THE TARGET VESSEL WAS THE RIGHT CORONARY ARTERY (RCA), WHICH WAS 2 TO 2.5MM IN DIAMETER AND HIGHLY DISEASED WITH EXTREME CALCIFICATION. THE GUIDE WIRE WAS INADVERTENTLY PLACED IN THE RIGHT MARGINAL VESSEL INSTEAD OF THE INTENDED RCA TARGET. TREATMENT WAS INITIATED, AND A PERFORATION OCCURRED. THE PERFORATION WAS NOT IN THE EXACT LOCATION OF THE CTO. ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED. THE PATIENT WAS TRANSFERRED TO THE ICU AND LATER EXPIRED.

  Patient problems: Perforation of Vessels

  MAUDE report 12488155 ↗
• InjurySep 7, 2021Material Separation; Material Separation

  THE PATIENT PRESENTED WITH CALCIFIED STENOSIS OF THE CIRCUMFLEX OSTIUM, AND THE IVUS CATHETER WOULD NOT CROSS THE LESION. ORBITAL ATHERECTOMY WAS SELECTED FOR TREATMENT AND THE VIPERWIRE GUIDE WIRE WAS INSERTED. SEVEN TREATMENT PASSES WERE PERFORMED WITH THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) IN THE OSTIAL CIRCUMFLEX. DURING THE SEVENTH ANTEGRADE TREATMENT PASS, THE TIP BUSHING OF THE OAD WAS NOTED TO BE DETACHED. TREATMENT WAS STOPPED AND THE OAD WAS REMOVED AND THE DEVICE FRAGMENT WAS OBSERVED TO REMAIN ON THE GUIDE WIRE. AN ADDITIONAL WIRE WAS INSERTED ALONGSIDE THE VIPERWIRE TO MAINTAIN WIRE POSITION, AND THE VIPERWIRE WAS THEN REMOVED FROM THE PATIENT ALONG WITH THE OAD FRAGMENT. THE PROCEDURE WAS CONTINUED WITH STENT PLACEMENT AND THE PATIENT WAS IN STABLE CONDITION THROUGHOUT.

  Patient problems: Foreign Body In Patient

  MAUDE report 12436442 ↗
• MalfunctionAug 26, 2021Entrapment of Device; Material Separation; Entrapment of Device; Material Separation

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A EXTREMELY CALCIFIED LESION IN THE LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE LAD WAS TORTUOUS AND VARIED BETWEEN 2.5 AND 3.5MM. FOUR PROXIMAL TO DISTAL TREATMENTS WERE PERFORMED, BUT THE OAD WAS UNABLE TO PASS THROUGH THE LESION DUE TO THE CALCIUM AND TORTUOSITY OF THE VESSEL. DURING THE FINAL TREATMENT, THE DISTAL TIP OF THE OAD BECAME STUCK IN THE LESION, AND THE DRIVESHAFT FRACTURED AT THE DISTAL EDGE OF THE CROWN. THE OAD FRAGMENT WAS RETRIEVED ON THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH BALLOON ANGIOPLASTY AND STENT PLACEMENT. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12374686 ↗
• InjuryAug 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A HEAVILY CALCIFIED, 90-95% STENOSED LESION IN THE PROXIMAL AND MID CIRCUMFLEX ARTERY. THE VESSEL WAS TORTUOUS AND 2.5-3.0MM IN DIAMETER. FOUR TREATMENTS WERE PERFORMED WITH THE OAD FOLLOWED BY BALLOON ANGIOPLASTY. IMAGING FOLLOWING BALLOON ANGIOPLASTY DID NOT REVEAL ANY ISSUE IN THE VESSEL. A STENT WAS INSERTED AND THE GUIDELINER WAS ADVANCE FOR ADDITIONAL SUPPORT. THE PATIENT EXPERIENCED CHEST PAIN, AND A SMALL PERFORATION WAS OBSERVED IN THE PROXIMAL VESSEL. A COVERED STENT WAS PLACED TO RESOLVE THE PERFORATION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. THE PHYSICIAN WAS UNABLE TO DETERMINE IF THE OAD CAUSED OR CONTRIBUTED TO THE PERFORATION.

  Patient problems: Chest Pain; Perforation of Vessels

  MAUDE report 12365219 ↗
• InjuryAug 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING TREATMENT OF A CALCIFIED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY, THE VIPERWIRE GUIDE WIRE WAS NOT PLACED AS DISTALLY IN THE VESSEL AS DESIRED. FOLLOWING THREE TREATMENT PASSES ON LOW SPEED WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), THE OAD WAS REMOVED IN ORDER TO PREVENT OPERATION TOO CLOSE TO THE GUIDE WIRE SPRING TIP. BALLOON ANGIOPLASTY WAS PERFORMED, BUT THE BALLOON WOULD NOT TRAVERSE DISTALLY. A GUIDE CATHETER WAS USED TO ENABLE ANOTHER BALLOON TO REACH THE DISTAL LOCATION, AND AFTER MULTIPLE INFLATIONS THE BALLOON BURST. IT WAS DETERMINED THAT ADDITIONAL ATHERECTOMY TREATMENT WAS REQUIRED TO FACILITATE STENT PLACEMENT, AND THE PHYSICIAN DECLINED TO USE IVUS. THE GUIDE WIRE WAS REMOVED AND NO DISSECTION WAS NOTED ANGIOGRAPHICALLY. GLIDEASSIST WAS USED TO ADVANCE THE OAD BEYOND THE AREA TREATED WITH ANGIOPLASTY AND 6-7 ADDITIONAL TREATMENT PASSES WERE PERFORMED UNTIL NO RESISTANCE WAS FELT. FOLLOWING THE FINAL TREATMENT PASS, IMAGING WAS PERFORMED AND A CONTAINED PERFORATION WAS OBSERVED. THE PERFORATION WAS RESOLVED WITH STENT PLACEMENTS AND THE PROCEDURE WAS CONTINUED WITH THE PATIENT IN STABLE CONDITION.

  Patient problems: Perforation of Vessels

  MAUDE report 12355651 ↗
• MalfunctionAug 13, 2021Break; Material Fragmentation

  CARDIOVASCULAR SYSTEMS INC. DIAMONBACK 360 ORBITAL ATHERECTOMY SYSTEM SEVERED THE VIPERWIRE ADVANCE® CORONARY GUIDE WIRE DURING ATHERECTOMY. AS A RESULT, THE DISTAL 20MM OF THE VIPERWIRE FRAGMENTED INTO THE DISTAL RIGHT CORONARY ARTERY. THE CLINICAL REPRESENTATIVE WAS PRESENT DURING THE SURGICAL PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 12318117 ↗
• InjuryAug 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORBITAL ATHERECTOMY TREATMENT WAS PERFORMED IN THE DISTAL AND MID TO PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. IMAGING WAS PERFORMED AND DID NOT REVEAL ANY ISSUES. STENT PLACEMENT WAS PERFORMED AND ADDITIONAL IMAGING CONFIRMED THAT THE LAD APPEARED NORMAL. LATER THAT DAY A VESSEL PERFORATION WAS IDENTIFIED AND TWO STENT PLACEMENTS WERE PERFORMED TO RESOLVE THE PERFORATION. THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: Perforation of Vessels

  MAUDE report 12312012 ↗
• MalfunctionAug 11, 2021Material Separation; Material Separation

  THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF DENSELY CALCIFIED PROXIMAL AND MID CIRCUMFLEX LESIONS. THREE TREATMENT PASSES WERE PERFORMED ON LOW SPEED IN THE MID CIRCUMFLEX, AND THE OAD WAS PULLED BACK TO THE PROXIMAL LESION. TWO ADDITIONAL PASSES WERE PERFORMED ON LOW SPEED. THE CROWN WAS ADVANCED DISTAL TO THE PROXIMAL LESION AND HIGH SPEED WAS SELECTED, HOWEVER THE OAD TURNED OFF. THE OAD WAS REBOOTED, HOWEVER THE CROWN WAS NOT MOVING WITH CONTROL KNOB MOVEMENT. THE OAD WAS TURNED OFF, THE CROWN WAS RE-POSITIONED AND WHEN THE OAD WAS POWERED BACK ON THE DEVICE STALLED. THE PHYSICIAN DECIDED TO ABORT ATHERECTOMY, AND AS THEY WERE UNABLE TO REMOVE THE DEVICE OFF OF THE GUIDE WIRE, BOTH THE DEVICE AND WIRE WERE REMOVED, WITH THE ASSISTANCE OF A GUIDE CATHETER AND SECOND GUIDE WIRE. UPON REMOVAL IT WAS REVEALED THAT THE DRIVESHAFT TIP HAD FRACTURED, AND THE FRAGMENT REMAINED ON THE GUIDE WIRE. THE VESSEL WAS RE-WIRED AND BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. PER THE PHYSICIAN, THERE WERE NO HEMODYNAMIC CHANGES OR COMPLICATIONS OBSERVED AS A RESULT OF THE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 12308088 ↗
• InjuryAug 10, 2021Unintended System Motion; Unintended System Motion

  A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF A LESION IN THE PROXIMAL CIRCUMFLEX ARTERY VIA FEMORAL ACCESS. THE OAD JUMPED FORWARD DURING THE FIRST TREATMENT. IMAGING SHOWED THE VESSEL WAS PATENT. A SECOND TREATMENT WAS STARTED, AND THE PATIENT EXPERIENCED CHEST PAIN AFTER SEVEN SECONDS. IMAGING REVEALED A PROXIMAL TYPE D DISSECTION, AND THE OAD WAS REMOVED. A STENT WAS PLACED REACHING THE CIRCUMFLEX ARTERY, HOWEVER THE DISSECTION WAS NOT RESOLVED. IT WAS UNCLEAR IF THE DISSECTION EXTENDED INTO THE LEFT MAIN ARTERY. KISSING STENTS WERE PLACED FROM THE LAD AND CIRCUMFLEX INTO THE LEFT MAIN, AND THE DISSECTION WAS RESOLVED AND THE PROCEDURE COMPLETED. AFTER SEEING THE STENTS ON IMAGING, THE PHYSICIAN NOTED THE TORTUOSITY OF THE VESSEL WAS MORE ACUTE THAN PREVIOUSLY THOUGHT. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND WAS TRANSFERRED TO THE INTENSIVE CARE UNIT.

  Patient problems: Vascular Dissection

  MAUDE report 12299903 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR TREATMENT OF THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. IMAGING REVEALED A VESSEL PERFORATION FOLLOWING THE THIRD ORBITAL ATHERECTOMY TREATMENT. THE DEVICE AND GUIDE WIRE WERE REMOVED FROM THE PATIENT. CHEST COMPRESSIONS WERE BEGUN. REGAINING ACCESS TO THE VESSEL WAS COMPLICATED BY SINGLE ACCESS THROUGH AN IMPELLA SHEATH; AN ALTERNATIVE ACCESS SITE WAS CREATED. BALLOON TAMPONADE AND STENT PLACEMENT WERE PERFORMED BUT WERE UNSUCCESSFUL IN RESOLVING THE PERFORATION. EFFORTS TO REVIVE THE PATIENT WERE DISCONTINUED SINCE THE FUNCTIONALITY OF THE HEART WAS DEEMED UNRECOVERABLE. THE PATIENT EXPIRED. IN THE OPINION OF THE PHYSICIAN, THE HIGH-RISK NATURE OF THE PROCEDURE AND THE PATIENT'S AGE CONTRIBUTED TO THE PATIENT DEATH.

  Patient problems: Perforation of Vessels

  MAUDE report 12210182 ↗
• MalfunctionJul 16, 2021Material Separation; Material Separation

  A DIAMONDBACK GEN 2 CORONARY ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT OF LESION IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) AND RIGHT CORONARY ARTERY (RCA) VIA RIGHT RADIAL ACCESS. THE CALCIFIED, MID-LAD LESION WAS ACCESSED WITH A NON-CSI GUIDE CATHETER AND WAS CROSSED WITH A NON-CSI MICROCATHETER AND GUIDE WIRE. FOLLOWING EXCHANGE TO VIPERWIRE, THE MICROCATHETER AND NON-CSI WIRE WERE REMOVED. THE OAD WAS SUCCESSFULLY TESTED EX VIVO AND ADVANCED TO THE TARGET LESION. GLIDEASSIST WAS USED TO ADVANCE THE CROWN PROXIMAL TO THE MID-LAD LESION. THREE TREATMENTS WERE PERFORMED ON LOW SPEED, EACH RANGING FROM 17 TO 20 SECONDS WITH 40 SECONDS OF REST BETWEEN. HOWEVER, THE OAD COULD NOT BE ADVANCED THROUGH THE LESION. GLIDEASSIST WAS ENABLED, AND THE OAD CROWN WAS ADVANCED DISTAL TO THE LESION WITHOUT ISSUE. FOUR LOW-SPEED TREATMENTS WERE PERFORMED RANGING FROM 16 TO 18 SECONDS EACH WITH 40 SECOND REST TIMES BETWEEN. IMAGING THEREAFTER SHOWED THAT THE CROWN AND NOSE OF THE OAD DRIVESHAFT WERE PROXIMAL TO THE LESION, BUT THE REMAINDER OF THE DRIVESHAFT WAS IN THE PROXIMAL LAD; THE OAD HAD FRACTURED PROXIMAL TO THE CROWN. FLUOROSCOPY SHOWED NO VESSEL COMPLICATIONS, AND THE PATIENT WAS

  Patient problems: Foreign Body In Patient

  MAUDE report 12181895 ↗
• InjuryJul 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THE CLINICAL EVENT COMMITTEE REVIEWED IMAGES AND CONCLUDED THAT THE USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED TO A MYOCARDIAL INFARCTION.

  Patient problems: Chest Pain; Myocardial Infarction; Perforation of Vessels

  MAUDE report 12160266 ↗
• InjuryJul 13, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  SEVERAL WIRES, CATHETERS, AND ANGIOPLASTY BALLOONS WERE USED IN THE PATIENT'S RIGHT CORONARY ARTERY (RCA) PRIOR TO INSERTION OF THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). THERE WAS NO OBSERVED VASCULAR INJURY PRIOR TO ADVANCING THE OAD TO THE AREA OF INTEREST. DIFFICULTY WAS EXPERIENCED IN ADVANCING THE OAD BEYOND THE MID SECTION OF THE ARTERY; GLIDEASSIST WAS ACTIVATED. THE DEVICE DID NOT ADVANCE AND WAS IMMEDIATELY REMOVED FROM THE PATIENT. ST ELEVATION WAS NOTED. A STENT COULD NOT BE DEPLOYED DUE TO DIFFICULTY IN ADVANCING IT, AND AN ANGIOPLASTY BALLOON WAS INFLATED IN THE DISTAL RCA. A DISSECTION IN THE MID-RCA WAS NOTED. SEVERAL ANGIOPLASTY BALLOONS AND STENTS WERE USED TO KEEP THE PATIENT STABLE. FOUR STENTS HAD BEEN PLACED AT THE CONCLUSION OF THE PROCEDURE, AND THE PATIENT WAS STABLE.

  Patient problems: Vascular Dissection

  MAUDE report 12158855 ↗
• InjuryJul 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORBITAL ATHERECTOMY TREATMENT WAS PERFORMED IN THE LEFT MAIN AND MID LEFT ANTERIOR DESCENDING (LAD) ARTERIES. FOLLOWING TREATMENT, A TYPE C DISSECTION WAS OBSERVED IN THE PROXIMAL LAD. INTRAVASCULAR ULTRASOUND (IVUS) REVEALED RESIDUAL CALCIUM. MINOR EXTRAVASATION WAS OBSERVED WHEN THE IVUS CATHETER WAS REMOVED. AN ECHOCARDIOGRAM REVEALED MINIMAL EFFUSION. ANGIOPLASTY AND STENT PLACEMENT RESOLVED THE DISSECTION. THE PATIENT REMAINED IN THE HOSPITAL, IN STABLE CONDITION.

  Patient problems: Extravasation; Vascular Dissection

  MAUDE report 12142527 ↗