Diamondback Coroanry DBEC-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 189 adverse event reports that list this exact device (DI 10852528005428), received between May 3, 2018 and May 1, 2025 — classified as 25 deaths, 133 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Material Separation” (26 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 189 reports, in the reporter's own words as published by the FDA.

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

  A DIAMONDBACK 360 ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION ON 14 MARCH 2019. THE PATIENT EXPIRED WEEKS AFTER THE PROCEDURE DUE TO CARDIAC DEATH. THE CLINICAL EVENTS COMMITTEE REVIEWED THE ANGIOGRAPHIC IMAGES AND CONCLUDED STENT THROMBOSIS OCCURRED WHICH WAS POSSIBLY THE CAUSE OF DEATH AND THE OAD MAY HAVE CONTRIBUTED. THE SITE DID NOT REPORT ANY ADVERSE EFFECTS. NO FURTHER INFORMATION IS AVAILABLE. SUBJECT ID: (B)(6).

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21944515 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIOGRAPHIC IMAGING WAS REVIEWED BY THE CLINICAL EVENTS COMMITTEE (CEC) AND SLOW FLOW RESULTING IN PERIPROCEDURAL MYOCARDIAL INFARCTION WAS OBSERVED. THE CEC SUSPECTED THAT ORBITAL ATHERECTOMY WAS POSSIBLY RELATED TO THE ADVERSE PATIENT EFFECTS. THE SITE DID NOT REPORT DEVICE MALFUNCTION ORADVERSE EVENTS.

  Patient problems: Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 21944358 ↗
• DeathSep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCESS WAS GAINED THROUGH THE RIGHT FEMORAL ARTERY. A 6FR SHEATH WAS USED TO ADVANCE THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) TO THE RAMUS ARTERY. THE VESSEL WAS 2.75MM, 90% STENOSED, 15 MM IN LENGTH, HEAVILY CALCIFIED, WITH 15MM TOTAL LENGTH OF CALCIUM. THE OAD WAS SPUN FOR TREATMENT FIVE TIMES ON LOW SPEED. ANGIOGRAPHIC IMAGING WAS PERFORMED POST OAD. ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019 FOR NSTEMI, MEDICATION OF TROPONIN WAS ADMINISTERED. CARDIAC CATHETERIZATION ON (B)(6) 2019 REVEALED IN-STENT THROMBOSIS OF RAMUS INTERMEDIUS. MEDICATION OF HEPARIN AND INTEGRILLIN DRIP, ALONG WITH ALBUTEROL WITH ASPIRIN WERE ADMINISTERED TO TREAT THE THROMBUS. THE PATIENT BECAME SEVERELY ANEMIC AND REQUIRED TWO BLOOD TRANSFUSIONS. DUE TO THE PATIENT'S COMORBIDITIES, ANEMIA, AND HIGH-RISK PERCUTANEOUS CORONARY INTERVENTION (PCI), IT WAS DECIDED TO NOT PROCEED WITH AGGRESSIVE TREATMENT. PATIENT WAS DISCHARGED TO HOME HOSPICE ON (B)(6) 2019. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2020 FOR HYPERTENSIVE HEART DISEASE WITH HEART FAILURE AND EXPIRED ON (B)(6) 2020. THE SITE WAS

  Patient problems: Myocardial Infarction; Thrombosis/Thrombus

  MAUDE report 20302006 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE WAS USED FOR TREATMENT OF 80% STENOSED, SEVERELY CALCIFIED, 3MM-DIAMETER LESION IN PROXIMAL CIRCUMFLEX (CX) ARTERY VIA RIGHT FEMORAL APPROACH. THREE HIGH-SPEED TREATMENTS WERE PERFORMED AT THE TARGET LESION. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 20196448 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING THE ATHERECTOMY PROCEDURE ON (B)(6) 2018, THE PATIENT HAD ELEVATED CARDIAC ENZYMES. THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE COULD NOT BE RULED OUT AS A CONTRIBUTING FACTOR TO THE SYMPTOMS. THE HEALTHCARE PROVIDER NOTED THAT THE ELEVATION IN TROPONIN LEVELS WAS NOT LIFE-THREATENING, DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, DID NOT LEAD TO A SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT, AND DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE PATIENT WAS STABLE AND DISCHARGED HOME THE DATE AFTER THE PROCEDURE. THE HOSPITALIZATION WAS THE SITE STANDARD OF CARE. ON 23JULY2024, THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Cardiac Enzyme Elevation; Myocardial Infarction

  MAUDE report 19986213 ↗
• InjuryAug 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING ATHERECTOMY USING DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ANGIOGRAPHIC IMAGING OBSERVED MINOR DISSECTION IN MID LEFT ANTERIOR DESCENDING ARTERY. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CLINICAL EVENT COMMITTEE (CEC). THE CEC REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 19976634 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE WAS USED FOR TREATMENT OF 90% STENOSED, SEVERELY CALCIFIED, 3.0MM-DIAMETER LESION IN MID RIGHT CORONARY ARTERY (RCA) VIA RIGHT RADIAL APPROACH. TWO LOW-SPEED AND ONE HIGH-SPEED TREATMENTS WERE PERFORMED AT THE TARGET LESION. BALLOON ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO CONCLUDE THE PROCEDURE. THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 19950610 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TARGET TREATMENT AREA WAS A 20MM LESION IN 80% STENOSED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SPUN THRICE ON LOW SPEED. ANGIOGRAPHIC IMAGING WAS PERFORMED THAT SHOWED NO PROCEDURAL COMPLICATIONS. THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Myocardial Infarction

  MAUDE report 19950239 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A 99% STENOSED, SEVERELY CALCIFIED, 4MM PROXIMAL CIRCUMFLEX ARTERY (CFX). 11 LOW SPEED TREATMENTS WERE PERFORMED. THERE WERE NO ORBITAL ATHERECTOMY RELATED ADVERSE EVENTS OBSERVED POST-PROCEDURE. 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 19929733 ↗
• InjuryJul 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE WAS USED FOR TREATMENT IN A 4MM, 80% STENOSED, CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THREE LOW SPEED TREATMENTS AND FIVE HIGH SPEED TREATMENTS WERE PERFORMED. THERE WERE NO PATIENT COMPLICATIONS OBSERVED. THE CLINICAL EVENT COMMITTEE REVIEWED PROCEDURAL IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE POSSIBLY CONTRIBUTED TO A MYOCARDIAL INFARCTION.

  Patient problems: Myocardial Infarction

  MAUDE report 19829670 ↗
• InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A SEVERELY CALCIFIED, 85% STENOSED, MID RIGHT CORONARY ARTERY (RCA). ONE LOW SPEED TREATMENT WAS PERFORMED. THERE WERE NO PATIENT COMPLICATIONS RELATED TO ORBITAL ATHERECTOMY REPORTED BY THE SITE AT THE END OF THE PROCEDURE. 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 19820266 ↗
• InjuryMar 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DEVELOPED ATRIAL FIBRILLATION SPONTANEOUSLY FOLLOWING TREATMENT WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). THE SITE DEEMED THE EVENT WAS NOT RELATED TO THE OAD. ADDITIONAL INFORMATION WAS RECEIVED INDICATING DURING AN ATHERECTOMY PROCEDURE USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), A MYOCARDIAL INFARCTION OCCURRED. THIS WAS IDENTIFIED DURING AN ANGIOGRAPHIC IMAGE REVIEW BY CLINICAL ENDPOINT COMMITTEES (CEC) ADJUDICATION FOLLOWING THE PROCEDURE. THE CEC DETERMINED THIS EVENT TO BE POSSIBLY RELATED TO ORBITAL ATHERECTOMY.

  Patient problems: Myocardial Infarction

  MAUDE report 18969247 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED FOR TREATMENT IN A 3.00MM, 80% STENOSED, HEAVILY CALCIFIED MID LEFT ANTERIOR DESCENDING ARTERY (LAD). THE OAD WAS SPUN FOR THREE TREATMENTS ON LOW SPEED. ANGIOPLASTY AND STENT PLACEMENT WERE PERFORMED TO COMPLETE THE PROCEDURE. ELEVATED CARDIAC ENZYMES WERE OBSERVED. THE ELEVATED CARDIAC ENZYMES WAS CHARACTERIZED AS A TYPE 4 NSTEMI MYOCARDIAL INFARCTION. NO FURTHER ACTION OR TREATMENT WERE TAKEN AND THE PATIENT WAS DISCHARGED HOME. IT WAS UNKNOWN IF THE OAD CAUSED OR CONTRIBUTED TO THE ELEVATION OF TROPONINS, BUT IT WAS POSSIBLE.

  Patient problems: Myocardial Infarction

  MAUDE report 18865599 ↗
• InjuryJan 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS USED TO TREAT A LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY ON (B)(6) 2019. TWO DRUG-ELUTING STENTS WERE PLACED. DURING A TWO-YEAR FOLLOW UP IN CLINIC ON (B)(6) 2021, THE PATIENT EXPERIENCED CHEST TIGHTNESS AND WAS PROVIDED INFORMATION REGARDING CARDIAC REHABILITATION. ELECTROCARDIOGRAM (EKG) REVEALED NORMAL SINUS RHYTHM (NSR) AND LEFT ANTERIOR FASCICULAR BLOCK (LAFB), UNCHANGED. PATIENT CALLED SITE ON (B)(6) 2022 INDICATING CHEST TIGHTNESS FOR THE PAST FOUR TO SIX WEEKS AND TINGLING DOWN HIS RIGHT ARM. HE WAS ADVISED TO GO TO EMERGENCY ROOM BUT REQUESTED AN APPOINTMENT. HE WAS SEEN IN CLINIC ON (B)(6) 2022. EKG THAT DAY REVEALED NSR, POSSIBLE LEFT ANTERIOR (LA) ENLARGEMENT, INCOMPLETE RIGHT BUNDLE BRANCH BLOCK (RBBB), AND LEFT ANTERIOR FASCICULAR BLOCK (LAFB). DUE TO HIGH RISK FOR CORONARY ARTERY DISEASE (CAD), HE WAS SCHEDULED FOR LEFT HEART CATHETERIZATION (LHC). PERCUTANEOUS CORONARY INTERVENTION (PCI) ON (B)(6) 2022 REVEALED IN-STENT RESTENOSIS (ISR) OF LAD AND RIGHT CORONARY ARTERY (RCA). THE MID LAD WAS STENTED, AND HE WAS SCHEDULED FOR STAGED PROCEDURE TO ADDRESS THE RCA. DURING PCI ON (B)(6) 2022 T

  Patient problems: Angina; Heart Block; Restenosis

  MAUDE report 18530306 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE PATIENT TROPONIN LEVELS WERE NOTED TO BE ELEVATED. THE PATIENT DID NOT EXHIBIT ANY ADDITIONAL SYMPTOMS. THE HEALTHCARE PROVIDER DOCUMENTED THAT THE ELEVATION IN TROPONIN LEVELS WAS NOT LIFE-THREATENING, DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, DID NOT LEAD TO A SERIOUS DETERIORATION IN THE HEALTH OF THE SUBJECT, AND DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE EVENT DID NOT RESULT IN ADDITIONAL OR EXTENDED HOSPITALIZATION. THE PHYSICIAN DOCUMENTED THAT THERE WERE NO NOTED COMPLICATIONS FROM THE PROCEDURE. THERE IS NO ALLEGATION AGAINST THE CSI DEVICE AND NO INDICATION THAT THE CSI DEVICE CONTRIBUTED TO THE ADVERSE EVENT. 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 18505528 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DIAMONDBACK 360 ORBITAL ATHERECTOMY DEVICE WAS USED TO TREAT A MID RIGHT CORONARY ARTERY. FIVE TREATMENTS WERE PERFORMED ON LOW SPEED. FOLLOWING ATHERECTOMY, A NON-FLOW LIMITING DISSECTION WAS OBSERVED. THE PROCEDURE WAS COMPLETED WITH NO INTERVENTION. THE PATIENT WAS STABLE. 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 MAJOR DISSECTION.

  Patient problems: Vascular Dissection

  MAUDE report 18505515 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING USE OF A DRUG ELUTED STENT, ANGIOGRAPHIC IMAGING OBSERVED A MAJOR DISSECTION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE MAY HAVE CONTRIBUTED.

  Patient problems: Vascular Dissection

  MAUDE report 18504392 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANGIOGRAPHIC IMAGING WAS PERFORMED FOLLOWING COMPLETION OF THE PROCEDURE AND A PERFORATION WAS OBSERVED. THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE PERFORATION OCCURRED FOLLOWING USE OF THE DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Perforation of Vessels

  MAUDE report 18498776 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Vascular Dissection

  MAUDE report 18498775 ↗
• 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 MID LATERAL ANTERIOR 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 18497477 ↗
• 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 TYPE D DISSECTION IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). 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 18496069 ↗
• 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 TYPE E DISSECTION AND THROMBUS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). 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: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 18495004 ↗
• 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 TYPE C DISSECTION IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). 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: Vascular Dissection

  MAUDE report 18493541 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OPTICAL COHERENCE TOMOGRAPHY (OCT) IMAGING DETECTED THROMBUS IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) DURING THE ATHERECTOMY PROCEDURE USING A DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD). THE CLINICAL EVENT COMMITTEE REVIEWED THE IMAGES AND CONCLUDED THAT THE USE OF THE OAD MAY HAVE CONTRIBUTED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 18493523 ↗
• 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) AND BALLOON ANGIOPLASTY, ANGIOGRAPHIC IMAGING OBSERVED A TYPE C DISSECTION IN THE DISTAL CIRCUMFLEX ARTERY (CX). 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 18493521 ↗