PROMUS Element™ Plus H7493911416350Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08714729808015), received between Jan 20, 2017 and Feb 27, 2018 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Occlusion Within Device” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND RESTENOSIS OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND MYOCARDIAL INFARCTION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY WAS PERFORMED. TARGET LESION # 1 WAS A DE NOVO LESION LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 100% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0MM AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00X16MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. TARGET LESION #2 WAS A DE NOVO LESION LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD) WITH 95% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5MM AND WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50X16MM PROMUS ELEMENT¿ PLUS STENT. FOLLOWING POST DILATATION, WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN. IN (B)(6) 2017, THE PATIENT WAS PRESENTED TO EMERGENCY DEPARTMENT WITH THE COMPLAINTS OF CHEST PAIN, CHEST PRESSURE. THE PATIENT HAD MILD SHORTNESS OF BREATH AND DIAPHORESIS AND WAS HOSPITALIZED ON

  Patient problems: Chest Pain; Dyspnea; Myocardial Infarction; Occlusion

  MAUDE report 7301650 ↗
• DeathMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT CONGESTIVE HEART FAILURE WAS EXPERIENCED AND THE PATIENT DIED. IN (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) WITH 95 % STENOSIS AND WAS 14 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 16 MM PROMUS ELEMENT¿ PLUS STENT WITH 0 % RESIDUAL STENOSIS. FOURTEEN DAYS AFTER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2016, THE PATIENT WAS DIAGNOSED WITH CONGESTIVE HEART FAILURE AND WAS HOSPITALIZED ON THE SAME DAY. MEDICATION WAS GIVEN IN RESPONSE TO THE EVENT. NINE DAYS AFTER, THE EVENT WAS CONSIDERED AS RESOLVED AND WAS DISCHARGED ON ASPIRIN AND PRASUGREL. IN (B)(6) 2016, THE PATIENT WAS PRESENTED TO EMERGENCY DEPARTMENT (ED) WITH INCREASING SHORTNESS OF BREATH, SWELLING OF LEG, SLIGHT DECREASE IN URINE OUTPUT AND WAS DIAGNOSED WITH DECOMPENSATED HEART FAILURE. PATIENT'S B-TYPE NATRIURETIC PEPTIDE (BNP) WAS NOTED TO BE ELEVATED, CHEST X-RAY REVEALED SO

  Patient problems: Congestive Heart Failure; Death; Diaphoresis; Dyspnea; High Blood Pressure/ Hypertension; Low Blood Pressure/ Hypotension

  MAUDE report 6421352 ↗
• InjuryJan 20, 2017Occlusion Within Device; Occlusion Within Device

  (B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS (ISR), CHEST PAIN, AND MYOCARDIAL INFARCTION (MI) OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA AND CORONARY ANGIOGRAPHY WAS PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS AND WAS 100 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.4 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 16 MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT WITH 0% RESIDUAL STENOSIS. TWO DAYS LATER, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2016, THE PATIENT PRESENTED WITH COMPLAINTS OF SHORTNESS OF BREATH AND WAS HOSPITALIZED ON THE SAME DAY. EMERGENCY MEDICAL SERVICES (EMS) PLACED THE PATIENT ON BI-LEVEL POSITIVE AIRWAY PRESSURE (BIPAP) BUT THE PATIENT'S SATURATION DID NOT IMPROVE ABOVE 85. THE PATIENT WAS THEN INTUBATED ON VENTILATOR FOR RESPIRATORY DISTRESS. THE PATIENT WAS NOTED TO BE IN FLASH PULMONARY EDEMA, WAS TREATED, AND GOT EXTUBATED. ON THE SAME DAY, ELECTROCARDIOGRAM (EKG) REVEALED POSSIBLE LEFT ATRIAL ENLARGEMENT, SEPTAL MI OF INTERMEDIATE AGE, T-WAVE ABNORMALITY TO CONSIDER LATERAL ISCHEMIA,

  Patient problems: Chest Pain; Dyspnea; Myocardial Infarction; Non specific EKG/ECG Changes; Pulmonary Edema; Reocclusion; Respiratory Distress

  MAUDE report 6267771 ↗