PROMUS Element PlusRecalls & reported problems across all models
Boston Scientific Corporation · 44 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 90
- Deaths reported
- 51
- Injuries reported
- 39
- Recalls
- 0
We found 44 models of PROMUS Element Plus by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 90 adverse event reports in the FDA's MAUDE database, received between Nov 28, 2016 and Dec 12, 2018 — classified as 51 deaths, 39 injuries.
The most frequently reported specific device problem is “Occlusion Within Device” (47 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Most reported PROMUS Element Plus problems
Device problems
- Adverse Event Without Identified Device or Use Problem67
- Occlusion Within Device47
- Obstruction of Flow5
Patient problems
- Death51
- Thrombosis32
- Reocclusion27
- Myocardial Infarction22
- Chest Pain19
- Dyspnea18
- Angina17
- Congestive Heart Failure9
PROMUS Element Plus models
44 models, most reported first. Each model has its own page with its reports, recalls and device details.
- PROMUS Element™ Plus H7493911420300Coronary drug-eluting stent5 deaths8 reports
- PROMUS Element™ Plus H7493911428250Coronary drug-eluting stent3 deaths5 reports
- PROMUS Element™ Plus H7493911416300Coronary drug-eluting stent4 deaths5 reports
- PROMUS Element™ Plus H7493911412250Coronary drug-eluting stent3 deaths4 reports
- PROMUS Element™ Plus H7493911416250Coronary drug-eluting stent3 deaths4 reports
- PROMUS Element™ Plus H7493911432250Coronary drug-eluting stent4 reports
- PROMUS Element™ Plus H7493911416220Coronary drug-eluting stent3 deaths3 reports
- PROMUS Element™ Plus H7493911412270Coronary drug-eluting stent3 deaths3 reports
- PROMUS Element™ Plus H7493911428270Coronary drug-eluting stent1 death3 reports
- PROMUS Element™ Plus H7493911412300Coronary drug-eluting stent3 deaths3 reports
- PROMUS Element™ Plus H7493911412350Coronary drug-eluting stent3 deaths3 reports
- PROMUS Element™ Plus H7493911416350Coronary drug-eluting stent1 death3 reports
- PROMUS Element™ Plus H7493911420350Coronary drug-eluting stent1 death3 reports
- PROMUS Element™ Plus H7493911438270Coronary drug-eluting stent2 deaths3 reports
- PROMUS Element™ Plus H7493911412220Coronary drug-eluting stent1 death2 reports
- PROMUS Element™ Plus H7493911428220Coronary drug-eluting stent2 deaths2 reports
- PROMUS Element™ Plus H7493911408220Coronary drug-eluting stent1 death2 reports
- PROMUS Element™ Plus H7493911420270Coronary drug-eluting stent1 death2 reports
- PROMUS Element™ Plus H7493911428300Coronary drug-eluting stent2 deaths2 reports
- PROMUS Element™ Plus H7493911438350Coronary drug-eluting stent1 death2 reports
- PROMUS Element™ Plus H7493911612250Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911616250Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911620250Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911612270Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911628270Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911608300Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911616350Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911628350Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911420220Coronary drug-eluting stent1 death1 report
- PROMUS Element™ Plus H7493911432220Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911420250Coronary drug-eluting stent1 death1 report
- PROMUS Element™ Plus H7493911424250Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911408250Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911416270Coronary drug-eluting stent1 death1 report
- PROMUS Element™ Plus H7493911424270Coronary drug-eluting stent1 death1 report
- PROMUS Element™ Plus H7493911424350Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911428350Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911412400Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911416400Coronary drug-eluting stent1 death1 report
- PROMUS Element™ Plus H7493911408400Coronary drug-eluting stent1 death1 report
- PROMUS Element™ Plus H7493911432270Coronary drug-eluting stent1 report
- PROMUS Element™ Plus H7493911438250Coronary drug-eluting stent1 death1 report
- PROMUS Element™ Plus H7493911438300Coronary drug-eluting stent1 death1 report
- PROMUS Element™ Plus H7493911438400Coronary drug-eluting stent1 report
Recent PROMUS Element Plus adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathDec 12, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT CARDIAC ARREST OCCURRED AND PATIENT DIED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. THE PATIENT WAS FOUND TO HAVE ELEVATED BIOMARKERS WHICH EVIDENCES INDICATIVE OF ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION WHICH RESULTED TO 80% STENOSIS IN THE PROXIMAL OBTUSE MARGINAL (OB) AND INDEX PROCEDURE WAS PERFORMED. TARGET LESION WAS LOCATED IN THE 1ST OB MARGINAL WITH 70% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5X28MM STUDY STENT AND THE RESIDUAL STENOSIS WAS FOUND TO BE 1%. TWO DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, WHILE DIVING THE PATIENT WENT INTO CRA (CARDIAC RESPIRATORY ARREST). HE WAS GIVEN BASIC CARDIOPULMONARY RESUSCITATION (CPR) BY LIFEGUARDS FOR APPROXIMATELY 8 MINUTES. EMERGENCY MEDICAL SERVICES CONTINUED WITH ADVANCED CPR, FIRST HEART RATE WAS PULSELESS ELECTRICAL ACTIVITY. OROTRACHEAL INTUBATION WAS CONDUCTED WITH OROTRACHEAL TUBE CONDUCTED WITH OROTRACHEAL TUBE NUMBER 7 WITH FROVA ANTERIOR GLOTIC INTUBATION. AFTER 24 MIN OF CPR THE PATIENT
Patient problems: Death
MAUDE report 8155570 ↗DeathDec 5, 2018Obstruction of Flow; Obstruction of Flow
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS FOUND TO HAVE EVIDENCES OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION# 1 WAS LOCATED IN THE FIRST OBTUSE MARGINAL BRANCH SEGMENT WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00X12MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 5%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT SUDDENLY FELT SICK AND COLLAPSED. IN (B)(6) 2018, DURING THE FOLLOW-UP, THE PATIENT'S RELATIVE WAS CONTACTED AND WAS INFORMED ABOUT THE PATIENT'S SUDDEN DEATH. THE CAUSE OF DEATH WAS UNKNOWN AND IT WAS UNKNOWN IF THE AUTOPSY WAS PERFORMED OR NOT. THE ADJUDICATION INDICATED POSSIBLE STENT THROMBOSIS.
Patient problems: Death; Thrombosis
MAUDE report 8132750 ↗InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA WITH ISCHEMIA AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. ABNORMAL STRESS TEST OR IMAGING STRESS TEST INDICATED ISCHEMIA PRIOR TO PROCEDURE AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.38 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF A 3.00 X 20 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE PROXIMAL RCA WITH 98% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.38 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF A 3.50 X 32/38 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 86% STENOSIS AND WAS 34 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.47 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 32/38 MM STUDY STE
Patient problems: Angina; Ischemia; Reocclusion
MAUDE report 8009668 ↗InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED ANGINA WITH ISCHEMIA AND TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. ABNORMAL STRESS TEST OR IMAGING STRESS TEST INDICATED ISCHEMIA PRIOR TO PROCEDURE AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.38 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF A 3.00 X 20 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE PROXIMAL RCA WITH 98% STENOSIS AND WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.38 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND DEPLOYMENT OF A 3.50 X 32/38 MM STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 86% STENOSIS AND WAS 34 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.47 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 32/38 MM STUDY STE
Patient problems: Angina; Ischemia; Reocclusion
MAUDE report 8009663 ↗InjurySep 5, 2018Obstruction of Flow; Obstruction of Flow
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT UNSTABLE ANGINA AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS FOUND TO HAVE ABNORMAL STRESS TEST OR IMAGING STRESS TEST INDICATIVE OF ISCHEMIA AND THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 95% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50X20MM STENT, FOLLOWING POST DILATION THE RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT HAD PRESENTED FOR CARDIOVASCULAR CONSULTATION WITH THE COMPLAINT OF CHEST PAIN, SHORTNESS OF BREATH AND CHEST DISCOMFORT. THE PATIENT WAS REFERRED FOR CORONARY ANGIOGRAPHY FOR FURTHER EVALUATION AND MANAGEMENT. SEVEN DAYS LATER CORONARY ANGIOGRAPHY REVEALED 20% IN-STENT RESTENOSIS OF THE PREVIOUSLY PLACED STUDY STENT IN PROXIMAL PORTION, MINOR PLAQUING IN MID AND DISTAL PORTION; MINOR PLAQUING IN POS
Patient problems: Angina; Obstruction/Occlusion; Reocclusion
MAUDE report 7847957 ↗InjuryAug 24, 2018Obstruction of Flow; Obstruction of Flow
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA AND THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 70% STENOSIS AND WAS 8.00 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 12 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW 3. THE TARGET LESION #2 WAS LOCATED IN THE MID LAD WITH 90% STENOSIS AND WAS 14MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 20 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW 3. ON THE NEXT DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT WAS NOTED WITH MILD TO MODERATE RESTENOSIS AT THE OUTLET OF THE DISTAL LEFT ANTERIOR DESCENDING STUDY STENT. NO ACTION WAS TAKEN IN RESPONSE TO THE EVENT.
Patient problems: Reocclusion
MAUDE report 7812525 ↗DeathAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) CLINICAL STUDY IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(4) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS NOTED TO HAVE ELEVATED BIOMARKERS INDICATIVE OF ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE RAMUS WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5X20MM STUDY STENT WITH 5% RESIDUAL STENOSIS, AND TIMI 3 FLOW. THE TARGET LESION # 2 WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 70% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 28 MM STUDY STENT WITH 1% RESIDUAL STENOSIS AND TIMI 3 FLOW. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT WAS ADMITTED IN THE HOSPITAL. THREE DAYS LATER, THE PATIENT DIED DUE TO CARDIAC ARREST.
Patient problems: Cardiac Arrest; Death; Encephalopathy
MAUDE report 7807237 ↗DeathAug 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS UNSTABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS NOTED TO HAVE ELEVATED BIOMARKERS INDICATIVE OF ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION #1 WAS LOCATED IN THE RAMUS WITH 70% STENOSIS AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5X20MM STUDY STENT WITH 5% RESIDUAL STENOSIS, AND TIMI 3 FLOW. THE TARGET LESION # 2 WAS LOCATED IN THE 1ST OBTUSE MARGINAL WITH 70% STENOSIS AND WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 28 MM STUDY STENT WITH 1% RESIDUAL STENOSIS AND TIMI 3 FLOW. THREE DAYS LATER, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT WAS ADMITTED IN THE HOSPITAL. THREE DAYS LATER, THE PATIENT DIED DUE TO CARDIAC ARREST.
Patient problems: Cardiac Arrest; Death; Encephalopathy
MAUDE report 7806412 ↗DeathAug 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS FOUND TO HAVE EVIDENCES INDICATIVE OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE 1ST OBTUSE MARGINAL (OM) BRANCH WITH 90% STENOSIS AND WAS 15MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 12MM STUDY STENT FOLLOWED BY POST DILATION AND THE RESIDUAL STENOSIS WAS FOUND TO BE 5%. ON THE NEXT DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT DIED. THE CAUSE OF DEATH HAS BEEN REPORTED AS SUDDEN DEATH.
Patient problems: Death
MAUDE report 7802503 ↗InjuryAug 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT RESTENOSIS OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND ST-SEGMENT ELEVATION INFERIOR WALL MYOCARDIAL INFARCTION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION WAS A DE NOVO AND CULPRIT LESION FOR STEMI LOCATED IN MID RIGHT CORONARY ARTERY (RCA) WITH 99% STENOSIS AND TIMI FLOW 1. IT WAS 22MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.50MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING 2.5 X 20MM EMERGE BALLOON CATHETER AND A 3.0 X 20MM EMERGE BALLOON, FOLLOWED BY A 3.50 X 28MM PROMUS ELEMENT PLUS DRUG-ELUTING STENT, WHICH WAS PLACED WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. AFTER TWO DAYS, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2014, THE PATIENT PRESENTED IN CARDIOLOGY DEPARTMENT FOR FOLLOW-UP CARE WITH COMPLAINS OF CHEST PAIN IN THE MIDDLE OF THE CHEST WITH SOME RADIATION TOWARDS LEFT SHOULDER WITH EXERTION. THE PATIENT STATED THAT THE PAIN WAS NOTICED WHILE USING ARMS AND IT RESOLVED AFTER 1-2 MINUTES WITH REST. SUBSEQUENTLY, THE PATIENT WAS SCHEDULED FOR A LEFT HEART CATHETERIZATION ELEVEN DAYS LATER. THE 99% SEVERE SUBTOTAL PROXIMAL OCCLUSION LOCATED J
Patient problems: Reocclusion
MAUDE report 7764922 ↗InjuryJul 27, 2018Obstruction of Flow; Obstruction of Flow
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT PATIENT EXPERIENCED UNSTABLE ANGINA AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT INDICATED THAT THE PATIENT'S QUALIFYING CONDITION WAS STABLE ANGINA. PRIOR TO PROCEDURE, THE PATIENT WAS INDICATIVE OF ISCHEMIA AND THE PATIENT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND THE INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 90% STENOSIS AND WAS 8MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. TARGET LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50X12MM STUDY STENT. FOLLOWING POST- DILATION, THE RESIDUAL STENOSIS WAS 0%. ON THE NEXT DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2017, THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST PAIN. THE PATIENT WAS RECOMMENDED FOR A CARDIAC CATHETERIZATION ON A LATER DATE AND WAS ADVISED TO TAKE SUBLINGUAL NITROGLYCERIN IN CASE OF RECURRENT ACUTE CHEST PAIN. THREE DAYS AFTER, THE PATIENT PRESENTED FOR THE EVALUATION OF CHEST PAIN AND WAS HOSPITALIZED ON THE SAME DAY. THE 70-80% TUBULAR STENOSIS IN MID LAD AND 80% IN-STENT
Patient problems: Angina; Reocclusion
MAUDE report 7726672 ↗DeathApr 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT MYOCARDIAL INFARCTION OCCURRED AND THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 75% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 20 MM STUDY STENT AND THE RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2018, THE PATIENT PRESENTED WITH THE COMPLAINTS OF SHORTNESS OF BREATH FOR TWO WEEKS AND WAS HOSPITALIZED ON THE SAME DAY. CARDIAC ENZYMES WERE FOUND TO BE ELEVATED. ELECTROCARDIOGRAM (ECG) REVEALED A-V BLOCK, WIDE QRS INTERVALS WITH LEFT BUNDLE BRANCH BLOCK AND CT REVEALED PULMONARY EDEMA AND BILATERAL EFFUSIONS. CHEST X-RAY REVEALED BILATERAL PLEURAL EFFUSION AND BASILAR AIRSPACE DISEASE WITH STABLE HILAR AND PERIHILAR OPACITIES. THE PATIENT WAS DIAGNOSED WITH ACUTE ON CHRONIC COMBINED SYSTOLIC AND DIASTOLIC CONGESTIVE HEART FAILURE (CHF), ACUTE HYPOXIC RESPIRATORY FAILURE AND PULMONARY EDEMA. THE PATIENT WAS PLACED ON
Patient problems: Death; Dyspnea; Myocardial Infarction
MAUDE report 7465800 ↗DeathApr 18, 2018Obstruction of Flow; Adverse Event Without Identified Device or Use Problem; Obstruction of Flow; Adverse Event Without Identified Device or Use Problem
(B)(4) CLINICAL STUDY. IT WAS REPORTED THAT THE PATIENT DIED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, CORONARY ANGIOGRAPHY AND INDEX PROCEDURE WERE PERFORMED. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 50% STENOSIS AND WAS 12MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5MM. THE LESION WAS TREATED WITH DIRECT PLACEMENT OF A 2.25X16MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST DILATATION, THE RESIDUAL STENOSIS WAS 0% WITH TIMI 3 FLOW. ON THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR. IN (B)(6) 2017, THE PATIENT EXPIRED DUE TO UNKNOWN CAUSE OF DEATH.
Patient problems: Death; Thrombosis
MAUDE report 7441764 ↗InjuryApr 18, 2018Occlusion Within Device; Occlusion Within Device
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT CHEST PAIN AND IN-STENT RESTENOSIS (ISR) OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED DUE TO UNSTABLE ANGINA. SUBSEQUENTLY, THE PATIENT WAS REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION # 1 WAS A DE NOVO LONG LESION LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) AND EXTENDING TO MID RCA, WITH 90% STENOSIS AND WAS 38 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.00 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.75 X 38 MM PROMUS ELEMENT¿ PLUS DRUG-ELUTING STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. IN (B)(6) 2018, THE PATIENT PRESENTED WITH CHEST PAIN AND LOWER BACK PAIN AND DESCRIBES THE PAIN AS SHARP AND ACROSS CHEST. THE PATIENT REPORTED TO BE FALLING SHORT OF BREATH WHILE TALKING AND RATED THE PAIN TO BE 7-8 OUT OF 10 IN TERMS OF SEVERITY. THE SUBJECT IS ON HYDROCODONE WHICH HELPS TO DECREASE THE PAIN. THE ELECTROCARDIOGRAM REVEALED NORMAL SINUS RHYTHM WITH T WAVE INVERSION IN V5 AND V6. CHEST X-RAY DEMONSTRATED NO EVIDENCE OF ACUTE CARDIOPULMONARY DISEASE. POST ASSESSMENT, THE PATIENT WAS NOTED TO HAVE AN ELEVATED D-DIMER AND R
Patient problems: Chest Pain; Reocclusion
MAUDE report 7441371 ↗InjuryApr 9, 2018Occlusion Within Device; Occlusion Within Device
(B)(6) CLINICAL STUDY. IT WAS REPORTED THAT CHEST DISCOMFORT AND IN-STENT RESTENOSIS OCCURRED. IN (B)(6) 2013, THE SUBJECT PRESENTED WITH SILENT ISCHEMIA AND WAS DIAGNOSED WITH STABLE ANGINA. THE SUBJECT WAS THEN REFERRED FOR CARDIAC CATHETERIZATION AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE DISTAL LEFT CIRCUMFLEX ARTERY (LCX) WITH 80% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 16 MM PROMUS ELEMENT¿ PLUS STUDY STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2017, THE SUBJECT PRESENTED WITH PROGRESSIVE ACCELERATING EXERTIONAL CHEST DISCOMFORT. SUBSEQUENTLY, THE SUBJECT WAS HOSPITALIZED AND CORONARY ANGIOGRAPHY WAS PERMED WHICH REVEALED AN 80% IN-STENT RESTENOSIS (ISR) OF THE PREVIOUSLY IMPLANTED 2.50 X 16 MM PROMUS ELEMENT¿ PLUS STUDY STENT IN DISTAL LCX. THE STRESS TEST PERFORMED ON THE SAME DAY REVEALED DISTAL, ANTERIOR, APICAL AND POSTEROLATERAL LATERAL WALL ISCHEMIA. THE SUBJECT WAS HOSPITALIZED AND REFERRED FOR CARDIAC CATHETERIZATI
Patient problems: Angina; Chest Pain; Reocclusion
MAUDE report 7409162 ↗
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Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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