SYNERGYRecalls & reported problems across all models
Boston Scientific Corporation · 74 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2,176
- Deaths reported
- 152
- Injuries reported
- 557
- Recalls
- 0
We found 74 models of SYNERGY by Boston Scientific Corporation in the FDA's device registry (GUDID). Together they are named in 2,176 adverse event reports in the FDA's MAUDE database, received between Nov 11, 2016 and Aug 11, 2025 — classified as 152 deaths, 557 injuries, 1,467 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (415 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
Reports received per month, all models
Most reported SYNERGY problems
Device problems
- Device Dislodged or Dislocated415
- Break408
- Bent332
- Material Deformation316
- Adverse Event Without Identified Device or Use Problem228
- Failure to Advance208
- Device Damaged Prior to Use139
- Difficult to Remove136
Patient problems
- No Consequences Or Impact To Patient1,195
- No Patient Involvement278
- Death138
- No Known Impact Or Consequence To Patient135
- Thrombosis129
- No Clinical Signs, Symptoms or Conditions117
- Chest Pain98
- Myocardial Infarction58
SYNERGY models
74 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SYNERGY™ H7493926038300Coronary drug-eluting stent8 deaths124 reports
- SYNERGY™ H7493926016300Coronary drug-eluting stent7 deaths106 reports
- SYNERGY™ H7493926020300Coronary drug-eluting stent9 deaths90 reports
- SYNERGY™ H7493926016250Coronary drug-eluting stent6 deaths82 reports
- SYNERGY™ H7493926024300Coronary drug-eluting stent3 deaths75 reports
- SYNERGY™ H7493926038250Coronary drug-eluting stent4 deaths73 reports
- SYNERGY™ H7493926012220Coronary drug-eluting stent6 deaths72 reports
- SYNERGY™ H7493926016350Coronary drug-eluting stent10 deaths70 reports
- SYNERGY™ H7493926012250Coronary drug-eluting stent4 deaths65 reports
- SYNERGY™ H7493926012300Coronary drug-eluting stent2 deaths65 reports
- SYNERGY™ H7493926016220Coronary drug-eluting stent6 deaths62 reports
- SYNERGY™ H7493926020250Coronary drug-eluting stent3 deaths62 reports
- SYNERGY™ H7493926028300Coronary drug-eluting stent3 deaths62 reports
- SYNERGY™ H7493926038350Coronary drug-eluting stent7 deaths59 reports
- SYNERGY™ H7493926024250Coronary drug-eluting stent5 deaths52 reports
- SYNERGY™ H7493926020400Coronary drug-eluting stent2 deaths49 reports
- SYNERGY™ H7493926020350Coronary drug-eluting stent3 deaths48 reports
- SYNERGY™ H7493926024400Coronary drug-eluting stent2 deaths47 reports
- SYNERGY™ H7493926028250Coronary drug-eluting stent5 deaths46 reports
- SYNERGY™ H7493926032300Coronary drug-eluting stent6 deaths45 reports
- SYNERGY™ H7493926038400Coronary drug-eluting stent1 death44 reports
- SYNERGY™ H7493926016400Coronary drug-eluting stent2 deaths43 reports
- SYNERGY™ H7493926028400Coronary drug-eluting stent41 reports
- SYNERGY™ H7493926024220Coronary drug-eluting stent1 death40 reports
- SYNERGY™ H7493926020220Coronary drug-eluting stent4 deaths39 reports
- SYNERGY™ H7493926028350Coronary drug-eluting stent38 reports
- SYNERGY™ H7493926032400Coronary drug-eluting stent1 death38 reports
- SYNERGY™ H7493926038220Coronary drug-eluting stent2 deaths37 reports
- SYNERGY™ H7493926012400Coronary drug-eluting stent3 deaths32 reports
- SYNERGY™ H7493926020270Coronary drug-eluting stent3 deaths32 reports
- SYNERGY™ H7493926012270Coronary drug-eluting stent1 death31 reports
- SYNERGY™ H7493926028220Coronary drug-eluting stent2 deaths30 reports
- SYNERGY™ H7493926032250Coronary drug-eluting stent2 deaths30 reports
- SYNERGY™ H7493926024350Coronary drug-eluting stent2 deaths29 reports
- SYNERGY™ H7493926016270Coronary drug-eluting stent1 death28 reports
- SYNERGY™ H7493926038270Coronary drug-eluting stent2 deaths28 reports
- SYNERGY™ H7493926012350Coronary drug-eluting stent5 deaths26 reports
- SYNERGY™ H7493926008250Coronary drug-eluting stent22 reports
- SYNERGY™ H7493926024270Coronary drug-eluting stent21 reports
- SYNERGY™ H7493926008300Coronary drug-eluting stent4 deaths20 reports
- SYNERGY™ H7493926032220Coronary drug-eluting stent20 reports
- SYNERGY™ H7493926008220Coronary drug-eluting stent1 death17 reports
- SYNERGY™ H7493926028270Coronary drug-eluting stent3 deaths17 reports
- SYNERGY™ H7493926032350Coronary drug-eluting stent16 reports
- SYNERGY™ H7493926008350Coronary drug-eluting stent3 deaths13 reports
- SYNERGY™ H7493926008400Coronary drug-eluting stent1 death13 reports
- SYNERGY™ H7493926032270Coronary drug-eluting stent1 death10 reports
- SYNERGY™ H7493926008270Coronary drug-eluting stent9 reports
- SYNERGY™ H7493926020450Coronary drug-eluting stent2 deaths7 reports
- SYNERGY™ H7493926016450Coronary drug-eluting stent2 deaths5 reports
- SYNERGY™ H7493926032450Coronary drug-eluting stent5 reports
- SYNERGY™ H7493926012500Coronary drug-eluting stent5 reports
- SYNERGY™ H7493926028450Coronary drug-eluting stent1 death4 reports
- SYNERGY™ H7493926020500Coronary drug-eluting stent4 reports
- SYNERGY™ H7493926024500Coronary drug-eluting stent3 reports
- SYNERGY™ H7493926108300Coronary drug-eluting stent2 reports
- SYNERGY™ H7493926112250Coronary drug-eluting stent2 reports
- SYNERGY™ H7493926116250Coronary drug-eluting stent2 reports
- SYNERGY™ H7493926012450Coronary drug-eluting stent2 reports
- SYNERGY™ H7493926024450Coronary drug-eluting stent2 reports
- SYNERGY™ H7493926028500Coronary drug-eluting stent2 reports
- SYNERGY™ H7493926112220Coronary drug-eluting stent1 report
- SYNERGY™ H7493926112270Coronary drug-eluting stent1 report
- SYNERGY™ H7493926112350Coronary drug-eluting stent1 report
- SYNERGY™ H7493926112400Coronary drug-eluting stent1 report
- SYNERGY™ H7493926116300Coronary drug-eluting stent1 report
- SYNERGY™ H7493926116400Coronary drug-eluting stent1 report
- SYNERGY™ H7493926120220Coronary drug-eluting stent1 report
- SYNERGY™ H7493926120270Coronary drug-eluting stent1 report
- SYNERGY™ H7493926120300Coronary drug-eluting stent1 report
- SYNERGY™ H7493926128250Coronary drug-eluting stent1 death1 report
- SYNERGY™ H7493926128400Coronary drug-eluting stent1 report
- SYNERGY™ H7493926132220Coronary drug-eluting stent1 report
- SYNERGY™ H7493926032500Coronary drug-eluting stent1 report
Recent SYNERGY adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
DeathAug 11, 2025Nonstandard Device; Off-Label Use; Failure to Advance; Defective Device; Nonstandard Device; Off-Label Use; Failure to Advance; Defective Device
IT WAS REPORTED THAT THE PATIENT DIED. TWO SYNERGY? 3.50 X 8 MM STENTS WERE IMPLANTED FOR TREATMENT OF A PATENT DUCTUS ARTERIOSUS (PDA). HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO FUNCTION AS INTENDED WHICH LED TO CARDIAC ARREST AND THE PATIENT DIED. IT WAS FURTHER REPORTED THAT THE PATIENT PRESENTED WITH A SMALL, SOMEWHAT TORTUOUS PDA TO CONFLUENT BRANCH PULMONARY ARTERIES. THE SYNERGY STENTS WERE SELECTED AS TREATMENT TO ALLOW FOR A STABLE SOURCE OF PULMONARY BLOOD FLOW. THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA AND ACCESS WAS OBTAINED VIA THE LEFT AXILLARY ARTERY. THE PDA WAS CROSSED WITH DIFFICULTY AND A SYNERGY? 3.50 X 12 MM WAS ADVANCED. THE STENT WAS UNABLE TO ADVANCE IT PAST THE PULMONARY END OF THE PDA. ANGIOGRAPHY SHOWED SPASM OF THE PDA WITH NO OPACIFICATION OF THE BRANCH PAS. THE PROXIMAL END OF THE STENT PROTRUDED SIGNIFICANTLY INTO THE AORTA. HIGH DOSE PROSTAGLANDIN E1 (PGE) INFUSION WAS INITIATED AND THE STENT WAS EXCHANGED FOR A SYNERGY? 3.50 X 8 MM. THE STENT WOULD ALSO NOT ADVANCE PAST THE PA END OF THE DUCTUS, BUT WAS DEPLOYED AT 16ATM IN HOPES OF EXPANDING THE PDA AND ALLOWING PGE FLOW TO REOPEN THE MORE DISTAL PDA. THE STENT WAS WELL EXPANDED, BU
Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Reduced Blood Flow; Respiratory Failure
MAUDE report 22773417 ↗InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT RESTENOSIS OCCURRED. ON (B)(6) 2019, A 2.50 MM X 20 MM SYNERGY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND A 3.00 MM X 20 MM SYNERGY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE PROXIMAL LAD. ON (B)(6) 2025, THE SUBJECT STARTED EXPERIENCING SYMPTOMS ASSOCIATED WITH UNSTABLE ANGINA. AT THE TIME OF THE EVENT THE SUBJECT WAS ON ASPIRIN AND TICAGRELOR. CORONARY ANGIOGRAPHY REVEALED 50 TO 60% IN STENT RESTENOSIS (ISR) AT THE LAD. ON (B)(6) 2025, THE SUBJECT WAS DIAGNOSED WITH UNSTABLE ANGINA AND WAS ADMITTED TO HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. TTE REVEALED 50-55% LVEF. ON (B)(6) 2025, THE 100% STENOSIS AT THE LEFT MAIN WAS TREATED WITH A DES AND BALLOON ANGIOPLASTY CATHETER. TARGET VESSEL REVASCULARIZATION WAS ALSO PERFORMED AND THE LEFT CIRCUMFLEX ARTERY WAS STENTED. POST REVASCULARIZATION, THE RESIDUAL STENOSIS WAS 0% AND TIMI FLOW WAS 3. THE EVENT WAS CONSIDERED AS RESOLVED AND SUBJECT WAS DISCHARGED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, THE SUBJECT STARTED EXPERIENCING SYMPTOMS ASSOCIATED WITH CHEST PAIN. ON (B)(6) 2025, THE SUBJECT PRESENTED TO HOSPITAL WITH CHEST PAIN AND WAS HOSPITALIZED F
Patient problems: Angina; Chest Pain; Myocardial Infarction; Restenosis
MAUDE report 21933308 ↗InjuryApr 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT UNSTABLE ANGINA OCCURRED. ON (B)(6) 2019, A 2.50 MM X 20 MM SYNERGY DRUG ELUTING STENT (DES) WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD). ADDITIONALLY, A 3 X 20 MM SYNERGY STENT WAS IMPLANTED IN PROXIMAL LAD. ON (B)(6) 2021, THE PATENT PRESENTED WITH UNSTABLE ANGINA. THE TARGET LESION WAS LOCATED AT THE MID LAD AND WAS 15 MM LONG WITH A REFERENCE VESSEL DIAMETER WAS 3.0 MM. THE TARGET LESION WAS PREDILATED WITH A 2.5 MM X 20 MM BALLOON ANGIOPLASTY CATHETER AND LASER CATHETER, RESULTING INTO 0% RESIDUAL STENOSIS AND TIMI FLOW OF 3. FOLLOWING PRE-DILATION, THE LESION WAS TREATED WITH A 3.00 MM X 20 MM AGENT DCB STUDY DEVICE SUCCESSFULLY WITH 0% RESIDUAL STENOSIS AND TIMI FLOW OF 3. THE PATIENT WAS DISCHARGED ON ASPIRIN AND TICAGRELOR.
Patient problems: Angina; Restenosis
MAUDE report 21930148 ↗DeathApr 18, 2025Nonstandard Device; Off-Label Use; Defective Device; Nonstandard Device; Off-Label Use; Defective Device
IT WAS REPORTED THAT THE PATIENT DIED. A SYNERGY? 3.50 X 8 WAS ADVANCED FOR TREATMENT OF A PATENT DUCTUS ARTERIOSUS (PDA). HOWEVER, DURING THE PROCEDURE, THE DEVICE FAILED TO FUNCTION AS INTENDED WHICH LED TO CARDIAC ARREST AND THE PATIENT DIED.
Patient problems: Bradycardia; Cardiac Arrest; Low Blood Pressure/ Hypotension; Reduced Blood Flow; Respiratory Failure
MAUDE report 21869018 ↗MalfunctionDec 9, 2024Migration; Failure to Deflate; Migration; Failure to Deflate
IT WAS REPORTED THAT DEFLATION ISSUES OCCURRED. UPON DEPLOYMENT OF A 5.0 X 20 SYNERGY DRUG-ELUTING STENT AT THE PROXIMAL SEGMENT OF THE RIGHT RENAL ARTERY, IT WAS OBSERVED THAT THE STENT BALLOON DID NOT FULLY DEFLATE, ONLY THE PROXIMAL PART DEFLATED. THE DELIVERY SYSTEM WAS REMOVED BUT THIS PARTIAL DEFLATION RESULTED IN A SEGMENT OF THE STENT BEING INADVERTENTLY PULLED INTO THE AORTA. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ALTERNATIVE DEVICE, AND NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20880858 ↗MalfunctionNov 26, 2024Break; Break
IT WAS REPORTED THAT SHAFT BREAK OCCURRED. A 4.50MM X 20MM SYNERGY II DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT. HOWEVER, DURING THE PROCEDURE, THE SHAFT OF THE STENT SYSTEM BROKE IN HALF. THE PHYSICIAN TOOK THE STENT OUT AND GOT A DIFFERENT ONE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20785325 ↗InjurySep 20, 2023Obstruction of Flow; Obstruction of Flow
EVOLVE_LV_CLV CLINICAL STUD. IT WAS REPORTED THAT MYOCARDIAL INFARCTION AND IN-STENT RESTENOSIS (ISR) OCCURRED. ON (B)(6) 2021, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE TARGET LESION WAS LOCATED IN THE PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 80% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 5.3 MM AND TIMI FLOW OF 3. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF A 4.00 MM X 20 MM STUDY STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS 0% WITH TIMI FLOW OF 3. IN ADDITION, A NON-TARGET LESION LOCATED IN MID LAD EXTENDING TO DISTAL LAD WAS TREATED WITH PLACEMENT OF A 2.50 MM X 16 MM SYNERGY DRUG ELUTING STENT (DES). A SECOND NON-TARGET LESION LOCATED IN 1ST DIAGONAL ARTERY WAS TREATED WITH A 2.25 MM X 12 MM SYNERGY DES. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2023, THE SUBJECT PRESENTED IN THE EMERGENCY DEPARTMENT (ED) WITH PRESSURE-LIKE SUBSTERNAL CHEST PAIN RADIATING TO BILATERAL ARMS AND LASTING 40 MINUTES IN DURATION WITH ASSOCIATED SHORTNESS OF BREATH. THE SUBJECT TOOK NITROGLYCERINE WHICH DID NOT PROVIDE COMPLETE PAIN RELIEF AND PARAMEDICS HAD GIVEN THE
Patient problems: Dyspnea; Myocardial Infarction; Restenosis
MAUDE report 17780482 ↗DeathDec 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EVOLVE LV_XLV STUDY: IT WAS REPORTED THAT THE SUBJECT DIED. IN OCTOBER 2020, THE SUBJECT WAS ENROLLED IN THE CLINICAL STUDY AND ON THE SAME DAY INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS LOCATED IN THE SAPHENOUS VEIN GRAFT (SVG) TO THE RIGHT CORONARY ARTERY (RCA) WITH 75% STENOSED LESION AND WAS 16 MM LONG WITH A DISTAL VESSEL DIAMETER OF 4.5 MM AND TIMI FLOW OF 3. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF 4.50 MM X 16 MM STUDY STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW OF 3. ON THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN DECEMBER 2021, THE SUBJECT EXPIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15916109 ↗MalfunctionDec 2, 2022Failure to Advance; Device Dislodged or Dislocated; Failure to Advance; Device Dislodged or Dislocated
IT WAS REPORTED THAT STENT DISLODGMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A CALCIFIED VESSEL. A 3.00 X 38 SYNERGY DRUG-ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, DURING THE PROCEDURE, THE STENT CAME OFF AND FAILED TO CROSS THE LESION. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15906308 ↗DeathOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
EVOLVE LV XLV STUDY. IT WAS REPORTED THAT THE SUBJECT DIED. IN (B)(6) 2020, THE SUBJECT WAS REFERRED FOR CARDIAC CATHETERIZATION AND ON THE SAME DAY INDEX PROCEDURE WAS PERFORMED. THE 80% STENOSED, 4.50 X 16MM, TARGET LESION WAS LOCATED IN PROXIMAL LEFT CIRCUMFLEX ARTERY (LCX) AND HAD TIMI FLOW OF 2. THE TARGET LESION WAS TREATED WITH PRE-DILATION AND PLACEMENT OF 4.50 MM X 16 MM STUDY STENT. FOLLOWING POST-DILATION, RESIDUAL STENOSIS WAS NOTED TO BE 0% WITH TIMI FLOW OF 3. ON THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. ON AN UNKNOWN DATE, THE SUBJECT EXPIRED. DURING THE SCHEDULING OF THE TWO-YEAR STUDY SPECIFIC FOLLOW UP, THE SITE HAD CONTACTED THE SUBJECT'S SON AND WAS INFORMED THAT THE SUBJECT HAD ORAL CANCER AND EXPIRED AROUND 2 MONTHS PREVIOUSLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15621603 ↗MalfunctionJul 14, 2022Device Dislodged or Dislocated; Material Deformation; Device Dislodged or Dislocated; Material Deformation
IT WAS REPORTED THAT MOVED ON BALLOON OCCURRED. DURING PREPARATION OF A 2.25 X 20 SYNERGY DRUG-ELUTING STENT, THE PHYSICIAN NOTICED A KINK IN THE DELIVERY SYSTEM CLOSE TO STENT AND THE STENT APPEARED TO BE LOSE ON THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH A NEW STENT. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15016202 ↗MalfunctionJul 14, 2022Failure to Advance; Material Deformation; Failure to Advance; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. A 3.00 X 32 SYNERGY DRUG-ELUTING STENT WAS ADVANCED FOR TREATMENT. HOWEVER, IT WAS NOTICED THE STENT BUCKLED BACK ON ITSELF WHEN IT WAS INSERTED INTO THE GUIDE AND THE DEVICE FAILED TO CROSS THE LESION. NO PATIENT COMPLICATIONS WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15016183 ↗MalfunctionJul 7, 2022Material Deformation; Material Deformation
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED DISTAL RIGHT CORONARY ARTERY. AFTER PRE-TREATING THE LESION WITH A ROTABLATOR, A 3.00 X 38 SYNERGY II DRUG ELUTING STENT WAS INSERTED TO TREAT THE LESION. HOWEVER, THE STENT STRUTS WERE DAMAGED. THE DEVICE WAS REMOVED INTACT AND IT WAS FOUND THAT THE DISTAL EDGE WAS CRIMPED ON THE BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14947147 ↗InjuryJul 5, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT STENT OBSTRUCTION AND HEART FAILURE OCCURRED. ON (B)(6) 2020, TWO 4.00 X 28 SYNERGY II DRUG-ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). LESS THAN A MONTH AGO, THE PATIENT WAS VERY SICK AND VISITED THE HOSPITAL TO CHECK ON THE STENTS. IT WAS NOTED THAT BOTH STENTS HAD COLLAPSED AND THE PATIENT WAS IN FULL CONGESTIVE HEART FAILURE.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 14917379 ↗InjuryJul 5, 2022Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT STENT OBSTRUCTION AND HEART FAILURE OCCURRED. ON (B)(6) 2020, TWO 4.00 X 28 SYNERGY II DRUG-ELUTING STENTS WERE IMPLANTED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). LESS THAN A MONTH AGO, THE PATIENT WAS VERY SICK AND VISITED THE HOSPITAL TO CHECK ON THE STENTS. IT WAS NOTED THAT BOTH STENTS HAD COLLAPSED AND THE PATIENT WAS IN FULL CONGESTIVE HEART FAILURE.
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 14917359 ↗
Other Boston Scientific Corporation products
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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