MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROMUS ELEMENT PLUS; STENT, CORONARY, DRUG-ELUTING

Device Problem Obstruction of Flow (2423)

Patient Problem Myocardial Infarction (1969)

Event Date 03/05/2022

Event Type  Injury  

Event Description

Agent ide study: it was reported that in-stent restenosis occurred.On (b)(6)2012, four promus stents were implanted in the right coronary artery (rca).On (b)(6) 2021, during the index procedure to treat the left circumflex artery (lcx) a promus premier stent was also implanted in the rca.On (b)(6) 2022, the subject presented emergently with complaints of worsening substernal pressure like chest pain, radiating to left neck and jaw.Sublingual nitroglycerin was given, that mildly decreased the chest pain from 8/10 to 2/10, along with imdur, which was ongoing at the time of admission.On examination, the subject was having shortness of breath, nausea, diaphoresis and mild epigastric discomfort.The subject was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with chest pain with acute coronary syndrome and acute inferior st elevation myocardial infarction.The subject was on clopidogrel at the time of the event.Diagnostic coronary angiography revealed 60% stenosis at distal segment of the previously placed promus drug eluting stents implanted in the rca.The 99% in-stent restenosis in the proximal to distal lcx was treated with percutaneous coronary intervention.The event was considered recovered/resolved and the subject was discharged on clopidogrel.On (b)(6) 2022, the subject presented emergently with worsening chest pain, which was not relieved by nitroglycerin.It was reported that the subject had experienced palpitation episodes at home with heart rate ranging from 40-186.The subject was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with severe in-stent restenosis involving the mid to distal large lcx.The subject was diagnosed with myocardial infarction and revascularization was recommended.On examination, the subject was having chest pain, occasional diaphoresis and shortness of breath.Medication was changed from eliquis to lovenox for paroxysmal atrial fibrillation.On (b)(6) 2022, diagnostic coronary angiography revealed 15% stenosis at the ostial to distal segment of the previously placed promus stents implanted in the rca and 100% stenosis at the rpda.Restenosis in the distal lcx was treated with percutaneous coronary intervention.The event was considered resolved with sequelae and the subject was discharged on eliquis and brilinta.

• Brand Name: PROMUS ELEMENT PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; IC
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16292684
• MDR Text Key: 308734508
• Report Number: 2124215-2023-04240
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Race: White