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

Device Problem Activation Failure (3270)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 04/01/2022

Event Type  Injury  

Event Description

Agent ide study.It was reported that in-stent restenosis (isr) and angina occurred.On (b)(6) 2013, the proximal left anterior descending artery (lad) was treated with a 3.50 x 16 promus premier drug eluting stent (des) and on an unknown date, stenosis at the mid lad was treated with a 2.75 mm x 16 mm promus premier des.On (b)(6) 2022, the subject presented with stable angina and was referred for the agent ide study.On (b)(6) 2022, coronary angiography revealed severe isr at the proximal lad extending up to the diagonal, previously treated with the 2.75 mm x 16 mm promus des at the mid lad and the 3.5 mm x 16 mm promus des at the proximal lad.There was also 85% isr at the proximal to mid lad and 100% stenosis from the mid to distal lad.Intravascular ultrasound revealed inadequate expansion of the stents at the lad extending up to the diagonal.The target lesion was located at the proximal lad extending to the 2nd diagonal and was 20.0 mm long with a reference vessel diameter of 3.0 mm.The target lesion was predilated with a 3,00 mm x 20 mm balloon angioplasty catheter and shockwave lithotripsy.Following pre-dilation, the lesion was successfully treated with a 3.00 mm x 30 mm study device with 5% residual stenosis and timi flow of 3.The subject was on aspirin and ticagrelor.One day later the subject was noted with elevated troponin levels and was diagnosed with myocardial infarction.The subject was stable the same day and discharged on aspirin and ticagrelor.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18476955
• MDR Text Key: 332490700
• Report Number: 2124215-2023-75700
• 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: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• 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: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female