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

Model Number	9576
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Angina (1710); High Blood Pressure/ Hypertension (1908); Myocardial Infarction (1969); Restenosis (4576)
Date of Event	09/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that restenosis occurred.On (b)(6) 2018, the patient presented with unstable angina.Coronary angiography revealed a bifurcated mid left anterior descending artery (lad) with 80-90% disease.The target lesion was directly stented with a 16 x 2.50 promus premier drug eluting stent resulting in 0% residual stenosis.The patient was stable and discharged on dual antiplatelet treatment.On (b)(6) 2023, the patient presented with unstable angina, experiencing left-sided chest pain radiating into the left shoulder and down the left arm for 2 days.Heparin drip was started, and the patient was stable, and their pain was resolved.The patient was diagnosed with non-st-elevation myocardial infraction and hypertension.Vascular access was obtained via the right femoral artery.Angiography revealed 99% in-stent restenosis of the previously deployed promus premier drug eluting stent.Following pre-dilation with a 2.00 x 12 emerge balloon, successful angioplasty was performed using a 2.75 x 22 non-bsc drug eluting stent.Following post dilation there was no residual stenosis.The patient became severely nauseated and hypertensive possibly due to a contrast allergy and was given medication.The patient felt better and was discharged on aspirin and statin therapy.

• Brand Name: PROMUS PREMIER
• Common Device Name: 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: 17924951
• Report Number: 2124215-2023-56641
• Device Sequence Number: 19576121
• Product Code: NIQ
• UDI-Device Identifier: 08714729828860
• UDI-Public: 08714729828860
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/08/2018
• Device Model Number: 9576
• Device Catalogue Number: 9576
• Device Lot Number: 0020544881
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDTRONIC: 2.75 X 22 RESOLUTE ONYX STENT; TERUMO: RUNTHROUGH 6F GUIDE CATHETER
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Patient Race: White