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

Model Number 9551

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Non specific EKG/ECG Changes (1817); Thrombosis/Thrombus (4440)

Event Date 01/21/2024

Event Type  Injury  

Event Description

It was reported that stent thrombosis occurred requiring additional intervention.Patient presented with chest pain.A lesion in the left anterior descending artery (lad) was revealed via angiogram.A 2.75 x 38 mm promus premier and 3.00 x 24 mm promus premier were deployed overlapping at the lesion site.Within 10 hours, the patient experienced severe chest pain and changes in the electrocardiogram (ecg).Angiogram revealed stent thrombosis in the lad and no flow from middle to distal lad.An additional drug eluting stent was deployed in the distal mid lad bailing out the stent thrombosis.The patient was admitted to the hospital and is expected to fully recover.

Event Description

It was reported that stent thrombosis occurred requiring additional intervention.Patient presented with chest pain.A lesion in the left anterior descending artery (lad) was revealed via angiogram.A 2.75 x 38 mm promus premier and 3.00 x 24 mm promus premier were deployed overlapping at the lesion site.Within 10 hours, the patient experienced severe chest pain and changes in the electrocardiogram (ecg).Angiogram revealed stent thrombosis in the lad and no flow from middle to distal lad.An additional drug eluting stent was deployed in the distal mid lad bailing out the stent thrombosis.The patient was admitted to the hospital and is expected to fully recover.It was further reported that the patient was stable and fully recovered after procedure and discharged from the hospital.

• 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: 18688155
• MDR Text Key: 335151701
• Report Number: 2124215-2024-08059
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0031194779
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2023
• 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 Race: Asian