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

Model Number 9553

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

Patient Problem Myocardial Infarction (1969)

Event Date 10/19/2021

Event Type  Death  

Event Description

Promus premier (b)(6) registry it was reported that the patient died.In (b)(6) 2019, the subject presented with unstable angina and was referred for cardiac catheterization.The index procedure was performed on the same day.The target lesion 1 was located in the left main coronary artery (lmca) extending up to mid left anterior descending (lad) artery with 80% stenosis and was 44 mm long, with a reference vessel diameter of 3.05 mm.The target lesion 1 was treated with pre-dilatation and placement of a 3.50 mm x 32 mm and 2.75 mm x 16 mm promus premier stents system.Following post-dilatation, the residual stenosis was 0%.Three days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2021, the subject was diagnosed with acute myocardial infarction and hospitalized on the same day for further evaluation and treatment.Medication was given to treat the event.Four days later, the subject died and the primary cause of death was acute myocardial infarction (mi).It is unknown if an autopsy was performed.

• Brand Name: PROMUS PREMIER
• 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 ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14182287
• MDR Text Key: 289853128
• Report Number: 2134265-2022-04114
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2020
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0022607654
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2018
• 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; Death; Other
• Patient Age: 59 YR
• Patient Sex: Female