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

Model Number 9549

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2022

Event Type  Death  

Event Description

Promus premier china registry it was reported that the patient died.In (b)(6) 2018, the subject was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the mid left anterior descending (lad) artery with 100% stenosis and was 12 mm long with a reference vessel diameter of 2.5 mm.The target lesion #1 was treated with pre-dilatation and placement of a 2.50 mm x 16 mm promus premier stent system.Post-dilatation was not performed, and the residual stenosis was 0%.Seven days later, the subject was discharged on aspirin and clopidogrel.On an unknown date in (b)(6) 2022, the subject died.The primary cause of death is unknown.It is unknown if an autopsy was performed.

Manufacturer Narrative

Date of death: (b)(6) 2022.Date of event: used (b)(6) 2022 as event date as the date was not provided.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16064318
• MDR Text Key: 306296205
• Report Number: 2124215-2022-53731
• 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: 12/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2019
• Device Model Number: 9549
• Device Catalogue Number: 9549
• Device Lot Number: 0020749768
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2017
• 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): Death
• Patient Age: 57 YR
• Patient Sex: Male