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

Model Number 9554

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

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

Event Date 11/08/2023

Event Type  Death  

Event Description

Promus premier china registry.It was reported that the patient died.In (b)(6) 2019, the subject was referred for cardiac catheterization.The target lesion 1 was located in the proximal right coronary artery (rca) with 100% stenosis and was 34 mm long, with a reference vessel diameter of 2.75 mm.The target lesion 1 was treated with pre-dilation and followed by the placement of a 2.75 mm x 38 mm promus premier stent system.Following post-dilatation, the residual stenosis was noted to be 10%.In (b)(6) 2019, the subject was discharged on aspirin, clopidogrel and other.In (b)(6) 2023, the subject died.At the time of event the subject was on aspirin and clopidogrel.The primary cause of death is unknown.No action was taken to treat the event and it is unknown if an autopsy was performed.

Manufacturer Narrative

E1.Initial reporter phone: (b)(6).E1.Initial reporter fax: (b)(6).

• 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: 19195665
• MDR Text Key: 341189526
• Report Number: 2124215-2024-25442
• 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: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2019
• Device Model Number: 9554
• Device Catalogue Number: 9554
• Device Lot Number: 0021248103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2017
• 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: 75 YR
• Patient Sex: Male