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 Problems Myocardial Infarction (1969); Unspecified Heart Problem (4454)

Event Date 09/04/2023

Event Type  Death  

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) hospital.E1 - initial reporter phone: (b)(6).

Event Description

Promus premier china registry.It was reported that the patient died.In (b)(6) 2018, the index procedure was performed.The target lesion was located in the middle right coronary (rca) artery extending up to distal rca with 90% stenosis and was 10 mm long, with a reference vessel diameter of 2.5mm.The target lesion was treated with pre-dilatation and placement of 2.50 mm x 12 mm promus premier stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Eight days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject died.No action was taken to treat the event and the primary cause of death is unknown.It is unknown if an autopsy was performed.It was further reported that the primary cause of death is myocardial infarction.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6).E1 - initial reporter phone: (b)(6).

Event Description

Promus premier china registry.It was reported that the patient died.In (b)(6) 2018, the index procedure was performed.The target lesion was located in the middle right coronary (rca) artery extending up to distal rca with 90% stenosis and was 10 mm long, with a reference vessel diameter of 2.5mm.The target lesion was treated with pre-dilatation and placement of 2.50 mm x 12 mm promus premier stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Eight days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject died.No action was taken to treat the event and the primary cause of death is unknown.It is unknown if an autopsy was performed.It was further reported that the primary cause of death is acute myocardial infarction (mi).The location of the mi was anterior (septal).It was further reported that a 2.5 mm x 32 mm promus premier stent was implanted at the index procedure in (b)(6) 2018.It was further reported that the patient died, and the primary cause of death is cardiogenic.

Manufacturer Narrative

E1 - initial reporter facility name: (b)(6) university.E1 - initial reporter phone: (b)(6).

Event Description

Promus premier china registry it was reported that the patient died.In september 2018, the index procedure was performed.The target lesion was located in the middle right coronary (rca) artery extending up to distal rca with 90% stenosis and was 10 mm long, with a reference vessel diameter of 2.5mm.The target lesion was treated with pre-dilatation and placement of 2.50 mm x 12 mm promus premier stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Eight days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2023, the subject died.No action was taken to treat the event and the primary cause of death is unknown.It is unknown if an autopsy was performed.It was further reported that the primary cause of death is acute myocardial infarction (mi).The location of the mi was anterior (septal).It was further reported that a 2.5 mm x 32 mm promus premier stent was implanted at the index procedure in (b)(6) 2018.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17980708
• MDR Text Key: 326232506
• Report Number: 2124215-2023-57019
• 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,Followup,Followup
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/04/2020
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0021601218
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2018
• 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): Death
• Patient Age: 62 YR
• Patient Sex: Male