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 Problem Atrial Flutter (1730)

Event Date 10/28/2018

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

(b)(6) clinical study.It was reported that the patient experienced atrial flutter.In (b)(6) 2018, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the proximal circumflex (cx) to distal cx with 95% stenosis and was 73mm long, with a reference vessel diameter of 3.5mm.The target lesion #1 was treated with pre-dilatation and placement of a 3.50mm x 24mm promus premier stent.Following this intervention, post dilatation was performed with post procedural stenosis of 0%.The study stent was overlapped with a non-bsc stent.Eight days later, the patient was discharged.In (b)(6) 2018, the patient was diagnosed with atrial flutter.The event resulted in life threatening illness or injury and was considered recovering/resolving.

Event Description

Promus premier china clinical study.It was reported that the patient experienced atrial flutter.In (b)(6) 2018, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the proximal circumflex (cx) to distal cx with 95% stenosis and was 73mm long, with a reference vessel diameter of 3.5mm.The target lesion #1 was treated with pre-dilatation and placement of a 3.50mm x 24mm promus premier stent.Following this intervention, post dilatation was performed with post procedural stenosis of 0%.The study stent was overlapped with a non-bsc stent.Eight days later, the patient was discharged.In (b)(6) 2018, the patient was diagnosed with atrial flutter.The event resulted in life threatening illness or injury and was considered recovering/resolving.Previously it was reported that the lesion length was 73mm.Now, it is reported that the length was 69mm long.

Manufacturer Narrative

Device is combination product.Corrections b5: previously it was reported that the lesion length was 73mm.Now, it is reported that the length was 69mm long.

Event Description

Promus premier china clinical study it was reported that the patient experienced atrial flutter.In (b)(6) 2018, the patient was referred for cardiac catheterization and the index procedure was performed on the same day.The target lesion #1 was located in the proximal circumflex (cx) to distal cx with 95% stenosis and was 73mm long, with a reference vessel diameter of 3.5mm.The target lesion #1 was treated with pre-dilatation and placement of a 3.50mm x 24mm promus premier stent.Following this intervention, post dilatation was performed with post procedural stenosis of 0%.The study stent was overlapped with a non-bsc stent.Eight days later, the patient was discharged.In (b)(6) 2018, the patient was diagnosed with atrial flutter.The event resulted in life threatening illness or injury and was considered recovering/resolving.Previously it was reported that the lesion length was 73mm.Now, it is reported that the length was 69mm long.It was further reported that the patient presented myocardial infarction on the same day index procedure was performed and the patient received heparin or other anti-thrombin.Also, two additional non study drug eluting stents were placed.Three days post index procedure, the patient was noted with unknown symptoms and was diagnosed with atrial flutter that was treated with medication.In (b)(6) 2018, the patient was discharged on aspirin and clopidogrel.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8274170
• MDR Text Key: 133980555
• Report Number: 2134265-2019-00332
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 09/02/2020

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: 02/20/2020
• Device Model Number: 9551
• Device Catalogue Number: 9551
• Device Lot Number: 0021818603
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 03/26/2020; 08/14/2020
• Supplement Dates FDA Received: 04/16/2020; 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR