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

Model Number 9553

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Restenosis (4576)

Event Date 05/26/2021

Event Type  Injury  

Event Description

(b)(6) registry.It was reported that angina and restenosis occurred.In (b)(6) 2019, 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 proximal right coronary artery (rca) extending up to mid rca with 85% stenosis and was 64 mm long, with a reference vessel diameter of 3.5 mm.The lesion was treated with pre-dilatation and placement of a 3.50 mm x 38 mm and a 3.50 mm x 32 mm promus premier stent systems.Following this, post-dilatation was performed with residual stenosis as 10%.Seven days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2021, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further evaluation and treatment.On the following day, the subject was referred for coronary angiography which revealed 60% stenosis in mid rca which had previously placed study device was treated with percutaneous coronary balloon dilatation (tvr) and percutaneous coronary intervention (pci).Post intervention, residual stenosis was 10%.The rationale of intervention was angina.Two days later, the event was recovered and resolved and, on the same day, the subject was discharged on aspirin and clopidogrel.

Manufacturer Narrative

Corrected: h6 - device codes: corrected to (a1409) obstruction of flow.

Event Description

Promus premier china registry.It was reported that angina and restenosis occurred.In march 2019, 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 proximal right coronary artery (rca) extending up to mid rca with 85% stenosis and was 64 mm long, with a reference vessel diameter of 3.5 mm.The lesion was treated with pre-dilatation and placement of a 3.50 mm x 38 mm and 3.50 mm x 32 mm promus premier stent systems.Following this, post-dilatation was performed with residual stenosis as 10%.Seven days later, the subject was discharged on aspirin and clopidogrel.In may 2021, the subject was diagnosed with unstable angina pectoris and was hospitalized on the same day for further evaluation and treatment.On the following day, the subject was referred for coronary angiography which revealed 60% stenosis in mid rca which had previously placed study device was treated with percutaneous coronary balloon dilatation (tvr) and percutaneous coronary intervention (pci).Post intervention, residual stenosis was 10%.The rationale of intervention was angina.Two days later, the event was recovered and resolved and, on the same day, the subject 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: 12471458
• MDR Text Key: 271464605
• Report Number: 2134265-2021-11025
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: 9553
• Device Catalogue Number: 9553
• Device Lot Number: 0022322444
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 68 YR